Clinical Study to Evaluate Dental Plaque

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758290
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008
  Purpose

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.


Condition Intervention Phase
Gingival Diseases
Drug: Triclosan/Fluoride
Drug: Fluoride/triclosan
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: Clinical Study to Evaluate Dental Plaque

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Dental Plaque Index [ Time Frame: 4 Day ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Triclosan/Fluoride
Brush twice daily for 3 weeks
Experimental: B Drug: Fluoride/triclosan
Brush daily for 3 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 51 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers at least 20 - 51 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 15 natural uncrowned teeth (excluding third molars) must be present
  • 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:

  • Subjects unable or unwilling to sign the informed consent form
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus)
  • 5 or more decayed untreated dental sites at screening (cavities)
  • 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 are currently affecting salivary function
  • 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 1 week 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
  • Presence of an orthodontic appliance which interferes with plaque scoring
  • History of allergy to common toothpaste ingredients
  • History of allergy to arginine (amino acid)
  • 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: NCT00758290

Locations
United States, New York
Bluestone Center for Clinical Research, NYU College of Dentistry
New York, New York, United States, 10016
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Patricia Corby, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP- Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00758290     History of Changes
Other Study ID Numbers: CRO-2008-PLA-13-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: November 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Gingival Diseases
Dental Deposits
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Tooth Diseases
Fluorides
Triclosan
Anti-Infective Agents
Anti-Infective Agents, Local
Antimetabolites
Cariostatic Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014