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Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Primary Purpose

Dental Plaque

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Fluoride

Fluoride and triclosan

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

fluoride toothpaste from Thailand

fluoride/triclosan/copolymer toothpaste

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00762853

First Posted

September 26, 2008

Last Updated

February 16, 2012

Sponsor

Colgate Palmolive

1. Study Identification

Unique Protocol Identification Number

NCT00762853

Brief Title

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Official Title

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Colgate Palmolive

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Plaque

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

fluoride toothpaste from Thailand

Arm Title

Arm Type

Active Comparator

Arm Description

fluoride/triclosan/copolymer toothpaste

Intervention Type

Drug

Intervention Name(s)

Fluoride

Intervention Description

Brush half mouth once with assigned study treatment

Intervention Type

Drug

Intervention Name(s)

Fluoride and triclosan

Other Intervention Name(s)

Colgate Total toothpaste

Intervention Description

Brush half mouth once with assigned study treatment

Primary Outcome Measure Information:

Title

Triclosan Concentration in Dental Plaque

Description

Time Frame

12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terdphong Triantana, DDS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mahidol University

City

Bangkok

State/Province

Bangkok 10110

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

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