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Surgical Robot or Static Guide for Dental Implant Placement

5. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

112

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Robot assisted dental implant placement surgery
Novel robotic implant placement
Procedure: 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.
Aktiv komparator: 3D printed static guide assisted dental implant placement surgery
standard of care
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Degrees of Implant misangulation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant positioning error
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

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Sponsor

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

Samarbejdspartnere

Air Force Military Medical University, China

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

30. oktober 2028

Datoer for studieregistrering

Først indsendt

19. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SH9H-2026-T177-2
  • JYXK-2026-047 (Andet bevillings-/finansieringsnummer: Shanghai Ninth People's Hospital)

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