Trial Outcomes & Findings for Clinical Research Study Efficacy of a Prototype Oral Rinse (NCT NCT01021007)

Results Overview

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

67 participants

Primary outcome timeframe

6 weeks

Results posted on

2009-12-01

Participant Flow

At clinical site

Participant milestones

Participant milestones
Measure	Negative Control Rinse Placebo mouthrinse	Iocide Mouthrinse Experimental mouthrinse
Overall Study STARTED	36	37
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Negative Control Rinse Placebo mouthrinse	Iocide Mouthrinse Experimental mouthrinse
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	1	3

Baseline Characteristics

Clinical Research Study Efficacy of a Prototype Oral Rinse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Negative Control Rinse n=36 Participants Placebo mouthrinse	Iocide Mouthrinse n=37 Participants Experimental mouthrinse	Total n=73 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	36 Participants n=93 Participants	37 Participants n=4 Participants	73 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	37.8 years STANDARD_DEVIATION 8.3 • n=93 Participants	36.6 years STANDARD_DEVIATION 10.9 • n=4 Participants	37.2 years STANDARD_DEVIATION 9.6 • n=27 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	24 Participants n=4 Participants	53 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	13 Participants n=4 Participants	20 Participants n=27 Participants
Region of Enrollment United States	36 participants n=93 Participants	37 participants n=4 Participants	73 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

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	Negative Control Rinse n=34 Participants Placebo mouthrinse	Iocide Mouthrinse n=33 Participants Experimental mouthrinse
Gingival Index	1.90 Units on a scale Standard Deviation 0.19	1.84 Units on a scale Standard Deviation 0.23

PRIMARY outcome

Timeframe: 6 weeks

0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 \& 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.

Outcome measures

Outcome measures
Measure	Negative Control Rinse n=34 Participants Placebo mouthrinse	Iocide Mouthrinse n=33 Participants Experimental mouthrinse
EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale	40.82 bleeding sites Standard Deviation 16.93	34.91 bleeding sites Standard Deviation 23.83

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)

Outcome measures

Outcome measures
Measure	Negative Control Rinse n=34 Participants Placebo mouthrinse	Iocide Mouthrinse n=33 Participants Experimental mouthrinse
Plaque Index (Quigley-Hein Score)	2.47 Units on a scale Standard Deviation 0.61	2.11 Units on a scale Standard Deviation 0.70

Adverse Events

Negative Control Rinse

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Iocide Mouthrinse

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Negative Control Rinse n=34 participants at risk Placebo mouthrinse	Iocide Mouthrinse n=33 participants at risk Experimental mouthrinse
Social circumstances discomfort in mouth or body	23.5% 8/34 • Number of events 8 • 7 week study period	0.00% 0/33 • 7 week study period
General disorders Tooth staining	2.9% 1/34 • Number of events 1 • 7 week study period	21.2% 7/33 • Number of events 7 • 7 week study period
General disorders slight swelling or inflammation of the gums	8.8% 3/34 • Number of events 3 • 7 week study period	6.1% 2/33 • Number of events 2 • 7 week study period

Additional Information

William DeVizio - 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