A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Overview
- Phase
- Phase 3
- Intervention
- Fluoride
- Conditions
- Dental Caries
- Sponsor
- GlaxoSmithKline
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).
Exclusion Criteria
- Not provided
Arms & Interventions
1000 ppm Fluoride Toothpaste
Experimental toothpaste containing 1000 ppm Fluoride
Intervention: Fluoride
500 ppm Toothpaste
Experimental toothpaste containing 500 ppm Fluoride
Intervention: Fluoride
Fluoride free toothpaste
toothpaste with no fluoride
Intervention: Placebo
1426ppm Fluoride Toothpaste
Experimental toothpaste containing 1426 ppm Fluoride
Intervention: Fluoride
Outcomes
Primary Outcomes
Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
Time Frame: Baseline to 4 hours
Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100.
Secondary Outcomes
- Enamel Fluoride Uptake(Baseline to 4 hours)
- Percent Net Acid Resistance (%NAR) of Enamel Specimens(Baseline to 4 hours)
- %SMHR of Enamel Specimens Exposed to Test Treatments(Baseline to 4 hours)