DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects

A Clinical and Radiographic Evaluation of DFDBA (Demineralised Freeze Dried Bone Allograft) With Amniotic Membrane (AM) in the Treatment of Periodontal Osseous Defects-12 Month Randomized Controlled Clinical Trial

Amniotic membrane may be considered as a biologically active scaffold, which in combination with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs would enhance the regeneration of periodontium.

Study Overview

• Status: Unknown
• Conditions: Periodontal Intrabony Defects
• Intervention / Treatment: Procedure: OFD+ DFDBA; Procedure: OFD+ DFDBA+ AM

Detailed Description

Periodontitis is a bacterially induced inflammatory disease of the supporting tissues of the teeth. It is one of the major dental diseases that affect human populations worldwide and has a huge economic impact on national health care systems.The consequence of periodontitis is commonly the formation of intrabony defects.Intrabony defects are more amenable for regenerative procedures. Periodontal regeneration remains a fundamental therapeutic goal for the preservation of teeth through the restoration of health, function, and esthetics of the periodontium. Several treatment procedures like open flap debridement (OFD), autogenous bone replacement bone grafts (BRG), guided tissue regeneration (GTR), bioactive agents like EMD, rhPDGF-BB, laser assisted regeneration (LAR) have shown histologic proof of principle that the periodontal ligament apparatus can be regenerated in human studies. Intrabony defects with the depth of >3 mm and radiographic defect angle ≤ 25 are amenable for periodontal regeneration. DFDBA has stood the test of time and has shown consistent good quality patient oriented evidence in achieving periodontal regeneration with long term stability. GTR techniques have shown added advantage of space maintenance, clot stability, guided cell population, epithelial cell occlusion and the combination therapies. Periodontal regeneration with GTR and BRG demonstrates better results as compared with GTR alone. More recently in the realm of reconstructive biology, the concept of Tissue engineering (TE) has been introduced which utilizes mechanical, cellular or biologic mediators to facilitate reconstruction/regeneration of a particular tissue.

The combination of this novel biologic membrane AM and the already established BRG-DFDBA can be an added advantage in treatment of IBDs. To the best of the investigators knowledge only one clinical trial reports this combination therapy in the scientific literature. There is a need for further research in this area.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Recruiting
      • Krishnadevaraya college of dental sciences and hospital
      • Contact: Dr Joann P George; Phone Number: 9448541637; Email: drjoannpaulinegeorge@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Age group of 25-45 years
• Moderate periodontitis with pocket probing depth more than 6mm
• Bilaterally similar intrabony defects
• Systemically healthy patients
• Vital or endodontically treated teeth
• Good compliance

Exclusion criteria:

• Medically compromised
• Pregnant and lactating women
• Smoking
• Teeth with mobility and furcation involvement

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OFD + DFDBA; Intrabony defects treatment was carried out with OFD + DFDBA	Procedure: OFD+ DFDBA; After Phase I therapy, patient's were assigned for OFD+DFDBA group. Mucoperiosteal flap were reflected.After Open Flap Debridement (OFD), DFDBA graft was placed for the treatment of intrabony defects.
Active Comparator: OFD+DFDBA+AM; Intrabony defects treatment was carried out with OFD + DFDBA+ AM	Procedure: OFD+ DFDBA+ AM; After Phase I therapy, patient's were assigned for OFD+DFDBA + AM group. Mucoperiosteal flap were reflected. After Open Flap Debridement (OFD). DFDBA and AM was placed for the treatment of intrabony defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	Clinical attachment level measured in mm from cementoenamel junction to base of the pocket)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	Plaque index is measured for periodontal health	1 year
Gingival index	Gingival index is measured for periodontal health	1 year
Bleeding index	Bleeding index is measured for periodontal health	1 year
Pocket Probing depth	Pocket probing depth level measured in mm from gingival margin to base of the pocket)	1 year
Bone Fill	Bone fill measured in mm in radiographs from alveolar crest to base of the pocket	1 year

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Study Director: DR JOANN P GEORGE, MDS, Krishnadevaraya College of Dental Science and Hospital

Publications and helpful links

General Publications

• Kiany F, Moloudi F. Amnion membrane as a novel barrier in the treatment of intrabony defects: a controlled clinical trial. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):639-47. doi: 10.11607/jomi.3590.

Helpful Links

• reference article

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 02_D012_44443