CN1842319A - Dye composition and method for detection of demineralized lesions in teeth - Google Patents

Abstract

The present invention relates to an oral care dye composition for detection of demineralization lesions comprising: a first phase (or first composition) comprising from about 0.1% to about 10% by weight of the composition of a blue dye and mixtures thereof; a second phase (or second composition) comprising from about 0.1% to about 10% by weight of the composition of a red dye or a yellow dye or mixtures thereof; a safe and effective amount of a solvent wherein the dye is soluble in the solvent; and optionally a safe and effective amount of a flavor; wherein the composition is effective for detection of demineralized lesions. The present invention further relates to method of visually highlighting demineralization lesions, in tooth surfaces, or a method of detecting the mineralization health of teeth, wherein the above dye composition is applied to the oral cavity or to the teeth, of a human or animal subject, in need thereof. In one embodiment a first dye composition and a second dye composition are applied, sequentially, to a human or animal subject's oral cavity or teeth, in need thereof, wherein after the dye compositions are applied, the teeth are visually observed to assess demineralized lesions stained by the dyes.

Description

The inspection method of dye composite and the infringement of tooth demineraliting

The present patent application requirement has all authority of the U.S. Provisional Patent Application 60/502,152 of JIUYUE in 2003 proposition on the 11st.

Technical field

The present invention relates to a kind of method of checking the demineraliting infringement.The present invention also relates to comprise indigo plant and compositions red or the yellow dye system, in order to check that the demineraliting infringement is as early stage caries infringement (for example white macula), carious lesions, teeth corrosion and/or just abnormal inductive demineraliting through selecting.

Background technology

Although the dental caries sickness rate is 40 years existing declines in inherent a plurality of areas in the past, worldwide, dental caries is still general disease, and it is the main cause that causes the tooth loss.Fluoride is fluoridized water and is fluoridized dentifrice and be provided by public, and it has been proved to be the corrosive most economical effective public health mechanism of prophylaxis of teeth.Yet the acquisition of fluoride is still worldwide problem.In the U.S., fluoridizing in 1945 of public drinking water just begins, but still has high colony to 40% significant proportion not obtain having the drinking water of the fluoride of optimum content.Can further cause the development of demineraliting infringement and dominance dental caries in addition to the too much dietary intake of sugar and bad oral sanitary habit.Thereby worldwide dental caries sickness rate is still significantly.

Prior art proposes to use the vision haptic methods, uses some dyestuff and X ray to check carious lesions.For example, in below with reference to document, come into question via the dental caries inspection of using dyestuff to carry out: US6,084,005, people such as Fukunishi are published on July 4th, 2000 (help holing and between convalescent period tooth infect removing of part); US 4,347,233, and people such as Yamauchi are published in August 31 nineteen eighty-two (propose using the part of dyestuff with the caries infection of distinguishing healthy tooth and tooth); With Caries detector dyes-An in vitro assessment of somenew compounds, people such as Ansari, J.of Oral Rehabilitation, the 1999,26, the 453rd to 458 pages (dyestuff lacks specificity as the dental caries detector).

Dental professional also can use visible sensation method, haptic methods and X ray to help to check carious lesions in dentist's office.

All these instruments (comprise and use dyestuff) all lack specificity, are difficult to discern the early symptom such as the white macula of demineraliting infringement and demineraliting infringement, also lack the caries infection specificity partly that is enough to distinguish healthy tooth and tooth.Also needing a kind ofly provides safer diagnostic method to substitute the use of X ray in the dental caries inspection.Therefore, not only need the prevention of dental caries or treatment product and the processing method that improve, but also need optionally to check the diagnostic method of demineraliting infringement.

The invention provides a kind of easy, rapidly and also not expensive inspection tooth " mineral nitrogen health " or demineraliting degree methods.The process that individual physical ability uses the present invention to handle with more frequent monitoring Remineralization as the autognostic instrument comprises the dentifrice of fluoride or the oral sanitary habit of improvement as use.In case demineraliting is found, and after using the Remineralization agent to handle, individual physical ability reuses the present invention handles back tooth Remineralization with required frequency monitoring situation.Because the present invention is easy to use and is also not expensive, the monitoring process that individual physical ability is more frequent is especially when significant demineraliting exists.In addition, the early stage caries infringement is checked and is made that using the Remineralization agent to carry out early time treatment becomes possibility, is possible at this stage reverse demineraliting or Remineralization.The early stage caries inspection makes processing more early to begin.If the degree of demineraliting is not too serious, use the Remineralization agent infringement to be handled the formation that can stop the dominance dental caries.If thereby become in infringement and to begin before irreversible to handle, just can minimize or avoid holing, dental tissue remove and damage filling (for example repairing).

In addition, the present invention can instruct dental professional to determine to remove and recover how many dental tissues during repairing, and avoids removing the tooth health part.

The present invention is safer, more economical, because it only needs visual observation, does not need to use the enhancing light source of laser, other type or X ray to highlight the demineraliting infringement.

Summary of the invention

The present invention relates in order to check the mouth care dye composite of demineraliting infringement, said composition comprises: first phase (or first compositions) comprises by the blue dyestuff of the weight of compositions about 0.1% to about 10% or their mixture; Second phase (or second compositions) comprises red or yellow dye or their mixture by the weight of compositions about 0.1% to about 10%; The solvent of safe and effective amount, wherein dye soluble is separated in solvent; Flavoring agent with the safe and effective amount of choosing wantonly; Wherein compositions is effective to the inspection of demineraliting infringement.The invention further relates to the method for the demineraliting infringement that visually highlights dental surface or the method for inspection tooth mineral nitrogen health, wherein above-mentioned dye composite is applied to the human or animal patient's who needs them oral cavity or tooth.In one embodiment, first dye composite and second dye composite are administered in regular turn the human or animal patient's who needs them oral cavity or tooth.After dye composite is applied, to tooth observe with the assessment dyestuff demineraliting is damaged painted effect.

Summary of drawings

Though by particularly pointing out and clearly claimed claim of the present invention is drawn a conclusion, it is believed that by the explanation of following embodiment and contrast accompanying drawing, this description can understand the present invention better, the identical identical element of reference number representative among the figure.This mouth care dye composite can use by the monoblock carrier.The monoblock carrier comprises material bar, dens supporter, sponge material and their mixture.In one embodiment of the invention, described monoblock carrier comprises the material bar.Via compositions or via link as a monoblock carrier part, the material bar is connected to tooth, for example, the monoblock carrier can be chosen enough sizes and/or width wantonly, and enough viscosity is arranged so that once using, monoblock carrier and oral soft tissue crossover cause more dental surface to contact with the mouth care dye composite.

Be not intended to limit the present invention, material bar embodiment is more detailed description hereinafter:

Fig. 1 is the perspective view with flat substantially material bar of fillet;

Fig. 2 is the perspective view of one embodiment of the invention, this figure discloses above-mentioned Fig. 1 material bar and the second layer compositions on it, said composition comprises mouth care dye composite as herein described, but combining of dyestuff and monoblock carrier and/or this dye composite release property wherein;

Fig. 3 is the profile of the hatching 3-3 intercepting in Fig. 2, the figure illustrates the thickness of the little second layer thereon of the thickness coating of material bar embodiment;

Fig. 4 is a profile, the figure illustrates an alternate embodiment of the present invention, on its material bar shallow pocket is arranged, and it is used for storing the unnecessary amount of second layer coating on the material bar;

Fig. 5 is cross section plane graph, and this figure shows alternate embodiment, and the second layer compositions that will have the material bar in this embodiment is applied on the tooth that is adjacent, and will expect that by the second layer compositions between tooth and the material bar bar pastes on the tooth;

Fig. 6 is the front view of the tooth cross section of the hatching 6-6 intercepting in Fig. 5, the figure illustrates material bar of the present invention and conforms to and paste on the tooth by the second layer compositions between tooth and the material bar;

Fig. 7 is and the similar cross section plane graph of Fig. 5, the figure illustrates material bar of the present invention and is consistent with tooth by the second layer compositions between tooth and the material bar and connects with soft tissue, and paste the tooth both sides;

Fig. 8 is the cross-sectional elevational view along Fig. 7 section line 8-8 intercepting, the figure illustrates material bar of the present invention and is consistent with tooth by the second layer compositions between tooth and the material bar and connects with soft tissue, and paste the tooth both sides;

Fig. 9 is the perspective view of the alternative embodiment of the present invention, this Figure illustrates the material bar with release liner, and this material bar is coated with nursing tooth of representing just like Fig. 2 and the second layer compositions that connects soft tissue;

Figure 10 is the profile of the intercepting of the hatching 10-10 in Fig. 9 in the alternative embodiment of the present invention, the figure illustrates release liner and adheres on the material bar by the second layer compositions on the material bar.

Detailed Description Of The Invention

Definition

Term used herein " anti-dental calculus " or " anti-calculus " agent are meant and can effectively reduce, control, suppress, prevent and/or minimizing farthest forms the sedimentary material of relevant inorganic matter (as calcium phosphate) with dental calculus or tartar.

Term used herein " demineraliting infringement " is included in the D that any dental surface comprises that early stage caries infringement, carious lesions, dominance carious lesions (clinical relevant infringement), use DMFS or the DMFT evaluation methodology of bright finish, occlusal surface or teeth roots are made ₁, D ₂, D ₃And D ₄Infringement, teeth corrosion, just abnormal inductive demineraliting infringement.Term used herein " demineraliting infringement " does not comprise dental plaque and dental calculus.

Term used herein " early stage caries infringement " is meant that white macula, white macula are the demineralized areas of tooth, and it is reversible, and for example, dental surface is by using the Remineralization agent or can being resumed by improving patients oral hygiene habits.

Term used herein " carious lesions " is meant that teeth corrosion, teeth corrosion are the progressively decalcificationizations of tooth enamel and dentine, is characterised in that to use DMFS or DMFT to be evaluated as D ₂, D ₃And D ₄

Term used herein " teeth corrosion " is meant the permanent loss of the tooth material of dental surface, teeth corrosion is by the factor (acid in the oral food of outside, as acidic beverages or fruit juice, with the acid water in environmental factors such as ingress of air pollutant or the swimming pool) or inner factor (the endogenous acid that stomach produces, it touches tooth in vomiting or reflux course) cause that demineraliting or dental caries under the dental surface that this and bacterial activity cause are opposite.

