search
Back to results

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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
minocycline
surface and root planning
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic periodontitis, Minocycline, Surface and root planning, Pocket depth, Sulcus bleeding index, Prevotella intermedia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    surface and root planning

    locally delivered minocycline

    surface and root planning+minocycline

    Arm Description

    surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)

    Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth

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

    Outcomes

    Primary Outcome Measures

    Pocket Depth
    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

    Bleeding on Probing
    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)
    Bacterial Load
    Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.

    Full Information

    First Posted
    January 31, 2015
    Last Updated
    October 29, 2015
    Sponsor
    Zhejiang University
    Collaborators
    Academic Centre for Dentistry in Amsterdam
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02355977
    Brief Title
    The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang University
    Collaborators
    Academic Centre for Dentistry in Amsterdam

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Chronic periodontitis, Minocycline, Surface and root planning, Pocket depth, Sulcus bleeding index, Prevotella intermedia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    surface and root planning
    Arm Type
    Active Comparator
    Arm Description
    surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)
    Arm Title
    locally delivered minocycline
    Arm Type
    Active Comparator
    Arm Description
    Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth
    Arm Title
    surface and root planning+minocycline
    Arm Type
    Experimental
    Arm Description
    surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
    Intervention Type
    Drug
    Intervention Name(s)
    minocycline
    Other Intervention Name(s)
    Periocline dental ointment
    Intervention Description
    Periocline dental ointment
    Intervention Type
    Procedure
    Intervention Name(s)
    surface and root planning
    Intervention Description
    surface and root planning
    Primary Outcome Measure Information:
    Title
    Pocket Depth
    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
    Secondary Outcome Measure Information:
    Title
    Bleeding on Probing
    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
    Title
    Bacterial Load
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shuli Deng, Master
    Organizational Affiliation
    Affiliated Hospital of Stomatology, Medical College, Zhejiang University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs