Radiographic Assessment of Mandibular Biological Drilling at Different Drilling Speeds: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 39
- 主要终点
- Marginal Bone Level Change
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effect of different biological drilling speeds (50, 150, and 300 rpm) during implant osteotomy preparation in the mandible on marginal bone level changes and implant stability. Thirty-nine patients requiring a single dental implant in the mandible will be randomly allocated into three groups according to drilling speed. All implants will be placed using a biological drilling protocol without irrigation. Implant stability will be measured using resonance frequency analysis at implant placement and follow-up visits. Marginal bone levels will be evaluated radiographically using standardized periapical radiographs during the follow-up period up to 12 months. The study aims to determine whether different low-speed drilling protocols influence peri-implant bone remodeling and implant stability.
详细描述
This randomized parallel-group clinical trial will investigate the influence of different biological drilling speeds on radiographic marginal bone level changes and implant stability in mandibular dental implant placement.
Thirty-nine partially edentulous adult patients requiring a single implant in the mandible will be recruited from the outpatient clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. Eligible participants will be randomly assigned to one of three groups according to drilling speed used during osteotomy preparation: 50 rpm, 150 rpm, or 300 rpm.
Implant site preparation will be performed using the same sequential drilling protocol and implant system in all groups. Biological drilling will be performed without irrigation, with careful control of drilling pressure and intermittent drilling to minimize thermal trauma.
Implant stability will be measured using resonance frequency analysis (RFA) at implant placement and during follow-up visits. Radiographic assessment of marginal bone levels will be conducted using standardized periapical radiographs obtained using the paralleling technique. Radiographic measurements will be performed at baseline and during follow-up visits up to 12 months.
The primary outcome of the study will be marginal bone level changes measured radiographically in millimeters. The secondary outcome will be implant stability expressed as Implant Stability Quotient (ISQ) values.
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
Outcome assessors evaluating radiographic marginal bone levels and implant stability measurements will be blinded to group allocation. The surgeon cannot be blinded due to the nature of the intervention.
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 aged 20-60 years.
- •Partially edentulous patients requiring a single dental implant in the mandible.
- •Adequate bone height and width at the implant site to accommodate the planned implant dimensions without the need for advanced grafting.
- •Good oral hygiene (full-mouth plaque and bleeding scores within acceptable limits).
- •Patients willing to participate, available for 12-month follow-up, and able to sign informed consent.
排除标准
- •Systemic diseases or conditions that may compromise bone healing (e.g. uncontrolled diabetes, immunosuppression, recent radiotherapy in head and neck region).
- •Smoking more than 10 cigarettes/day or heavy vaping.
- •Pregnant or lactating women.
- •History of bisphosphonate or other anti-resorptive therapy affecting bone metabolism.
- •Active periodontal disease or poor oral hygiene.
- •Acute infection or pathology at the planned implant site.
- •Need for simultaneous major bone grafting at the same site.
- •Bruxism or severe parafunctional habits.
研究组 & 干预措施
Biological drilling at 50 rpm
Participants in this group will undergo dental implant site preparation using a very low-speed "biological" drilling protocol set at 50 rpm. This arm tests the effect of maximal biologic preservation on peri-implant bone maintenance and stability.
干预措施: biological drilling at 50 RPM (Procedure)
Biological drilling at 150 rpm
Participants in this group will undergo dental implant site preparation using an intermediate low-speed protocol set at 150 rpm. This arm represents a balance between cutting efficiency and reduced thermal risk
干预措施: biological drilling at 150 RPM (Procedure)
Biological drilling at 300 rpm
Participants in this group will undergo dental implant site preparation using a higher low-speed protocol set at 300 rpm. This arm tests whether increasing speed within the "biological" range affects marginal bone remodeling
干预措施: biological drilling at 300 RPM (Procedure)
结局指标
主要结局
Marginal Bone Level Change
时间窗: Baseline (Surgery) and 12 months postoperatively.
Change in bone level measured from a fixed implant reference point to the crestal bone level using periapical radiographs.
次要结局
- Implant Stability(At time of insertion and 3 months postoperatively.)