Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Dental Plaque Clinical Trial

Official title:

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762853
• Other study ID #: CRO-2008-PLA-16-RR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: February 16, 2012
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: August 2010
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Fluoride
Brush half mouth once with assigned study treatment
• Fluoride and triclosan
Brush half mouth once with assigned study treatment

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok	Bangkok 10110

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triclosan Concentration in Dental Plaque	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.	12 hours	No