In Situ Caries Efficacy of Fluoride Toothpastes

Study Overview
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Brief Summary
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This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model

Detailed Description
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In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).

Official Title
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Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model

Conditions
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Caries

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. Age:Aged between 18 and 80 years. Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions. General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side. b) Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and all restorations in a good state of repair Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate = 0.8 mL/minute) Exclusion Criteria: Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Breast-feeding:Women who are breast-feeding. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study. Substance abuse: Recent history (within the last year) of alcohol or other substance abuse. Personnel:a) A member of the site study staff living in same household.b)An employee of the sponsor. c) Any employee of any toothpaste manufacturer or their spouse or family member

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- |
| Experimental: NaF toothpaste(1450 ppmF)<br>Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. | Drug: NaF<br>* Fluoride<br>* Other names: Fluoride;|
| Active Comparator: NaF toothpaste (1400 ppmF)<br>Study toothpaste containing 1400 ppm F as NaF | Drug: NaF<br>* Fluoride<br>* Other names: Fluoride;|
| Active Comparator: NaMFP/NaF toothpaste (1450 ppmF)<br>Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF | Drug: NaF<br>* Fluoride<br>* Other names: Fluoride;Drug: NaMFP<br>* Fluoride<br>|
| Active Comparator: NaF toothpaste (675 ppmF)<br>Study toothpaste containing 675 ppm F as NaF | Drug: NaF<br>* Fluoride<br>* Other names: Fluoride;|
| Placebo Comparator: Placebo toothpaste (0 ppmF)<br>Fluoride free placebo toothpaste (0 ppm F) | Drug: Placebo<br>* Placebo<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 Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | 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 SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100. | Baseline to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | 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 SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100. | Baseline to 14 days | 
| Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | 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 SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100. | Baseline to 14 days | 
| Enamel Fluoride Uptake (Sound Enamel Specimens) | 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 | 
| Enamel Fluoride Uptake (Demineralized Specimens) | 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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fluoride, in situ, remineralization, enamel, caries