Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

This study has been completed.
Information provided by (Responsible Party):
Colgate Palmolive Identifier:
First received: September 26, 2008
Last updated: August 8, 2013
Last verified: August 2013

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

Condition Intervention Phase
Drug: Triclosan, fluoride
Drug: Fluoride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Resource links provided by NLM:

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Gingivitis Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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)

  • Plaque Index [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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)

Enrollment: 120
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00926328

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

No publications provided

Responsible Party: Colgate Palmolive Identifier: NCT00926328     History of Changes
Other Study ID Numbers: CRO-0507-PL-SP-CT-BS
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Colgate Palmolive:
Gingivitis and Plaque

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents processed this record on April 17, 2014