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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Fluorides; Triclosan

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