Surgical Robot or Static Guide for Dental Implant Placement
5 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
112
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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SH
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Shanghai, SH, Chine, 201206
- International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
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Contact:
- Yuan Li, PhD
- Numéro de téléphone: 8615000102368
- E-mail: ly9919@hotmail.com
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Shanxi
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Xi’an, Shanxi, Chine
- Center for Robotic Dentistry, Airforce University Medical Hospital
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Contact:
- Shizhu Bai, PhD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Degrees of Implant misangulation
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Implant positioning error
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
31 juillet 2027
Achèvement de l'étude (Estimé)
30 octobre 2028
Dates d'inscription aux études
Première soumission
19 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
11 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SH9H-2026-T177-2
- JYXK-2026-047 (Autre subvention/numéro de financement: Shanghai Ninth People's Hospital)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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