Term used herein " just abnormal inductive demineraliting infringement " is meant the tooth demineraliting of the early stage caries infringement, carious lesions, dominance carious lesions, teeth corrosion or other type that are caused by the just abnormal device of patient wear such as tooth protection, facing, holder etc.

Term used herein " tooth mineral nitrogen health " is meant the content of mineral substances level of tooth or is damaged or the demineraliting existence of other state or the mineral deficiency degree that degree causes by demineraliting.

" visual-tactile caries assessment " is the inspection that the oral cavity is carried out, and is meant particularly single tooth or dental surface are checked to measure the integrity degree of tooth or dental surface.This inspection comprises sense of vision assessment determining the position of white macula or open infringement, and the contact assessment of using tooth utensil or detector is to determine the corrosivity on tooth or dental surface, the position of softening or " viscosity " infringement.When carrying out the strict visual caries assessment, do not carry out the contact assessment.DMFS or DMFT are the typical evaluation methods that is used for the visual-tactile caries assessment.

Term used herein " DMFS " is indicative evaluation methodology, is used for assessing dental surface in the visual-tactile caries of human patients.In this evaluation methodology, each non-sound dental surface obtains following scoring: " D " represents corrosion, and " M " represents disappearance, or " F " expression was repaired." S " represents (tooth) surface.Scoring " D " can further be categorized as D ₁, D ₂, D ₃And D ₄, it represents different diagnostic thresholds respectively, described threshold value relates to the seriousness of dental caries.D ₁Represent the enamel infringement on clinical detectable whole surface.D ₂Represent clinical detectable be limited to adamantine " chamber ".D ₃Represent clinical detectable dentine infringement, it is opening or closure.D ₄Expression extends to the infringement of pulp chamber.According to the index of ADA, be chosen as the evidence that corroded surface must have clinical relevant carious lesions.The surface that only is proved the tooth structure with sense of vision and/or contact loss just is considered to reflect clinical relevant carious lesions.Therefore, in one embodiment of the invention, only be characterized by D ₂, D ₃Or D ₄Infringement be used for just determining that dental surface is corrosion.In one embodiment, when not having the sense of vision variation to show the loss of enamel structure, the surface with demineraliting sign will be cited as D ₁, (the comprising initial lesion, white macula infringement and the insufficient full surface of mineral nitrogen) that expression is sound.In the DMFS evaluation system, estimate for each dental surface.For five surfaces of each backteeth, four surfaces of buccal surface, lingual surface, occlusal surface, medial surface and tip face and each labial teeth specifically, buccal surface, lingual surface, medial surface and tip face are marked specifically.Carry out total DMFS scoring, the sum of numeral burn into disappearance or patched dental surface for each experimental subject.

Term used herein " DMFT " is interchangeable evaluation methodology, and it can be used for tooth is carried out vision-sense of touch assessment.In the DMFT evaluation methodology, that " D ", " M " and " F " represent respectively is corrosive, disappearance with patched." T " represents tooth.In the present invention, tooth is further divided into above-mentioned D ₁, D ₂, D ₃And D ₄In the DMFT evaluation methodology, only once give a mark respectively for whole tooth, rather than each independent dental surface is given a mark independently.Total DMFT mark for each experimental subject has reflected sum corrosive, disappearance or patched tooth.

Term as used herein " prevention of dental caries or treatment product " is meant any product with potential processing dental caries effect, the product of dental caries agent arbitrarily for example, this product is not intended to reach being administered systemically of dental caries agent by swallowing, but stops the long enough time to contact all dental surfaces at dental surface.Described product can be the form of any needs.In one embodiment, the prevention of dental caries or treatment product are the dentifrice product that contains the toothpaste form of fluoride sources.

Term as used herein " tooth reparation " is meant any processing, material or device, and it can be repaired dental surface or replace a tooth or all tooth and adjacent tissue.

Term used herein " mouth care dye composite " or " oral care composition " are meant a kind of like this product, this product is not intended to reach being administered systemically of agent or inorganic agent by swallowing, but in the oral cavity, stop time enough, to contact with some or nearly all hard dental surface.In addition, this term can refer to a kind of like this product, and this product can be intended to swallow, but is not intended to carry out being administered systemically of agent or inorganic agent by swallowing.

Term used herein " safe and effective amount " is meant in rational medical science/odontology determination range, the amount of composition is enough high to change disease that desire handles or the curative effect that reaches expectation with significantly (really), but content enough hang down again with avoid serious adverse (with rational effect/danger than).The safe and effective amount of component depend on seriousness, processing cycle, the associated treatment of age of pending concrete disease (for example diagnosing dental caries etc.), pending patient and physiological status, disease character, use concrete form and apply the concrete excipient of component.

" tooth surface " used herein is meant between the fossa, crack, occlusal surface, breach, crackle, groove, scrobicula, gap, irregular, tooth and/or along the medial surface of gums line, shiny surface and/or the grinding of tooth or the face that bites of tooth.

Except as otherwise noted, all hereinafter used percentage ratios and ratio are all in the weight of total composition.

Except as otherwise noted, all measurements of relating to of this paper are all carried out at 25 ℃.

Except as otherwise noted, the percent of all the components that this paper relates to, ratio and content is all based on the actual content of this composition, and is not included in the commercially available prod solvent, filler or other material that can use with these compositions.

The patent of all publications, patent application and announcement that the present invention mentions is all introduced for your guidance in full.Quoting of any document is not to its approval as the availability of claimed prior art of the present invention.

Dyestuff

Dye selection of the present invention to demineraliting infringement dyeing, make these infringements under visible light via " naked eyes " as seen.Dye strength in this compositions is generally about by weight 0.001% to about 10%, in another embodiment for by weight about 0.01% to about 3%, be by weight about 0.1% to about 1% in another embodiment.First phase (or first dye composite) comprises any blue dyestuff, and second phase (or second compositions) comprises any red or yellow dye.First phase is not mixed usually in compositions described herein with second but is kept separating in one embodiment.

In one embodiment, this indigo plant dyestuff is selected from the listed dyestuff of those tables 1 (and their mixture).

Table 1

The cyan coloring agent tabulation

The pigment index name	CAS number and CI number	Another name	Description/chemical name
				Blue VRS	129-17-9	42045 (European titles)	Hydrogen [4-[4-(lignocaine)-2 ', 4 '-the diphenyl methylene disulfone] 2,5-cyclohexadiene-1-subunit] the diethyl ammonium, sodium salt
Acid blue 3	3536-49-0	42051 (European titles)	Two [hydrogen [4-[4-(lignocaine)-5 '-hydroxyl-2 ', 4 '-the diphenyl methylene disulfone] 2,5-cyclohexadiene-1-subunit] the diethyl ammonium], calcium salt
				Acid blue 5	3374-30-9	Acid blue 5 (the blue #202 of Japanese title)

The pigment index name	CAS number and CI number	Another name	Description/chemical name
				Acid blue 5	3374-30-9	Acid blue 5 (the blue #203 of Japanese title)	The phenyl ammonium carbamate, N-ethyl-N-[4-[[4-ethyl (phenyl methyl) amino] phenyl] (5-hydroxyl-2,4-dithio phenyl) methylene]-2,5-cyclohexadiene-1-subunit]-, hydroxyl, inner salt, calcium salt (2: 1)
Acid Blue 7	3486-30-4	42080 (European titles)	Hydrogen (benzyl) [4-[[4-[benzyl ethylamino] phenyl] (2,4-phenyl disulfone) methylene] 2,5-cyclohexadiene-1-subunit] (ethyl) ammonium, sodium salt
				Edible blue 2	2650-18-2	The blue #1 (U.S.) of 42090 (European title) blue #1 (Japan) FD﹠C	Diamino (ethyl) [4-[[4-[ethyl (3-benzyl sulfone) ammonia] phenyl] (2-benzyl sulfone) methylene] 2,5-cyclohexadiene-1-subunit] (3-benzyl sulfone) ammonium
Acid blue 9	3844-45-9	The blue #4 of 42090 (European title) blue #205 (Japan) FD﹠C	Dihydro (ethyl) [4-[4-[ethyl (3-benzyl sulfone)] ammonia]-2 '-diphenyl methylene] 2,5-cyclohexadiene-1-subunit] (3-benzyl sulfone) ammonium, disodium salt
				Alkali blue 26, alizarol saphirol 2	2580-56-5	44045 (Europe)	[4-[[4-phenylamino-1-naphthyl] [4-(dimethylamino) phenyl] methylene] 2,5-cyclohexadiene-1-subunit] alkyl dimethyl ammonium chloride
Solvent blue 63	6408-50-0	Blue #403 (Japan)
				Acid blue 80	4474-24-2	61585 (Europe)	3,3 '-(9,10-anthraquinone-1,4-diimino) two (2,4, the 6-tri-methyl p-toluenesulfonate) sodium
Acid blue 62	4368-56-3	62045 (Europe)	1-amino-4-(hexamethylene amino)-9,10-dihydro-9,10-anthraquinone-2-sodium
				Vat blue 4	81-77-6	69800 (Europe)	6,15-dihydro anthrene-5,9,14,18-tetraketone
Reductive blue 6; Alizarol saphirol 64	130-20-1	The blue #204 in 69825 (Europe) (Japan)	7,16-two chloro-6,15-dihydro anthrene-5,9,14,18-tetraketone
				Vat blue 1; Alizarol saphirol 66	482-89-3	The blue #201 in 7300 (Europe) (Japan)	2-(1,3-dihydro-3-oxygen-2H-indazole-2-subunit)-1,2-dihydro-3H-indole-3-ketone
Acid Blue 74; Edible blue 1	860-22-0	The blue #2 in 73015 (Europe) (Japan)	5,5 '-(2-(1,3-dihydro-3-oxygen-2H-indazole-2-subunit)-1,2-dihydro-3H-indole-3-ketone) sodium disulfonate
				Pigment blue 16	574-93-6	74100 (Europe)	29H, the 31H-phthalocyanine
Pigment blue 15	147-14-8	The blue #404 in 74160 (Europe) (Japan)	29H, 31H-phthalocyanine (2-)-N29, N30, N31, N32 copper
				Sun blue 86	1330-38-7	74180 (Europe)	[29H, 31H-phthalocyanine disulfone (4-)-N29, N30, N31, N32] copper acid (2-)
Alizarol saphirol 29	1302-83-6	77007 (Europe) lazurite ultramarine pigment (Japan) ultramarine pigment (U.S.)

