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The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02355977
Recruitment Status : Completed
First Posted : February 4, 2015
Results First Posted : December 2, 2015
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Academic Centre for Dentistry in Amsterdam
Information provided by (Responsible Party):
Shuli Deng, Zhejiang University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Periodontitis
Interventions Drug: minocycline
Procedure: surface and root planning
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Hide Arm/Group Description

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 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+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment

Period Title: Overall Study
Started 21 26 23
Completed 21 26 23
Not Completed 0 0 0
Arm/Group Title Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline Total
Hide Arm/Group Description

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 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+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment

Total of all reporting groups
Overall Number of Baseline Participants 21 26 23 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 26 participants 23 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  95.2%
22
  84.6%
22
  95.7%
64
  91.4%
>=65 years
1
   4.8%
4
  15.4%
1
   4.3%
6
   8.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 26 participants 23 participants 70 participants
47  (15) 50  (13) 49  (11) 49  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 26 participants 23 participants 70 participants
Female
13
  61.9%
9
  34.6%
12
  52.2%
34
  48.6%
Male
8
  38.1%
17
  65.4%
11
  47.8%
36
  51.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 26 participants 23 participants 70 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
21
 100.0%
26
 100.0%
23
 100.0%
70
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 21 participants 26 participants 23 participants 70 participants
21 26 23 70
1.Primary Outcome
Title Pocket Depth
Hide Description PD is measured using a standard CPI(community periodontal index) probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Hide Arm/Group Description:

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 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+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment

Overall Number of Participants Analyzed 21 26 23
Mean (Standard Deviation)
Unit of Measure: mm
4.34  (0.57) 4.81  (0.99) 4.5  (0.53)
2.Secondary Outcome
Title Bleeding on Probing
Hide Description BOP 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)
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Hide Arm/Group Description:

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 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+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment

Overall Number of Participants Analyzed 21 26 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.42  (0.55) 1.23  (0.70) 1.42  (0.55)
3.Secondary Outcome
Title Bacterial Load
Hide Description Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analyzed units of the gene load of bacteria are log10.
Arm/Group Title Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Hide Arm/Group Description:

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 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+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment

Overall Number of Participants Analyzed 21 26 23
Mean (Standard Deviation)
Unit of Measure: log10 (copies/ml)
Aggregatibacter actinomycetemcomitans (Aa) 5.55  (0.59) 4.32  (1.67) 4.77  (0.86)
Fusobacterium nucleatum (Fn) 6.77  (0.39) 6.37  (0.43) 6.72  (0.42)
Porphyromonas gingivalis (Pg) 7.11  (1.77) 6.72  (1.73) 7.13  (1.78)
Prevotella intermedia (Pi) 4.98  (0.72) 4.58  (1.16) 4.77  (0.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Hide Arm/Group Description

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 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+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.

minocycline: Periocline dental ointment

All-Cause Mortality
Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/26 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surface and Root Planning Locally Delivered Minocycline Surface and Root Planning+Minocycline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/26 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ying Wang
Organization: Zhejiang University
Phone: 86-571-87217437
Responsible Party: Shuli Deng, Zhejiang University
ClinicalTrials.gov Identifier: NCT02355977     History of Changes
Other Study ID Numbers: 2013-25
First Submitted: January 31, 2015
First Posted: February 4, 2015
Results First Submitted: September 26, 2015
Results First Posted: December 2, 2015
Last Update Posted: December 2, 2015