WO1991015189A1 - Procede et composition servant a prevenir les stomatites chez les utilisateurs de dentiers - Google Patents

Procede et composition servant a prevenir les stomatites chez les utilisateurs de dentiers Download PDF

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Publication number
WO1991015189A1
WO1991015189A1 PCT/US1990/001706 US9001706W WO9115189A1 WO 1991015189 A1 WO1991015189 A1 WO 1991015189A1 US 9001706 W US9001706 W US 9001706W WO 9115189 A1 WO9115189 A1 WO 9115189A1
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WO
WIPO (PCT)
Prior art keywords
chlorohexidine
concentration
composition
reducing
sodium monofluorophosphate
Prior art date
Application number
PCT/US1990/001706
Other languages
English (en)
Inventor
Perry A. Ratcliff
Original Assignee
Ratcliff Perry A
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ratcliff Perry A filed Critical Ratcliff Perry A
Priority to PCT/US1990/001706 priority Critical patent/WO1991015189A1/fr
Publication of WO1991015189A1 publication Critical patent/WO1991015189A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/17—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine
    • A61K31/175—Amides, e.g. hydroxamic acids having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine having the group, >N—C(O)—N=N— or, e.g. carbonohydrazides, carbazones, semicarbazides, semicarbazones; Thioanalogues thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/20—Halogens; Compounds thereof
    • A61K8/21—Fluorides; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/43—Guanidines

