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Clinical Study to Evaluate Dental Plaque

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758290
First Posted: September 25, 2008
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Colgate Palmolive
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 51 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 25, 2008
Last Update Posted: July 29, 2009
Last Verified: November 2008

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