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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Demineralized bone matrix in putty form
Amnion chorion membrane
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Oral and Dental Medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bone allograft

Amnion chorion membrane

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical attachment level
Change from baseline in clinical attachment level in mm in chronic periodontitis patients

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2016
Last Updated
April 23, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02679209
Brief Title
Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects
Official Title
Clinical and Radiographic Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft for Management of Periodontal Intrabony Defects: a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone allograft
Arm Type
Experimental
Arm Description
commercially available demineralized bone matrix putty allograft will be used to fill in the defect after opening a periodontal flap
Arm Title
Amnion chorion membrane
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Demineralized bone matrix in putty form
Other Intervention Name(s)
DBM
Intervention Description
it is a type of bone graft from human cadavers.
Intervention Type
Biological
Intervention Name(s)
Amnion chorion membrane
Other Intervention Name(s)
bioresorbable membrane
Intervention Description
A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.
Primary Outcome Measure Information:
Title
Clinical attachment level
Description
Change from baseline in clinical attachment level in mm in chronic periodontitis patients
Time Frame
change from Baseline at 6 months
Secondary Outcome Measure Information:
Title
pocket depth
Description
Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months
Time Frame
Baseline and 6 months
Title
bone defect area
Description
Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riham Hamdy, pHD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial Radiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amr Temraz, BDs
Organizational Affiliation
Master student at Oral medicine and Periodontology department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Omnia Abouldahab, phD
Organizational Affiliation
Professor of Oral Medicine & Periodontology, Cairo Unv.
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine, Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19277899
Citation
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.
Results Reference
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Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects

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