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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248103
• Other study ID #: MPP graft_GTR
• Status: Completed
• Phase: N/A
• First received: September 20, 2014
• Last updated: April 21, 2017
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• Periosteal pedicle graft
Autogenous pedicle graft harvested from the periosteum

Biological:
• Bioresorbable collagen membrane
Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (5)

Bunyaratavej P, Wang HL. Collagen membranes: a review. J Periodontol. 2001 Feb;72(2):215-29. Review. — View 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. — View 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 — View 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.2012.110 — View Citation

Stoecklin-Wasmer C, Rutjes AW, da Costa BR, Salvi GE, Jüni 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pocket Depth	Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration	Baseline and 6 months
Secondary	Bone Defect Area	linear measurements collected from a digital radiography program to estimate percentage of defect fill.	Baseline and 6 months