Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

NCT00762853 | Completed Phase 3 Results

• 1 other identifier: CRO-2008-PLA-16-RR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A

PLACEBO COMPARATOR

fluoride toothpaste from Thailand

Drug: Fluoride

B

ACTIVE COMPARATOR

fluoride/triclosan/copolymer toothpaste

Drug: Fluoride and triclosan

Interventions

Fluoride DRUG

Brush half mouth once with assigned study treatment

A

Fluoride and triclosan DRUG

Brush half mouth once with assigned study treatment

Also known as: Colgate Total toothpaste

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Mahidol University

Bangkok, Bangkok 10110, Thailand

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Fluorides; Triclosan; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William Devizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Terdphong Triantana, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 17, 2012
• Results First Posted: September 14, 2010

Record last verified: 2010-08

Locations

TH (1)