Surgical Robot or Static Guide for Dental Implant Placement
5 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
112
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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SH
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Shanghai, SH, Kina, 201206
- International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
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Kontakt:
- Yuan Li, PhD
- Telefonnummer: 8615000102368
- E-post: ly9919@hotmail.com
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Shanxi
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Xi’an, Shanxi, Kina
- Center for Robotic Dentistry, Airforce University Medical Hospital
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Kontakt:
- Shizhu Bai, PhD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Degrees of Implant misangulation
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Implant positioning error
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
31 juli 2027
Avslutad studie (Beräknad)
30 oktober 2028
Studieregistreringsdatum
Först inskickad
19 april 2026
Först inskickad som uppfyllde QC-kriterierna
5 maj 2026
Första postat (Faktisk)
11 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SH9H-2026-T177-2
- JYXK-2026-047 (Annat bidrag/finansieringsnummer: Shanghai Ninth People's Hospital)
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