NCT Number: NCT02949557
DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects
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.
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Notify MeKey information
Conditions
Age range
25 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
clinical attachment level
Time frame: 9 months
clinical attachment level measured in mm from cementoenamel junction to the base of the pocket
-
Bone fill
Time frame: 9 months
Bone fill measured in mm in radiographs from alveolar crest to base of the pocket
-
Pocket probing depth
Time frame: 9 months
pocket probing depth level measured in mm from gingival margin to base of the pocket
Secondary outcomes
-
Plaque Index (PI)
Time frame: 9 month
Plaque index is measured for periodontal health
-
Periodontal disease index
Time frame: 9 months
Periodontal disease index is measured for periodontal health
-
Gingival Bleeding Index
Time frame: 9 months
Gingival bleeding index is measured for periodontal health
Sponsors and collaborators
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Oct 31, 2016
- Registry last updated
- Oct 31, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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