Definitions

  • the present invention relates to a method and composition for disinfection, prevention of bacterial colony accumulation, dental plaque and calculus formation and related malodors. More particularly, the present invention relates to the use of a chlorohexidine fluoride paste or rinse for reducing the number of bacteria, reduction of the dental plaque and calculus formation on oral prosthetic devices and dentures, and at the same time reduce or eliminate accumulated stains and odors.
  • Chlorohexidine digluconate has been shown to be an effective antimicrobial agent. It is currently being used as a mouth rinse under the trade name of Peridex and marketed by Proctor and Gamble Co.. It has been studied as a dentifrice additive, but the problem of staining has persisted except as modified by the addition of fluorides.
  • the sulfur compounds, hydrogen sulfide (H 2 S) methylmercaptan (CH 3 )2S are recognized in the current dental literature as being the major contributors of oral malodor. Numerous researchers using organoleptic, chemical or gas chromatographic methods have demonstrated that these volatile sulfur compounds are present in the head space and vapor of putrified saliva and in individual samples of mouth air.
  • Dental plaque accumulates on oral prosthetic devices and dentures. Dental plaque is formed by a combination of events starting with a salivary proteinaceous coating of the prosthesis and the subsequent adhesion to the coating (pellicle) by streptococcus forms.
  • Dextrans produced by bacteria principally S. mutans and S. sanguis, are produced from sucrose, and with the assistance of bacterially produced glucosyltransferases, convert sucrose into glucose and fructose, and ultimately the glucose into dextrans.
  • the dextrans act as a nutrient substrate for the growth of additional organisms and the production of acids which demineralize both enamel and dentin causing decay.
  • Other strains of alpha streptococci and lactobacillus organisms include but are not limited to S.
  • Yeasts are normal residents of the human body flora, and most are potential pathogens. The most frequently involved species are Candida albicans, Candida tropicalis and Candida glabrata. The species have been found in the oral cavity of patients with denture stomatitis, and with systemic diseases such as neoplasia, cachexia and alcoholism. See Staib, F. , et al, International Congress Series, Amsterdam, Exerpta Medica, 1980, p. 481 and Bergendhal, T. , Treatment of denture stomatitis. A clinical, microbiological and histologic evaluation, thesis, University of Sweden 1982. For in-vitro studies see Bonesvoll, P., and Olsen, I.: J.
  • toothpastes have been supplemented with additives which claim to have beneficial effects against several dental diseases.
  • fluoride added to toothpaste has been shown to reduce dental caries but has not been shown to prevent gingivitis and periodontal disease.
  • Chlorohexidine has been shown to be effective as an antimicrobial agent. See Brown, A. , et al Co pend. Contin. Educ. Dent. 7:719-724, and also Emilson, C.G. Scandinavian Journal of Dental Research 85:255-265
  • chlorohexidine is currently applied as an oral rinse in a 0.12% aqueous solution. In this form it has been effective in reducing plaque and gingivitis but has also been associated with staining of the teeth, tongue and composite restorations. See Addy, M. et al Journal of Clinical Periodontoloqy 9:134-140 (1982) and also Loe, H. and Rindom Schiott, R. C. Journal of Periodontal Research 5:79-83 (1970) .
  • chlorohexidine digluconate 0.8% chlorohexidine digluconate, respectively, were tested against a placebo over a period of two months.
  • the chlorohexidine paste caused more staining than was observed in the control group; indeed, the rate of discoloration was higher than that reported following use of chlorohexidine mouthwashes.
  • a denture cleansing creme or solution contains chlorohexidine digluconate together with sodium monofluorophosphate as a composition for cleansing prosthetic devices and dentures, inhibiting the development of denture stomatitis and controlling oral malodor.
  • the chlorohexidine digluconate is an effective agent for reducing aerobic and anaerobic bacteria and Candida fungi, a causative factor in denture stomatitis and oral malodor.
  • the sodium monofluorophosphate reduces chlorohexidine staining.
  • Preferred concentrations of chlorohexidine digluconate are in the range of between 0.02%-2.0%, and the preferred concentrations of sodium monofluorophosphate are in the range of 0.05%-2.0%.
  • Another object of the present invention is to provid a method for preventing and treating stomatitis.
  • Still another object of the present invention is to provide a method for reducing the population of yeasts in the mouth.
  • Yet another object of the present invention is to provide a method for reducing the population of bacteria in the mouth.
  • a further object of the present invention is to provide a composition for preventing and treating oral malodor.
  • a still further object of the present invention is to provide a composition for preventing and treating stomatitis.
  • a yet further object of the present invention is to provide a composition for reducing the population of yeasts in the mouth.
  • a yet further object of the present invention is to provide a composition for reducing the bacteria in the mouth.
  • the present invention contemplates the use of chlorohexidine digluconate in combination with sodium monofluorophosphate to prevent and treat oral malodor and denture stomatitis by reducing the population of yeasts and bacteria in the mouth.
  • the use and efficacy of this composition is described below.
  • the toothpastes tested were: 1) a monofluorophosphate toothpaste with 0.2% chlorohexidine (the composition as stated in Table 1) , and 2) a placebo toothpaste identical in composition to the first toothpaste, but without chlorohexidine (the composition as stated in Table 2) .
  • the toothpaste was distributed in unmarked tubes. Identical soft toothbrushes were given to each subject every three months and the subjects were asked to use those brushes for the duration of the study. Subjects were asked to brush at least twice daily, once in the morning and once in the evening. Examinations of the subjects were conducted at a dental clinic having good lighting, compressed air, mouth mirrors and Marquis dental probes. Each of the following parameters were evaluated.
  • MICROBIAL ANALYSIS A bacterial sample was taken from eighty of the subjects (forty were randomly selected from eac group) . The results of the studies of bleeding, gingivitis and stain are set forth in Table 3. The microbial study results indicated that the mean count of anaerobic bacteria in the control group was 6,600,000 contrasted to the mean count of the test group of 4,800,000. Therefore, there was a significant reduction in anaerobic bacteria, the main cause of gingivitis and periodontitis, in the test group compared to the control group. Significantly, this reduction in anaerobic bacteria, undoubtedly caused by the action of chlorohexidine digluconate on the mouth, was not accompanied by chlorohexidine staining of the teeth.
  • test group stain was halved in a three month period and was only slightly higher than the stain observed in the control group. Gingivitis and bleeding were also significantly decreased in the test group and was on a par with reductions observed in the control group.
  • chlorohexidine digluconate combined with sodium monofluorophosphate in a dentifrice is effective in reducing anaerobic bacteria, the causative factor in periodontal disease, without an increase in tooth staining.
  • the composition also effectively reduces bleeding and gingivitis. Shelf life analysis of the original 2.0% chlorohexidine containing dentifrice indicated that after a 27 month shelf life, the concentration of chlorohexidine was 0.15%.
  • Titanium Dioxide 0.50%
  • Group I Sixty patients having either full dentures or partial dentures fabricated with acrylic resin were divided into three groups.
  • Group I was provided a denture creme containing 1.5% chlorohexidine gluconate (CHX) and 0.85% sodium monofluorophosphate and were advised to scrub the prosthesis twice daily.
  • Group II was provided an aqueous solution of 1.5% CHX and 0.85% sodium monofluorophosphate and advised to soak their prostheses for five minutes twice daily.
  • Group III was provided a 0.6 normal saline solution and instructed to soak their prostheses twice daily for five minutes; this group could be used as a control group. All subjects provided their prostheses for evaluation after eight weeks.
  • Each prosthesis was placed in a beaker, covered with 0.6 normal saline solution, sonicated for two minutes, centrifuged and the precipitate was spread on glass slides for Gram staining and study by dark field microscopy with an ocular grid.
  • chlorohexidine fluoride paste, creme or solution will not leave residual chlorohexidine staining and will reduce or prevent denture and other oral prosthesis appliance adhesion of bacteria and Candida which is the required step in preventing oral mucositis, bacterial accumulations leading to known intraoral microbiologically induced diseases as well as the related malodor.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Birds (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cosmetics (AREA)

Abstract

L'invention se rapporte à une pâte, crème ou solution contenant du digluconate de chlorohexidine conjointement avec du monofluorophosphate de sodium et qui est utilisée pour prévenir l'apparition des stomatites, des mauvaises odeurs et de la plaque dentaire ainsi que la prolifération de bactéries et de levures Candida. Le digluconate de chlorohexidine est un agent efficace de réduction de la prolifération de levures Candida et de bactéries aérobies et anaréobies, qui sont le facteur causant les stomatites ou les inflammations de la muqueuse buccale. Le monofluorophosphate de sodium réduit l'apparition des tâches de chlorohexidine. Les concentrations préférées de digluconate de chlorohexidine sont comprises entre 0,02 % et 2,0 % et celles de monofluorophosphate de sodium entre 0,05 % et 2,0 %.
PCT/US1990/001706 1990-03-30 1990-03-30 Procede et composition servant a prevenir les stomatites chez les utilisateurs de dentiers WO1991015189A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US1990/001706 WO1991015189A1 (fr) 1990-03-30 1990-03-30 Procede et composition servant a prevenir les stomatites chez les utilisateurs de dentiers

