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

April 23, 2018 updated by: Noha Ayman Ghallab, Cairo University

Clinical and Radiographic Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft for Management of Periodontal Intrabony Defects: a Randomized Clinical Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • faculty of oral and dental medicine, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone allograft
commercially available demineralized bone matrix putty allograft will be used to fill in the defect after opening a periodontal flap
Biological: Demineralized bone matrix in putty form
it is a type of bone graft from human cadavers.
Other Names:
  • DBM
Experimental: 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
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.
Other Names:
  • bioresorbable membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: change from Baseline at 6 months
Change from baseline in clinical attachment level in mm in chronic periodontitis patients
change from Baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pocket depth
Time Frame: Baseline and 6 months
Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months
Baseline and 6 months
bone defect area
Time Frame: Baseline and 6 months
Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Riham Hamdy, pHD, Associate Professor of Oral and Maxillofacial Radiology
  • Principal Investigator: Amr Temraz, BDs, Master student at Oral medicine and Periodontology department
  • Study Director: Omnia Abouldahab, phD, Professor of Oral Medicine & Periodontology, Cairo Unv.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 7, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aminonchorion_DBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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