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Evaluate Clinical Research From Commerical Oral Care Products
This study has been completed.
First Received: September 23, 2008   Last Updated: November 11, 2008   History of Changes
Sponsored by: Colgate Palmolive
Information provided by: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00759187
  Purpose

The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.


Condition Intervention Phase
Gingival Diseases
Drug: Fluoride
Drug: Triclosan/Fluoride
Drug: Chlorhexidine Gluconate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Evaluate Clinical Research From Commerical Oral Care Products

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: 25
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator Drug: Fluoride
Brush twice daily
B: Active Comparator Drug: Triclosan/Fluoride
Half mouth toothbrushing twice daily for 4 days
C: Active Comparator Drug: Chlorhexidine Gluconate
Mouth rinsing twice a day for 4 days

Detailed Description:

The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

  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
  • Minimum of 20 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) requiring more than one visit of cleaning sessions
  • 2 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.
  • 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.
  • Allergy to chlorhexidine
  • 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.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759187

Locations
United States, Massachusetts
Boston University School of Dental Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Thomas Van Dyke, DDS Unaffiliated
  More Information

No publications provided

Responsible Party: Colgate Palmolive ( William DeVizio/VP - Clinical Research )
Study ID Numbers: CRO-0607-PLA-11-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00759187     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Mouth Diseases
Anti-Infective Agents
Gingival Diseases
Chlorhexidine
Antilipemic Agents
Anti-Infective Agents, Local
Periodontal Diseases
Disinfectants
Chlorhexidine gluconate
Hexachlorophene
Stomatognathic Diseases
Fluorides
Triclosan

Additional relevant MeSH terms:
Antimetabolites
Mouth Diseases
Anti-Infective Agents
Gingival Diseases
Chlorhexidine
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Anti-Infective Agents, Local
Disinfectants
Periodontal Diseases
Cariostatic Agents
Chlorhexidine gluconate
Hexachlorophene
Therapeutic Uses
Stomatognathic Diseases
Fluorides
Dermatologic Agents
Triclosan
Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009