Effect on Bacterial Glycolytic Acid Formation on Plaque

Study Overview
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Brief Summary
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To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.

Official Title
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Effect on Bacterial Glycolytic Acid Formation on Plaque

Conditions
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Dental Plaque

Intervention / Treatment
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* Drug: Triclosan, Fluoride
* Drug: fluoride
* Drug: Fluoride, triclosan, amino acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maxillary dentition is preferentially natural. Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition. Natural mandibular front teeth and first premolars (4-4) are retained. Second mandibular molars are ideally present to serve as abutment teeth. Mandibular restorations and/or reconstructions must be in clinically good condition. Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition. Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax). Willingness to give their informed consent and comply with the protocol. No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: Current participation in other dental clinical trials. Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment). Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse. Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases. Subjects taking drugs known to currently affect salivary flow. Subjects with un-stimulated salivary flow <0.3 ml/min and/or stimulated flow <0.9 ml/min. Women who are pregnant or breastfeeding History of allergy to common dentifrice ingredients Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms) Medical condition which requires premedication prior to dental procedures/visits History of allergy to amino acids

Ages Eligible for Study
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Minimum Age: 72 Years
Maximum Age: 79 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 |
| --- | --- |
| Active Comparator: A- Positive Control<br>fluoride/triclosan/copolymer toothpaste | Drug: Triclosan, Fluoride<br>* Rinse 3 times daily with assigned toothpaste slurry<br>* Other names: Total+ Whitening toothpaste;|
| Placebo Comparator: B - Silica control<br>fluoride only toothpaste | Drug: fluoride<br>* Rinse 3 times daily with assigned toothpaste slurry<br>* Other names: placebo toothpaste (No triclosan, no amino acid);|
| Experimental: C- Experimental product<br>fluoride/triclosan/amino acid toothpaste | Drug: Fluoride, triclosan, amino acid<br>* Rinse 3 times daily with assigned toothpaste slurry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ph of Dental Plaque After Sucrose Challenge | Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth. | 1 week |