Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00926328
First received: September 26, 2008
Last updated: August 8, 2013
Last verified: August 2013

September 26, 2008
August 8, 2013
June 2007
December 2007   (final data collection date for primary outcome measure)
  • 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)
  • Gingivitis Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Plaque Index [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gingivitis
  • Drug: Triclosan, fluoride
    Six Month study, brush twice daily
    Other Name: Colgate Total Advanced Freshening toothpaste
  • Drug: Fluoride
    twice daily usage
    Other Name: Crest Cavity Protection toothpaste
  • Active Comparator: A -Experimental toothpaste
    triclosan/copolymer/fluoride toothpaste
    Intervention: Drug: Triclosan, fluoride
  • Placebo Comparator: B - control toothpaste
    sodium fluoride only toothpaste (placebo)
    Intervention: Drug: Fluoride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00926328
CRO-0507-PL-SP-CT-BS
No
Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Augusto E Boneta, DDS Dental Research Associates
Colgate Palmolive
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP