Trial Outcomes & Findings for Efficacy of Salivary Bacteria and Post Brushing (NCT NCT00981825)
NCT ID: NCT00981825
Last Updated: 2011-06-14
Results Overview
Total number of salivary bacterial colony forming units (lower number = less colonies present)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
4 hours
Results posted on
2011-06-14
Participant Flow
At clinical site
Participant milestones
| Measure |
Fluoride 1st , Triclosan/Fluoride 2nd
Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
|
Triclosan/Fluoride 1st, Fluoride 2nd
Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
11
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout After 1st Intervention
STARTED
|
11
|
11
|
|
Washout After 1st Intervention
COMPLETED
|
11
|
11
|
|
Washout After 1st Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
11
|
|
Second Intervention
COMPLETED
|
11
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Salivary Bacteria and Post Brushing
Baseline characteristics by cohort
| Measure |
Fluoride 1st, Triclosan/Fluoride 2nd
n=11 Participants
Fluoride toothpaste (placebo)
|
Triclosan/Fluoride 1st, Fluoride 2nd
n=11 Participants
Triclosan/Fluoride toothpaste (experimental)
|
Total
n=22 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
|
11 Participants
n=7 Participants
|
22 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
|
30.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
30.6 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursTotal number of salivary bacterial colony forming units (lower number = less colonies present)
Outcome measures
| Measure |
Fluoride Toothpaste (Control)
n=22 Participants
Fluoride toothpaste (control)
|
Triclosan/Fluoride Toothpaste
n=22 Participants
Triclosan/Fluoride toothpaste (experimental)
|
|---|---|---|
|
CFU (Colony Forming Units)
|
7.18 number of colony forming units
Standard Deviation 0.61
|
6.94 number of colony forming units
Standard Deviation 0.40
|
Adverse Events
Fluoride 1st , Triclosan/Fluoride 2nd
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triclosan/Fluoride 1st, Fluoride 2nd
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