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

NCT ID: NCT02248103

Last Updated: 2017-04-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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periosteal pedicle graft

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

Group Type EXPERIMENTAL

Periosteal pedicle graft

Intervention Type PROCEDURE

Autogenous pedicle graft harvested from the periosteum

Bioresorbable collagen membrane

Equine Achilles tendon collagen barrier membrane

Group Type ACTIVE_COMPARATOR

Bioresorbable collagen membrane

Intervention Type BIOLOGICAL

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

Interventions

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Periosteal pedicle graft

Autogenous pedicle graft harvested from the periosteum

Intervention Type PROCEDURE

Bioresorbable collagen membrane

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ayman Ghallab

Associate Professor of periodontology, faculty of oral and dental medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha Ghallab, M.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.

References

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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.

Reference Type RESULT
PMID: 22612365 (View on PubMed)

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.

Reference Type RESULT
PMID: 19055224 (View on PubMed)

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.

Reference Type RESULT
PMID: 20583915 (View on PubMed)

Bunyaratavej P, Wang HL. Collagen membranes: a review. J Periodontol. 2001 Feb;72(2):215-29. doi: 10.1902/jop.2001.72.2.215.

Reference Type RESULT
PMID: 11288796 (View on PubMed)

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.

Reference Type RESULT
PMID: 23842107 (View on PubMed)

Other Identifiers

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MPP graft_GTR

Identifier Type: -

Identifier Source: org_study_id

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