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Completed

NCT Number: NCT02679209

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

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

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Key information

Conditions

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

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Demineralized bone matrix in putty form

Biological

it is a type of bone graft from human cadavers.

Other names: DBM

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.

Other names: bioresorbable membrane

Primary outcomes

  1. Clinical attachment level

    Time frame: change from Baseline at 6 months

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

Secondary outcomes

  1. pocket depth

    Time frame: Baseline and 6 months

    Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months

  2. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2016
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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