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Trial record 22 of 42 for:    FLUORIDE ION AND TRICLOSAN

Evaluating Commercial Anti-Plaque Products and Oral Rinse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014143
Recruitment Status : Completed
First Posted : November 16, 2009
Results First Posted : November 16, 2009
Last Update Posted : June 14, 2011
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Chlorhexidine digluconate Drug: Fluoride, triclosan Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating Commercial Anti-Plaque Products and Oral Rinse
Study Start Date : August 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 81 Years   (Adult, Older Adult)
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).

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 identifier (NCT number): NCT01014143

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United States, New Jersey
New Institutional Service Company
Northfield, New Jersey, United States, 08225
Sponsors and Collaborators
Colgate Palmolive
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Principal Investigator: Matthew Cronin, DDS
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Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT01014143    
Other Study ID Numbers: CRO-2007-PLA-15-RR
First Posted: November 16, 2009    Key Record Dates
Results First Posted: November 16, 2009
Last Update Posted: June 14, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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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