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

Phase 3

Completed

Interventions: Drug: Fluoride
Drug: Triclosan, fluoride
Drug: Chlorhexidine Gluconate

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Fluoride toothpaste	Fluoride	negative control toothpaste
Triclosan/Fluoride toothpaste	Triclosan, fluoride	positive control toothpaste (Total toothpaste)
Chlorhexidine Oral Rinse	Chlorhexidine Gluconate	positive control oral rinse

Primary Outcome Measures

Name	Time	Method
Plaque Index	4 Days	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)

Secondary Outcome Measures