Trial Outcomes & Findings for Clarithromycin as Adjuvant to Periodontal Debridement (NCT NCT02829983)
NCT ID: NCT02829983
Last Updated: 2017-11-21
Results Overview
Distance from bottom of pocket to the cement-enamel junction (CEJ).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2017-11-21
Participant Flow
Participant milestones
| Measure |
Clarithromycin Group
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
Placebo Group
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Placebo: Use of placebo tablets twice a day for 3 days.
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clarithromycin Group
n=20 Participants
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
Placebo Group
n=20 Participants
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Placebo: Use of placebo tablets twice a day for 3 days.
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 3.7 • n=20 Participants
|
31.25 years
STANDARD_DEVIATION 4.6 • n=20 Participants
|
31.32 years
STANDARD_DEVIATION 0.10 • n=40 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Probing depht
|
3.34 milimeter
STANDARD_DEVIATION 0.56 • n=20 Participants
|
3.53 milimeter
STANDARD_DEVIATION 0.6 • n=20 Participants
|
3.43 milimeter
STANDARD_DEVIATION 0.13 • n=40 Participants
|
|
clinical attachment level
|
3.48 milimeter
STANDARD_DEVIATION 0.66 • n=20 Participants
|
3.63 milimeter
STANDARD_DEVIATION 0.7 • n=20 Participants
|
3.55 milimeter
STANDARD_DEVIATION 0.1 • n=40 Participants
|
|
bleeding on probing
|
53 percentage of sites
STANDARD_DEVIATION 19 • n=20 Participants
|
54 percentage of sites
STANDARD_DEVIATION 30 • n=20 Participants
|
53.5 percentage of sites
STANDARD_DEVIATION 0.7 • n=40 Participants
|
|
gingival recession
|
0.14 milimeter
STANDARD_DEVIATION 0.16 • n=20 Participants
|
0.1 milimeter
STANDARD_DEVIATION 0.12 • n=20 Participants
|
0.12 milimeter
STANDARD_DEVIATION 0.028 • n=40 Participants
|
|
plaque index
|
59 percentage of sites
STANDARD_DEVIATION 23 • n=20 Participants
|
62 percentage of sites
STANDARD_DEVIATION 25 • n=20 Participants
|
60.5 percentage of sites
STANDARD_DEVIATION 2.12 • n=40 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDistance from bottom of pocket to the cement-enamel junction (CEJ).
Outcome measures
| Measure |
Clarithromycin Group
n=20 Participants
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
Placebo Group
n=20 Participants
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Placebo: Use of placebo tablets twice a day for 3 days.
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
|---|---|---|
|
Clinical Attachment Level
|
2.71 milimeter
Standard Deviation 0.35
|
3.03 milimeter
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 6 monthsDistance from the bottom of sulcus/pocket to gingival margin
Outcome measures
| Measure |
Clarithromycin Group
n=20 Participants
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
Placebo Group
n=20 Participants
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Placebo: Use of placebo tablets twice a day for 3 days.
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
|---|---|---|
|
Probing Depth
|
2.53 milimeter
Standard Deviation 0.3
|
2.86 milimeter
Standard Deviation 0.52
|
Adverse Events
Clarithromycin Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clarithromycin Group
n=20 participants at risk
20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
Placebo Group
n=20 participants at risk
20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Placebo: Use of placebo tablets twice a day for 3 days.
One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal discomfort
|
10.0%
2/20 • Number of events 2 • 1 week after periodontal treatment.
|
0.00%
0/20 • 1 week after periodontal treatment.
|
Additional Information
Mauro Pedrine Santamaria
Universidade Estadual Paulista Júlio de Mesquita Filho
Phone: 3947-9033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place