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OpenTrials
Completed

NCT Number: NCT00926328

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Fernando Autran

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triclosan, fluoride

Drug

Six Month study, brush twice daily

Other names: Colgate Total Advanced Freshening toothpaste

Fluoride

Drug

twice daily usage

Other names: Crest Cavity Protection toothpaste

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 23, 2009
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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