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

NCT02679209 | Completed DMC

• 1 other identifier: Aminonchorion_DBM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

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

  change from Baseline at 6 months

Secondary Outcomes (2)

• pocket depth

  Baseline and 6 months

• bone defect area

  Baseline and 6 months

Study Arms (2)

Bone allograft

EXPERIMENTAL

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

Amnion chorion membrane

EXPERIMENTAL

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

Interventions

Demineralized bone matrix in putty form BIOLOGICAL

it is a type of bone graft from human cadavers.

Also known as: DBM

Bone allograft

Amnion chorion membrane BIOLOGICAL

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

Also known as: bioresorbable membrane

Amnion chorion membrane

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 19277899 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riham Hamdy, pHD

  Associate Professor of Oral and Maxillofacial Radiology

  STUDY CHAIR

• Amr Temraz, BDs

  Master student at Oral medicine and Periodontology department

  PRINCIPAL INVESTIGATOR

• Omnia Abouldahab, phD

  Professor of Oral Medicine & Periodontology, Cairo Unv.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral Medicine and Periodontology

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: February 10, 2016
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

EG (1)