The pigment index name	CAS number and CI number	Another name	Description/chemical name
				Pigment blue 27	14038-43-8	Prussian blue; Ferric ferrocyanide (Japan, the U.S.) 77510 (Europe)
Pigment blue 27 CI 77520	14038-43-8	Prussian blue; Ammonium ferrocyanide ferrum (Japan, the U.S.)
				Bromophenol blue	76-59-5	Bromophenol blue (Europe)	3 ' 3 " bromothymol blue C 27H 28Br 2O 53
Blue oil hydrocarbon indigo plant	489-84-9	Blue oil hydrocarbon (Japan, the U.S.)	Isopropyl-7-dimethyl-4, the 4-azulene

Blue in another embodiment dyestuff is selected from acid blue 9, edible indigo plant 1, edible indigo plant 2 and their mixture.

Red in one embodiment or yellow dye is selected from those listed materials of table 2 (comprising salt, sodium salt, potassium salt, free acid, free alkali, their color lake and their mixture) 1: see the international pigment handbook of CTFA the 2nd edition 1., The Cosmetic, Toiletry, andFragrance Association, Inc., 1985,1992, comprise 185 to 201 pages.Also see Coloring of Food, Drugs, and Cosmetics, G.Otterstatter, MarcelDekker, Inc.1999 comprises the 9th chapter, 222 to 236 pages.

Table 2

The pigment index name	CAS number and CI number	Another name	Description/chemical name
				Indian yellow 73	518-47-8 CI No. 45350	Yellow #8 (U.S.) fluorescein sodium salt (other) of the yellow yellow #202 of #11 (before the EC-) (1) (Japan) D﹠C	Fluorescein sodium salt hydroxyl phthalein
Indian yellow 73	6417-85-2 CI 45350	Yellow #202 (2) (Japan) fluorescein potassium salt (other)	Hydroxyl phthalein fluorescein potassium salt
				Indian yellow 73	2321-07-5 CI 45350∶1	Yellow #7 (U.S.) the fluorescein free acid (other) of yellow #201 (Japan) D﹠C	Hydroxyl phthalein fluorescein free acid

The pigment index name	CAS number and CI number	Another name	Description/chemical name
				Solvent red 72	596-03-2 CI 45370∶1	The orange #201 of red #17 (before the EC-) (Japan) D﹠C orange #5 (U.S.) dibromofluorescein free acid (other)	Hydroxyl phthalein 4,5-2-dichloroethylk dimethyl phosphate-fluorescein, free acid 4,5-2-dichloroethylk dimethyl phosphate-fluorescein, sodium salt (CI 45370)
Acid red 87	17372-87-1 CI 45380	Red #18 (before the EC-) red #230 (1) (Japan) D﹠C red #22 (U.S.) eosin sodium salt (other)	Hydroxyl phthalein (potassium salt)
				Acid red 87	548-26-5 CI 45380	Red #230 (2) (Japan) fluorescein potassium salt (other)	Hydroxyl phthalein (potassium salt)
Pigment Red 90	1326-05-2 CI 45380∶1
				Solvent red 43	15086-94-9 CI 45380: 2 or: 1	The red #21 of the red #223 of red #18 (before the EC-) (Japan) D﹠C (U.S.) eosin free acid	Hydroxyl phthalein (free acid)
Xylene Red 98	6441-77-6 CI 45405	The red sodium salt of flame (other)	2,4,5,7-tetrabromo-3 " 6 "-dichlorofluorescein, potassium salt
				Acid red 92	18472-87-2 CI 45410	Red #20 (before the EC-) red #104 (1) (Japan) D﹠C red #28 (U.S.) the red B sodium salt of flame (other)	Hydroxyl phthalein 2,4,5,6-tetrabromo-3 ", 4 ", 5 "; 6 "-tetrachloro-fluorescein, sodium salt
Acid red 92	13473-26-2 CI 45410	Red #231 (Japan) Japan Red 231 salt (other)	Hydroxyl phthalein potassium salt
				Solvent red 48	13473-26-2 CI 45410∶1	Red #218 (Japan) D﹠C red #27 (U.S.) the red B free acid of flame (other)	Hydroxyl phthalein 2,4,5,6-tetrabromo-3 ", 4 ", 5 "; 6 "-tetrachloro-fluorescein, free acid
Acid red 92/paratonere 174	15876-58-1 CI 45410∶2
				Xylene Red 95	33239-19-9 CI 45425	The orange #207 of red #21 (before the EC-) (Japan) D﹠C orange #11 (U.S.) diiodofluorescein sodium salt (other)	2,4-two iodo-fluoresceins, sodium salt hydroxyl phthalein
Solvent red 73	38577-97-8 CI 45425∶1	Orange #206 (Japan) D﹠C orange #10 (U.S.) diiodofluorescein free acid (other)	2,4-two iodo-fluoresceins, free acid hydroxyl phthalein 2,4-two iodo-fluoresceins, aluminum color lake (CI 45425: 2)
				Xylene Red 51/ edible red 14	16423-68-0 CI 45430	Red #22 (before the EC-) red #3 (Japan) FD﹠C red #3 (U.S.) erythrosine sodium salt (other)	2,4,5, the 7-tetraiodo-fluorescein, sodium salt hydroxyl phthalein

The pigment index name	CAS number and CI number	Another name	Description/chemical name
				Paratonere 172	12227-78-0 CI 45430∶1		2,4,5, the 7-tetraiodo-fluorescein, aluminum color lake 2,4,5, the 7-tetraiodo-fluorescein, (CI 45430: 2-solvent red 140) for free acid
Xylene Red 94	632-68-8 CI 45440	Red #232 (Japan) rose-red potassium salt (other)	The hydroxyl phthalein
				Xylene Red 94	632-69-90 CI 45440	Red #105 (1) (Japan) rose bengal sodium salt (other)	2,4,5, the 7-tetraiodo-3 ', 4 ', 5 ', 6 '-Tetrachlorofluorescein. sodium salt or potassium salt
Solvent orange 16	24545-86-6 2 CI 45396		Xanthene dyestuff 4,5-dinitro-fluorescein, free acid hydroxyl phthalein
				C.I. Xylene Red 52	3520-42-1 CI 45100	Red #102 (Japan) sulfo-rhodamine B	Xanthene dyestuff 3, two (the diethylamino)-9-(2 of 6-, 4-dithio phenyl)-and xanthene-imido, sodium salt
C.I. Xylene Red 50	5873-16-5 CI 45220	The sulfo-rhodamine G	Xanthene 3, two (diethylamino)-2 of 6-, 7-dimethyl-9-(2,4-dithio phenyl)-and xanthene-imido, sodium salt
				Xylene Red 289	12220-28-9
Alkali red 1:1	989-38-8 CI 45160	Rhodamine 6G
				Pigment red 81	12224-98-5 CI 45160∶1
Solvent red 49	509-34-2 CI 45170∶1	Rhodamine B alkali
				Alkali violet 11:1	2390-63-8 CI 45175	The red 6BM of fanal (IG)
Medium red 27	6539-22-4 CI 45180	Comply with the chromium azarin

²Sigma Aldrich production number 35,882-7:C2OH10N2O9.

Described in another embodiment red or yellow dye is a C.I. Xylene Red 52.

Solvent

The present composition also comprises the solvent of safe and effective amount.The content of solvent counts about 30% to about 99.999% by the weight of described compositions, is about 60% to about 98% in another embodiment, and is about 70% to about 95% in another embodiment.

The solvent of compositions of the present invention must be selected so that dyestuff is solvable in solvent.Solvent is also selected to provide compositions certain viscosity, is beneficial to compositions and penetrates into infected dentine.Solvent comprises water miscible solvent, and it can be easy to mix to obtain homogeneous solution with arbitrary ratio with water.

Solvent is selected from the organic single, double or trihydroxy compositions of 2 to 10 carbon atoms in one embodiment.The embodiment of suitable monohydroxy compositions comprises monohydric alcohol, for example ethanol, normal propyl alcohol, isopropyl alcohol, isobutanol, n-amyl alcohol, isoamyl alcohol, neopentyl alcohol, 2-hexanol, 1-enanthol, nonyl alcohol and decanol.Solvent also comprises the dihydroxy monoether, for example glycol monoethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, diethylene glycol monoethyl ether, diethylene glycol monobutyl ether, triethylene glycol monomethyl ether, Triethylene glycol ethyl ether, TEG monomethyl ether and Triethylene glycol ethyl ether.Solvent also comprises the dihydroxy monoesters, for example ethylene glycol ethyl ethers acid esters and diethylene glycol acetas.The embodiment of suitable dihydroxy composition comprises dihydroxy alcohol, for example ethylene glycol, propylene glycol, 1, ammediol, 1,2-butanediol, 1,4-butanediol, 1,2-propylene glycol, 1, ammediol, 1,3-butanediol, diethylene glycol, triethylene glycol, TEG, five ethylene glycol and dipropylene glycol, and monoether and trihydroxy monoesters, for example methylin and glycerol ethyl ester, ethylene glycol ethyl ethers acid esters, diethylene glycol monoacetate.Suitable trihydroxy compositions comprises glycerol and five glycerol.Other solvent comprises oxolane, dimethyl formamide, dimethyl sulfoxide, dioxane, acetone and dimethoxy-ethane, and their analog.Also can use the mixture of above-mentioned solvent.In another embodiment, solvent is selected from 1, ammediol, propylene glycol, 1,2-propylene glycol, dipropylene glycol and their mixture.Solvent is a propylene glycol in another embodiment.

The carrier of monoblock and the combination of dye composite

The present invention relates to one in one embodiment comprises this mouth care dye composite and works in coordination with the delivery system of the carrier of the monoblock of using with it.The carrier of monoblock is selected from material bar, dens supporter, sponge material and their mixture in one embodiment.In one embodiment, this delivery system comprises: the ground floor of material bar; The second layer that comprises above-mentioned mouth care dye composite is discharged by collaborative with compositions and/or material bar by its dyestuff.

