Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

NCT ID: NCT00762853

Last Updated: 2012-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

fluoride toothpaste from Thailand

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush half mouth once with assigned study treatment

B

fluoride/triclosan/copolymer toothpaste

Group Type ACTIVE_COMPARATOR

Fluoride and triclosan

Intervention Type DRUG

Brush half mouth once with assigned study treatment

Interventions

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Fluoride

Brush half mouth once with assigned study treatment

Intervention Type DRUG

Fluoride and triclosan

Brush half mouth once with assigned study treatment

Intervention Type DRUG

Other Intervention Names

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Colgate Total toothpaste

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Colgate Palmolive

Principal Investigators

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Terdphong Triantana, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

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Mahidol University

Bangkok, Bangkok 10110, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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CRO-2008-PLA-16-RR

Identifier Type: -

Identifier Source: org_study_id

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