To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study

Study Overview
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Brief Summary
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This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.

Official Title
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Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Control toothpaste containing no anti-cavity ingredients
* Drug: Experimental toothpaste containing fluoride and amino acid (arginine)
* Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or female subjects 18 to 50 years inclusive Minimum of 20 natural uncrowned teeth (excluding third molars) must be present Willing to wear retainer 24 hours per day No active, unrestored cavities Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry Available throughout entire study Willing to use only assigned products for oral hygiene throughout the duration of the study Must give written informed consent Must be in good general health No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: Advanced periodontal disease Medical condition which requires premedication prior to dental visits/procedures Not enough teeth to secure the oral retainer Diseases of the soft or hard oral tissues Wear an Orthodontic appliances Impaired salivary function Current use drugs that can affect salivary flow Use antibiotics one (1) month prior to or during this study Pregnant or breastfeeding Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period Use tobacco products Allergic to common toothpaste ingredients Allergic to amino acids Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride free, silica based toothpaste<br>Control toothpaste containing no anti-cavity ingredients | Drug: Control toothpaste containing no anti-cavity ingredients<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Fluoride free toothpaste control;Drug: Experimental toothpaste containing fluoride and amino acid (arginine)<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Experimental toothpaste;Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Fluoride only toothpaste control;|
| Experimental: fluoride + amino acid in a silica toothpaste<br>Experimental toothpaste containing fluoride and amino acid (arginine) | Drug: Control toothpaste containing no anti-cavity ingredients<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Fluoride free toothpaste control;Drug: Experimental toothpaste containing fluoride and amino acid (arginine)<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Experimental toothpaste;Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Fluoride only toothpaste control;|
| Active Comparator: 1450 ppm fluoride in a silica base toothpaste<br>Fluoride toothpaste containing fluoride as the anti-cavity ingredient | Drug: Control toothpaste containing no anti-cavity ingredients<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Fluoride free toothpaste control;Drug: Experimental toothpaste containing fluoride and amino acid (arginine)<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Experimental toothpaste;Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient<br>* Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.<br>* Other names: Fluoride only toothpaste control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mineral Change (delta Z) | Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change (∆ Z). | Baseline | 
| Mineral Change (delta Z) | Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of wearing the study retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm). These post use values will be compared to the Baseline values to give a delta mineral change (∆ Z). | 2 weeks (from Baseline) |