Trial Outcomes & Findings for Clinical Study to Compare Dental Plaque Control (NCT NCT00758394)
NCT ID: NCT00758394
Last Updated: 2013-08-15
Results Overview
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
29 participants
Primary outcome timeframe
4-Day
Results posted on
2013-08-15
Participant Flow
At clinical site
Participant milestones
| Measure |
Fluoride First
Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
|
Triclosan/Fluoride First
Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
|
Triclosan/Fluoride/Arginine First
Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
|
Triclosan/Fluoride/Cavistat First
Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
|
|---|---|---|---|---|
|
Washout After 1st Intervention
COMPLETED
|
8
|
7
|
6
|
8
|
|
1st Intervention
STARTED
|
8
|
7
|
6
|
8
|
|
1st Intervention
COMPLETED
|
8
|
7
|
6
|
8
|
|
1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout After 1st Intervention
STARTED
|
8
|
7
|
6
|
8
|
|
Washout After 1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
2nd Intervention Order
STARTED
|
8
|
7
|
6
|
8
|
|
2nd Intervention Order
COMPLETED
|
8
|
6
|
6
|
8
|
|
2nd Intervention Order
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Washout After 2nd Intervention
STARTED
|
8
|
6
|
6
|
8
|
|
Washout After 2nd Intervention
COMPLETED
|
8
|
6
|
6
|
8
|
|
Washout After 2nd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
3rd Intervention
STARTED
|
8
|
6
|
6
|
8
|
|
3rd Intervention
COMPLETED
|
7
|
6
|
6
|
7
|
|
3rd Intervention
NOT COMPLETED
|
1
|
0
|
0
|
1
|
|
Washout After 3rd Intervention
STARTED
|
7
|
6
|
6
|
7
|
|
Washout After 3rd Intervention
COMPLETED
|
7
|
6
|
6
|
7
|
|
Washout After 3rd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
4th Intervention
STARTED
|
7
|
6
|
6
|
7
|
|
4th Intervention
COMPLETED
|
7
|
6
|
6
|
7
|
|
4th Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fluoride First
Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
|
Triclosan/Fluoride First
Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
|
Triclosan/Fluoride/Arginine First
Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
|
Triclosan/Fluoride/Cavistat First
Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
|
|---|---|---|---|---|
|
2nd Intervention Order
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
3rd Intervention
Lost to Follow-up
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Clinical Study to Compare Dental Plaque Control
Baseline characteristics by cohort
| Measure |
Fluoride - A
n=8 Participants
Negative control
|
Fluoride/Triclosan - B
n=7 Participants
Positive control comparator
|
Triclosan/Fluoride/Arginine
n=6 Participants
toothpaste containing amino acid
|
Triclosan/Fluoride/Cavistat
n=8 Participants
toothpaste containing bicarbonate
|
Total
n=29 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 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
|
30.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
33.6 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
29 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4-Dayplaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
Outcome measures
| Measure |
Fluoride - A
n=7 Participants
Negative control
|
Fluoride/Triclosan - B
n=6 Participants
Positive control comparator
|
Triclosan/Fluoride/Arginine
n=6 Participants
toothpaste containing amino acid
|
Triclosan/Fluoride/Cavistat
n=7 Participants
toothpaste containing bicarbonate
|
|---|---|---|---|---|
|
Dental Plaque Index
|
3.12 Units on a scale
Standard Deviation 0.38
|
2.90 Units on a scale
Standard Deviation 0.36
|
2.92 Units on a scale
Standard Deviation 0.42
|
2.94 Units on a scale
Standard Deviation 0.42
|
Adverse Events
Fluoride First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triclosan/Fluoride First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triclosan/Fluoride/Arginine First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triclosan/Fluoride/Cavistat First
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60