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Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects

Primary Purpose

Periodontal Pocket

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Regenerative therapy
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • No systemic diseases that could influence the outcome of therapy
  • Good compliance for plaque control instructions after initial therapy
  • Vital teeth
  • Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth
  • Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs,

Exclusion Criteria:

  • Pregnant females and patients presented with opened interproximal contact

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PRF

    MPP

    Arm Description

    Platelets rich fibrin,

    Marginal periosteal pedicle

    Outcomes

    Primary Outcome Measures

    Intrabony defect
    measurements of intrabony gain from CEJ to base of defect

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2014
    Last Updated
    February 9, 2015
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02359539
    Brief Title
    Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects
    Official Title
    Marginal Periosteal Pedicle Flap and Platelet Rich Fibrin Barriers for the Treatment of Periodontal Intrabony Defects -Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. This study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers for treating intrabony defects. In spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as PRF that could offer predictable outcomes.
    Detailed Description
    Material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm intrabony defect had participated in this randomized clinical study. Subjects were randomly divided into2 groups, Group 1(MPP) defect coverage with xenograft defect fill(10 patients),Group 2(PRF) defect coverage with xenograft defect fill(10 patients).Clinical and radiographic measurements were carried out at 3,6 and 9 months postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Pocket

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRF
    Arm Type
    Experimental
    Arm Description
    Platelets rich fibrin,
    Arm Title
    MPP
    Arm Type
    Experimental
    Arm Description
    Marginal periosteal pedicle
    Intervention Type
    Procedure
    Intervention Name(s)
    Regenerative therapy
    Other Intervention Name(s)
    Guided tissue regeneration
    Intervention Description
    Periosteal pedicle, Platelets rich fibrin
    Primary Outcome Measure Information:
    Title
    Intrabony defect
    Description
    measurements of intrabony gain from CEJ to base of defect
    Time Frame
    9 month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: No systemic diseases that could influence the outcome of therapy Good compliance for plaque control instructions after initial therapy Vital teeth Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs, Exclusion Criteria: Pregnant females and patients presented with opened interproximal contact

    12. IPD Sharing Statement

    Learn more about this trial

    Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects

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