Trial Outcomes & Findings for Evaluate Inflammation Caused by Gingivitis in Adults (NCT NCT00941668)
NCT ID: NCT00941668
Last Updated: 2015-08-27
Results Overview
Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-08-27
Participant Flow
subjects were recruited by the PI at the clinical site
Participant milestones
| Measure |
Total Toothpaste (Active)
triclosan/copolymer/fluoride toothpaste
|
Colgate Great Regular Flavor (Placebo)
sodium monofluorophosphate toothpaste
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Inflammation Caused by Gingivitis in Adults
Baseline characteristics by cohort
| Measure |
Total Toothpaste (Active)
n=24 Participants
triclosan/copolymer/fluoride toothpaste
|
Colgate Cavity Protection (Placebo)
n=25 Participants
sodium monofluorophosphate toothpaste
|
Total
n=49 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
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 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
|
39.9 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
34 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
36.25 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
25 participants
n=107 Participants
|
49 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksLevels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)
Outcome measures
| Measure |
Total Toothpaste (Active)
n=24 Participants
triclosan/copolymer/fluoride toothpaste
|
Colgate Cavity Protection (Placebo)
n=25 Participants
sodium monofluorophosphate toothpaste
|
|---|---|---|
|
Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours
|
492.2 Micrograms
Standard Deviation 545.5
|
326.3 Micrograms
Standard Deviation 307.7
|
PRIMARY outcome
Timeframe: 4 weeksLevels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)
Outcome measures
| Measure |
Total Toothpaste (Active)
n=24 Participants
triclosan/copolymer/fluoride toothpaste
|
Colgate Cavity Protection (Placebo)
n=25 Participants
sodium monofluorophosphate toothpaste
|
|---|---|---|
|
Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours
|
12.8 Micrograms
Standard Deviation 23.3
|
21.3 Micrograms
Standard Deviation 46.4
|
Adverse Events
Total Toothpaste (Active)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Colgate Cavity Protection (Placebo)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Total Toothpaste (Active)
n=24 participants at risk
triclosan/copolymer/fluoride toothpaste
|
Colgate Cavity Protection (Placebo)
n=25 participants at risk
sodium monofluorophosphate toothpaste
|
|---|---|---|
|
General disorders
Tooth Sensitivity to Cold
|
4.2%
1/24 • Number of events 1 • 29 days
|
8.0%
2/25 • Number of events 2 • 29 days
|
|
General disorders
Oral irritation
|
4.2%
1/24 • Number of events 1 • 29 days
|
4.0%
1/25 • Number of events 1 • 29 days
|
|
General disorders
Cold and/or flu like symptoms
|
4.2%
1/24 • Number of events 1 • 29 days
|
8.0%
2/25 • Number of events 2 • 29 days
|
|
General disorders
pulled muscle
|
4.2%
1/24 • Number of events 1 • 29 days
|
4.0%
1/25 • Number of events 1 • 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60