Trial Outcomes & Findings for Clinical Study to Evaluate Dental Plaque (NCT NCT00758290)
NCT ID: NCT00758290
Last Updated: 2008-11-25
Results Overview
Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
4 Day
Results posted on
2008-11-25
Participant Flow
At clinical site
Participant milestones
| Measure |
Fluoride/Triclosan
|
Triclosan/Fluoride
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Evaluate Dental Plaque
Baseline characteristics by cohort
| Measure |
Fluoride/Triclosan
n=11 Participants
|
Triclosan/Fluoride
n=12 Participants
|
Total
n=23 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
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
32.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 DayPlaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Outcome measures
| Measure |
Fluoride/Triclosan
n=12 Participants
|
Triclosan/Fluoride
n=12 Participants
|
|---|---|---|
|
Dental Plaque Index
|
2.48 Units on a scale
Standard Deviation 0.34
|
2.42 Units on a scale
Standard Deviation 0.39
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60