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

Phase 4

Completed

• Conditions: Periodontal Intrabony Defects

• Registration Number: NCT02949557
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2014-11
• Primary Completion: 2015-06
• Study Completion: 2016-04
• Status Verified: 2016-08
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Last Update Submitted: 2016-10-27
• Study First Posted: 2016-10-31
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pocket probing depth	9 months	pocket probing depth level measured in mm from gingival margin to base of the pocket
Bone fill	9 months	Bone fill measured in mm in radiographs from alveolar crest to base of the pocket
clinical attachment level	9 months	clinical attachment level measured in mm from cementoenamel junction to the base of the pocket

Secondary Outcome Measures

Name	Time	Method
Plaque Index (PI)	9 month	Plaque index is measured for periodontal health
Gingival Bleeding Index	9 months	Gingival bleeding index is measured for periodontal health
Periodontal disease index	9 months	Periodontal disease index is measured for periodontal health