I. ground floor

Referring now to legend, especially Fig. 1 and Fig. 2.They have shown first embodiment of the present invention, and this scheme is typically expressed as 10, and its expression is used for sending to tooth the delivery system of dyestuff.Delivery system 10 has material bar 12, and this material bar is essentially flat pattern, preferably has fillet.

It is releasable that what be applied to described material bar 12 is second layer compositions 14.In one embodiment, second layer compositions 14 is homogenizations, can be coated on the material bar 12, as shown in Figure 3 by homogeneous, successive.Yet second layer compositions 14 is alternative can be laminated material or composition isolated layer, (one deck wherein comprises first dye composite, and the second layer comprises second dye composite) isolating band or point or other comprises the form of first and/or second dye composite, the perhaps combination of these structures comprises the continuously coating of second dye composite 14 along the longitudinal axis of material bar 12 parts.

As shown in Figure 4, in alternative embodiment, on material bar 12, form shallow pocket 18.When second layer compositions 14 was coated on the material bar 12, additional second layer compositions 14 (if existence) just was filled in the shallow pocket 18, and stores.

Fig. 5 and Fig. 6 have shown that the present invention is applied to the delivery system 24 on dental surface and a plurality of adjacent teeth thereof.A plurality of adjacent teeth 22 are implanted in the adjacent soft tissue 20.This paper adjacent soft tissue is defined as and is enclosed in tooth structure soft tissue surfaces on every side, it comprises: emulsus is outstanding, the gingiva viscosity structure on gingival edge, gingival sulcus, inner gingiva and tongue and oral surfaces top, and it comprises the viscosity gingiva that is connected with buccal.

In Fig. 5 and Fig. 6, delivery system 24 expression material bar 12 and second layer compositionss 14, wherein second layer compositions 14 is on material bar 12 one side towards tooth 22.Second layer compositions 14 can be applied on the material bar 12 in advance, perhaps can be applied in advance before being applied to tooth on the material bar 12 by user.In an alternative embodiment, second layer compositions can directly apply to tooth 22 by the user, and then above will expecting that bar 12 covers.Under any circumstance, the thickness of material bar 12 is all wanted and can be conformed to tooth 22 surface profiles and adjacent soft tissue 20 thereof with bending strength.In one embodiment, the material bar has enough flexibilities to form the oral surfaces shape, and this surface is exactly most of adjacent teeth.When using delivery system, the material bar is easy to adapt to dental surface and tooth space, can't produce permanent distortion.Delivery system does not need big pressure when using.

Fig. 7 and Fig. 8 represent that the present invention is applied to the front and back surface of most adjacent teeth 22 and the delivery system 24 of adjacent soft tissue 20.Delivery system 24 expression material bar 12 and second layer compositionss 14, wherein second layer compositions 14 is on material bar 12 one side towards tooth 22.

Fig. 9 and Figure 10 represent the release liner 27 chosen wantonly.Release liner 27 is connected on the material bar 12 by second layer compositions 14.Second layer compositions 14 is on material bar 12 one side towards release liner 27.When removing release liner, on one side this of material bar is applied to tooth and dental bed surface.

The ground floor of delivery system of the present invention is made of the material bar in one embodiment.This ground floor material is described in more detail in the following United States Patent (USP): 6,136,297,6,096,328,5,894,017,5,891,453 and 5,879,691, and these all are people's such as Sagel patents, and all transfer The Procter ﹠amp; Gamble Company also is described in the following United States Patent (USP): 5,989,569 and 6,045,811, and be people's such as Dirksing patent, and all transfer The Procter ﹠amp; Gamble Company.

The material bar is the protection barrier as dyestuff.It prevents tongue, lip and saliva leaching and/or the corrosion second layer of user.This makes second layer compositions act on the hard surface in oral cavity and keeps appropriate time of contact as herein described.

The material bar can comprise polymer, natural and synthesising textile material, non-textile material, paper tinsel, paper, rubber, foamed materials, and their combination.The material bar can be a monolayer material, also can be multiwalled laminated material.Do not consider the quantity of layer, the material bar is non-water-soluble basically.The material bar also can be fluid-tight.In one embodiment, this material can be the compositions of any polymer or polymer, as long as it satisfies required flexural rigidity coefficient and compatible with described compositions.Suitable polymers includes but not limited to polyethylene, acetic acid ethylethylene alcohol ester, polyester, ethyl vinyl alcohol, and compositions.The embodiment of polyester comprises Mylar ^With fluoroplastics such as Teflon ^, produce by E.I.Du Pont Company.This in one embodiment material is a polyethylene.Usually the thickness of material bar in one embodiment less than about 0.05mm, is that about 0.001mm is to about 0.03mm less than about 1mm in another embodiment.The thickness of polyethylene material bar is usually less than about 0.1mm, and is about 0.005mm about 0.02mm extremely in one embodiment.

The shape of expecting bar in one embodiment can be Any shape and size, and it will cover required hard tissue surface, oral cavity.In one embodiment, the material bar has fillet to avoid stimulating the soft tissue in the oral cavity.Term " fillet " is meant without any wedge angle or cusp.In one embodiment, the length of material bar makes it can cover all upper teeth or lower tooth, and length is extremely about 12cm of about 2cm in another embodiment, and length is that about 4cm is to about 9cm in another embodiment.The width of material bar also depends on the teeth number that will cover.The width of material bar is generally about 0.5cm to about 4cm, is that about 1cm is to about 2cm in one embodiment.In another embodiment, the material bar can be made patch and is attached on one or many teeth and pastes the zone to monitor this institute.Second layer compositions is applied on the carrier of monoblock in the mode of avoiding contacting with oral soft tissue in one embodiment.

The material bar can comprise shallow pocket.When compositions was applied on the material bar, compositions or additional cosmetics and processing were filled shallow pocket so that the reservoir of these components to be provided with oral care active.Shallow in addition pocket helps to provide texture to delivery system.Described in one embodiment material bar has the shallow pocket of a row.It is wide and about 0.1mm is dark that shallow pocket is generally about 0.4mm.When including shallow pocket on the material bar, compositions is applied on the material bar and just presents different thickness, but the thickness of whole delivery system is less than about 1mm.In one embodiment, the thickness of whole delivery system is less than about 0.5mm.

Bending stiffness is the character of material, and it is material bar thickness, width and the comprehensive function of elasticity of materials modulus.This test is to measure polyolefin film and the inflexible method of thin slice.This method is come the bending resistance of measuring samples by the deformeter that use is fixed on the horizontal beam end.Terminal horizontal being pressed on the sample of another of beam forces the part ribbon to enter perpendicular grooves on the levelling bench (sample is put thereon).To be connected on the strain gauge with tinsel with the microammeter that angular force is calibrated.The stiffness coefficient of sample can directly read from microammeter, and it is wide that it is expressed as the gram per centimeter sample strip.In the present invention, the bending stiffness of material bar is less than about 5g/cm, and it is measured on the model #211-300 at Handle-O-Meter, this instrument is provided by Philadelphia Thwing-Albert Instrument Company, and PA is as the method ASTM D2923-95 of each test.The bending stiffness of expecting bar in one embodiment in another embodiment less than about 2g/cm, and is again that about 0.1g/cm is to about 1g/cm less than about 3g/cm in another embodiment.Generally, the bending stiffness of material bar is constant basically, and can not change between the normal operating period.For example, the material bar does not need to combine with water the low bending stiffness that just can reach in the declared range above.

This lower bending stiffness makes the material bar just can cover the profile of oral surfaces under the situation of exerting oneself slightly.Can keep expecting the concordance of the oral surfaces profile of bar and user in other words, reason is that the residual stress in the material bar is very little, and this stress makes the material bar reply the shape before using, for example flat basically shape.The pliability of material bar can contact it with hard or softish tissue and painless.The pressure that the material bar does not need to continue yet makes it to be retained on the oral surfaces.

Expect that in one embodiment bar is placed on the oral surfaces by the adhesion that this compositions provides.This compositions makes the material bar can stick on the oral surfaces to viscosity and the general thickness of doing the surface in one embodiment, and basically can be owing to not drinking water in a minute etc., because lip, tooth, tongue and other oral surfaces be to the caused additional force of friction of material bar and slippage.Yet, this enough low with the adherent intensity of oral surfaces, as long as user can be removed the material bar once scraping gently easily with finger.This delivery system can be removed from oral surfaces easily, and does not need to utilize instrument, chemical solvent or reagent or over-drastic friction.

Expect that in another embodiment the adhesion that the carrier self of bar by monoblock provides is placed on the oral surfaces.Expect that in one embodiment bar can extend, stick and adhere on the oral soft tissue.Alternatively, binding agent can be applied to the material bar that delivery system is adhered on the part of oral soft tissue.In one embodiment, second layer compositions does not contact oral soft tissue.

The second layer

The second layer comprises the mouth care dye composite of safe and effective amount as herein described in one embodiment.

Optional release liner

Release liner can be made with any material in one embodiment, and this material and the intermediary affinity of second layer compositions are less than the affinity between the ground floor of second layer compositions itself and material bar.Release liner comprises the rigidity flaky substance, for example polyethylene, paper, polyester or other material, and this material scribbles the non-stick material.The size of release liner is cut into and the size and the shape of expecting that bar is the same basically with shape, and perhaps its size makes it to separate from the material bar easily greatly than the material bar.Release liner is made of frangible material makes it can split when the material bar is crooked, and perhaps it constitutes by the multi-disc material or by impressed material.Alternatively, release liner can be two doubling forms, for example typical adhesive bandage design.The description that is suitable as releasing agent is present in Kirk-Othmer, Encyclopediaof Chemical Technology (chemical technology encyclopaedia), the 4th edition, the 21st volume, the 207th to 218 page.

Softness/rigidity dens supporter combination

Dens supporter or sponge material (foamed materials) and dye composite

The mouth care dye composite can be united use with dens supporter, the dens supporter of for example knowing in whitening technology.The general process of preparation dens supporter is known in the art.For example, make alginate impression, it can write down all dental surfaces and gingival edge zone, and die can be made plaster mold rapidly thus.Reservoir if desired, it prepares by make one deck rigid material on the plaster mold on the pending concrete dental surface.Use routine techniques from the mould of modification, vacuum to form dens supporter then.In case form, dens supporter is preferably removed gingival edge on buccal surface and the lingual surface by pruning.Should stay enough denture base materials with guarantee all teeth be covered to completion with the dens supporter periphery of bevel on the about 1/4mm of gingival edge extremely in about 1/3mm.Dens supporter is cut into fan-shaped so that the dens supporter of finishing does not cover them along mastoid process between tooth in one embodiment.The shape of all dens supporter edge preferred smooth is so that the imperceptible edge of lip and tongue is outstanding.In one embodiment, resulting dens supporter provides the perfect stickiness of patient's tooth, and dens supporter is optional to be had reservoir or rigid material and place space on the plaster mold.Dens supporter can comprise the vinyl material of soft and transparent, and its preformed thickness is that about 0.1cm (about 0.04 inch) is to about 0.15cm (about 0.06 inch).Flexible material is worn more comfortable for patients.The higher material (or thicker plastic material) of hardness also can be used to make dens supporter.

Other dens supporter used herein or foamed materials comprise rigid mount, and this device accurately fits to patient's dental arch.Second type rigidity customization tooth apparatus is a kind of " especially big " rigidity customization tooth apparatus.Make inflexible customization tooth apparatus and must make the plaster mold of patient's dental arch die, and heating and vacuum forming thermal plasticity slice are to meet the plaster mold of patient's dental arch.Thermoplastic film is sold with rigidity or semi-rigid form, has multiple size and thickness to use.The laboratory manufacturing technology of especially big rigidity tooth apparatus relates to increasing dental surface as punch die interval insulant or treated light acryhic material on plaster mold.Then the thermal plasticity slice is heated and centers on immediately the increase plaster mold vacuum forming of dental arch.The net effect of the method causes " super large " rigidity customization tooth apparatus.

The rigidity of the third type customization tooth apparatus is a kind of inflexible double-deck compression set system tooth apparatus, and this device is suppressed by material layer and made, scope from softish porous foam to thin film inflexible, atresia.These are double-deck press tooth apparatus atresia, inflexible thermoplasticity shell encases and supports the internal layer of soft porous foam.

The 4th type dens supporter replaces rigidity customization tooth apparatus with the soft foam dens supporter of disposable U-shaped, and this disposable dens supporter can individual packaging, and can be saturated with the compositions of the present invention of having measured quantity in advance.Soft foamed materials is the plastic material of perforate normally.This device is by Cadco DentalProducts in Oxnard, and Calif. is commercially available, trade name VitalWhite ^TMThese soft foam dens supporter comprise that a back lining materials (for example plasticity back lining materials of a closed pore) to minimize the loss of dyestuff from device, minimizes painted, patient's the absorption of soft tissue and/or the discomfort of oral cavity tissue in the oral cavity in one embodiment.Soft in another embodiment foam dens supporter is enclosed in the flexible polymer of atresia.Open celled foam is connected to the preceding inwall and/or the back inwall of tooth apparatus in another embodiment.

The thickness of this oral cavity dye composite must be enough to make it can not run out of foamy open-celled structure easily in one embodiment, also must be enough to make it can be easy to pass through open celled foam.In other words, open-cell foam materials internal structure at regular intervals, size is relevant with the composition viscosity of absorption, with absorbing composition and compositions is passed through.

An embodiment of closed-cell materials is a closed cell polyolefin foam, is sold by Voltek branch company, Sekisui America Corporation, and Lawrence, Mass., trade name Volora, thickness 0.8mm (1/32 ") is to 3.2mm (1/8 ").Closed-cell materials also comprises flexible polymeric material.

A polyethylene that embodiment is perforate of open-cell material is sold by Sentinel FoamProducts branch company, Packaging Industries Group, Inc., Hyannis, Mass., trade name Opcell, thickness 1.6mm (1/16 ") is to 9.5mm (3/8 ").Can be used for other open celled foam of the present invention and comprise that hydrophilic open-cell foam materials such as aquogel polymer are (as Medicell ^TMFoam, available from Hydromer, Inc.Branchburg, J.J.).Open celled foam also is to absorb to give the hydrophilic open-cell foam materials of fluid high-absorbable with agent, for example polyurethane or the polyvinylpyrrolidone that absorbs with multiple thinner.

The device of the above-mentioned type further describes in following patent: United States Patent (USP) 5,980,249, M.G.Fontenot and United States Patent (USP) 5,575,654, M.G.Fontenot.

Above-mentioned tooth apparatus can be designed as and disposablely maybe can re-use.More dens supporter used herein is disclosed United States Patent (USP) 6,368,576, and Steven D.Jensen is published on April 9th, 2002; United States Patent (USP) 6,309,625, people such as Jensen are published in October 30 calendar year 2001; United States Patent (USP) 6,183,251, Dan E.Fischer is published in February 6 calendar year 2001; United States Patent (USP) 6,036,943, Dan E.Fischer is published on March 14th, 2000; United States Patent (USP) 5,985,249, Dan E.Fischer is published on November 16th, 1999; United States Patent (USP) 5,846,058, Dan E.Fischer was published in December in 1998 8; United States Patent (USP) 6,382,979, Sherrill F.Lindquist is published on May 7th, 2002; United States Patent (USP) 5,098,303, Fischer is published on March 24th, 1992 and United States Patent (USP) 5,855,870, and Dan E.Fischer is published on January 5th, 1999.

Optional member

The film destruction agent

Optional thin film (or biomembrane) disrupting agent that comprises safe and effective amount of compositions as herein described and method.Term used herein " thin film (or biomembrane) disrupting agent " is meant removing or minimize film or the effective agent of biomembrane that is formed by protein, lipoid and glycolipid in saliva and the level in gingival sulcus fluid on the tooth.In one embodiment, the film destruction agent is included in the dye composite as herein described to measure safely and effectively, content counts about 0.01% to about 20% by the weight of compositions in another embodiment, and content counts about 0.1% to about 10% by the weight of compositions in another embodiment.Described dose can include but not limited to anti-calculus agent as herein described, enzyme for example protease, elastoser, halogenation furanone etc.

Thin film also can physical method such as remove by ultrasonic degradation, Pumex polishing, electric toothbrush, grinding agent Tooth paste brush and remove.

Thickening agent

This compositions comprises gel in one embodiment., need usually to add some thickening materials during gel described herein in preparation, required in use release characteristics is provided, provide frame to hide stability, and the stability etc. of compositions is provided so that required denseness to be provided to compositions.Thickening agent is selected from water soluble salt such as sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose sodium and the carboxymethyl hydroxyethyl cellulose sodium of carboxy vinyl polymer, carrageenin, hydroxyethyl-cellulose, LAPONITE and cellulose ether in one embodiment.Also can use natural gum such as karaya, xanthan gum, Radix Acaciae senegalis and Tragacanth.The silicon dioxide of colloidal magnesium aluminum silicate or segmentation can be used as the part thickening agent, with the further texture that improves.

Thickening agent can comprise polymeric polyether compound, for example to contain 1 alkyl or end capped polyethylene glycol oxide of acyl group or polypropylene oxide (molecular weight is 300 to 1,000,000) to about 18 carbon atoms.

Thickening agent or gellant comprise a class homopolymer or the carbomer that acrylic acid and pentaerythritol alkyl ether or sucrose alkyl ether are crosslinked in one embodiment.Carbomer is with Carbopol ^The series city is sold by B.F.goodrich.Especially preferred Carbopol comprises Carbopol 934,940,941,956, and their mixture.

By the weight of total composition, the amount of the spendable thickening agent of this paper is about 0.1% to about 15%, in another embodiment, for about 0.2% to about 6%, in another embodiment, is about 0.4% to about 5%.

Buffer agent

By the weight of combinations of buffers thing, the present composition randomly contains 0.01% to about 10% the buffer agent of having an appointment; Contain 0.1% to about 3% the buffer agent of having an appointment in another embodiment; Contain 0.3% to about 2.5% the buffer agent of having an appointment in another embodiment.Buffer agent used herein refers to can be used for regulating the reagent of compositions pH to about pH6.5 to about pH10.These buffer agents comprise alkali metal hydroxide, carbonate, sesquicarbonate, borate, silicate, phosphate, imidazoles, and their mixture.Concrete buffer agent comprises tertiary sodium phosphate, disodium hydrogen phosphate, sodium hydrogen phosphate, sodium dihydrogen phosphate, monosodium phosphate, sodium hydroxide, potassium hydroxide, alkali carbonate, sodium carbonate, imidazoles, pyrophosphate, citric acid and sodium citrate, and their mixture.

Flavoring agent

Also can add flavoring agent in the present composition.Flavoring agent strengthens the taste of this compositions and attractive in appearance, because the dyestuff of some addings can cause disgusting taste.Flavoring agent also strengthens the permeability that dyestuff enters the infringement of tooth demineraliting in addition.The flavoring agent that is fit to comprises wintergreen oil, Oleum menthae, Oleum Menthae Rotundifoliae, clove bud oil, menthol, anethole, methyl salicylate, eucalyptol, acetic acid 1-menthyl ester, Salvia japonica Thunb., acetaminol, parsley oil, frambinone, α-Zi Luolantong, origanum, Fructus Citri Limoniae, orange, 1-ethoxy-2-hydroxy-4-propenyl benzene, Cortex Cinnamomi, vanillin, thymol, linalool, is called the cinnamic aldehyde glycerine acetal of CGA, and their mixture.In one embodiment, flavoring agent is selected from spearmint oil, Cortex cinnamomi japonici (Ramulus Cinnamomi), acetaminol, Oleum menthae, and their mixture.By the weight of described compositions, the content that flavoring agent is generally used for this compositions is about 0.001% to about 20%, is about 0.1% to about 3% in another embodiment, is about 0.8% to about 2% in another embodiment.

Oral care active agents

The present invention can comprise the oral care active agents of safe and effective amount, described oral care active agents is selected from anti-calculus agent, fluorine ion source, antimicrobial, dentin desensitizer, anesthetis, antifungal, antiinflammatory, selectivity H-2 antagonist, caries preventive agent, and their mixture.

