Trial Outcomes & Findings for The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis (NCT NCT02355977)
NCT ID: NCT02355977
Last Updated: 2015-12-02
Results Overview
PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
7 days
Results posted on
2015-12-02
Participant Flow
Participant milestones
| Measure |
Surface and Root Planning
surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning
|
Locally Delivered Minocycline
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning
|
Surface and Root Planning+Minocycline
surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
26
|
23
|
|
Overall Study
COMPLETED
|
21
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis
Baseline characteristics by cohort
| Measure |
Surface and Root Planning
n=21 Participants
surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning
|
Locally Delivered Minocycline
n=26 Participants
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning
|
Surface and Root Planning+Minocycline
n=23 Participants
surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment
|
Total
n=70 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
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 15 • n=5 Participants
|
50 years
STANDARD_DEVIATION 13 • n=7 Participants
|
49 years
STANDARD_DEVIATION 11 • n=5 Participants
|
49 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
23 participants
n=5 Participants
|
70 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysPD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.
Outcome measures
| Measure |
Surface and Root Planning
n=21 Participants
surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning
|
Locally Delivered Minocycline
n=26 Participants
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning
|
Surface and Root Planning+Minocycline
n=23 Participants
surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment
|
|---|---|---|---|
|
Pocket Depth
|
4.34 mm
Standard Deviation 0.57
|
4.81 mm
Standard Deviation 0.99
|
4.5 mm
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 7 daysBOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)
Outcome measures
| Measure |
Surface and Root Planning
n=21 Participants
surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning
|
Locally Delivered Minocycline
n=26 Participants
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning
|
Surface and Root Planning+Minocycline
n=23 Participants
surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment
|
|---|---|---|---|
|
Bleeding on Probing
|
1.42 units on a scale
Standard Deviation 0.55
|
1.23 units on a scale
Standard Deviation 0.70
|
1.42 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 7 daysPopulation: The analyzed units of the gene load of bacteria are log10.
Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.
Outcome measures
| Measure |
Surface and Root Planning
n=21 Participants
surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
surface and root planning: surface and root planning
|
Locally Delivered Minocycline
n=26 Participants
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
minocycline: Periocline dental ointment
surface and root planning: surface and root planning
|
Surface and Root Planning+Minocycline
n=23 Participants
surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
minocycline: Periocline dental ointment
|
|---|---|---|---|
|
Bacterial Load
Aggregatibacter actinomycetemcomitans (Aa)
|
5.55 log10 (copies/ml)
Standard Deviation 0.59
|
4.32 log10 (copies/ml)
Standard Deviation 1.67
|
4.77 log10 (copies/ml)
Standard Deviation 0.86
|
|
Bacterial Load
Fusobacterium nucleatum (Fn)
|
6.77 log10 (copies/ml)
Standard Deviation 0.39
|
6.37 log10 (copies/ml)
Standard Deviation 0.43
|
6.72 log10 (copies/ml)
Standard Deviation 0.42
|
|
Bacterial Load
Porphyromonas gingivalis (Pg)
|
7.11 log10 (copies/ml)
Standard Deviation 1.77
|
6.72 log10 (copies/ml)
Standard Deviation 1.73
|
7.13 log10 (copies/ml)
Standard Deviation 1.78
|
|
Bacterial Load
Prevotella intermedia (Pi)
|
4.98 log10 (copies/ml)
Standard Deviation 0.72
|
4.58 log10 (copies/ml)
Standard Deviation 1.16
|
4.77 log10 (copies/ml)
Standard Deviation 0.92
|
Adverse Events
Surface and Root Planning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Locally Delivered Minocycline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surface and Root Planning+Minocycline
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