Trial Outcomes & Findings for Evaluate Clinical Research From Commerical Oral Care Products (NCT NCT00759187)

NCT ID: NCT00759187

Last Updated: 2010-03-04

Results Overview

Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 25 participants
• Primary outcome timeframe: 4-Day
• Results posted on: 2010-03-04

Participant Flow

At clinical site

Participant milestones

Measure	Fluoride	Fluoride/Triclosan	Chlorhexidine Gluconate
Overall Study STARTED	8	8	9
Overall Study COMPLETED	8	8	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate Clinical Research From Commerical Oral Care Products

Baseline characteristics by cohort

Measure	Fluoride n=8 Participants	Fluoride/Triclosan n=8 Participants	Chlorhexidine Gluconate n=9 Participants	Total n=25 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	25 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	29.4 years STANDARD_DEVIATION 6.9 • n=5 Participants	32.6 years STANDARD_DEVIATION 8.8 • n=7 Participants	33.1 years STANDARD_DEVIATION 9.0 • n=5 Participants	31.8 years STANDARD_DEVIATION 8.1 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	25 participants n=4 Participants

PRIMARY outcome

Timeframe: 4-Day

Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)

Outcome measures

Measure	Fluoride n=9 Participants	Fluoride/Triclosan n=8 Participants	Chlorhexidine Gluconate n=8 Participants
Dental Plaque Index	2.79 Units on a scale Standard Deviation 0.37	2.82 Units on a scale Standard Deviation 0.39	1.99 Units on a scale Standard Deviation 0.41

Adverse Events

Fluoride

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Fluoride/Triclosan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Chlorhexidine Gluconate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fluoride n=9 participants at risk	Fluoride/Triclosan n=8 participants at risk	Chlorhexidine Gluconate n=8 participants at risk
General disorders Canker sore	11.1% 1/9 • Number of events 1 • 4 day treatment period	0.00% 0/8 • 4 day treatment period	0.00% 0/8 • 4 day treatment period
General disorders Cold symptoms	44.4% 4/9 • Number of events 4 • 4 day treatment period	0.00% 0/8 • 4 day treatment period	0.00% 0/8 • 4 day treatment period
General disorders Conjunctivitis	11.1% 1/9 • Number of events 1 • 4 day treatment period	0.00% 0/8 • 4 day treatment period	0.00% 0/8 • 4 day treatment period
General disorders Heavy menstrual bleeding	0.00% 0/9 • 4 day treatment period	12.5% 1/8 • Number of events 1 • 4 day treatment period	0.00% 0/8 • 4 day treatment period

Additional Information

William DeVizio- DMD

Colgate Palmolive

Phone: 732-878-7901

Email: William_Devizio@colpal.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60