WO1995022308A1 - Procede pour diagnostiquer et soigner des caries dentaires - Google Patents

Procede pour diagnostiquer et soigner des caries dentaires Download PDF

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Publication number
WO1995022308A1
WO1995022308A1 PCT/CA1995/000081 CA9500081W WO9522308A1 WO 1995022308 A1 WO1995022308 A1 WO 1995022308A1 CA 9500081 W CA9500081 W CA 9500081W WO 9522308 A1 WO9522308 A1 WO 9522308A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
streptococcus mutans
stage
antimicrobial
varnish
Prior art date
Application number
PCT/CA1995/000081
Other languages
English (en)
Inventor
John J. Connelly
Original Assignee
The Oralife Group, Inc.
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
Priority claimed from CA002115853A external-priority patent/CA2115853A1/fr
Application filed by The Oralife Group, Inc. filed Critical The Oralife Group, Inc.
Publication of WO1995022308A1 publication Critical patent/WO1995022308A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/50—Preparations specially adapted for dental root treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/20—Protective coatings for natural or artificial teeth, e.g. sealings, dye coatings or varnish
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/60—Preparations for dentistry comprising organic or organo-metallic additives
    • A61K6/69—Medicaments

Definitions

  • the present invention relates to the diagnosis and reduction of dental caries which involves monitoring and reducing Streptococcus mutans levels in the oral cavity.
  • U.S. Patent No. 4,496,322 issued to Sandham and Balanyk discloses a varnish which may be applied to teeth which contains a dentally acceptable antimicrobial agent, such as chlorhexidene acetate, a benzoin gum, and an orally acceptable solvent.
  • a dentally acceptable antimicrobial agent such as chlorhexidene acetate, a benzoin gum, and an orally acceptable solvent.
  • the composition once applied to the teeth, is allowed to dry thereon and gives a transparent, translucent or tooth coloured film which is effectively invisible, but provides sustained release of the antimicrobial agent to an infection site over a period of a few days.
  • the above inventors in their U.S. Patent No. 4,883,534 describe the use of a sealing composition applied over the varnish.
  • the sealing composition is preferably solvated polyurethane which upon evaporation of solvent is cured.
  • test kit for the determination of Streptococcus mutans in the oral cavity of a dental patient.
  • the test is a semi-quantitative determination which is suitable for use by dentists and dental professionals in a non-laboratory environment.
  • the test kit is sold commercially under the trade-mark CARIESCREEN SM by APO Diagnostics Inc. of Markham, Ontario, Canada.
  • the test is an in vitro semi-quantitative dip-slide culture test for the detection of Streptococcus mutans in the oral cavity by use of a selective culture medium.
  • the test uses a selective medium which, when used in conjunction with the diluent plus a dissolved bacitracin tablet, inhibits the growth of most salivary bacteria except for Streptococcus mutans.
  • a carbon dioxide generating tablet is used to provide a carbon dioxide environment which enhances the growth of Streptococcus mutans.
  • the CARIESCREEN SM test kit has been on the market for some time, but very little use has been made of it, in the clinical setting.
  • the proposed method for the diagnosis and reduction of dental caries in patients would substantially reduce the cost of the antimicrobial coating for Streptococcus mutans bacteria control, since it would only be applied in instances where it was required, and further its use in the required instances would be in accordance with the levels of Streptococcus mutans found in monitoring tests.
  • the method provides an early warning indicator of dental problems which may otherwise go unnoticed.
  • the method allows for treatment cost reduction and the problems of patient compliance are substantially eliminated.
  • a method for the diagnosis and reduction of dental caries in patients comprising testing the level of Streptococcus mutans in an oral cavity of a patient to determine the level of Streptococcus mutans in the oral cavity and establish what treatment, if any, the patient requires in accordance with the following guidelines: a. for a patient with normal level of Streptococcus mutans, the patient is not subjected to any treatment, but is asked to return for routine checkups and testing of Streptococcus mutans levels;
  • Streptococcus mutans bacteria Generally what constitutes normal, higher than normal and substantially higher than normal levels of Streptococcus mutans bacteria is dependant on all of the previously mentioned factors. However, it is generally understood that levels of Streptococcus mutans ranging from 0 or nothing detected to 250,000 colonies per ml constitute a low level, for which no treatment would be indicated.
  • a person who would have slightly above normal levels and who would benefit from at least one treatment would have Streptococcus mutans levels ranging from 250,000 to 500,000 colonies per ml. Substantially higher than normal levels would range from upwards of 500,000 colonies per ml and such a person would necessarily require multiple treatments over the space of corresponding weeks, often about four treatments over about four weeks, with one treatment per week being applied.
  • Streptococcus mutans testing clearly helps to demonstrate the efficacy of the CHLORZOIN antimicrobial two stage coating. Such testing clearly indicates how many CHLORZOIN coating applications are required, and whether in fact they are working.
  • CHLORZOIN coating treatments allows a dentist to determine when retreatment with CHLORZOIN coating is required on an individual basis.
  • the means for testing the level of Streptococcus mutans in the kit and method of the present invention may be selected from any suitable test available, examples of which include that commercially available under the trade-mark CARIESCREEN SM, which is described in detail in Canadian Patent No. 1,235,986 and which may be described generally in the following manner.
  • the CARIESCREEN SM test kit generally comprises the following components:
  • a sealed container for an antiseptic solid substrate which substrate has at least one surface coated with a selected solid medium to reduce the growth of Streptococcus mutans and a predetermined amount of saccharide compound; 2. a second sealed container for a buffered saline solution into which a test sample is deposited for determining Streptococcus mutans level; 3. a solid bacitracin composition in an amount and concentration, which in combination with the quantity of saccharide is not sufficient to preclude growth of Streptococcus mutans, but is sufficient to
  • SUBSTITUTE SHEET prevent growth of substantial amounts of any interfering microorganism
  • a carbon dioxide generating composition for providing a carbon dioxide atmosphere for incubation of the solid substrate; 5. means are included to examine the surface of the incubated solid substrate for the colony density of Streptococcus mutans;
  • means are provided to prepare the colony density of the tested Streptococcus mutans with a comparison standard in order to determine in a semi-quantitative manner colony density of the Streptococcus mutans of the test sample;
  • the two stage antimicrobial coating composition comprises at least one antimicrobial agent which is effective against Streptococcus mutans and which preferably may be selected from chlorhexidene, salts of chlorhexidene and erythromycin.
