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Trial record 16 of 43 for:    FLUORIDE ION AND TRICLOSAN

Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

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: NCT00926328
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : June 23, 2009
Last Update Posted : August 15, 2013
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Condition or disease Intervention/treatment Phase
Gingivitis Drug: Triclosan, fluoride Drug: Fluoride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A -Experimental toothpaste
triclosan/copolymer/fluoride toothpaste
Drug: Triclosan, fluoride
Six Month study, brush twice daily
Other Name: Colgate Total Advanced Freshening toothpaste

Placebo Comparator: B - control toothpaste
sodium fluoride only toothpaste (placebo)
Drug: Fluoride
twice daily usage
Other Name: Crest Cavity Protection toothpaste

Primary Outcome Measures :
  1. Gingivitis Index [ Time Frame: 6 months ]

    Units on a scale 0 to 3 (0 = no inflammation ,

    1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.

    3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  2. Plaque Index [ Time Frame: 6 Months ]
    Units on a 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:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Availability for the six-month duration of the study.
  • Good general health.
  • Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
  • Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  • Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
  • Signed Informed Consent Form.

Exclusion Criteria:

  • Presence of orthodontic bands.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
  • periodontal attachment or alveolar bone).
  • Five or more carious lesions requiring immediate restorative treatment.
  • Use of antibiotics any time during the one month prior to entry into the study.
  • Participation in any other clinical study or test panel within the one month prior to entry
  • into the study.
  • Pregnant women or women who are breast feeding.
  • Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
  • History of allergic to personal care/consumer products or their ingredients.
  • Taking any prescription medicines. That might interfere with the study outcome.
  • Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.

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): NCT00926328

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Dr. Fernando Autran
Barcelona, Spain
Sponsors and Collaborators
Colgate Palmolive
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Principal Investigator: Augusto E Boneta, DDS Dental Research Associates

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Responsible Party: Colgate Palmolive Identifier: NCT00926328     History of Changes
Other Study ID Numbers: CRO-0507-PL-SP-CT-BS
First Posted: June 23, 2009    Key Record Dates
Results First Posted: June 23, 2009
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by Colgate Palmolive:
Gingivitis and Plaque
Additional relevant MeSH terms:
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Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
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