Oral care active agents can suitable amount be present in the present composition and the method.These content will be known to those skilled in the art, and open below.

Caries preventive agent and fluorine ion source

The present composition can comprise the caries preventive agent of safe and effective amount.In one embodiment, this caries preventive agent is selected from xylitol, fluorine ion source, and their mixture.This fluorine ion source can provide free fluorion during using compositions.In one embodiment, oral care active agents is a fluorine ion source, and it is selected from sodium fluoride, stannous fluoride, indium, organic fluoride, as amine fluoride and sodium monofluorophosphate.In another embodiment, sodium fluoride is a fluorion.The people's such as Widder that the people's such as Norris that announce July 26 nineteen sixty United States Patent (USP) 2,946,725 and on July 18th, 1972 announce United States Patent (USP) 3,678,154 discloses above-mentioned fluoride salt and other can be used as the material of fluorine ion source.The present composition can contain the free fluorine ion of 50ppm to about 3500ppm of having an appointment; Contain the free fluorine ion of 100ppm of having an appointment in another embodiment to about 3000ppm; Contain the 200ppm that has an appointment in another embodiment to about 2, the free fluorine ion of 800ppm; Contain the 500ppm that has an appointment in another embodiment to about 1, the free fluorine ion of 500ppm.

Anti-calculus agent

This compositions can comprise at least a anti-calculus agent of safe and effective amount.By the weight of described compositions, this content is generally about 0.01% to about 40%; Be about 0.1% to about 25% in another embodiment; Be about 4.5% to about 20% in another embodiment; Be about 5% to about 15% in another embodiment.Anti-calculus agent also should be compatible substantially with other composition of compositions.

The dental calculus preventing agent is selected from polyphosphate and salt thereof, poly-amino propane sulfonic acid (AMPS) and salt thereof, poly-sulfonic acid alkene ester and salt, polyphosphoric acid vinyl acetate and salt thereof, polyphosphoric acid alkene ester and salt, bisphosphonates and salt thereof, phosphonoalkyl carboxylic acid and salt, polyphosphonates and salt thereof, pyrophosphate and salt thereof, polyphosphonic acid vinyl acetate and salt thereof, polyphosphonic acid alkene ester and salt thereof, polypeptide, and composition thereof.In one embodiment, salt is alkali metal salt.In another embodiment, anti-calculus agent is selected from poly phosphate and salt, bisphosphonates and salt thereof, and their mixture.In another embodiment, anti-calculus agent is selected from pyrophosphate, Quadrafos, and their mixture.

Quadrafos

In one embodiment of the invention, anti-calculus agent is a Quadrafos.Although there are some cyclic polyphosphates derivants, it has been generally acknowledged that Quadrafos is by mainly forming with two or more phosphate molecules of linear configuration arrangement.Straight-chain polyphosphate meets formula (X PO ₃) _n, wherein n is about 2 to about 125, wherein n is preferably greater than 4, and X is for example sodium, potassium etc.For (X PO ₃) _n, when n at least 3 the time, Quadrafos has glass performance.These phosphatic counter ions can be alkali metal, alkaline-earth metal, ammonium, C ₂-C ₆The mixture of alkanol ammonium and salt.Usually used Quadrafos is its all or part of neutral water-soluble alkali metal salts, as potassium salt, sodium salt, ammonium salt, and their mixture.Inorganic polyphosphate comprises that alkali metal (for example, sodium) tripolyphosphate, four Quadrafos, metal diaikyl are (for example, disodium) binary acid, trialkyl metal are (for example, trisodium) monoacid, potassium hydrogen phosphate, dibastic sodium phosphate and alkali metal are (for example, sodium) hexametaphosphate, and their mixture.The Quadrafos bigger than four Quadrafos occurs with the amorphous glass material usually.In one embodiment, Quadrafos is those that produced by FMC Corporation, is called Sodaphos (n ≈ 6), Hexaphos (n ≈ 13) and Glass H (n ≈ 21) on its commodity, and their mixture.Typically, by the weight of described compositions, this compositions comprises about 0.5% to about 20% Quadrafos, and its content is about 4% to about 15% in one embodiment, and its content is about 6% to about 12% in another embodiment.

At Kirk ﹠amp; The Encyclopedia of Chemical Technology of Othermer, the 4th edition, the 18th volume, Wiley-Interscience Publishers (1996) in the 685-707 page or leaf, has described the phosphate source in more detail, it is incorporated herein by reference, and comprises Kirk ﹠amp; All lists of references that Othermer quotes.

In one embodiment, this Quadrafos is straight chain " nature of glass " Quadrafos with following formula:

XO (XPO ₃) _nX wherein X is sodium or potassium; And n average out to about 6 to about 125.

In one embodiment, when n in above-mentioned arbitrary Quadrafos chemical formula at least 2 the time, by the weight of described compositions, the content of anti-calculus agent is about 4.5% to about 40%; Be about 5% to about 25% in another embodiment; Be about 8% to about 15% in another embodiment.Quadrafos is at United States Patent (USP) 4,913, and is further open in 895.

Pyrophosphate

The pyrophosphate that is used for this compositions comprises alkali metal pyrophosphate salts, pyrophosphoric acid two, three and a potassium or sodium, pyrophosphoric acid two alkali metal salts, pyrophosphoric acid four alkali metal salts, and their mixture.In one embodiment, pyrophosphate is selected from Sodium phosphate (Na3HP2O7), Sodium Acid Pyrophosphate (Na ₂H ₂P ₂O ₇), Dipotassium pyrophosphate, tetrasodium pyrophosphate (Na ₄P ₂O ₇), tetrapotassium pyrophosphate (K ₄P ₂O ₇), and their mixture.Pyrophosphate is described in the United States Patent (USP) 4,885,155 that the United States Patent (USP) 4,515,772 announced in 7 days Mays in 1985 of all authorizing people such as Parran and December in 1989 announced on the 5th, its in full and wherein disclosed list of references be incorporated herein by reference.At Kirk ﹠amp; The Encyclopedia of Chemical Technology of Othermer, the third edition, the 17th volume, Wiley-Interscience Publishers (1982) in the 685th to 707 page, has described pyrophosphate in more detail, it is incorporated herein by reference, and comprises Kirk ﹠amp; All lists of references that Othermer quotes.

In one embodiment, compositions of the present invention comprises tetrasodium pyrophosphate.In this compositions, tetrasodium pyrophosphate can be anhydrous salt form or decahydrate form, or any other is stable at the kind of solid form.Salt is its solid particulate form, and this form can be its crystallization and/or amorphous state, and the particle diameter of salt is preferred enough little of can accept and easily dissolving in use on attractive in appearance.

The content of pyrophosphate is any safe and effective amount in the present composition, and is generally about 1.5% to about 15% by the weight of described compositions, is about 2% to about 10% in another embodiment, is about 3% to about 8% in another embodiment.

Be used to replace pyrophosphate or comprise those known substances with optional reagent that pyrophosphate is used in combination, as synthetic anionic polymer, it comprises the copolymer (for example Gantrez) of polyacrylate and maleic anhydride or maleic acid and methyl ethyl ester, these substance descriptions are in the United States Patent (USP) 4 of for example authorizing people such as Gaffar, 627, in 977, the disclosure of this patent is incorporated herein by reference, and for example poly-aminopropyl sulfonic acid (AMPS), Zinc citrate trihydrate., Quadrafos (tripolyphosphate for example; Hexametaphosphate), diphosphate (for example EHDP, AHP), polypeptide (as poly-aspartate and polyglutamic acid), and their mixture.

Antimicrobial

The antimicrobial antiplaque agent also can be chosen wantonly and be present in the present composition.These reagent can include but not limited to triclosan, 5-chloro-2-(2, the 4-dichlorophenoxy)-phenol, as " The MerckIndex ", the 11st edition (1989), 1529 pages (entry number 9573), United States Patent (USP) 3,506, the Beecham Group that on January 7th, 720 and 1988 announced, the european patent application 0,251 of PLC is described in 591; Chlohexidine (Merck Index, entry number 2090), Win-21904 (Merck Index, entry number 222); Hexatidine (Merck Index, entry number 4624); Sanguinarine (Merck Index, entry number 8320); Alkyl benzyl dimethyl ammonium chloride (Merck Index, entry number 1066); Salicylamide (Merck Index, entry number 8299); Brominated phenododecinium bromide (Merck Index, entry number 3411); Cetylpyridinium chloride (CPC) (Merck Index, entry number 2024); TPC (TPC); Chlorination N-myristyl-4-ethylpyridine (TDEPC); Octenidine; Delmopinol, Octapinol and other sub-base derivatives of piperidine; The effectively quintessence oil of antimicrobial amount, and their combination, for example citral, geranial, and the combination of menthol, eucalyptol, thymol and methyl salicylate; Antimicrobial metal and salt thereof for example can provide those of zinc ion, stannous ion, copper ion and/or their mixture; Bis-biguanide or phenol; Antibiotic such as augmentin, amoxicillin, tetracycline, doxycycline, minocycline and metronidazole; And the analog of above-mentioned antimicrobial antiplaque agent and salt; Antifungal is as being used to handle those of Candida albicans.If contain these reagent, then it exists with safe and effective amount usually, for example, counts about 0.1% to about 5% by the weight of compositions of the present invention.

Antiinflammatory

Antiinflammatory also can be present in the oral cavity composition of the present invention.This class reagent includes but not limited to non-steroidal anti-inflammatory agents, for example aspirin, ketorolac, flurbiprofen, ibuprofen, naproxen, indometacin, aspirin, ketoprofen, piroxicam and meclofenamic acid, cox 2 inhibitor such as valdecoxib, celecoxib and rofecoxib, and their mixture.If present, by the weight of compositions of the present invention, the common content of antiinflammatory is about 0.001% to about 5%.Ketorolac is described in the United States Patent (USP) of announcing on May 6th, 1,997 5,626,838.

The H-2 antagonist

The present invention also comprises the selectivity H-2 antagonist of safe and effective amount, and it comprises disclosed chemical compound in the United States Patent (USP) of announcing on March 15th, 1,994 5,294,433 of authorizing people such as Singer.

