Comparison of Robotic and Static Guide Assisted Surgery for Rehabilitation of Monolateral Distal Extension Edentulism With Implant-supported Fixed Partial Dentures: a Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 2
研究概览
简要总结
Precision in implant placement is a key requirement for safety and to support the long-term success of dental implants. Optimal placement requires implementing a diagnostic standard that includes careful digital planning based on CBCT and intraoral scanning data. Once the case is planned, adherence to the plan during surgery cannot be achieved through freehand surgery; guidance is needed. Guidance has two key components: real-time tracking of osteotomy site preparation (achieved with dynamic navigation technology) and constraining instrumentation to the planned site (achieved through the application of a surgical template that guides the position and direction of bone drilling). Robotic surgery enables both objectives: real-time monitoring and guidance. Previous studies have shown high precision for both static guidance and robotic surgery, but the evidence is limited to a few small-sample-size studies, mostly in single-tooth gap applications. Evidence of the applicability of the technologies to more challenging clinical conditions, such as the more complex distal extension, is lacking. In addition, so far, dental implant robotics studies have focused only on metrics of implant placement precision and have failed to capture a broader context that may be equally important for clinical decision-making and patient preferences. In this respect, it is important to emphasize the recent implant dentistry core outcome set and measurement (ID-COSM) framework that mandates capturing and reporting a full range of outcomes across multiple domains.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor, the doctor performing the digital planning and the statistician will be blind to the treatment allocation.
Allocation concealment of the surgeon will be maintained until the beginning of the surgery according to the sugical CONSORT extension
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Monlateral distal free-end edentulism
- •Presence of natural teeth or reliable fixed restorations mesial to the edentulous area to provide support and stability for the surgical guide
- •Preoperative CBCT assessment shows available bone height ≥8 mm and bone width ≥5 mm in the edentulous area, allowing implant placement without concomitant complex bone augmentation
排除标准
- •Uncontrolled periodontitis or acute oral infection
- •Uncontrolled systemic diseases (e.g., diabetes, severe osteoporosis) or pregnancy/lactation
- •History of head and neck radiotherapy or current use of intravenous bisphosphonates
- •Severe limited mouth opening (interincisal distance <35 mm) affecting surgical instrument manipulation
- •Psychiatric or psychological disorders that prevent cooperation with study procedures
