Trial Outcomes & Findings for Evaluating Commercial Anti-Plaque Products and Oral Rinse (NCT NCT01014143)
NCT ID: NCT01014143
Last Updated: 2011-06-14
Results Overview
Plaque 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
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Four days
Results posted on
2011-06-14
Participant Flow
Recruitment was performed by the clinical site
Participant milestones
| Measure |
Fluoride Toothpaste First
Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
|
Total Toothpaste First
triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
|
Chlorhexidine Oral Rinse First
chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
|
|---|---|---|---|
|
First Intervention
STARTED
|
10
|
9
|
9
|
|
First Intervention
COMPLETED
|
10
|
9
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period After 1st Intervention
STARTED
|
10
|
9
|
9
|
|
Washout Period After 1st Intervention
COMPLETED
|
10
|
9
|
9
|
|
Washout Period After 1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
9
|
9
|
|
Second Intervention
COMPLETED
|
8
|
9
|
9
|
|
Second Intervention
NOT COMPLETED
|
2
|
0
|
0
|
|
Washout After 2nd Intervention
STARTED
|
8
|
9
|
9
|
|
Washout After 2nd Intervention
COMPLETED
|
8
|
9
|
9
|
|
Washout After 2nd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
8
|
9
|
9
|
|
Third Intervention
COMPLETED
|
8
|
9
|
9
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fluoride Toothpaste First
Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
|
Total Toothpaste First
triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
|
Chlorhexidine Oral Rinse First
chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
|
|---|---|---|---|
|
Second Intervention
Lost to Follow-up
|
2
|
0
|
0
|
Baseline Characteristics
Evaluating Commercial Anti-Plaque Products and Oral Rinse
Baseline characteristics by cohort
| Measure |
Fluoride Toothpaste
n=10 Participants
negative control
|
Total Toothpaste
n=9 Participants
triclosan/fluoride toothpaste (positive control toothpaste)
|
Chlorhexidine Oral Rinse
n=9 Participants
chlorhexidine mouthrinse (positive control rinse)
|
Total
n=28 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age Continuous
|
47.6 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
39 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
47.2 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
44.5 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
28 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Four daysPopulation: per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.
Plaque 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=28 Participants
negative control
|
Total Toothpaste
n=26 Participants
triclosan/fluoride toothpaste (positive control toothpaste)
|
Chlorhexidine Oral Rinse
n=26 Participants
chlorhexidine mouthrinse (positive control rinse)
|
|---|---|---|---|
|
Plaque Index
|
2.63 Units on a scale
Standard Deviation 0.61
|
2.65 Units on a scale
Standard Deviation 0.56
|
1.23 Units on a scale
Standard Deviation 0.59
|
Adverse Events
Fluoride Toothpaste First
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Total Toothpaste First
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Chlorhexidine Oral Rinse First
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=28 participants at risk
Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
|
Total Toothpaste First
n=28 participants at risk
triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
|
Chlorhexidine Oral Rinse First
n=28 participants at risk
chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
|
|---|---|---|---|
|
Social circumstances
Upset stomach - non related to product use
|
3.8%
1/26 • Number of events 1 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
0.00%
0/26 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
0.00%
0/26 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
|
Social circumstances
Sinus headache - non related to product use
|
0.00%
0/26 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
3.8%
1/26 • Number of events 1 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
0.00%
0/26 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
|
Social circumstances
Menstrual cramps
|
0.00%
0/26 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
0.00%
0/26 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
3.8%
1/26 • Number of events 1 • 6 weeks
subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60