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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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
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
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
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Comparison of Autogenous Periosteal Pedicle Graft and Collagen Membrane in Management of Periodontal Intrabony Defects
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