Surgical Robot or Static Guide for Dental Implant Placement

Official title

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.

Overview

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.

Interventions

• Procedure Robot assisted dental implant placement surgery
  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.
• Procedure 3D printed static guide assisted dental implant placement surgery
  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.

Primary outcome measures

• Degrees of Implant misangulation [Time frame: 3 months after implant surgery]

Secondary outcome measures (12)

• Implant positioning error [Time frame: 3 months after implant surgery]
• Food Frequency Questionnaire (FFQ) [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Oral Health-Related Quality of Life (OHIP-14) [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Oral Rinse Sample Microbiome [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Stool Metagenome [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Blood Sample [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Masticatory Function [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Postoperative Diary (First 2 Weeks) [Time frame: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).]
• Clinician-Reported Outcomes [Time frame: Immediately after surgery.]
• Treatment Planning and Surgical Procedure Times [Time frame: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.]
• Implant-Supported Restoration Examination [Time frame: 3 months after prothesis delivery; 12 months after prothesis delivery.]
• Oral Rinse Sample Inflammation [Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Center for Robotic Dentistry, Airforce University Medical Hospital — Xi’an
• International Medical Department Shanghai Ninth People's Hospital affiliated to the Shangh — Shanghai

Publications

• Shi JY, Wu XY, Lv XL, Liu M, Fu XJ, Liu BL, Lai HC, Tonetti MS. Comparison of Implant Precision with Robots, Navigation, or Static Guides. J Dent Res. 2025 Jan;104(1):37-44. doi: 10.1177/00220345241285566. Epub 2024 Nov 25. PMID 39586816

Identifiers

NCT: NCT07577245 · SH9H-2026-T177-2 · JYXK-2026-047

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