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

Periodontal Pocket Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359539
• Other study ID #: Ain Shams University
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2014
• Last updated: February 9, 2015
• Start date: August 2009
• Est. completion date: May 2013

Study information

• Verified date: November 2014
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontal Pocket

Intervention

Procedure:
• Regenerative therapy
Periosteal pedicle, Platelets rich fibrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrabony defect	measurements of intrabony gain from CEJ to base of defect	9 month after surgery	Yes