search
Back to results

Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periosteal pedicle graft
Bioresorbable collagen membrane
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Severe chronic periodontitis patients with at least two sites with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss 2- or 3-wall intrabony defect depth ranging from 3 to 6 mm as detected in periapical radiographs
  • The facial surface of teeth adjacent to the interproximal defect should be free of extensive recession and marginal bone loss, with at least a 4 to 5 mm band of keratinized gingiva to allow for periosteal manipulation

Exclusion Criteria:

  • Pregnant women
  • Subjects had <22 permanent teeth
  • Having any given systemic disease
  • Taking any type of medication and/or antibiotic therapy during the 3 months before the study
  • Received periodontal treatment within the past 12 months
  • Current or former smokers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    periosteal pedicle graft

    Bioresorbable collagen membrane

    Arm Description

    autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.

    Equine Achilles tendon collagen barrier membrane

    Outcomes

    Primary Outcome Measures

    Clinical Attachment Level
    Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration

    Secondary Outcome Measures

    Pocket Depth
    Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration
    Bone Defect Area
    linear measurements collected from a digital radiography program to estimate percentage of defect fill.

    Full Information

    First Posted
    September 20, 2014
    Last Updated
    April 21, 2017
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02248103
    Brief Title
    Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects
    Official Title
    Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison with collagen membrane for management of periodontal intrabony defects.
    Detailed Description
    Twenty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched pairs of two- or three-walled intrabony defects. Each pair of periodontal defects were randomly assigned into the experimental group; periosteal pedicle graft guided tissue membrane or the positive control group; bioresorbable collagen guided tissue regeneration membrane. Clinical and radiographic parameters were recorded at baseline and at 6 months postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    periosteal pedicle graft
    Arm Type
    Experimental
    Arm Description
    autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
    Arm Title
    Bioresorbable collagen membrane
    Arm Type
    Active Comparator
    Arm Description
    Equine Achilles tendon collagen barrier membrane
    Intervention Type
    Procedure
    Intervention Name(s)
    Periosteal pedicle graft
    Intervention Description
    Autogenous pedicle graft harvested from the periosteum
    Intervention Type
    Biological
    Intervention Name(s)
    Bioresorbable collagen membrane
    Intervention Description
    Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
    Primary Outcome Measure Information:
    Title
    Clinical Attachment Level
    Description
    Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration
    Time Frame
    Baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    Pocket Depth
    Description
    Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration
    Time Frame
    Baseline and 6 months
    Title
    Bone Defect Area
    Description
    linear measurements collected from a digital radiography program to estimate percentage of defect fill.
    Time Frame
    Baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Severe chronic periodontitis patients with at least two sites with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss 2- or 3-wall intrabony defect depth ranging from 3 to 6 mm as detected in periapical radiographs The facial surface of teeth adjacent to the interproximal defect should be free of extensive recession and marginal bone loss, with at least a 4 to 5 mm band of keratinized gingiva to allow for periosteal manipulation Exclusion Criteria: Pregnant women Subjects had <22 permanent teeth Having any given systemic disease Taking any type of medication and/or antibiotic therapy during the 3 months before the study Received periodontal treatment within the past 12 months Current or former smokers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noha Ghallab, M.D.
    Organizational Affiliation
    Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22612365
    Citation
    Singhal R, Nandlal, Kumar A, Rastogi P. Role of space provision in regeneration of localized two-wall intrabony defects using periosteal pedicle graft as an autogenous guided tissue membrane. J Periodontol. 2013 Mar;84(3):316-24. doi: 10.1902/jop.2012.110734. Epub 2012 May 21.
    Results Reference
    result
    PubMed Identifier
    19055224
    Citation
    Gamal AY, Mailhot JM. A novel marginal periosteal pedicle graft as an autogenous guided tissue membrane for the treatment of intrabony periodontal defects. J Int Acad Periodontol. 2008 Oct;10(4):106-17.
    Results Reference
    result
    PubMed Identifier
    20583915
    Citation
    Paolantonio M, Femminella B, Coppolino E, Sammartino G, D'Arcangelo C, Perfetti G, Perinetti G. Autogenous periosteal barrier membranes and bone grafts in the treatment of periodontal intrabony defects of single-rooted teeth: a 12-month reentry randomized controlled clinical trial. J Periodontol. 2010 Nov;81(11):1587-95. doi: 10.1902/jop.2010.100094. Epub 2010 Jun 28.
    Results Reference
    result
    PubMed Identifier
    11288796
    Citation
    Bunyaratavej P, Wang HL. Collagen membranes: a review. J Periodontol. 2001 Feb;72(2):215-29. doi: 10.1902/jop.2001.72.2.215.
    Results Reference
    result
    PubMed Identifier
    23842107
    Citation
    Stoecklin-Wasmer C, Rutjes AW, da Costa BR, Salvi GE, Juni P, Sculean A. Absorbable collagen membranes for periodontal regeneration: a systematic review. J Dent Res. 2013 Sep;92(9):773-81. doi: 10.1177/0022034513496428. Epub 2013 Jul 10.
    Results Reference
    result

    Learn more about this trial

    Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects

    We'll reach out to this number within 24 hrs