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NOT YET RECRUITING
NCT07577245
NA

Surgical Robot or Static Guide for Dental Implant Placement

Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

View on ClinicalTrials.gov

Summary

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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-06-01

Completion Date

2028-10-30

Last Updated

2026-05-11

Healthy Volunteers

No

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.

Locations (2)

Center for Robotic Dentistry, Airforce University Medical Hospital

Xi’an, Shanxi, China

International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine

Shanghai, SH, China