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.
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
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
Parallel
Robot assisted dental implant placement surgery
Procedure/SurgeryThe test intervention will comprise autonomous dental implant placement using the YakeRobot. The 3Shape treatment planning will be exported into the YakeRobot software for robotic planning and the robotic planning will be finalized. Two Straumann implants will be positioned to retain a bridge, following the standard YakeRobot implant placement procedure.
3D printed static guide assisted dental implant placement surgery
Procedure/SurgeryThe control intervention will consist of guided implant surgery with a static guide, planned using the 3Shape software and custom 3D-printed following the international standard of best practice. Two Straumann implants will be positioned to retain a bridge, following the Straumann guided surgery placement protocol.
Degrees of Implant misangulation
The implant position was acquired 3 months after implant surgery with an intraoral scan (TRIOS 3; 3Shape) with a scan body in place. The actual position was compared with the digital plan by the accuracy analysis software (DentalNavi 2.2; YakeRobot Technology Ltd) by an independent calibrated examiner blind to group allocation. The discrepancy between planned and actual implant axis angulation will be measured in degrees.
Implant positioning error
Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space
Food Frequency Questionnaire (FFQ)
Dietary intake assessed using a validated Food Frequency Questionnaire that calculates the long term dietary intake in grams of the different food types
Oral Health-Related Quality of Life (OHIP-14)
Oral health-related quality of life measured by the OHIP-14 questionnaire (14 items), using a 5-point Likert scale with Higher scores indicate poorer quality of life.
Oral Rinse Sample Microbiome
Collection of oral rinse fluid for analysis of microbiome
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead sponsor
Air Force Military Medical University, China
Collaborator
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