Surfactant

Compositions of the present invention is also chosen wantonly and is comprised suitable surfactant.Surfactant can make the present composition disperse better in the oral cavity.Surfactant comprises nonionic, anion, both sexes, cation, amphion, synthetic detergent and their mixture.Many suitable nonionics and amphoteric surfactant are disclosed in the United States Patent (USP) 3 of authorizing Benedict, 988,433, the United States Patent (USP) 4 of JIUYUE in 1977 announcement on the 27th, 051, in 234, and many suitable non-ionic surface active agents are disclosed in the people's such as Agricola that announced on May 25th, 1976 the United States Patent (USP) 3,959,458.

This compositions typically comprises the surfactant of safe and effective amount, by the weight of described compositions, comprises about 0.001% to about 20% in another embodiment; About in another embodiment 0.05% to about 9%; About in another embodiment 0.1% to about 5%.

Sweeting agent, coolant, heat agent and sialorrhea agent

The sweeting agent that can choose use wantonly comprises sucralose, sucrose, glucose, glucide, dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, saccharin salt, African hesperidium element, aspartame, D-tryptophan, dihydrochalcone, acesulfame and cyclamate, especially encircle sodium sulfonate and saccharin sodium, and their mixture.Compositions preferably comprises these agent by the weight of described compositions about 0.1% to about 10%, and about in another embodiment 0.1% to about 1%, about in another embodiment 0.5% to about 2%.

Except flavoring agent and sweeting agent, coolant, sialorrhea agent, heat agent and numb agent also can be used as the optional components of the present composition.By the weight of compositions, the content of these agent in compositions is about 0.001% to about 10%; Be about 0.1% to about 3% in another embodiment; Be about 0.5% to about 2% in another embodiment.

Coolant can be any various material.Comprise that these materials in the present invention are amide, menthol, ketal, glycol, and their mixture.Preferred coolant in this compositions is to alkylamino formyl reagent in the Meng, and as N-ethyl-right-Meng alkane-3-carboxylic acid amides, commodity are called " WS-3 ", N, and 2,3-trimethyl-2-isopropyl butyramide, commodity are called " WS-23 ", and their mixture.The 3-1-menthoxypropane-1 that is called TK-10 that preferred in addition coolant is selected from menthol, is produced by Takasago, 2-glycol, the menthone glycerine acetal of producing by Haarmann and Reimer that is called MGA and be called Frescolat by what Haarmann and Reimer produced ^Menthyl lactate.Term menthol as used herein and menthyl comprise the dextrorotation and the laevoisomer of these chemical compounds and their racemic mixture.TK-10 is described in the people's such as Amano that announced on July 10th, 1984 United States Patent (USP) 4,459,425.WS-3 and other reagent are described in the people's such as Watson that announced on January 23rd, 1979 United States Patent (USP) 4,136,163.

Sialorrhea agent of the present invention comprises the Jambu that is made by Takasago ^The agent of heating comprises Fructus Capsici and nicotinate, as benzyl nicotinate.Numb agent comprises benzocaine, lignocaine, clove bud oil, ethanol, and their mixture.

Sensory agent/anesthetis

Pain relieving or desensitizer also can be present in the compositions of the present invention with safe and effective amount.Analgesic is such activating agent, and it is not hindering consciousness or is changing under the situation of other sensory modality, palliates the agonizing sufferings to increase painful threshold value by working at maincenter.This class medicament includes but not limited to strontium chloride, potassium nitrate, Chile saltpeter, sodium fluoride, acetanilide, Phenacetin, acetophen, N-(3-sulfydryl-2-benzyl propiono) glycine, spiradoline, aspirin, codeine, thebaine, left-handed phenol, hydromorphone, oxymorphone, phenazocine, fentanyl, buprenorphine, tetracaine hydrochloride, nalbuphine, pentazocine, natural medicinal herbs, for example Galla Chinensis, Herba Asari, cubebin, Rhizoma Alpiniae Officinarum, Radix Scutellariae, Radix Zanthoxyli, the Radix Angelicae Dahuricae etc.Also can there be anesthetis or local anesthetic, for example acetaminophen, sodium salicylate, trolamine salicylate, lignocaine and benzocaine.These analgesic active substances are described in detail in Encyclopedia of Chemical Technology the 4th edition the 2nd volume of Kirk-Othmer, and Wiley-Interscience Publishers is in (1992) the 729th to 737 pages.

Compositions is used

The present invention relates to diagnostic method and compositions in order to the improvement of checking the demineraliting infringement.The present invention has the following advantages.At first, compare, the invention provides a kind of safer, more economical alternative method with some currently used diagnotors.It only needs to use the visual observation of visible light, does not need (though they can randomly be used) to use the enhancing light source of laser, other type or X ray to highlight the demineraliting infringement.The present invention also can easily use, and can be used at home by consumer, is perhaps used in the clinic by dental professional.It also can be used as the method for checking the demineraliting infringement and uses when the multiple dental caries of Clinical Laboratory (prevention or processing) product.In addition, the present invention can check optionally that how many tooth surfaces are the dominance carious lesions determine to remove to help dental professional during repairing, prevent to remove the tooth health part.In addition, the inspection to the early stage caries infringement provided by the invention makes that using the Remineralization agent to carry out early time treatment becomes possibility, is possible at this stage reverse demineraliting or Remineralization.If the degree of demineraliting is not too serious, for example be reversible, then the formation that can stop the dominance dental caries is handled in infringement.Importantly, the present invention can be used as the method for the process of more frequent monitoring Remineralization processing and use, and comprises any oral care product of fluorion as use.It can used the Remineralization agent or improve the degree of patient's oral sanitary habit (for example better brush teeth, dental floss cleans the teeth etc.) back monitoring tooth Remineralization.

The invention provides the incentive mechanism that a kind of patient of making forms good oral sanitary habit at last.The invention provides a kind of " close friend's of consumer " method, the improvement and the success of the method monitoring progress and demonstration Remineralization facture.This can further encourage the patient to continue to handle and keep them to being obedient to of handling.Be obedient to the development that to avoid irreversible lesion preferably and avoid boring, dental structure removes and damage fillings (for example repairing).

The compositions and methods of the invention can be applied to required form in the oral cavity, and this form includes but not limited to the chaw form of compositions (for example insoluble backing material bar), tablet, chewable tablet, capsule, the liquid filling of the carrier of gel (perhaps brush on tooth or with applicator or finger and use), powder, spraying, mousse, aerosol, use monoblock, dissolving dish or tablet, chewing gum, edible film, collutory, solution and make product be applied to the analog of dental surface fast.Rinsing liquid, solution, gel can use the device of brush, sponge, swab, pipette, finger or any other transmissibility potion close set compound to be applied to one or more dental surfaces.

First mutually and second quilt while or being administered on one or more teeth in regular turn mutually in one embodiment.

By administration in regular turn, the patient uses or administration first phase (or first dye composite) arrives one or more teeth or oral cavity.If open-assembly time is long, may not optionally be dyeed.The patient makes the first especially tooth at least 5 seconds to about 1 minute of oral surfaces that contacts then, is about 6 seconds to about 30 seconds in another embodiment, is about 10 seconds to about 20 seconds in another embodiment.The patient gargles spue oral cavity and optional water of compositions to wash oral cavity (gargle 30 seconds to 1 minute, spue then) subsequently.The patient uses second phase (or second dye composite) then to the oral cavity and allow especially tooth at least 5 seconds to about 1 minute of described compositions contact oral surfaces, being about 6 seconds to about 30 seconds in another embodiment, is about 10 seconds to about 20 seconds in another embodiment.The patient is with the compositions oral cavity that spues then.Patient's water is gargled and was washed the oral cavity about 15 seconds to about 1 minute then, spues then.Patient or dental professional visual observation tooth and observe the demineraliting extent of damage or tooth mineral nitrogen health degree subsequently.This program can repeat according to patient or dentist's needs with the monitoring treatment effect.Common frequency of utilization is to make an appointment with every day to per approximately 12 months once, in another embodiment, and approximately weekly to per approximately 6 months.Dyestuff is usually by scrubbing or gargling after observation, and for example, water is gargled to remove from tooth or other oral soft tissue.

In another embodiment,, then use outside first phase, carry out according to said procedure equally except at first using second phase.

To the situation of while administration, the patient carries out according to said procedure equally except not spuing first mutually or gargle and wash the oral cavity after first uses mutually.

Alternative, the situation patient of while administration is mixed first mutually and second also use mixture mutually subsequently and arrive one or more teeth or oral cavity.The patient oral cavity that then compositions spued, water is gargled and was washed the oral cavity about 15 seconds to about 1 minute.Then carry out visual observation mentioned above.

The patient for every tooth use first mutually and second mutually the volume be generally extremely about 127 μ m (about 5mil) of about 1.27 μ m (about 0.05mil), being extremely about 25.4 μ m (about 1mil) of about 2.54 μ m (about 0.1mil) in another embodiment, is that about 3.81 μ m (about 0.15mil) are to about 7.62 μ m (about 0.3mil) in another embodiment.

In one embodiment, use first phase (or first dye composite) before the patient remove dental plaque or dental calculus via method as herein described or reagent from tooth.

Edible film compositions and their manufacture method are disclosed in U.S.6, and 419,903, people such as Xu are published on July 16th, 2002, Colgate Palmolive Company; U.S. Patent application No.2003/0053962 is published on March 20th, 2003, people such as Zerbe, LTSLohmann; WO 02/02085 A2, LTS Lohmann Therapie-Systeme AG is published on January 10th, 2002; U.S. Patent application 2001/022964 is published in calendar year 2001 JIUYUE 20 days, people such as Leung, Warner-Lambert Company; U.S. Patent application 2002/0131990 was published in JIUYUE in 2002 19, Wm.Wrigley Jr.Company; US 2003/0054039, and people such as Zyck are published on March 20th, 2003, Wm.WrigleyJr.Company; With US 2002/0127254 (Lavipharm); U.S.5,948,430, U.S.6,284,264B1, U.S.6,177,096B1, LTS Lohmann.

