Compare the Clinical Efficacy of Prototype Toothpastes.

Study Overview
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Brief Summary
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Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Official Title
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Compare the Clinical Efficacy of Prototype Toothpastes.

Conditions
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Gingival Diseases

Intervention / Treatment
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* Drug: Fluoride
* Drug: Triclosan and fluoride
* Drug: Herbal Ingredient and fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers 18-65 years of age Good general health Must sign informed consent form Minimum of 16 natural uncrowned teeth (excluding third molars) must be present. No 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. Dental Selection Criteria: Average full mouth GI score should be in the range of - 2.0. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0 If of child bearing potential and on birth control (diaphragm, birth control pills, Birth control implants, IUD (Intrauterine device), condoms) Exclusion Criteria: Subjects unable or unwilling to sign the informed consent form. Medical condition which requires pre-medication prior to dental visits/procedures Moderate or advanced periodontal disease 2 or more decayed untreated dental sites at screening. Other disease of the hard or soft oral tissues. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). Use of medications that are currently affect salivary flow. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. Pregnant or nursing women. Participation in any other clinical study within 1 week prior to enrollment into this study. Use of tobacco products Subjects who must receive dental treatment during the study dates. Current use of Antibiotics for any purpose. History of allergy to common dentifrice ingredients Presence of an orthodontic appliance which interferes with plaque scoring. History of allergy to natural remedies, such as herbal ingredients Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) Smoker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>commercially available Fluoride toothpaste | Drug: Fluoride<br>* Brush twice daily<br>* Other names: Colgate Great Regular Flavor toothpaste;|
| Active Comparator: B<br>fluoride/triclosan/copolymer toothpaste | Drug: Triclosan and fluoride<br>* Brush twice daily<br>* Other names: Colgate Total toothpaste;|
| Experimental: C<br>fluoride/herbal toothpaste | Drug: Herbal Ingredient and fluoride<br>* Brush twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque | Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored. | 6 weeks | 
| Gingivitis Score | Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored. | 6 weeks | 
| Bleeding Index (EIBI) | Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100. | 6 weeks |