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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00926328
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Gingivitis
 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:

U.S. FDA Resources

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: 94
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00926328

Locations
Spain
Barcelona, Spain
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Augusto E Boneta, DDS Dental Research Associates
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov 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: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Colgate Palmolive:
Gingivitis and Plaque

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Triclosan
Hexachlorophene
Cariostatic Agents
Protective Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 23, 2013