Confection and chewing gum compositions and their manufacture method are disclosed U.S.5, and 702,687, Church ﹠amp; Dwight; U.S. 4,170,632, General Mills; U.S. 4,151,270, Wm.Wrigley Jr.; U.S. 5,306,519 Universal Foods; U.S. 5,194,288Universal Foods; U.S. 5,958,472 Warner Lambert; U.S. 4,931,295Wm.Wrigley, Jr.; U.S. 5,017,385 P﹠amp; G; U.S. 5,158,789 ICAAmericas; U.S. 4,976,972 Wm Wrigley Jr.; EP 453,402 WarnerLambert; U.S. 4,997,654 Warner Lambert; U.S. 4,513,012 WarnerLambert; U.S. 4,513,012 Warner Lambert; U.S. Patent application No.2003/00728 41-A1 is published on April 17th, 2003, P﹠amp; G.

In one embodiment, the gel (for example insoluble backing material bar) that dosage form is selected from gel, solution, rinsing liquid, is used in combination with the carrier of monoblock, form that is applied directly to one or more teeth and their mixture are provided when minimizing dye composite contact opening transmucosal soft tissue.These dosage forms can be applied directly on one or many teeth.

Gel on insoluble backing material bar and their method of manufacturing are disclosed hereinbefore.

The present composition can be applied to humans and animals (for example house pet, zoo animal or domestic animal).

Embodiment

Following non-limiting examples further describes the embodiment in the scope of the invention.In the case without departing from the scope of the present invention, a lot of changes of these embodiment are possible.

Example I (solution)

	Embodiment 1		Embodiment 2		Embodiment 3
							Composition	First phase first compositions (% weight)	Second phase second compositions (% weight)	First phase first compositions (% weight)	Second phase second compositions (% weight)	First phase first compositions (% weight)	Second phase second compositions (% weight)
Blue dyestuff 1	0.5		0.1		1.0
							Red 2		0.5				1.0
Yellow dye 3				0.4
							Propylene glycol	99.45	99.45	99.87	99.57	98.95	98.95
Flavoring agent 4	0.05	0.05	0.03	0.03	0.05	0.05

¹Acid blue 9, edible indigo plant 1, or edible blue 2.

²Xylene Red 52

³Yellow dye 5

⁴Flavoring agent is selected from spearmint, acetaminol, Oleum menthae and/or Cortex cinnamomi japonici (Ramulus Cinnamomi).

Example II (gel)

	Embodiment 4		Embodiment 5		Embodiment 6
							Composition	First phase first compositions (% weight)	Second phase second compositions (% weight)	First phase first compositions (% weight)	Second phase second compositions (% weight)	First phase first compositions (% weight)	Second phase second compositions (% weight)
Blue dyestuff 1	0.5		0.1		1.0
							Red 2		0.5				1.0
Yellow dye 3				0.4
							Propylene glycol	97.45	97.45	98.87	98.57	96.45	96.45
Flavoring agent 4	0.05	0.05	0.03	0.03	0.05	0.05
							Acrylate copolymer 956 5	2.0	2.0			2.5	2.5
HPMC 6			1.0	1.0

¹Acid blue 9, edible blue 1 or edible blue 2.

²Xylene Red 52

³Yellow dye 5.

⁴Flavoring agent is selected from spearmint, acetaminol, Oleum menthae and/or Cortex cinnamomi japonici (Ramulus Cinnamomi).

⁵Available from BF Goodrich.

First be used with identical umber with second mutually in the above-described embodiments.Above-mentioned solution and gel are applied to all teeth with the device of applicator brush, disposable pipette, sponge, swab or other transmissibility potion close set compound.

Dyestuff administration in regular turn:

Human patients distributes first phase of about 2.54 μ m to 5.08 μ m (about 0.1mil to 0.2mil) on every tooth to be analyzed, and it was stopped about 10 to 20 seconds.The patient gargles spue oral cavity and optional water of any excessive solution or gel to wash the oral cavity about 45 seconds subsequently.The patient distributes second phase of 2.54 μ m to 5.08 μ m (0.1mil to 0.2mil) subsequently on every tooth to be analyzed, and stops about 10 seconds to 20 seconds.The patient gargles spue oral cavity and water of excessive solution or gel to wash the oral cavity about 45 seconds subsequently.The all dental surface of last patient's visual observation is with the demineraliting degree of the dental surface of assessment dyeing.Use fluoride dental cream such as Crest then ^Oral cavity health care toothpaste (having fluorion to exist) brushed teeth twice every day, and the patient repeated the method every 6 months.Described method provides the method for pretreatment tooth with respect to the number of the demineraliting infringement of post processing tooth of observing.

Dyestuff administration simultaneously:

Alternative, human patients distributes first phase of about 2.54 μ m to 5.08 μ m (about 0.1mil to 0.2mil) on every tooth to be analyzed.The patient keeps first and makeed an appointment 10 seconds to 20 seconds on tooth, distribute second phase of about 2.54 μ m to 5.08 μ m (about 0.1mil to 0.2mil) then on first same the tooth of handling mutually.The patient keeps second and makeed an appointment 10 to about 20 seconds on tooth, water is gargled and washed the oral cavity about 45 seconds subsequently.

The all dental surface of patient's visual observation is with the demineraliting degree of the dental surface of assessment dyeing then.The patient uses fluoride dental cream such as Crest then ^Oral cavity health care toothpaste (having fluorion to exist) is brushed teeth twice every day.The patient repeated the method every 6 months.The number of demineraliting infringement has been reduced.Described method provides the method for pretreatment tooth with respect to the number of the demineraliting infringement minimizing of post processing tooth of observing.

The relevant part of all references is incorporated herein by reference in detailed Description Of The Invention; It is to its approval as prior art of the present invention that the quoting of any document not can be regarded as.

Although illustrated and described the present invention with specific embodiments, it will be apparent to those skilled in the art that many other variations and modifications may be made in the case of without departing from the spirit and scope of protection of the present invention.Therefore, in additional claims, comprise all such changes and modifications in the scope of the invention consciously.

Claims (10)

1. oral care composition of checking demineraliting infringement, described oral care composition comprises:

A. first phase, described first comprises the weight 0.001% to 10% by described compositions, preferred 0.01% to 3% blue dyestuff or their mixture mutually;

B. second phase, described second comprises the weight 0.001% to 10% by described compositions, preferred 0.01% to 3% red or yellow dye or their mixture mutually;

C. the solvent of safe and effective amount, wherein said dye soluble is in described solvent; With

D. the flavoring agent of safe and effective amount;

Wherein said compositions is to checking that the demineraliting infringement is effectively, and wherein preferably described blue dyestuff is selected from acid blue 9, edible blue 1, edible blue 2 and their mixture, and preferably described red or yellow dye is a C.I. Xylene Red 52.

2. the method for a demineraliting infringement that visually highlights dental surface or check the method for tooth mineral nitrogen health, dye composite wherein as claimed in claim 1 is applied to the human or animal patient's who needs them oral cavity or tooth.

3. the needed method that visually highlights the method for patient's dental surface demineraliting infringement or check patient's tooth mineral nitrogen health of a patient, described method comprises:

1) first dye composite and second dye composite are administered in regular turn the human or animal patient's who needs them oral cavity or tooth, wherein

A. described first dye composite comprises the weight 0.001% to 10% by described compositions, preferred 0.01% to 3% blue dyestuff or their mixture;

B. described second dye composite comprises the weight 0.001% to 10% by described compositions, preferred 0.01% to 3% red or yellow dye or their mixture; With

2) by the demineraliting of described dyeing infringement, wherein preferably described blue dyestuff is selected from acid blue 9, edible blue 1, edible blue 2 and their mixture to the described tooth of visual observation with assessment, and preferably described red or yellow dye is a C.I. Xylene Red 52.

4. a mouth care of checking the demineraliting infringement is overlapped box, and described mouth care cover box comprises:

A) dye composite, described dye composite comprises:

1. first phase, described first comprises the weight 0.001% to 10% by described compositions, preferred 0.01% to 3% blue dyestuff or their mixture mutually;

2. second phase, described second comprises the weight 0.001% to 10% by described compositions, preferred 0.01% to 3% red or yellow dye or their mixture mutually;

3. wherein said first phase and described second comprises the solvent of safe and effective amount mutually, and wherein said dye soluble is in described solvent; Preferably described first is composition isolated with second mutually mutually;

B) operation instruction that is used to check described tooth demineraliting infringement inspection or is used to monitor described Remineralization treatment effect, wherein preferably described blue dyestuff is selected from acid blue

9, edible blue 1, edible blue 2 and their mixture, and preferably described red or yellow dye is a C.I. Xylene Red 52.

5. as each described cover box in claim 1 or 4, wherein said solvent is selected from propylene glycol, 1, ammediol, 1, and 2-propylene glycol, dipropylene glycol, and their mixture, wherein preferably described solvent is a propylene glycol.

6. cover box as claimed in claim 4, wherein said operation instruction remove dental plaque or dental calculus from described tooth before being included in and using described first phase.

7. as each described cover box in claim 1 or 4, wherein said compositions also comprises film destruction agent, oral care active agents, system buffer, the surfactant of safe and effective amount, and their mixture.

8. cover box as claimed in claim 4, wherein said operation instruction comprises the use of the prevention of dental caries or treatment product.

9. a delivery system overlaps box, and described delivery system cover box comprises:

A) first compositions, described compositions comprises:

1. by the blue dyestuff of the weight 0.001% to 10% of described compositions and their mixture;

2. the solvent of safe and effective amount, wherein said dye soluble is in described solvent;

3. the carrier of monoblock; With

B) second compositions, described compositions comprises:

1. by the red or yellow dye of the weight 0.001% to 10% of described compositions and their mixture;

2. the solvent of safe and effective amount, wherein said dye soluble is in described solvent; With

3. the carrier of monoblock, preferably the carrier of wherein said monoblock is material bar or dens supporter.

10. a delivery system overlaps box, and described delivery system cover box comprises:

A) dye composite

I. first phase, described first comprises mutually by the blue dyestuff of the weight 0.001% to 10% of described compositions or their mixture;

Ii. second phase, described second comprises red or yellow dye or their mixture by the weight 0.001% to 10% of described compositions mutually;

B) check the operation instruction that demineraliting damages on the described tooth;

C) carrier of monoblock, preferably the carrier of wherein said monoblock is material bar or dens supporter.

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