Surgical Robot or Static Guide for Dental Implant Placement
5 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Studietype
Ingrijpend
Inschrijving (Geschat)
112
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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SH
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Shanghai, SH, China, 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
- Telefoonnummer: 8615000102368
- E-mail: ly9919@hotmail.com
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Shanxi
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Xi’an, Shanxi, China
- Center for Robotic Dentistry, Airforce University Medical Hospital
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Contact:
- Shizhu Bai, PhD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Degrees of Implant misangulation
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Implant positioning error
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juni 2026
Primaire voltooiing (Geschat)
31 juli 2027
Studie voltooiing (Geschat)
30 oktober 2028
Studieregistratiedata
Eerst ingediend
19 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
5 mei 2026
Eerst geplaatst (Werkelijk)
11 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
5 mei 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- SH9H-2026-T177-2
- JYXK-2026-047 (Ander subsidie-/financieringsnummer: Shanghai Ninth People's Hospital)
Plan Individuele Deelnemersgegevens (IPD)
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ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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