Surgical Robot or Static Guide for Dental Implant Placement
5 de mayo de 2026 actualizado por: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
112
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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SH
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Shanghai, SH, Porcelana, 201206
- International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
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Contacto:
- Yuan Li, PhD
- Número de teléfono: 8615000102368
- Correo electrónico: ly9919@hotmail.com
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Shanxi
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Xi’an, Shanxi, Porcelana
- Center for Robotic Dentistry, Airforce University Medical Hospital
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Contacto:
- Shizhu Bai, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Robot assisted dental implant placement surgery
Novel robotic implant placement
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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.
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Comparador activo: 3D printed static guide assisted dental implant placement surgery
standard of care
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Degrees of Implant misangulation
Periodo de tiempo: 3 months after implant surgery
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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.
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3 months after implant surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Implant positioning error
Periodo de tiempo: 3 months after implant surgery
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Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space
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3 months after implant surgery
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Food Frequency Questionnaire (FFQ)
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Dietary intake assessed using a validated Food Frequency Questionnaire that calculates the long term dietary intake in grams of the different food types
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral Health-Related Quality of Life (OHIP-14)
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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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.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral Rinse Sample Microbiome
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Collection of oral rinse fluid for analysis of microbiome
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Stool Metagenome
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Fecal sample collection for gut microbiome analysis using a metagenomic approach.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Blood Sample
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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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.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Masticatory Function
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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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.
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Postoperative Diary (First 2 Weeks)
Periodo de tiempo: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
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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.
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From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
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Clinician-Reported Outcomes
Periodo de tiempo: Immediately after surgery.
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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.
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Immediately after surgery.
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Treatment Planning and Surgical Procedure Times
Periodo de tiempo: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
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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.
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Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
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Implant-Supported Restoration Examination
Periodo de tiempo: 3 months after prothesis delivery; 12 months after prothesis delivery.
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Multidimensional clinical assessment of implants and prostheses following the ID-COSM (implant dentistry core outcome set and measurement)
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3 months after prothesis delivery; 12 months after prothesis delivery.
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Oral Rinse Sample Inflammation
Periodo de tiempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Collection of oral rinse fluid for analysis of inflammatory markers
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Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
31 de julio de 2027
Finalización del estudio (Estimado)
30 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
19 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
11 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SH9H-2026-T177-2
- JYXK-2026-047 (Otro número de subvención/financiamiento: Shanghai Ninth People's Hospital)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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