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

NCT ID: NCT02679209

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bone allograft

commercially available demineralized bone matrix putty allograft will be used to fill in the defect after opening a periodontal flap

Group Type EXPERIMENTAL

Demineralized bone matrix in putty form

Intervention Type BIOLOGICAL

it is a type of bone graft from human cadavers.

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

Group Type EXPERIMENTAL

Amnion chorion membrane

Intervention Type BIOLOGICAL

A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.

Interventions

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Demineralized bone matrix in putty form

it is a type of bone graft from human cadavers.

Intervention Type BIOLOGICAL

Amnion chorion membrane

A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.

Intervention Type BIOLOGICAL

Other Intervention Names

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DBM bioresorbable membrane

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ayman Ghallab

Professor of Oral Medicine and Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riham Hamdy, pHD

Role: STUDY_CHAIR

Associate Professor of Oral and Maxillofacial Radiology

Amr Temraz, BDs

Role: PRINCIPAL_INVESTIGATOR

Master student at Oral medicine and Periodontology department

Omnia Abouldahab, phD

Role: STUDY_DIRECTOR

Professor of Oral Medicine & Periodontology, Cairo Unv.

Locations

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Faculty of Oral and Dental Medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Kothiwale SV, Anuroopa P, Gajiwala AL. A clinical and radiological evaluation of DFDBA with amniotic membrane versus bovine derived xenograft with amniotic membrane in human periodontal grade II furcation defects. Cell Tissue Bank. 2009 Nov;10(4):317-26. doi: 10.1007/s10561-009-9126-3. Epub 2009 Mar 10.

Reference Type BACKGROUND
PMID: 19277899 (View on PubMed)

Other Identifiers

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Aminonchorion_DBM

Identifier Type: -

Identifier Source: org_study_id

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