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

NCT ID: NCT02359539

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-05-31

Brief Summary

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.

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.

Conditions

Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRF

Platelets rich fibrin,

Group Type: EXPERIMENTAL

Regenerative therapy

Intervention Type: PROCEDURE

Periosteal pedicle, Platelets rich fibrin

MPP

Marginal periosteal pedicle

Group Type: EXPERIMENTAL

Regenerative therapy

Intervention Type: PROCEDURE

Periosteal pedicle, Platelets rich fibrin

Interventions

Regenerative therapy

Periosteal pedicle, Platelets rich fibrin

Intervention Type: PROCEDURE

Other Intervention Names

Guided tissue regeneration

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Y Gamal

Professor of Periodontology Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Ain Shams University

Identifier Type: -

Identifier Source: org_study_id