NCT Number: NCT07577245
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.
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Get Notified18 year and older
All sexes
Interventional
Not applicable
International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine, Shanghai, SH, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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.
The 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.
Time frame: 3 months after implant surgery
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.
Time frame: 3 months after implant surgery
Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Dietary intake assessed using a validated Food Frequency Questionnaire that calculates the long term dietary intake in grams of the different food types
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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.
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Collection of oral rinse fluid for analysis of microbiome
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Fecal sample collection for gut microbiome analysis using a metagenomic approach.
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Venous blood will be collected and processed to obtain plasma. Plasma samples will be analyzed using metabolomics profiling to assess metabolic changes associated with the intervention.
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Masticatory performance is assessed using a two-color chewing gum test. Participants chew a dual-color gum (e.g., blue and red) for a standardized number of cycles. The degree of color mixing is evaluated by image analysis, providing an objective measure of chewing efficiency.
Time frame: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
Patient-recorded daily symptoms including pain (0-10 scale), swelling, analgesic use, bleeding, and any unusual events during the first 14 days after surgery. Diary is collected at the 2-week suture removal visit.
Time frame: Immediately after surgery.
Surgeon-reported outcomes assessed immediately after surgery, including: surgical difficulty (e.g., VAS), intraoperative complications, calibration issues, need for conversion to freehand, and overall procedural success.
Time frame: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
Composite of two time-based efficiency measures: (1) preoperative digital planning time (minutes), and (2) total surgical procedure time from incision to final suture (minutes). Both are recorded separately.
Time frame: 3 months after prothesis delivery; 12 months after prothesis delivery.
Multidimensional clinical assessment of implants and prostheses following the ID-COSM (implant dentistry core outcome set and measurement)
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Collection of oral rinse fluid for analysis of inflammatory markers
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Other
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.
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