Evaluate Clinical Research From Commerical Oral Care Products

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00759187
First received: September 23, 2008
Last updated: February 24, 2010
Last verified: November 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 ]
    Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)


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
Placebo Comparator: A Drug: Fluoride
Brush twice daily
Other Name: monofluorophosphate
Active Comparator: B Drug: Triclosan/Fluoride
Half mouth toothbrushing twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
Active Comparator: C Drug: Chlorhexidine Gluconate
Mouth rinsing twice a day for 4 days
Other Name: Chlorhexidine Gluconate oral rinse

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
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: 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
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00759187     History of Changes
Other Study ID Numbers: CRO-0607-PLA-11-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: February 24, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014