Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Evaluating Commercial Anti-Plaque Products and Oral Rinse

This study has been completed.
Information provided by:
Colgate Palmolive Identifier:
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating Commercial Anti-Plaque Products and Oral Rinse

Resource links provided by NLM:

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Plaque Index [ Time Frame: Four days ]
    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.

Ages Eligible for Study:   23 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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 identifier: NCT01014143

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

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive 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

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on April 21, 2017