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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014