Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice

Study Overview
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Brief Summary
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In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.

Official Title
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In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice

Conditions
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Caries

Intervention / Treatment
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* Drug: Calcium sodium phosphosilicate
* Drug: Sodium monoflurophosphate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens [required dimensions 12 x 7 millimeters (mm)].

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSP/SMFP Dentifrice<br>Dentifrice containing high fluoride content as SMFP and CSP | Drug: Calcium sodium phosphosilicate<br>* CSP high percentage weight by weight<br>Drug: Sodium monoflurophosphate<br>* 500 to 1500 parts per million (ppm) of fluoride<br>|
| Active Comparator: SMFP Dentifrice Prototype 1<br>Dentifrice containing high fluoride content as SMFP and no CSP | Drug: Sodium monoflurophosphate<br>* 500 to 1500 parts per million (ppm) of fluoride<br>|
| Active Comparator: SMFP Dentifrice Prototype 2<br>Dentifrice containing low fluoride content as SMFP and no CSP | Drug: Sodium monoflurophosphate<br>* 500 to 1500 parts per million (ppm) of fluoride<br>|
| Active Comparator: CSP Dentifrice<br>Dentifrice containing CSP but no fluoride | Drug: Calcium sodium phosphosilicate<br>* CSP high percentage weight by weight<br>|
| Placebo Comparator: Placebo Dentifrice<br>Dentifrice containing no CSP and no fluoride | Drug: Placebo<br>* No CSP and no fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Percent SMH recovery (SMHR) was calculated from hardness 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. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. | Baseline to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Percent SMH recovery (SMHR) was calculated from hardness 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. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. | Baseline to 21 days | 
| Enamel Fluoride Uptake (EFU) | Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens. | Baseline to 21 days |