Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
A clinical and radiographic evaluation of autogenous periosteal pedicle graft in comparison with collagen membrane for management of periodontal intrabony defects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 20, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedResults Posted
Study results publicly available
October 9, 2015
CompletedApril 24, 2017
April 1, 2017
1.1 years
September 20, 2014
August 10, 2015
April 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level
Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration
Baseline and 6 months
Secondary Outcomes (2)
Pocket Depth
Baseline and 6 months
Bone Defect Area
Baseline and 6 months
Study Arms (2)
periosteal pedicle graft
EXPERIMENTALautogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.
Bioresorbable collagen membrane
ACTIVE COMPARATOREquine Achilles tendon collagen barrier membrane
Interventions
Autogenous pedicle graft harvested from the periosteum
Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (5)
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.
PMID: 22612365RESULTGamal 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.
PMID: 19055224RESULTPaolantonio 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.
PMID: 20583915RESULTBunyaratavej P, Wang HL. Collagen membranes: a review. J Periodontol. 2001 Feb;72(2):215-29. doi: 10.1902/jop.2001.72.2.215.
PMID: 11288796RESULTStoecklin-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.
PMID: 23842107RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ass. Prof. Dr. Noha Ghallab
- Organization
- Faculty of Oral and Dental Medicine Cairo University
Study Officials
- PRINCIPAL INVESTIGATOR
Noha Ghallab, M.D.
Associate Professor of periodontology faulty of oral and dental medicine Cairo Unv.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of periodontology, faculty of oral and dental medicine
Study Record Dates
First Submitted
September 20, 2014
First Posted
September 25, 2014
Study Start
March 1, 2013
Primary Completion
April 1, 2014
Study Completion
May 1, 2014
Last Updated
April 24, 2017
Results First Posted
October 9, 2015
Record last verified: 2017-04