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Clinical Study to Compare Dental Plaque Control

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: NCT00758394
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 19, 2008
Last Update Posted : August 15, 2013
Information provided by:
Colgate Palmolive

Brief Summary:
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Triclosan/Fluoride Phase 3

Detailed Description:
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Compare Dental Plaque Control
Study Start Date : September 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Fluoride - A
Fluoride only toothpaste
Drug: Fluoride
Brush two times a day for 4 days.
Other Name: monofluorophosphate

Active Comparator: Total + Whitening toothpaste - B
Triclosan/fluoride toothpaste
Drug: Triclosan/Fluoride
Brush two times daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan

Experimental: Triclosan/fluoride/Amino Acid - C
toothpaste containing amino acid #1
Drug: Triclosan/Fluoride
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid

Experimental: Triclosan/fluoride/Cavistat -D
toothpaste containing amino acid/bicarbonate
Drug: Triclosan/Fluoride
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid/bicarbonate

Primary Outcome Measures :
  1. Dental Plaque Index [ Time Frame: 4-Day ]
    plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 53 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female volunteers at least 18 - 53 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).
  • 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 are currently affecting salivary function
  • 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.
  • 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 which interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • History of allergy to arginine (amino acid)
  • History of allergy to bicarbonate
  • 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): NCT00758394

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United States, New York
Bluestone Center for Clinical Research, NYU College of Dentistry
New York, New York, United States, 10016
Sponsors and Collaborators
Colgate Palmolive
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Principal Investigator: Patricia Corby, DDS

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Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT00758394     History of Changes
Other Study ID Numbers: CRO-0907-PLA-14-RR
First Posted: September 25, 2008    Key Record Dates
Results First Posted: November 19, 2008
Last Update Posted: August 15, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents