Surgical Robot or Static Guide for Dental Implant Placement

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Partial Edentulism Class II
• Intervention / Treatment: Procedure: Robot assisted dental implant placement surgery; Procedure: 3D printed static guide assisted dental implant placement surgery

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • SH
    • Shanghai, SH, China, 201206
      • International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
      • Contact: Yuan Li, PhD; Phone Number: 8615000102368; Email: ly9919@hotmail.com
  • Shanxi
    • Xi’an, Shanxi, China
      • Center for Robotic Dentistry, Airforce University Medical Hospital
      • Contact: Shizhu Bai, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Monlateral distal free-end edentulism
3. Presence of natural teeth or reliable fixed restorations mesial to the edentulous area to provide support and stability for the surgical guide
4. 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:

1. Uncontrolled periodontitis or acute oral infection
2. Uncontrolled systemic diseases (e.g., diabetes, severe osteoporosis) or pregnancy/lactation
3. History of head and neck radiotherapy or current use of intravenous bisphosphonates
4. Severe limited mouth opening (interincisal distance <35 mm) affecting surgical instrument manipulation
5. Psychiatric or psychological disorders that prevent cooperation with study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot assisted dental implant placement surgery; Novel robotic implant placement	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.
Active Comparator: 3D printed static guide assisted dental implant placement surgery; standard of care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after implant surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant positioning error	Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space	3 months after implant surgery
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	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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.	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Rinse Sample Microbiome	Collection of oral rinse fluid for analysis of microbiome	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Stool Metagenome	Fecal sample collection for gut microbiome analysis using a metagenomic approach.	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Blood Sample	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.	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Masticatory Function	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.	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Postoperative Diary (First 2 Weeks)	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.	From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
Clinician-Reported Outcomes	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.	Immediately after surgery.
Treatment Planning and Surgical Procedure Times	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.	Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
Implant-Supported Restoration Examination	Multidimensional clinical assessment of implants and prostheses following the ID-COSM (implant dentistry core outcome set and measurement)	3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Rinse Sample Inflammation	Collection of oral rinse fluid for analysis of inflammatory markers	Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Collaborators: Air Force Military Medical University, China
• Investigators: Principal Investigator: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SH9H-2026-T177-2; JYXK-2026-047 (Other Grant/Funding Number: Shanghai Ninth People's Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No