  • Chlorhexidene acetate is a preferred salt, but other orally and biologically acceptable salts of chlorhexidene may be used such as hydrochloride or gluconate. Chlorhexidene acetate is preferred because of its solubility in water and in the solvent ethanol.
  • the resin binder may be selected from natural and synthetic resins which are physiologically acceptable, namely substances acceptable for application onto skin or mucosa and which do not cause negative taste perception.
  • the antimicrobial agent must be soluble in the resin or varnish
  • Preferred resins include benzoin gum, namely sandarac benzoin, in particular Sumatra or siam benzoin or fractions or recombined fractions thereof.
  • the resin is dissolved in a solvent, such as ethanol or water.
  • the solvent must be physiologically acceptable and ethanol is the solvent of choice.
  • Other alternatives would be apparent to the person skilled in the art.
  • the relative proportions of binder, antimicrobial agent and solvent in the composition may vary widely.
  • the lower solvent limit is fixed only by the maximum solubility of the other ingredients in the coating.
  • the ratio of antimicrobial agent to solvent can be anywhere from 0.001% w/v up to a saturated solution thereof e.g. 20%.
  • the ratio of antimicrobial agent to binder is suitably in the range of 10:1 to 1:10 by weight preferably 5:1 to 1:5 by weight, and most preferably 2:1 to 1:2 by weight. Precise preferred ratios depend to some extent on the rate of release of the antimicrobial agent from the film, once applied to the teeth. It is preferred to subject the site of infection initially to relatively large amounts of antimicrobial agents to reduce the chance of formation of antimicrobial resistance in the infection. In such instances, the amount of antimicrobial agent may range from about 10% to about 30%, preferably about 10% by weight. It is possible to include other ingredients in the antimicrobial coating.
  • any ingredient selected should not impart an unacceptable taste or texture, rendering it unpleasant to the user.
  • suitable additives include fluoride, such as sodium fluoride, stannous fluoride, amine fluoride and sodium monoflourophosphate. Fluoride is known to strengthen the hard tooth tissues against decalcification. It also has an additional effect on the suppression of Streptococcus mutans.
  • the fluoride may be present in an amount ranging from about 0.1 to 1% by weight with respect to the weight of the complete coating.
  • the second stage of the coating namely the polymeric sealant may be selected from a variety of materials known in the art to be physiologically acceptable for such application.
  • the preferred sealants are selected from varnishes such as polyurethane, acrylic, cellulose acetate, nitrocellulose and solid polyamide based, which are soluble in and used in suitable physiologically compatible solvents such as acetone or methylenechloride, with acetone being preferred.
  • Another preferred sealant comprises polyethyl methacrylate in ethyl acetate.
  • the polyethyl methacrylate may be selected from those commercially available under the trade-mark EIVACITE 2042, available from Dupont Canada Inc. and from ESSCHEM Co.
  • CHEMFIL II Varnish available from De Trey Division Dentsply Limited of Surrey, England, may be used.
  • methyl methacrylate will be present in from 9.0 to 11.0% w/w in ethyl acetate.
  • An example of a commercially available product is that sold under the trade-mark FLUOR-PROTECTOR.
  • FLUOR-PROTECTOR This formulation includes fluoride and is manufactured by Ivoclar-Vivadent.
  • Other commercially acceptable materials are sold under the trade-marks ADHESIT and PLUS-PROTECTOR. The latter formulation is similar to the FLUOR-PROTECTOR composition, without the fluoride component. In some instances, these formulations use ethanol or FREON as solvents.
  • the application of the polymeric sealant is made after the antimicrobial varnish layer has been applied and allowed to dry.
  • the sealant is applied in liquid form, usually in solution with a suitable solvent. It may be applied by painting over the entire area which is already covered by the antimicrobial layer.
  • the form of the sealant allows it to infiltrate crevices and other tooth surfaces whereby the already applied antimicrobial agent is sealed in position so that it maintains communication with the target site and hinders egress into the oral cavity.
  • the sealant once applied is allowed to cure by evaporation of
  • SUBSTITUTE SHEET solvent to form a hard transparent or translucent film over the first coating layer.
  • the sealing layer is dried rapidly and instantaneously. Drying may be assisted by use of an air syringe of the type usually employed by a dentist.
  • the formulations suitable for the antimicrobial coating layer are fully described in U.S. Patent No. 4,883,534. Typically, the product available commercially which falls within the scope of this patent is that sold under the trade-mark CHLORZOIN.
  • CARIESCREEN SM test for Streptococcus mutans was combined with the application of CHLORZOIN antimicrobial two stage coating in patients in a dental centre in Ottawa, Ontario, Canada.
  • CARIESCREEN SM test for Streptococcus mutans counts and 68% were found to have Streptococcus mutans levels of 250,000 colonies per ml of saliva or higher. It was determined that these patients would benefit best from the two stage antimicrobial coating sold under the trade-mark CHLORZOIN.
  • 6 out of 17 or 35% of patients had Streptococcus mutans counts in excess of 250,000 colonies per ml.
  • each of these patients was given one CHLORZOIN antimicrobial two stage coating application, and the levels noted subsequently were found three months after application.
  • the CARIESCREEN SM test allows the dentist to determine when retreatment with the CHLORZOIN antimicrobial two stage coating is required on an individual basis.
  • the objective is to keep the Streptococcus mutans counts below 250,000 colonies per ml in all patients and this is achievable by monitoring with the CARIESCREEN SM test on a three month basis.
  • This patient was tested for Streptococcus mutans using CARIESCREEN SM and the level was found to be 400,000 colonies per ml of saliva. Three and four months later, this patient was treated with three applications of the CHLORZOIN two stage antimicrobial coating. Two months afterwards, the patient was retested with CARIESCREEN SM test for Streptococcus mutans level and this was found to be 500,000 colonies per ml of saliva. Further examination revealed active decay at 37 mo root surface.
  • This patient was tested with CARIESCREEN SM test for S. mutans level which was found to be 500,000 colonies per ml of saliva. At this time, this patient was given one treatment of CHLORZOIN antimicrobial two stage coating. Subsequently three months later, this patient was retested with CARIESCREEN SM for Streptococcus mutans level and this was found to have remained at 500,000 colonies per ml of saliva. Five months later, the patient was the recipient of one filling for root decay. One month thereafter, the patient was the recipient of three CHLORZOIN antimicrobial two stage coating applications.
  • This patient was tested with CARIESCREEN SM for Streptococcus mutans level. The count was found to be 1,000,000 colonies per ml of saliva. The patient was then subjected to very careful examination and found to be suffering from deep root decay. Two extractions and two fillings were required. One month later, the patient was the recipient of four separate antimicrobial two stage applications.

