Development and characterization of flow able mixture of demineralized tooth matrix and injectable platelet rich fibrin graft material for socket preservation and characterization of regenerated bone
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bone formation in the tooth socket filled with autogenous graft and comparing with BIO-OSSE using cone beam computed tomography and if patients are willing to consent bone histological study after implant placement
概览
简要总结
Rationale-Autogenous bone grafts are proven to be superior in comparison with other graft materials as there is no rejection. The reason for requirement of human patients in this study is, for the preparation of autogenous injectable graft using patient blood and extracted tooth (considered a biological waste)
Aim - To develop an optimal flow able mixture of demineralized tooth matrix and platelet rich fibrin graft material for socket preservation and characterize the regenerated bone
Methods- All participants willing to provide written informed consent will be recruited to the present study after fully explaining the study procedure in their own language. Extracted tooth is cleaned, soft tissue removed and dried. The tooth is demineralized partially with 0.6mol Hydrochloric acid and powdered using smart dentine grinder and washed again with Phosphate Buffered solution. The Injectable Platelet Rich Fibrin (IPRF) is prepared, mixed with the powdered tooth in 1:1 ratio and the prepared autogenous graft is placed in the extracted socket and sutured. The active control BIO-OSS is placed in the opposite extracted tooth socket.
Cone beam tomography is obtained at baseline and at the end of the study (03 months). If the participant consents for implant placement, bone tissue will be subjected for histological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Teeth extracted for periodontal purpose (Grade 2 & 3 mobility).
排除标准
- •Infected and decayed tooth and root canal treated tooth
- •Uncontrolled diabetes mellitus, Hypertension, Heavy smokers
- •Pregnant and lactating women.
结局指标
主要结局
Bone formation in the tooth socket filled with autogenous graft and comparing with BIO-OSSE using cone beam computed tomography and if patients are willing to consent bone histological study after implant placement
时间窗: Baseline, 3 months
次要结局
- To compare the bone formation between the study groups at the end of the study(03 months)
研究者
Dr BH Harshitha Gowda
Faculty of Dental Sciences, MS Ramaiah university of applied sciences