Text Size

Evaluating Commercial Anti-Plaque Products and Oral Rinse

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01014143
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.


Condition Intervention Phase
Dental Plaque
 Drug: Fluoride
Drug: Chlorhexidine digluconate
Drug: Fluoride, triclosan
 Phase 2

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: Evaluating Commercial Anti-Plaque Products and Oral Rinse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Plaque Index [ Time Frame: Four days ] [ Designated as safety issue: No ]
    Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)


Enrollment: 26
Study Start Date: August 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fluoride toothpaste
Negative control
 Drug: Fluoride
Half mouth toothbrushing twice a day for four days.
Other Name: fluoride toothpaste
Active Comparator: Triclosan/Fluoride toothpaste
positive control toothpaste
 Drug: Fluoride, triclosan
Half mouth Brushing twice daily
Other Name: Total toothpaste
Active Comparator: Chlorhexidine Oral Rinse
Positive Control mouthrinse
 Drug: Chlorhexidine digluconate
Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
Other Name: Periogard oral rinse

Detailed Description:

This clinical research study was to train new examiners for short term plaque clinical methodologies.

  Eligibility

Ages Eligible for Study:   23 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers at least 18 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).
  • Two 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 are currently affect salivary function.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Allergy to chlorhexidine.
  • 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 pre-medication for dental treatment or for any other purpose.
  • Presence of an orthodontic appliance that interferes with plaque scoring.
  • 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: NCT01014143

Locations
United States, New Jersey
New Institutional Service Company
Northfield, New Jersey, United States, 08225
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Matthew Cronin, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01014143     History of Changes
Other Study ID Numbers: CRO-2007-PLA-15-RR
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013