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  • Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Cette invention se rapporte à un procédé pour diagnostiquer et soigner des caries dentaires, ce procédé utilisant: (i) un moyen de test pour contrôler le niveau de Streptococcus mutans dans la cavité buccale; et (ii) un enduit antimicrobien à deux couches, contenant comme première couche un vernis antimicrobien renfermant au moins un agent antimicrobien, dans une résine liante incorporée à un excipient liquide oralement acceptable, en vue de son application sur les dents, et comme seconde couche un produit de scellement polymère biodégradable, acceptable du point du vue dentaire et incorporé dans un excipient liquide oralement acceptable, ce produit de scellement étant appliqué sur le vernis, lorsque celui-ci a séché pour former un film translucide, transparent ou de la couleur des dents. Ce moyen de test est utilisé pour déterminer le niveau de Streptococcus mutans dans la cavité buccale d'un patient, afin d'établir, le cas échéant, de quel traitement a besoin le patient, en suivant les lignes directrices suivantes: a) pour un patient ayant des niveaux normaux de Streptococcus mutans, on demande au patient de revenir pour des contrôles de routine et pour surveiller le niveau de Streptococcus mutans au moyen de ce test effectué périodiquement; b) pour un patient ayant des niveaux de Streptococcus mutans supérieurs à la normale, on administre au patient une application de l'enduit antimicrobien à deux couches et on lui demande de revenir après trois mois, pour effectuer un nouveau test de dépistage de Streptococcus mutans; c) pour un patient ayant des niveaux de Streptococcus mutans considérablement supérieurs à la normale ou en permanence supérieurs à la normale, on administre au patient un total d'environ deux à environ quatre applications par semaine dudit enduit antimicrobien à deux couches; et d) pour un patient dont les niveaux de Streptococcus mutans restent inchangés après les applications de l'enduit à deux couches préconisées au paragraphe (c), on soumet le patient à un réexamen approfondi de sa dentition pour rechercher toute carie préalablement non détectée, ainsi que les détériorations récurrentes des racines ou les éventuelles défectuosités des obturations.
PCT/CA1995/000081 1994-02-17 1995-02-17 Procede pour diagnostiquer et soigner des caries dentaires WO1995022308A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CA002115853A CA2115853A1 (fr) 1994-02-17 1994-02-17 Trousse dentaire et traitement
CA2,115,853 1994-02-17
AU61997/94A AU6199794A (en) 1994-02-17 1994-05-10 Method for the diagnosis and reduction of dental caries
AU61997/94 1994-05-10

