Surgical Robot or Static Guide for Dental Implant Placement

NCT07577245 | Not Yet Recruiting

• 2 other identifiers: SH9H-2026-T177-2JYXK-2026-047
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Partial Edentulism Class II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Implant positioning error

  3 months after implant surgery

• Food Frequency Questionnaire (FFQ)

  Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.

• Oral Health-Related Quality of Life (OHIP-14)

  Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.

• Oral Rinse Sample Microbiome

  Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.

• Stool Metagenome

  Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.

Study Arms (2)

Robot assisted dental implant placement surgery

EXPERIMENTAL

Novel robotic implant placement

Procedure: Robot assisted dental implant placement surgery

3D printed static guide assisted dental implant placement surgery

ACTIVE COMPARATOR

standard of care

Procedure: 3D printed static guide assisted dental implant placement surgery

Interventions

Robot assisted dental implant placement surgery PROCEDURE

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.

Robot assisted dental implant placement surgery

3D printed static guide assisted dental implant placement surgery 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.

3D printed static guide assisted dental implant placement surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• Air Force Military Medical University, China: collaborator

Study Sites (2)

Center for Robotic Dentistry, Airforce University Medical Hospital

Xi’an, Shanxi, China

Location

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

Shanghai, SH, 201206, China

Location

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Maurizio S. Tonetti, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor, the doctor performing the digital planning and the statistician will be blind to the treatment allocation. Allocation concealment of the surgeon will be maintained until the beginning of the surgery according to the sugical CONSORT extension
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment, 1:1 randomization to robotic-guided surgery versus static guide surgery. Randomization will be performed using a random number table and using a block size of 4. The study registrar will perform minimization to balance allocation based on location (upper and lower arch distal edentulism). Allocation will be concealed by opaque envelopes that will be opened only upon approval of the completed digital planning of the case.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-04

Locations

CN (2)