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Surgical Robot or Static Guide for Dental Implant Placement

5 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

112

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • SH
      • Shanghai, SH, Cina, 201206
        • International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
        • Contatto:
    • Shanxi
      • Xi’an, Shanxi, Cina
        • Center for Robotic Dentistry, Airforce University Medical Hospital
        • Contatto:
          • Shizhu Bai, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Robot assisted dental implant placement surgery
Novel robotic implant placement
Procedura: 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.
Comparatore attivo: 3D printed static guide assisted dental implant placement surgery
standard of care
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Degrees of Implant misangulation
Lasso di tempo: 3 months after implant surgery
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Implant positioning error
Lasso di tempo: 3 months after implant surgery
Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space
3 months after implant surgery
Food Frequency Questionnaire (FFQ)
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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)
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Collection of oral rinse fluid for analysis of microbiome
Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Stool Metagenome
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Fecal sample collection for gut microbiome analysis using a metagenomic approach.
Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Blood Sample
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
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)
Lasso di tempo: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
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
Lasso di tempo: Immediately after surgery.
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
Lasso di tempo: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
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
Lasso di tempo: 3 months after prothesis delivery; 12 months after prothesis delivery.
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
Lasso di tempo: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Collection of oral rinse fluid for analysis of inflammatory markers
Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

Air Force Military Medical University, China

Investigatori

  • Investigatore principale: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 luglio 2027

Completamento dello studio (Stimato)

30 ottobre 2028

Date di iscrizione allo studio

Primo inviato

19 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SH9H-2026-T177-2
  • JYXK-2026-047 (Altro numero di sovvenzione/finanziamento: Shanghai Ninth People's Hospital)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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