Partial Edentulism Class II
Conditions
Brief summary
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.
Interventions
PROCEDURERobot 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.
PROCEDURE3D 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.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor, the doctor performing the digital planning and the statistician will be blind to the treatment allocation. Allocation concealment of the surgeon will be maintained until the beginning of the surgery according to the sugical CONSORT extension
Intervention model description
Parallel assignment, 1:1 randomization to robotic-guided surgery versus static guide surgery. Randomization will be performed using a random number table and using a block size of 4. The study registrar will perform minimization to balance allocation based on location (upper and lower arch distal edentulism). Allocation will be concealed by opaque envelopes that will be opened only upon approval of the completed digital planning of the case.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degrees of Implant misangulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant positioning error | 3 months after implant surgery | Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space |
| Food Frequency Questionnaire (FFQ) | 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 |
| Oral Health-Related Quality of Life (OHIP-14) | 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. |
| Oral Rinse Sample Microbiome | Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery. | Collection of oral rinse fluid for analysis of microbiome |
| Stool Metagenome | Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery. | Fecal sample collection for gut microbiome analysis using a metagenomic approach. |
| Blood Sample | 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. |
| Masticatory Function | 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. |
| Postoperative Diary (First 2 Weeks) | 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. |
| Clinician-Reported Outcomes | 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. |
| Treatment Planning and Surgical Procedure Times | 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. |
| Implant-Supported Restoration Examination | 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) |
| Oral Rinse Sample Inflammation | Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery. | Collection of oral rinse fluid for analysis of inflammatory markers |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMaurizio S. Tonetti, Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Outcome results
None listed