Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Phase 3

Completed

• Conditions: Dental Plaque
• Interventions: Drug: Fluoride; Drug: Fluoride and triclosan

• Registration Number: NCT00762853
• Lead Sponsor: Colgate Palmolive

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Status Verified: 2010-08
• Results First Submitted: 2010-08-19
• Results First Submitted QC: 2010-08-19
• Results First Posted: 2010-09-14
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Fluoride	fluoride toothpaste from Thailand
B	Fluoride and triclosan	fluoride/triclosan/copolymer toothpaste

Primary Outcome Measures

Name	Time	Method
Triclosan Concentration in Dental Plaque	12 hours	Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Bangkok, Bangkok 10110, Thailand