Surgical Robot or Static Guide for Dental Implant Placement
5. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
112
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
SH
-
Shanghai, SH, China, 201206
- International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
-
Kontakt:
- Yuan Li, PhD
- Telefonnummer: 8615000102368
- E-Mail: ly9919@hotmail.com
-
-
Shanxi
-
Xi’an, Shanxi, China
- Center for Robotic Dentistry, Airforce University Medical Hospital
-
Kontakt:
- Shizhu Bai, PhD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Robot assisted dental implant placement surgery
Novel robotic implant placement
|
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.
|
|
Aktiver Komparator: 3D printed static guide assisted dental implant placement surgery
standard of care
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Degrees of Implant misangulation
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Implant positioning error
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Maurizio S. Tonetti, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
31. Juli 2027
Studienabschluss (Geschätzt)
30. Oktober 2028
Studienanmeldedaten
Zuerst eingereicht
19. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Mai 2026
Zuerst gepostet (Tatsächlich)
11. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Mai 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- SH9H-2026-T177-2
- JYXK-2026-047 (Andere Zuschuss-/Finanzierungsnummer: Shanghai Ninth People's Hospital)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .