Trial Outcomes & Findings for Investigation of Dental Plaque and Gingival Index (NCT NCT00759031)
NCT ID: NCT00759031
Last Updated: 2012-04-13
Results Overview
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
1 day
Results posted on
2012-04-13
Participant Flow
At clinical site
Participant milestones
| Measure |
Fluoride 1st, Triclosan +Fluoride 2nd
Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
|
Triclosan + Fluoride 1st, Fluoride 2nd
Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
10
|
9
|
|
First Intervention (1 Day)
COMPLETED
|
8
|
8
|
|
First Intervention (1 Day)
NOT COMPLETED
|
2
|
1
|
|
Washout After 1st Intervention (1 Week)
STARTED
|
8
|
8
|
|
Washout After 1st Intervention (1 Week)
COMPLETED
|
8
|
8
|
|
Washout After 1st Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
8
|
8
|
|
Second Intervention (1 Day)
COMPLETED
|
8
|
8
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fluoride 1st, Triclosan +Fluoride 2nd
Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
|
Triclosan + Fluoride 1st, Fluoride 2nd
Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
|
|---|---|---|
|
First Intervention (1 Day)
Physician Decision
|
1
|
0
|
|
First Intervention (1 Day)
Withdrawal by Subject
|
0
|
1
|
|
First Intervention (1 Day)
Screening failure
|
1
|
0
|
Baseline Characteristics
Investigation of Dental Plaque and Gingival Index
Baseline characteristics by cohort
| Measure |
Fluoride 1st, Then Triclosan +Fluoride 2nd
n=10 Participants
Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
|
Triclosan + Fluoride 1st, Then Fluoride 2nd
n=9 Participants
Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
32.1 years
STANDARD_DEVIATION 11.14 • n=99 Participants
|
33 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
32.53 years
STANDARD_DEVIATION 9.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayScale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
Outcome measures
| Measure |
Fluoride
n=16 Participants
Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
|
Triclosan + Fluoride
n=16 Participants
Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
|
|---|---|---|
|
Gingival Margin Plaque Index
|
15.4 Units on a scale
Standard Deviation 14.74
|
12.81 Units on a scale
Standard Deviation 14.06
|
Adverse Events
Fluoride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triclosan + Fluoride
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