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
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedOctober 31, 2016
August 1, 2016
7 months
October 27, 2016
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
clinical attachment level
clinical attachment level measured in mm from cementoenamel junction to the base of the pocket
9 months
Bone fill
Bone fill measured in mm in radiographs from alveolar crest to base of the pocket
9 months
Pocket probing depth
pocket probing depth level measured in mm from gingival margin to base of the pocket
9 months
Secondary Outcomes (3)
Plaque Index (PI)
9 month
Periodontal disease index
9 months
Gingival Bleeding Index
9 months
Study Arms (2)
Decortication +DFDBA
ACTIVE COMPARATORAfter 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.
Decortication+ Xenograft (Cerabone)TM
ACTIVE COMPARATORAfter 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age group 25-45 years
- Moderate periodontitis with pocket probing depth more than 5 mm
- Bilaterally similiar intrabony defects
- systemically healthy patients
- Good compliance
You may not qualify if:
- medically compromised
- Pregnant and lactating women
- Smoking
- teeth with mobility and furcation involvement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
November 1, 2014
Primary Completion
June 1, 2015
Study Completion
April 1, 2016
Last Updated
October 31, 2016
Record last verified: 2016-08