Colgate® Duraphat® Varnish 50mg/ml Dental Suspension

 

Product Details

  • EFFICACY & SAFETY OF 
    COLGATE® DURAPHAT® VARNISH

    COLGATE® DURAPHAT® VARNISH 50MG/ML DENTAL SUSPENSION 
    2.26% (22,600PPM) SODIUM FLUORIDE IS A PRESCRIPTION ONLY FLUORIDE VARNISH

    Colgate® Duraphat® Varnish for professional application, is currently the only medically licensed (Prescription Only Medicine, POM) varnish clinically proven for the prevention of caries. For more information on licensed medicinal products and implications for your patients please visit: www.gov.uk/drug-safety-update/off-label-or-unlicensed-use-of-medicines-prescribers-responsibilities#prescribing-in-a-patients-best-interests

    • Colgate® Duraphat® Varnish reduces caries by 37% in primary dentition and by 43% in permanent dentition1
    • Colgate® Duraphat® Varnish is also clinically proven and medicinally licensed for the treatment of dentine hypersensitivity2
    PRODUCT CHARACTERISTICS
    • Contains 22,600ppm sodium fluoride
    • Tinted for ease of visualisation when applied to tooth surfaces
    PRODUCT BENEFITS
    • Clinically proven efficacy for caries control1. Also clinically proven efficacy against dentine hypersensitivity, for 30 days with just one application2
    • Clinically proven efficacy against dentine hypersensitivity, for 30 days with just one application2
    • Quick and easy application 

      The ‘Delivering better oral health’ guidance document3 states: Clinicians should be aware that there are many fluoride varnishes on the market. They may not be licensed for caries control, although they may have similar formulations, and this should be taken into consideration with respect to prescriber’s responsibilities.

     

    1Marinho VCC, et.al. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database of Systematic reviews 2013, Issue 7. Art No. CD002279. 
    2 Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628
    3 Delivering better oral health – An evidence-based toolkit for prevention, third edition, Public Health England, June 2014.

    • Fluoride varnishes for preventing dental caries in children and adolescents
      Marinho V et al (2002) Cochrane Database Syst. Rev. No. 3
    • An open study of the Relative Efficacy of Duraphat vs. Extra Strength AIM in the Treatment of Dentinal Hypersensitivity
      Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628 
      (digital view not available) 
      If you would like to request a copy of this clinical research paper, please call 01483 401901. Thank You.
  • PRODUCT INFORMATION

    Usage: Medically licensed for professional application for caries control and treatment of dentine hypersensitivity.

    Product benefits: Colgate® Duraphat® Varnish is clinically proven for the prevention of caries.1 It is tinted for easy visualisation and sets rapidly on contact with saliva, making it quick and easy to apply.

    Colgate® Duraphat® Varnish is clinically proven to be effective against dentine hypersensitivity for 30 days with just one application.2

    Mode of action: Colgate® Duraphat® Varnish covers teeth with a film of suspension which hardens in the presence of saliva. It then persists over the following hours to cause Fluoride to accumulate at a measurable depth in the tooth enamel to deliver:

    1. Prevention of caries. Forms calcium fluoride on the tooth surface, providing a fluoride reservoir for protection against cariogenic acid attack.
    2. Desensitisation of hypersensitive teeth. Forms calcium fluoride globules which occlude dentine tubules.

    Active ingredients: Contains 22,600ppm sodium fluoride.

    Directions for use: Treatment is recommended every 6 months or a maximum of every three months. For hypersensitivity 2-3 applications are recommended within a few days.

    For further guidance on usage and frequency of application, please see summary guidance and section 3 on increasing F availability in ‘Delivering better oral health - An evidence based toolkit for prevention’. Third edition, published by Public Health England, 20143

    For further information on application to children, please see: Colgate® Duraphat® Varnish application

     


    1 Marinho VCC, et.al. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database of Systematic reviews 2013, Issue 7. Art No. CD002279. 
    2 Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628 
    3 Delivering better oral health - An evidence based toolkit for prevention. Third edition, published by Public Health England, 2014

    • The UK has a governing body for all medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) that reviews the safety, quality and efficacy of all products with medical licenses. If the product meets the required specifications and can demonstrate that it delivers the medicinal benefits it claims then it can be granted a license. Once granted a medical licence, is the MHRA monitors the clinical evidence and the manufacturing process by systems of inspections and testing for quality assurance throughout the lifetime of the medicine. The MHRA also continuously monitor the safety of medicines to ensure that the information patients and healthcare professionals receive is up-to-date and accurate. Due to this process, any side-effects of a medicine need to be clearly stated on the product packaging or in the patient leaflet. This ensures that the dispensing healthcare professional is fully aware of any risk associated with the product and can weigh up the benefits of recommending the medicine.

    • Colgate® Duraphat® varnish is clinically proven and has a medical license (Prescription Only Medicine, POM) for the prevention and treatment of caries.1 It is also clinically proven and medicinally licensed to relieve dentine hypersensitivity for 30 days with just one application.2

    • Unopened, please refer to expiry date on pack and aluminium tube. After opening, use within three months.

    • Patients should be advised not to brush their teeth or chew hard food for at least 4 hours after treatment. During this time, soft foods and liquids may be consumed after 30 minutes.

    • Instruments, clothing, etc. which come into contact with Colgate® Duraphat® varnish can be cleaned with alcohol.

    • Colgate® Duraphat® varnish should be applied as a thin layer to all susceptible surfaces of the dentition.

      ‘Delivering better oral health - An evidence-based toolkit for prevention’3 published by Public Health England, recommends two or more applications of fluoride varnish for caries prevention in all children aged 3 years and above. Adults who are giving cause for concern should also receive twice yearly applications of fluoride varnish. Tailored preventive advice about home care to control caries should also be provided at each application.

       

    • No, Colgate® Duraphat® varnish is to be applied by a dental professional.

       

    • Colgate® Duraphat® varnish works in two ways:

      1. Prevention of caries. Forms calcium fluoride on the tooth surface, providing a fluoride reservoir for protection against cariogenic acid attack.
      2. Desensitisation of hypersensitive teeth. Forms calcium fluoride globules which occlude dentine tubules.
    • Colgate® Duraphat® varnish is indicated for caries control and desensitisation of hypersensitive teeth.

    1 Marinho VCC, et.al. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database of Systematic reviews 2013, Issue 7. Art No. CD002279. 
    2 Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628
    3 Delivering better oral health – An evidence-based toolkit for prevention, third edition, Public Health England, June 2014.