Clinical trial NCT02949557: DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Intrabony Defects
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical attachment level
timeFrame: 9 months
measure: Bone fill
timeFrame: 9 months
measure: Pocket probing depth
timeFrame: 9 months
Secondary outcomes:
measure: Plaque Index (PI)
timeFrame: 9 month
measure: Periodontal disease index
timeFrame: 9 months
measure: Gingival Bleeding Index
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References: