Impact of Mandibular Biological Drilling Speeds on Implant Stability and Osteogenic Potential of Autogenous Bone Particles: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Implant Stability
研究概览
简要总结
This randomized clinical trial aims to evaluate the effect of different low-speed biological drilling protocols on implant stability and the osteogenic potential of autogenous bone particles collected during implant osteotomy. Patients requiring single dental implant placement in the mandible will be randomly assigned to different drilling speed protocols without irrigation. Implant stability will be measured clinically, while collected bone particles will be analyzed for osteogenic markers. The study aims to determine whether biological drilling improves implant stability and preserves the regenerative potential of autogenous bone.
详细描述
Primary implant stability and the biological quality of bone particles generated during osteotomy are important determinants of successful osseointegration. Conventional implant site preparation typically uses high-speed drilling with irrigation to prevent thermal injury; however, this technique may compromise the biological quality and viability of harvested bone particles.
Low-speed biological drilling without irrigation has been proposed as an alternative technique that may preserve bone vitality, reduce thermal trauma, and allow collection of viable autogenous bone particles with regenerative potential.
This randomized clinical trial evaluates the influence of different mandibular drilling speeds (50 rpm, 150 rpm, and 300 rpm) during implant osteotomy on implant stability and on the osteogenic potential of the collected autogenous bone particles.
Implant stability will be assessed clinically, while the osteogenic potential of harvested bone particles will be evaluated using molecular biomarkers related to osteogenesis. The results of this study may provide evidence-based guidance for optimizing implant drilling protocols and improving bone regeneration potential in implant dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The investigator responsible for laboratory analysis of bone particle samples and outcome assessment will be blinded to the drilling speed group allocation.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients requiring single dental implant placement in the mandible
- •Adequate bone volume for implant placement without need for bone grafting
- •Good general health
- •Ability to provide informed consent
排除标准
- •Systemic diseases affecting bone metabolism or healing
- •History of radiotherapy in the head and neck region
- •Uncontrolled diabetes mellitus
- •Active periodontal disease
- •Heavy smoking
- •Pregnancy or lactation
研究组 & 干预措施
50 rpm Biological Drilling
Implant osteotomy will be performed using low-speed biological drilling at 50 rpm without irrigation. Bone particles produced during drilling will be collected for evaluation of osteogenic potential.
干预措施: Implant osteotomy using biological drilling at 50 rpm without irrigation. (Procedure)
150 rpm Biological Drilling
Implant osteotomy will be performed using biological drilling at 150 rpm without irrigation. Autogenous bone particles generated during drilling will be collected and analyzed for osteogenic potential.
干预措施: Implant osteotomy using biological drilling at 150 rpm without irrigation. (Procedure)
300 rpm Biological Drilling
Implant osteotomy will be performed using biological drilling at 300 rpm without irrigation with collection of autogenous bone particles for laboratory analysis.
干预措施: Implant osteotomy using biological drilling at 300 rpm without irrigation. (Procedure)
结局指标
主要结局
Implant Stability
时间窗: At time of insertion and 3 months postoperatively.
Implant stability will be measured immediately after implant placement and 3 months postoperatively, using resonance frequency analysis (RFA). Implant stability will be recorded as an Implant Stability Quotient (ISQ) value to evaluate the mechanical stability of the implant in relation to the drilling speed used during osteotomy.
次要结局
- Osteogenic Potential of Autogenous Bone Particles(Immediately after bone particle collection and subsequent laboratory analysis.)