DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects

October 27, 2016 updated by: Krishnadevaraya College of Dental Sciences & Hospital

A Comparative Clinical and Radiographic Evaluation of Demineralized Freeze Dried Bone Allograft (DFDBA) and Xenograft (Cerabone)TM With Decortication in the Treatment of Periodontal Intraosseous Defects

DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has the potential for osteoinduction due to increased expression of bone morphogenetic protein (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication is performed as a part of guided bone regeneration (GBR) procedure as it enhances the healing process.Therefore a combination of decortication and bone graft when applied in periodontal intrabony defect would enhance the regeneration of periodontium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There have been great strides in the management of periodontal intrabony defects, especially with the use of bone graft materials. It is necessary to choose the most appropriate material and procedure in order to obtain the desired regeneration. Among the bone grafts, Demineralised freezed dried bone allograft (DFDBA) and xenografts have shown good results in the management of intrabony defects. Recently, a novel bovine xenograft i.e., Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct bone defects. Decortication or intramarrow penetration of the bone has shown favourable results in guided bone regeneration procedures. So the goal of the present study was to check the efficacy of decortication with decalcified freeze dried bone allograft (DFDBA) and Cerabone™ bone grafts and to compare the response between the bonegrafts placed following decortication using RVG and CBCT, in intrabony defect.

The combination of decortication with bone grafts i.e., DFDBA and (Cerabone)TM can be an added advantage in the treatment of intrabony defects. To the best of the investigators knowledge no clinical trial reports this combination therapy in scientific literature. There is need for further research in this area.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age group 25-45 years
  • Moderate periodontitis with pocket probing depth more than 5 mm
  • Bilaterally similiar intrabony defects
  • systemically healthy patients
  • Good compliance

Exclusion Criteria:

  • medically compromised
  • Pregnant and lactating women
  • Smoking
  • teeth with mobility and furcation involvement

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Decortication +DFDBA
After phase 1 therapy patients were assigned for decortication+ DFDBA group. Mucoperiosteal flaps were reflected. After open flap debridement, decortication was performed and DFDBA graft was placed in the treatment of intrabony defects.
Procedure: Decortication + bone grafts
Active Comparator: Decortication+ Xenograft (Cerabone)TM
After phase 1 therapy patients were assigned for decortication+ xenograft (Cerabone)TM group. Mucoperiosteal flaps were reflected. After open flap debridement, decortication was performed and DFDBA graft was placed in the treatment of intrabony defects.
Procedure: Decortication + bone grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical attachment level
Time Frame: 9 months
clinical attachment level measured in mm from cementoenamel junction to the base of the pocket
9 months
Bone fill
Time Frame: 9 months
Bone fill measured in mm in radiographs from alveolar crest to base of the pocket
9 months
Pocket probing depth
Time Frame: 9 months
pocket probing depth level measured in mm from gingival margin to base of the pocket
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index (PI)
Time Frame: 9 month
Plaque index is measured for periodontal health
9 month
Periodontal disease index
Time Frame: 9 months
Periodontal disease index is measured for periodontal health
9 months
Gingival Bleeding Index
Time Frame: 9 months
Gingival bleeding index is measured for periodontal health
9 months

Collaborators and Investigators

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

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

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

November 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 02_D012_54500

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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