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

Periodontal Intrabony Defects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949557
• Other study ID #: 02_D012_54500
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2016
• Last updated: October 27, 2016
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Intrabony Defects

Intervention

Procedure:
• Decortication + bone grafts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical attachment level	clinical attachment level measured in mm from cementoenamel junction to the base of the pocket	9 months
Primary	Bone fill	Bone fill measured in mm in radiographs from alveolar crest to base of the pocket	9 months
Primary	Pocket probing depth	pocket probing depth level measured in mm from gingival margin to base of the pocket	9 months
Secondary	Plaque Index (PI)	Plaque index is measured for periodontal health	9 month
Secondary	Periodontal disease index	Periodontal disease index is measured for periodontal health	9 months
Secondary	Gingival Bleeding Index	Gingival bleeding index is measured for periodontal health	9 months