Clinical trial NCT02248103: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Pocket Depth
timeFrame: Baseline and 6 months
measure: Bone Defect Area
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.
name: Noha Ghallab, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.