A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
- Conditions
- Dental Caries
- Interventions
- Drug: PlaceboDrug: Fluoride
- Registration Number
- NCT01607411
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fluoride free toothpaste Placebo toothpaste with no fluoride 1426ppm Fluoride Toothpaste Fluoride Experimental toothpaste containing 1426 ppm Fluoride 500 ppm Toothpaste Fluoride Experimental toothpaste containing 500 ppm Fluoride 1000 ppm Fluoride Toothpaste Fluoride Experimental toothpaste containing 1000 ppm Fluoride
- Primary Outcome Measures
Name Time Method Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice 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 Outcome Measures
Name Time Method Enamel Fluoride Uptake Baseline to 4 hours Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)\* F/centimeters(cm)\^2. Difference between treatments was calculated with respect to F uptake by enamel.
Percent Net Acid Resistance (%NAR) of Enamel Specimens Baseline to 4 hours Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: \[(D1-D2)/ (D1-B)\]\*100.
%SMHR of Enamel Specimens Exposed to Test Treatments 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.
Trial Locations
- Locations (1)
Indiana University School of Dentistry
🇺🇸Indianapolis, Indiana, United States