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

NCT ID: NCT02949557

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Periodontal Intrabony Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Decortication + bone grafts

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Decortication + bone grafts

Intervention Type PROCEDURE

Interventions

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Decortication + bone grafts

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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02_D012_54500

Identifier Type: -

Identifier Source: org_study_id