Enamel Remineralization Potential of Dentifrices in Situ

Study Overview
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Brief Summary
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This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

Official Title
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Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: NaF
* Drug: SnF
* Drug: NaMFP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health. No current active caries or periodontal disease that may compromise the study or health of the subject. All restorations in a good state of repair Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm. Willing to have their denture modified to accomodate enamel test specimens Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods. Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute. Exclusion Criteria: Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit. Current active caries or periodontal disease that may compromise the study or health of the subject.

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride Toothpaste 1<br>Fluoride toothpaste containing sodium fluoride (NaF) | Drug: NaF<br>* Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.<br>|
| Experimental: Fluoride Toothpaste 2<br>Fluoride toothpaste containing stannous fluoride (SnF) and NaF. | Drug: NaF<br>* Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.<br>Drug: SnF<br>* Fluoride toothpaste containing stannous fluoride (1100 ppmF)<br>|
| Experimental: Fluoride Toothpaste 3<br>Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF. | Drug: NaF<br>* Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.<br>Drug: NaMFP<br>* Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)<br>|
| Active Comparator: Reference Dentifrice<br>Low fluoride toothpaste containing NaF | Drug: NaF<br>* Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/(D-B)]*100. | Baseline to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/ (D-B)]*100. | Baseline to 14 days | 
| Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. | Baseline to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enamel remineralization, Fluoride, caries