Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to develop a method to determine active ingredient uptake in oral care products.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female volunteer 18 - 65 years of age (inclusive).

• Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)

• Able and willing to sign the informed consent form.

• Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.

• No known 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

Exclusion Criteria:

• Medical condition which requires pre-medication prior to dental procedures/visits

• Medical condition which precludes not eating/drinking for 2 hours

• Advanced periodontal disease (gum disease)

• 5 or more decayed, untreated dental sites (cavities)

• Diseases of the soft or hard oral tissues

• Orthodontic appliances

• Abnormal salivary function

• Use of drugs that can affect salivary flow

• 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, etc)

• Pregnant or breastfeeding.

• Participation in another clinical study in the month preceding this study

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)