跳至主要内容
临床试验/CTRI/2024/04/065101
CTRI/2024/04/065101
尚未招募
4 期

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

未提供1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月15日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr BH Harshitha Gowda

Faculty of Dental Sciences, MS Ramaiah university of applied sciences

研究点 (1)

Loading locations...

相似试验