Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects

Marginal Periosteal Pedicle Flap and Platelet Rich Fibrin Barriers for the Treatment of Periodontal Intrabony Defects -Randomized Clinical Trial

The use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. This study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers for treating intrabony defects. In spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as PRF that could offer predictable outcomes.

Study Overview

• Status: Completed
• Conditions: Periodontal Pocket
• Intervention / Treatment: Procedure: Regenerative therapy

Detailed Description

Material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm intrabony defect had participated in this randomized clinical study. Subjects were randomly divided into2 groups, Group 1(MPP) defect coverage with xenograft defect fill(10 patients),Group 2(PRF) defect coverage with xenograft defect fill(10 patients).Clinical and radiographic measurements were carried out at 3,6 and 9 months postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No systemic diseases that could influence the outcome of therapy
• Good compliance for plaque control instructions after initial therapy
• Vital teeth
• Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth
• Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs,

Exclusion Criteria:

• Pregnant females and patients presented with opened interproximal contact

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF; Platelets rich fibrin,	Procedure: Regenerative therapy; Periosteal pedicle, Platelets rich fibrin; Other Names: Guided tissue regeneration
Experimental: MPP; Marginal periosteal pedicle	Procedure: Regenerative therapy; Periosteal pedicle, Platelets rich fibrin; Other Names: Guided tissue regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrabony defect	measurements of intrabony gain from CEJ to base of defect	9 month after surgery

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 16, 2014
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: Ain Shams University (Registry Identifier: passant abdalla)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No