Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

Study Overview
=================
Brief Summary
-----------------
The objective is to compare two commerical oral products for the treatment of gingivitis.

Official Title
-----------------
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

Conditions
-----------------
Dental Plaque

Intervention / Treatment
-----------------
* Drug: Fluoride
* Drug: Triclosan
* Drug: Fluoride


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0 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 History of allergy to iodine History of thyroid disease History of diabetes 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. Presence of an orthodontic appliance. History of allergy to common dentifrice ingredients Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms). Smoker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 only toothpaste | Drug: Fluoride<br>* Brush teeth two times daily for 6 weeks<br>|
| Active Comparator: B<br>Commercially available triclosan/copolymer/fluoride toothpaste | Drug: Triclosan<br>* Brush two times daily for 6 weeks<br>Drug: Fluoride<br>* Brush two times daily for 6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control Established Plaque in Adults | 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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control Gingivitis in Adults | Gingivitis Index (GI) is described as 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 score = Sum of all scores divided by the number of sites (teeth scored). | 6 weeks |