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OpenTrials
Completed

NCT Number: NCT02248103

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

A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison with collagen membrane for management of periodontal intrabony defects.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periosteal pedicle graft

Procedure

Autogenous pedicle graft harvested from the periosteum

Bioresorbable collagen membrane

Biological

Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration

Primary outcomes

  1. Clinical Attachment Level

    Time frame: Baseline and 6 months

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

Secondary outcomes

  1. Pocket Depth

    Time frame: Baseline and 6 months

    Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration

  2. Bone Defect Area

    Time frame: Baseline and 6 months

    linear measurements collected from a digital radiography program to estimate percentage of defect fill.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 25, 2014
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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