Clinical Trial: Compare the Clinical Efficacy of Prototype Toothpastes.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Compare the Clinical Efficacy of Prototype Toothpastes.

Brief Summary: Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Detailed Summary:
Sponsor: Colgate Palmolive

Current Primary Outcome:

• Dental Plaque [ Time Frame: 6 weeks ]
  Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
• Gingivitis Score [ Time Frame: 6 weeks ]

  Gingivitis score (GI)= 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. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.

• Bleeding Index (EIBI) [ Time Frame: 6 weeks ]
  Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.

Original Primary Outcome: Dental plaque [ Time Frame: 7 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Colgate Palmolive

Dates:
Date Received: September 26, 2008
Date Started: March 2008
Date Completion:
Last Updated: August 8, 2013
Last Verified: August 2013