Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Study Overview
=================
Brief Summary
-----------------
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Detailed Description
-----------------
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Official Title
-----------------
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

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

Intervention / Treatment
-----------------
* Drug: Fluoride
* Drug: Triclosan, fluoride
* Drug: Chlorhexidine Gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be aged 18 to 65 years inclusive Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present Give written informed consent Be in good general health No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms) Exclusion Criteria: Medical condition which requires pre-medication (antibiotics) prior to dental Visits/procedures Allergy to chlorhexidine Advanced periodontal disease (gum disease) 5 or more decayed, untreated dental sites (cavities) Diseases of the soft or hard oral tissues (gums or palate) Orthodontic appliances that interfere with plaque rating Abnormal salivary function Use of drugs that can affect currently salivary flow or production Use of antibiotics one (1) month prior to or during this study Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn) Pregnant or breastfeeding. Participation in another research study in the month preceding this study Allergic to common toothpaste or mouth rinse ingredients. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride toothpaste<br>negative control toothpaste | Drug: Fluoride<br>* Brush half mouth twice daily for four days.<br>|
| Active Comparator: Triclosan/Fluoride toothpaste<br>positive control toothpaste (Total toothpaste) | Drug: Triclosan, fluoride<br>* Brush twice daily<br>* Other names: Total toothpaste;|
| Active Comparator: Chlorhexidine Oral Rinse<br>positive control oral rinse | Drug: Chlorhexidine Gluconate<br>* Rinse mouth twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Plaque score is 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) | 4 Days |