Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

September 14, 2009 updated by: Colgate Palmolive
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642-8315
        • Eastman Dental Center - University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female volunteers 18-65 years of age.
  • Good general health.
  • Must sign informed consent form.
  • Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
  • No 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 eating/drinking for 12 hrs.
  • History of allergy to common dentifrice ingredients.
  • Subjects unable or unwilling to sign the informed consent form.
  • Moderate or advanced periodontal disease.
  • Two or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that can currently affect salivary flow.
  • Current use of antibiotics.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 30 days prior to enrollment into this study.
  • Use of tobacco products.
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Fluoride Toothpaste
fluoride control
Drug: Fluoride
Brush twice daily
Other Names:
  • honokiol
Active Comparator: Total/Whitening
positive control
Drug: Triclosan/Fluoride toothpaste
Brush twice daily
Experimental: antibacterial plant extract 1
Honokiol
Drug: Fluoride
Brush twice daily
Other Names:
  • honokiol
Experimental: antibacterial plant extract 2
magnolol
Drug: Fluoride
Brush twice daily
Other Names:
  • honokiol
Other: antibacterial plant extract
Brush twice daily
Other Names:
  • Honokiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 8 weeks
Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Yanfang Ren, DDS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

July 20, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERO-0907-PLA-16-RR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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