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Clinical Study to Evaluate Dental Plaque

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ClinicalTrials.gov Identifier: NCT00758290
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 25, 2008
Last Update Posted : November 25, 2008
Sponsor:
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Gingival Diseases Drug: Triclosan/Fluoride Drug: Fluoride/triclosan Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate Dental Plaque
Study Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: Triclosan/Fluoride
Brush twice daily for 3 weeks
Experimental: B Drug: Fluoride/triclosan
Brush daily for 3 weeks



Primary Outcome Measures :
  1. Dental Plaque Index [ Time Frame: 4 Day ]


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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)

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

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 Posted: September 25, 2008    Key Record Dates
Results First Posted: November 25, 2008
Last Update Posted: November 25, 2008
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