Trial Outcomes & Findings for Compare the Clinical Efficacy of Prototype Toothpastes. (NCT NCT00761930)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

103 participants

Primary outcome timeframe

6 weeks

Results posted on

2013-08-15

Participant Flow

subjects were recruited by the PI at the clinical site

subjects were screened for meeting medical and oral health criteria. Then completed a 1 week washout period with fluoride toothpaste prior to receiving any study treatments.

Participant milestones

Participant milestones
Measure	A- Placebo Comparator Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)	B - Active Comparator fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)	C - Experimental Toothpaste fluoride/herbal toothpaste
Overall Study STARTED	34	34	35
Overall Study COMPLETED	34	34	35
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compare the Clinical Efficacy of Prototype Toothpastes.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A- Placebo Comparator n=34 Participants Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)	B - Active Comparator n=34 Participants fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)	C - Experimental Toothpaste n=35 Participants fluoride/herbal toothpaste	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	34 Participants n=7 Participants	34 Participants n=5 Participants	102 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	40.3 years STANDARD_DEVIATION 12.2 • n=5 Participants	42.68 years STANDARD_DEVIATION 11.83 • n=7 Participants	40.8 years STANDARD_DEVIATION 11.7 • n=5 Participants	41.3 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	34 participants n=5 Participants	34 participants n=7 Participants	35 participants n=5 Participants	103 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	A- Placebo Comparator n=34 Participants Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)	B - Active Comparator n=34 Participants fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)	C - Experimental Toothpaste n=35 Participants fluoride/herbal toothpaste
Dental Plaque	2.273 Units on a scale Standard Deviation 0.328	1.806 Units on a scale Standard Deviation 0.523	2.041 Units on a scale Standard Deviation 0.403

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	A- Placebo Comparator n=34 Participants Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)	B - Active Comparator n=34 Participants fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)	C - Experimental Toothpaste n=35 Participants fluoride/herbal toothpaste
Gingivitis Score	0.942 Units on a scale Standard Deviation 0.302	0.722 Units on a scale Standard Deviation 0.369	0.705 Units on a scale Standard Deviation 0.387

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	A- Placebo Comparator n=34 Participants Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)	B - Active Comparator n=34 Participants fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)	C - Experimental Toothpaste n=35 Participants fluoride/herbal toothpaste
Bleeding Index (EIBI)	0.325 Units on a scale Standard Deviation .246	0.164 Units on a scale Standard Deviation 0.194	0.141 Units on a scale Standard Deviation 0.183

Adverse Events

A- Placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B - Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C - Experimental Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Devizio

Colgate Palmolive Co.

Phone: 732-878-7901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60