Surgical Robot or Static Guide for Dental Implant Placement

Официальное название

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.

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Degrees of Implant misangulation [Срок оценки: 3 months after implant surgery]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

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

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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