Trial Outcomes & Findings for Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis (NCT NCT00926328)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

6 months

Results posted on

2013-08-15

Participant Flow

Performed by the Research Department School of Dentistry UPR

Participant milestones

Participant milestones
Measure	Experimental Treatment triclosan/copolymer/fluoride toothpaste	Placebo Control sodium fluoride toothpaste
Overall Study STARTED	60	60
Overall Study COMPLETED	48	46
Overall Study NOT COMPLETED	12	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Treatment triclosan/copolymer/fluoride toothpaste	Placebo Control sodium fluoride toothpaste
Overall Study Lost to Follow-up	12	14

Baseline Characteristics

Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Treatment n=60 Participants triclosan/copolymer/fluoride toothpaste	Placebo Control n=60 Participants sodium fluoride toothpaste	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age Continuous	34.72 years STANDARD_DEVIATION 8.51 • n=5 Participants	35.95 years STANDARD_DEVIATION 10.24 • n=7 Participants	35.33 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Spain	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Experimental Treatment n=48 Participants triclosan/copolymer/fluoride toothpaste	Placebo Control n=46 Participants sodium fluoride toothpaste
Gingivitis Index	1.00 Units on a scale Standard Deviation 0.17	1.27 Units on a scale Standard Deviation 0.28

PRIMARY outcome

Timeframe: 6 Months

Population: Per protocol

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)

Outcome measures

Outcome measures
Measure	Experimental Treatment n=48 Participants triclosan/copolymer/fluoride toothpaste	Placebo Control n=46 Participants sodium fluoride toothpaste
Plaque Index	2.22 Units on a scale Standard Deviation 0.49	2.88 Units on a scale Standard Deviation 0.52

Adverse Events

Experimental Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

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 De Vizio, DMD

Colgate Palmolive

Phone: 732-878-7901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60