跳至主要内容
临床试验/CTRI/2025/08/092222
CTRI/2025/08/092222尚未招募3 期

Evaluation of Hard Tissue Outcomes Around Bisphosphonate - Coated and Injectable-Platelet Rich Fibrin - Coated Dental Implants: A Randomized Clinical Trial

Institute of dental sciences1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
To assess and compare peri implant bone density and volume changes across bisphosphonate coated iPRF coated and uncoated implants using CBCT

研究概览

简要总结

My thesis focuses on evaluating and comparing the clinical performance of dental implants coated with bisphosphonates and injectable platelet rich fibrin against standard uncoated implants with specific emphasis on peri implant hard tissue outcomes

Dental implants rely heavily on osseointegration the direct structural and functional connection between living bone and the surface of an implant However achieving optimal and long term stability depends not only on mechanical placement but also on biological enhancements that support bone regeneration and prevent bone loss

To improve these biological outcomes my study explores two advanced surface modification techniques

Bisphosphonate coating known for its antiresorptive properties which helps prevent bone resorption by inhibiting osteoclast activity and maintaining bone density

Injectable platelet rich fibrin  a regenerative biomaterial rich in autologous growth factors that promotes angiogenesis fibroblast activity and new bone formation

Using cone beam computed tomography as the imaging modality the study measures changes in bone density bone volume and crestal bone levels over a 6 month period following implant placement The research involves three groups bisphosphonate coated implants iPRF coated implants and uncoated implants and applies a randomized clinical trial methodology to ensure unbiased comparisons

The primary objective is to determine whether these coatings can enhance osseointegration and reduce bone loss around the implants thereby improving implant success rates The findings aim to provide valuable insights for clinicians on the potential benefits of surface bioactivation in implant dentistry and contribute to more predictable treatment outcomes

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Healthy adult patients requiring single or multiple dental implants Adequate interocclusal and mesiodistal space in the edentulous area Sufficient bone volume in the implant site confirmed through pre-operative CBCT.

排除标准

  • Patient with any systemic disease like uncontrolled diabetes hypothyroidism Patient with habits of smoking or heavy alcohol consumption parafunctional habit Patients currently undergoing steroids or medications which are known to affect bone metabolism osteoporosis and history or chemotherapy at least 6 months prior to implant placement coagulation defects or currently on anticoagulant treatment
  • Pregnant or lactating women.

结局指标

主要结局

To assess and compare peri implant bone density and volume changes across bisphosphonate coated iPRF coated and uncoated implants using CBCT

时间窗: 1 month 3 months 6 months post surgery

To evaluate extent of crestal bone level changes across three groups using CBCT

时间窗: 1 month 3 months 6 months post surgery

次要结局

  • To evaluate extent of crestal bone level changes across three groups using CBCT

研究者

发起方
Institute of dental sciences
申办方类型
Other [Private dental college ]
责任方
Principal Investigator
主要研究者

Dr Purbabha Mondal

Institute of dental sciences Bareilly

研究点 (1)

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