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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

Brief Summary:
To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: minocycline Procedure: surface and root planning Phase 4

Detailed Description:
In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters [Pocket depth (PD) and sulcus bleeding index (SBI)] and the loads of four main periodontal pathogens [Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Response of Periodontal Pathogens to the Respective or Combined Treatment of Scaling and Root Planning and Locally Delivered Minocycline in Patients With Chronic Periodontitis- a Short-term Randomized Clinical Trial
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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)
Procedure: surface and root planning
surface and root planning

Active Comparator: locally delivered minocycline
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
Drug: minocycline
Periocline dental ointment
Other Name: Periocline dental ointment

Procedure: surface and root planning
surface and root planning

Experimental: 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.
Drug: minocycline
Periocline dental ointment
Other Name: Periocline dental ointment




Primary Outcome Measures :
  1. Pocket Depth [ Time Frame: 7 days ]
    PD is measured using a standard CPI(community periodontal index) probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.


Secondary Outcome Measures :
  1. Bleeding on Probing [ Time Frame: 7 days ]
    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)

  2. Bacterial Load [ Time Frame: 7 days ]
    Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth

Exclusion Criteria:

  • pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355977


Sponsors and Collaborators
Zhejiang University
Academic Centre for Dentistry in Amsterdam
Investigators
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Principal Investigator: Shuli Deng, Master Affiliated Hospital of Stomatology, Medical College, Zhejiang University

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Responsible Party: Shuli Deng, Dr., Zhejiang University
ClinicalTrials.gov Identifier: NCT02355977     History of Changes
Other Study ID Numbers: 2013-25
First Posted: February 4, 2015    Key Record Dates
Results First Posted: December 2, 2015
Last Update Posted: December 2, 2015
Last Verified: October 2015

Keywords provided by Shuli Deng, Zhejiang University:
Chronic periodontitis
Minocycline
Surface and root planning
Pocket depth
Sulcus bleeding index
Prevotella intermedia

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents