Colgate<sup>®</sup> Duraphat<sup>®</sup> Varnish (Rx, In-office Treatment)

Colgate® Duraphat® Varnish (Rx, In-office Treatment)

A topical fluoride which is clinically proven for the prevention of caries.

  • Colgate® Duraphat® varnish is also clinically proven for the treatment of dentine hypersensitivity

  • Clinically proven pain relief with just one application

Ingredients

1 mL of this suspension contains 50 mg sodium fluoride, equivalent to 22.6 mg of fluoride

How It Works

Colgate® Duraphat® varnish works in two ways:

  1. Prevents caries. Forms calcium fluoride on the tooth surface, providing a fluoride reservoir for protection against cariogenic acid attack.
  2. Controls dentine hypersensitivity. Forms calcium fluoride globules which occlude dentine tubules.
Proven Effectiveness

  • Clinically proven efficacy against caries1
  • Clinically proven efficacy against dentine hypersensitivity, for 30 days with just one application 2
  • Quick and easy application
  • 1. Marinho V et al (2002) Cochrane Database Syst. Rev. No. 3
    2. Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628

Prescribing Information

Colgate® Duraphat® Varnish (Rx, In-office treatment)

Description

Duraphat prevents tooth decay and desensitizes hypersensitive teeth. The active ingredient, Sodium Fluoride is an anti-caries agent. When Duraphat is applied on to the teeth, globules of calcium fluoride form on the enamel. These globules break down to release fluoride which penetrates deep into the tooth and provides long-term protection against tooth decay.

Composition

1 ml of Duraphat contains 50 mg of the active ingredient Sodium Fluoride equivalent to 22.6 mg of Fluoride. Other ingredients are Ethanol, White wax (E901), Shellac (E904), Colophony, Mastic, Saccharin (E954) and Raspberry Essence (which contains Ethyl Butyrate, Geraniol, Iris Resinoid, Isoamyl Acetate, Jasmine Absolute, Vanillin and Propylene Glycol). Duraphat is a brown/yellow opaque suspension. It is supplied in tubes of 10 ml or 30 ml or cylinders of 1.6 ml.

Indications

For the prevention of caries in children and adults as part of a comprehensive control programme.

For the:

  • Prevention of recurring (or marginal) caries
  • Prevention of progression of caries
  • Prevention of decalcification around orthodontic appliances
  • Prevention of pit and fissure (occlusal) caries.
  • For the desensitization of hypersensitive teeth as part of a treatment regimen which includes the daily use of a suitable toothpaste

    Dosage

    Duraphat 50mg/ml Dental Suspension is to be applied by the dentist. Before applying Duraphat, excess plaque should be removed and the teeth dried. Duraphat is applied as a thin layer to the most susceptible areas of dentition using a brush, probe or swab. Recommended dosage for single application: For milk teeth: up to 0.25 ml (=5.65 mg Fluoride) For mixed dentition: up to 0.40 ml (=9.04 mg Fluoride) For permanent dentition: up to 0.75 ml (=16.95 mg Fluoride) For caries prophylaxis, the application is usually repeated every 6 months but more frequent applications (every 3 months) may be made. For hypersensitivity, 2 or 3 applications should be made within a few days. The patient should not brush the teeth or chew food for 4 hours after treatment.

    Directions for Use

    1. If necessary the teeth should be cleaned, especially at the sites most susceptible to caries. When groups of patients (e.g. children) are to be treated, they should clean the teeth themselves using a toothbrush. To start, clear one or two quadrants of excessive saliva using a miniature cotton swab, probe or brush, painting and dabbing repeatedly to form a thin layer. Then treat the next quadrants in the same manner. It is advisable to begin by applying the dental suspension to teeth in the lower jaw before too much saliva collects and interferes. It may not be necessary to paint the lingual surfaces since these are generally more caries-resistant; Duraphat should preferably be applied to those spots most susceptible to caries attack.
    2. Application of Duraphat from the cylinders is particularly suited to targeted, low-dose application. A blunt cannula is used with the end bent to an angle to facilitate application to approximal and distal surfaces. For application to approximal surfaces place the cannula between adjacent teeth and deliver a small amount of Duraphat. The dental suspension should be applied from both sides of the interproximal space and occlusally.
    3. For fissures, a drop of Duraphat should be spread along the fissure using the cannula. Edges of fillings and crowns and hypersensitive tooth necks can be treated in the same way.
    4. The smooth surfaces of the teeth should be treated when caries activity is high, particularly if decalcification is evident. The cannula should be placed tangentially to the teeth and Duraphat distributed with the side of curved cannula end.
    5. Areas around fixed orthodontic devices can be treated with Duraphat using the cannula.
    6. The yellowish colour of Duraphat facilitates its application and control, Duraphat sets in the presence of saliva. The effect of Duraphat depends upon the prolonged activity of the fluoride. The dental suspension film should not be removed prematurely. Patients should be advised not to brush their teeth or chew food for at least 4 hours after treatment; during this time, soft foods and liquids may be consumed. However, if you need to, the dental suspension layer can easily be removed by brushing or rinsing.
    7. Instruments, clothing, etc. which comes into contact with Duraphat can be cleaned with alcohol.

    Contraindications

    Hypersensitivity to colophony and/or any other constituents.
    Ulcerative gingivitis.
    Stomatitis.
    Bronchial asthma.

    Interactions

    The presence of alcohol in the Duraphat formula should be considered.

    Adverse Reactions

    Edematous swellings have been reported only in rare instances in some fluoride varnish products, especially after application to extensive surfaces. Dyspnea, although extremely rare, has occurred in asthmatic children. Nausea has been reported when extensive applications have been made. If required, varnish film can be removed with a thorough brushing. Store in a cool, dry place.