Trial Outcomes & Findings for Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing. (NCT NCT00966953)
NCT ID: NCT00966953
Last Updated: 2009-09-22
Results Overview
Plaque score scale: 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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
8 weeks
Results posted on
2009-09-22
Participant Flow
The dental clinic staff recruited for this study.
Participant milestones
| Measure |
Fluoride Control, Magnolol,Total/Whitening,Honokiol
1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
|
Total/Whitening, Honokiol, Fluoride Control, Magnolol
1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
|
Honokiol, Fluoride Control, Magnolol, Total/Whitening
1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
|
Magnolol, Total/Whitening, Honokiol, Fluoride Control
1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
|
|---|---|---|---|---|
|
1st Intervention
STARTED
|
6
|
6
|
6
|
7
|
|
1st Intervention
COMPLETED
|
6
|
6
|
6
|
7
|
|
1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1 Week Washout After 1st Intervention
STARTED
|
6
|
6
|
6
|
7
|
|
1 Week Washout After 1st Intervention
COMPLETED
|
6
|
6
|
6
|
7
|
|
1 Week Washout After 1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
2nd Intervention
STARTED
|
6
|
6
|
6
|
7
|
|
2nd Intervention
COMPLETED
|
6
|
6
|
6
|
7
|
|
2nd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1 Week Washout After 2nd Intervention
STARTED
|
6
|
6
|
6
|
7
|
|
1 Week Washout After 2nd Intervention
COMPLETED
|
6
|
6
|
6
|
7
|
|
1 Week Washout After 2nd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
3rd Intervention Order
STARTED
|
6
|
6
|
6
|
7
|
|
3rd Intervention Order
COMPLETED
|
6
|
6
|
6
|
7
|
|
3rd Intervention Order
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1 Week Washout After 3rd Intervention
STARTED
|
6
|
6
|
6
|
7
|
|
1 Week Washout After 3rd Intervention
COMPLETED
|
6
|
6
|
6
|
7
|
|
1 Week Washout After 3rd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
4th Intervention Order
STARTED
|
6
|
6
|
6
|
7
|
|
4th Intervention Order
COMPLETED
|
6
|
6
|
6
|
7
|
|
4th Intervention Order
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Baseline characteristics by cohort
| Measure |
Fluoride Control, Magnolol,Total/Whitening,Honokiol
n=6 Participants
1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
|
Total/Whitening, Honokiol, Fluoride Control, Magnolol
n=6 Participants
1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
|
Honokiol, Fluoride Control, Magnolol, Total/Whitening
n=6 Participants
1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
|
Magnolol, Total/Whitening, Honokiol, Fluoride Control
n=7 Participants
1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
42 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 7 • n=4 Participants
|
42.1 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPlaque score scale: 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
| Measure |
Fluoride Only
n=25 Participants
Control toothopaste
|
Total/Whitening
n=25 Participants
Control toothpaste
|
Herbal Extract Toothpaste
n=25 Participants
Fluoride/Honokiol extract toothpaste
|
Herbal Extract Toothpaste
n=25 Participants
Fluoride/Magnolol extract toothpaste
|
|---|---|---|---|---|
|
Plaque Index
|
2.45 Units on a scale
Standard Deviation 0.47
|
2.22 Units on a scale
Standard Deviation 0.46
|
2.54 Units on a scale
Standard Deviation 0.44
|
2.56 Units on a scale
Standard Deviation 0.46
|
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