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1990/001706 WO1991015189A1 (fr) 1990-03-30 1990-03-30 Procede et composition servant a prevenir les stomatites chez les utilisateurs de dentiers

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WO1991015189A1 true WO1991015189A1 (fr) 1991-10-17

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997025966A1 (fr) * 1996-01-15 1997-07-24 Henkel Kommanditgesellschaft Auf Aktien Produits d'hygiene dentaire
US6440395B1 (en) 1992-06-22 2002-08-27 Barry M. Libin Antiplaque mouth rinse
JP2012509271A (ja) * 2008-11-17 2012-04-19 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 歯科器具クレンザー

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3842168A (en) * 1971-03-22 1974-10-15 Colgate Palmolive Co Method of preparing stable dentifrice
US3843779A (en) * 1971-03-22 1974-10-22 Colgate Palmolive Co Process for preparing stable dentifrice
US3887701A (en) * 1974-11-01 1975-06-03 Colgate Palmolive Co Antibacterial oral compositions containing preservative-antioxidants
US3925543A (en) * 1973-11-01 1975-12-09 Colgate Palmolive Co Antibacterial oral compositions containing preservative-antioxidants
US3937807A (en) * 1973-03-06 1976-02-10 The Procter & Gamble Company Oral compositions for plaque, caries, and calculus retardation with reduced staining tendencies
US3937805A (en) * 1971-11-10 1976-02-10 Colgate-Palmolive Company Method of making dentifrice compositions containing insolubilized salts of 1,6-di-(p-chlorophenyl biguanido) hexane
US3957967A (en) * 1973-07-27 1976-05-18 Blendax-Werke R. Schneider & Co. Agent for the care and the cleaning of teeth and dentures
US3989813A (en) * 1973-01-26 1976-11-02 Colgate-Palmolive Company Stabilized dentifrice
US4001393A (en) * 1973-01-20 1977-01-04 Blendax-Werke R. Schneider Gmbh & Co. Means for caries prophylaxis
US4137303A (en) * 1975-06-18 1979-01-30 Colgate Palmolive Company Antibacterial oral composition
US4725428A (en) * 1984-11-06 1988-02-16 Lion Corporation Dental caries-preventive composition containing antibody

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3842168A (en) * 1971-03-22 1974-10-15 Colgate Palmolive Co Method of preparing stable dentifrice
US3843779A (en) * 1971-03-22 1974-10-22 Colgate Palmolive Co Process for preparing stable dentifrice
US3937805A (en) * 1971-11-10 1976-02-10 Colgate-Palmolive Company Method of making dentifrice compositions containing insolubilized salts of 1,6-di-(p-chlorophenyl biguanido) hexane
US4001393A (en) * 1973-01-20 1977-01-04 Blendax-Werke R. Schneider Gmbh & Co. Means for caries prophylaxis
US3989813A (en) * 1973-01-26 1976-11-02 Colgate-Palmolive Company Stabilized dentifrice
US3937807A (en) * 1973-03-06 1976-02-10 The Procter & Gamble Company Oral compositions for plaque, caries, and calculus retardation with reduced staining tendencies
US3957967A (en) * 1973-07-27 1976-05-18 Blendax-Werke R. Schneider & Co. Agent for the care and the cleaning of teeth and dentures
US3925543A (en) * 1973-11-01 1975-12-09 Colgate Palmolive Co Antibacterial oral compositions containing preservative-antioxidants
US3887701A (en) * 1974-11-01 1975-06-03 Colgate Palmolive Co Antibacterial oral compositions containing preservative-antioxidants
US4137303A (en) * 1975-06-18 1979-01-30 Colgate Palmolive Company Antibacterial oral composition
US4725428A (en) * 1984-11-06 1988-02-16 Lion Corporation Dental caries-preventive composition containing antibody

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, Volume 88, No. 3, issued 16 January 1978, (KIYOSHIGE, T. et al.), "Effects of Chlorhexidine and Monofluorophosphate Combinations on the Reduction of Dental Caries and Plaque Accumulation in Rats", see page 48 col. 2, the Abstract No. 16056a; & KOKU EISEI GAKKAI ZASSHI (1977), 27(3): 100-105 (Japanse). *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6440395B1 (en) 1992-06-22 2002-08-27 Barry M. Libin Antiplaque mouth rinse
WO1997025966A1 (fr) * 1996-01-15 1997-07-24 Henkel Kommanditgesellschaft Auf Aktien Produits d'hygiene dentaire
JP2012509271A (ja) * 2008-11-17 2012-04-19 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 歯科器具クレンザー

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