Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Biological: Amnion chorion membrane; Biological: Demineralized bone matrix in putty form

• Registration Number: NCT02679209
• Lead Sponsor: Cairo University

Brief Summary

A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane and bone allograft for management of periodontal intrabony defects.

Detailed Description

Twenty-two patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed had two- or three-walled intrabony defects. Patients were randomly assigned into two groups; bioresorbable membrane or bone allograft. Clinical parameters were recorded at baseline and at 3 and 6 months postoperatively. Radiographic parameters were recorded at baseline and at 6 months postoperatively.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-02-07
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-10
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Severe chronic periodontitis patients.
• having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria

• Pregnant women
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amnion chorion membrane	Amnion chorion membrane	Amnion chorion commercially available allograft bioresorbable membrane as a guided tissue regeneration technique will be used to in the defect after opening a periodontal flap
Bone allograft	Demineralized bone matrix in putty form	commercially available demineralized bone matrix putty allograft will be used to fill in the defect after opening a periodontal flap

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	change from Baseline at 6 months	Change from baseline in clinical attachment level in mm in chronic periodontitis patients

Secondary Outcome Measures

Name	Time	Method
bone defect area	Baseline and 6 months	Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
pocket depth	Baseline and 6 months	Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University; 🇪🇬 Cairo, Egypt