Publications (1)

Publication Number Publication Date
WO1995022308A1 true WO1995022308A1 (fr) 1995-08-24

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PCT/CA1995/000081 WO1995022308A1 (fr) 1994-02-17 1995-02-17 Procede pour diagnostiquer et soigner des caries dentaires

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5738113A (en) * 1996-01-05 1998-04-14 Knowell Therapeutic Technologies, Inc. Caries treatment method with fluoride
EP1272152B1 (fr) * 2000-04-03 2012-03-07 CHX Technologies Inc. Utilisation de la chlorhexidine pour la prevention de la carie du cement

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4496322A (en) * 1983-05-11 1985-01-29 University Of Toronto Innovations Foundation Benzoin antimicrobial dental varnishes
EP0244118A1 (fr) * 1986-04-29 1987-11-04 Pharmetrix Corporation Système à libération contrôlée de drogues pour la poche périodontale
WO1989010113A1 (fr) * 1988-04-26 1989-11-02 Rijksuniversiteit Te Groningen Composition antimicrobienne possedant une activite a long terme
US4883534A (en) * 1983-05-11 1989-11-28 University Of Toronto Innovations Foundations Benzoin antimicrobial dental varnishes
EP0381446A1 (fr) * 1989-01-31 1990-08-08 Yissum Research Development Company Of The Hebrew University Of Jerusalem Compositions pour utilisation orale à activité fongicide
EP0436382A2 (fr) * 1990-01-03 1991-07-10 Minnesota Mining And Manufacturing Company Matériau dentaire contenant un additif anti-affaissement
US5178870A (en) * 1988-04-26 1993-01-12 Explore Antimicrobial composition with long-term activity

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4496322A (en) * 1983-05-11 1985-01-29 University Of Toronto Innovations Foundation Benzoin antimicrobial dental varnishes
US4883534A (en) * 1983-05-11 1989-11-28 University Of Toronto Innovations Foundations Benzoin antimicrobial dental varnishes
EP0244118A1 (fr) * 1986-04-29 1987-11-04 Pharmetrix Corporation Système à libération contrôlée de drogues pour la poche périodontale
WO1989010113A1 (fr) * 1988-04-26 1989-11-02 Rijksuniversiteit Te Groningen Composition antimicrobienne possedant une activite a long terme
US5178870A (en) * 1988-04-26 1993-01-12 Explore Antimicrobial composition with long-term activity
EP0381446A1 (fr) * 1989-01-31 1990-08-08 Yissum Research Development Company Of The Hebrew University Of Jerusalem Compositions pour utilisation orale à activité fongicide
EP0436382A2 (fr) * 1990-01-03 1991-07-10 Minnesota Mining And Manufacturing Company Matériau dentaire contenant un additif anti-affaissement

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5738113A (en) * 1996-01-05 1998-04-14 Knowell Therapeutic Technologies, Inc. Caries treatment method with fluoride
EP1272152B1 (fr) * 2000-04-03 2012-03-07 CHX Technologies Inc. Utilisation de la chlorhexidine pour la prevention de la carie du cement

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WO1995022308A1 (fr) Procede pour diagnostiquer et soigner des caries dentaires

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