Trial Outcomes & Findings for Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes (NCT NCT00762515)

Results Overview

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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

6 weeks

Results posted on

2010-12-28

Participant Flow

subjects recruited by the PI at the clinical site.

Screening for subjects that met the overall oral health criteria. Followed by a 1 week washout prior to starting any study treatments or procedures.

Participant milestones

Participant milestones
Measure	A -Placebo Comparator Fluoride toothpaste	B- Active Comparator Fluoride/triclosan toothpaste (Total)
Overall Study STARTED	22	22
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A -Placebo Comparator n=22 Participants Fluoride toothpaste	B- Active Comparator n=22 Participants Fluoride/triclosan toothpaste (Total)	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Region of Enrollment United States	22 participants n=93 Participants	22 participants n=4 Participants	44 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.

Outcome measures

Outcome measures
Measure	A -Placebo Comparator n=22 Participants Fluoride toothpaste	B- Active Comparator n=22 Participants Fluoride/triclosan toothpaste (Total)
Control Established Plaque in Adults	2.42 Units on a scale Standard Deviation 0.47	2.45 Units on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: 6 weeks

Gingivitis Index (GI) is described as 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 score = Sum of all scores divided by the number of sites (teeth scored).

Outcome measures

Outcome measures
Measure	A -Placebo Comparator n=22 Participants Fluoride toothpaste	B- Active Comparator n=22 Participants Fluoride/triclosan toothpaste (Total)
Control Gingivitis in Adults	0.54 Units on a scale Standard Deviation 0.16	0.63 Units on a scale Standard Deviation 0.19

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

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