Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

Overview

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: October 2009

Interventions

  • Drug: Sodium fluoride
    • Test fluoride toothpaste and test fluoride mouth rinse
  • Drug: Sodium monoflurophosphate
    • United Kingdom marketed fluoride toothpaste
  • Drug: Sterile water
    • Sterile water rinse

Arms, Groups and Cohorts

  • Experimental: Test Dentifrice + Test Mouth Rinse (MR)
    • Test fluoride dentifrice and test fluoride MR
  • Experimental: Test Dentifrice + Sterile Water Rinse
    • Test fluoride dentifrice and sterile water rinse
  • Experimental: Placebo Dentifrice + Test MR
    • Placebo dentifrice and test fluoride rinse
  • Active Comparator: Reference Dentifrice + Sterile Water Rinse
    • Marketed fluoride dentifrice with sterile water rinse
  • Placebo Comparator: Placebo Dentifrice + Sterile Water Rinse
    • Placebo dentifrice and sterile water rinse

Clinical Trial Outcome Measures

Primary Measures

  • Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
    • Time Frame: Baseline, 4 hours post treatment in each treatment period
    • Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.

Secondary Measures

  • Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse
    • Time Frame: Baseline, 4 hours post treatment in each treatment period.
    • SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.

Participating in This Clinical Trial

Inclusion Criteria

  • An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch – subjects may have fixed bridges replacing missing teeth – No current active caries or periodontal disease that may compromise the study or the health of the subjects – A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0.

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