Trial Outcomes & Findings for Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse (NCT NCT01024738)
NCT ID: NCT01024738
Last Updated: 2009-12-03
Results Overview
Plaque score is 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
22 participants
Primary outcome timeframe
4 Days
Results posted on
2009-12-03
Participant Flow
Performed at the clinic
Participant milestones
| Measure |
Fluoride Toothpaste First
Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
|
Triclosan/Fluoride Toothpaste First
triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
|
Chlorhexidine Oral Rinse
chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
|
|---|---|---|---|
|
First Intervention:
STARTED
|
7
|
7
|
8
|
|
First Intervention:
COMPLETED
|
7
|
7
|
8
|
|
First Intervention:
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout After 1st Intervention
STARTED
|
7
|
7
|
8
|
|
Washout After 1st Intervention
COMPLETED
|
7
|
7
|
8
|
|
Washout After 1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention:
STARTED
|
7
|
7
|
8
|
|
Second Intervention:
COMPLETED
|
7
|
7
|
8
|
|
Second Intervention:
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout After 2nd Intervention
STARTED
|
7
|
7
|
8
|
|
Washout After 2nd Intervention
COMPLETED
|
7
|
7
|
8
|
|
Washout After 2nd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention:
STARTED
|
7
|
7
|
8
|
|
Third Intervention:
COMPLETED
|
7
|
7
|
8
|
|
Third Intervention:
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Baseline characteristics by cohort
| Measure |
Fluoride Toothpaste
n=7 Participants
negative control toothpaste
|
Total Toothpaste
n=7 Participants
triclosan/fluoride toothpaste (positive control)
|
Chlorhexidine Oral Rinse
n=8 Participants
chlorhexidine oral rinse (positive control)
|
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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 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
|
|
Age Continuous
|
44.2 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
50.43 years
STANDARD_DEVIATION 8.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
22 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 DaysPlaque score is 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 Toothpaste
n=22 Participants
negative control toothpaste
|
Total Toothpaste
n=22 Participants
triclosan/fluoride toothpaste (positive control)
|
Chlorhexidine Oral Rinse
n=22 Participants
chlorhexidine oral rinse (positive control)
|
|---|---|---|---|
|
Plaque Index
|
3.31 Units on a scale
Standard Deviation 0.48
|
3.31 Units on a scale
Standard Deviation 0.38
|
2.91 Units on a scale
Standard Deviation 0.36
|
Adverse Events
Fluoride Toothpaste First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triclosan/Fluoride Toothpaste First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chlorhexidine Oral Rinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoride Toothpaste First
n=22 participants at risk
Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
|
Triclosan/Fluoride Toothpaste First
n=22 participants at risk
triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
|
Chlorhexidine Oral Rinse
n=22 participants at risk
chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
|
|---|---|---|---|
|
Social circumstances
Non related adverse event
|
0.00%
0/22 • 2 month test period
subjects used the product twice a day for 4 days with oral exams at beginning and end of treatment periods.
|
0.00%
0/22 • 2 month test period
subjects used the product twice a day for 4 days with oral exams at beginning and end of treatment periods.
|
4.5%
1/22 • Number of events 1 • 2 month test period
subjects used the product twice a day for 4 days with oral exams at beginning and end of treatment periods.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60