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

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00966953
First received: September 26, 2008
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment


Condition Intervention Phase
Gingival Diseases
Drug: Fluoride
Drug: Triclosan/Fluoride toothpaste
Other: antibacterial plant extract
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Plaque Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fluoride Toothpaste
fluoride control
Drug: Fluoride
Brush twice daily
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 Name: honokiol
Experimental: antibacterial plant extract 2
magnolol
Drug: Fluoride
Brush twice daily
Other: antibacterial plant extract
Brush twice daily
Other Name: Honokiol

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966953

Locations
United States, New York
Eastman Dental Center - University of Rochester
Rochester, New York, United States, 14642-8315
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Yanfang Ren, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00966953     History of Changes
Other Study ID Numbers: ERO-0907-PLA-16-RR
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: September 14, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Fluorides
Triclosan
Honokiol
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Lipid Regulating Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on April 22, 2014