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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949557
Enrollment
10
Registered
2016-10-31
Start date
2014-11-30
Completion date
2016-04-30
Last updated
2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Intrabony Defects

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.

Interventions

PROCEDUREDecortication + bone grafts

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
clinical attachment level9 monthsclinical attachment level measured in mm from cementoenamel junction to the base of the pocket
Bone fill9 monthsBone fill measured in mm in radiographs from alveolar crest to base of the pocket
Pocket probing depth9 monthspocket probing depth level measured in mm from gingival margin to base of the pocket

Secondary

MeasureTime frameDescription
Plaque Index (PI)9 monthPlaque index is measured for periodontal health
Periodontal disease index9 monthsPeriodontal disease index is measured for periodontal health
Gingival Bleeding Index9 monthsGingival bleeding index is measured for periodontal health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026