A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Fluoride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride free toothpaste<br>toothpaste with no fluoride | Drug: Placebo<br>* Fluoride free toothpaste<br>|
| Experimental: 1426ppm Fluoride Toothpaste<br>Experimental toothpaste containing 1426 ppm Fluoride | Drug: Fluoride<br>* Fluoride Toothpaste<br>|
| Experimental: 1000 ppm Fluoride Toothpaste<br>Experimental toothpaste containing 1000 ppm Fluoride | Drug: Fluoride<br>* Fluoride Toothpaste<br>|
| Experimental: 500 ppm Toothpaste<br>Experimental toothpaste containing 500 ppm Fluoride | Drug: Fluoride<br>* Fluoride Toothpaste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice | 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. | Baseline to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %SMHR of Enamel Specimens Exposed to Test Treatments | 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. | Baseline to 4 hours | 
| Percent Net Acid Resistance (%NAR) of Enamel Specimens | 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. | Baseline to 4 hours | 
| Enamel Fluoride Uptake | 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. | Baseline to 4 hours |