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Trial Outcomes & Findings for Compare the Clinical Efficacy of Prototype Toothpastes (NCT NCT00926029)

NCT ID: NCT00926029

Last Updated: 2012-02-17

Results Overview

Plaque Index score 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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

6 weeks

Results posted on

2012-02-17

Participant Flow

At the clinical site

Participant milestones

Participant milestones
Measure
Placebo Control
fluoride toothpaste (Winterfresh Gel)
Positive Control
triclosan/fluoride toothpaste
Experimental
triclosan/fluoride/metal salt toothpaste
Overall Study
STARTED
34
34
34
Overall Study
COMPLETED
32
33
33
Overall Study
NOT COMPLETED
2
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo Control
fluoride toothpaste (Winterfresh Gel)
Positive Control
triclosan/fluoride toothpaste
Experimental
triclosan/fluoride/metal salt toothpaste
Overall Study
Lost to Follow-up
2
1
1

Baseline Characteristics

Compare the Clinical Efficacy of Prototype Toothpastes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo Control
n=34 Participants
fluoride toothpaste
Positive Control
n=34 Participants
triclosan/fluoride toothpaste
Experimental
n=34 Participants
triclosan/fluoride/zinc toothpaste
Total
n=102 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
0.0 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
102.0 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0.0 Participants
n=4 Participants
Age Continuous
46.7 years
STANDARD_DEVIATION 11.2 • n=5 Participants
46.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
48.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
47.4 years
STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male
Female
25 Participants
n=5 Participants
26 Participants
n=7 Participants
29 Participants
n=5 Participants
80.0 Participants
n=4 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
8 Participants
n=7 Participants
5 Participants
n=5 Participants
22.0 Participants
n=4 Participants
Region of Enrollment
United States
34 participants
n=5 Participants
34 participants
n=7 Participants
34 participants
n=5 Participants
102.0 participants
n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Plaque Index score 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
Placebo Control
n=32 Participants
fluoride toothpaste (Winterfresh Gel)
Positive Control
n=33 Participants
triclosan/fluoride toothpaste
Experimental
n=33 Participants
triclosan/fluoride/metal salt toothpaste
Plaque Index
0.91 Units on a scale
Standard Deviation 0.91
0.84 Units on a scale
Standard Deviation 0.25
1.77 Units on a scale
Standard Deviation 0.44

PRIMARY outcome

Timeframe: 6 Weeks

Gingivitis score- 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
Placebo Control
n=32 Participants
fluoride toothpaste (Winterfresh Gel)
Positive Control
n=33 Participants
triclosan/fluoride toothpaste
Experimental
n=33 Participants
triclosan/fluoride/metal salt toothpaste
Gingivitis Index
0.63 Units on a scale
Standard Deviation 0.15
0.51 Units on a scale
Standard Deviation 0.17
0.98 Units on a scale
Standard Deviation 0.15

Adverse Events

Placebo Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Positive Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental

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 - DMD

Colgate Palmolive

Phone: 732-878-7901

Results disclosure agreements

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

Restriction type: GT60