Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Dental Plaque

Treatments

Drug: Fluoride and triclosan

Drug: Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

CRO-2008-PLA-16-RR

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)