Partial Edentulism Class IINCT07577245
Surgical Robot or Static Guide for Dental Implant Placement
A study testing Robot assisted dental implant placement surgery and 3D printed static guide assisted dental implant placement surgery in people with Partial Edentulism Class II, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism Class II
- What is being tested?
- Robot assisted dental implant placement surgery and 3D printed static guide assisted dental implant placement surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
Shanghai, SH, 201206
Yuan Li, PhD, 8615000102368, ly9919@hotmail.com
Center for Robotic Dentistry, Airforce University Medical Hospital
Xi’an, Shanxi
Shizhu Bai, PhD
About this study
Official title: 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.
- Conditions
- Partial Edentulism Class II
- Being tested
- Robot assisted dental implant placement surgery, 3D printed static guide assisted dental implant placement surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted dental implant placement surgeryProcedure or 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.
3D printed static guide assisted dental implant placement surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted dental implant placement surgery | Experimental | Novel robotic implant placement Receives: Procedure: Robot assisted dental implant placement surgery |
| 3D printed static guide assisted dental implant placement surgery | Active comparator | standard of care Receives: Procedure: 3D printed static guide assisted dental implant placement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of Implant misangulation
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.
Measured: 3 months after implant surgery
Secondary outcomes (12)
Implant positioning error
Implant depth (apex deviation) and horizontal position (platform deviation) in the 3 planes of space
Measured: 3 months after implant surgery
Food Frequency Questionnaire (FFQ)
Dietary intake assessed using a validated Food Frequency Questionnaire that calculates the long term dietary intake in grams of the different food types
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Health-Related Quality of Life (OHIP-14)
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.
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Rinse Sample Microbiome
Collection of oral rinse fluid for analysis of microbiome
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Stool Metagenome
Fecal sample collection for gut microbiome analysis using a metagenomic approach.
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Blood Sample
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.
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Masticatory Function
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.
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Postoperative Diary (First 2 Weeks)
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.
Measured: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
Clinician-Reported Outcomes
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.
Measured: Immediately after surgery.
Treatment Planning and Surgical Procedure Times
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.
Measured: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
Implant-Supported Restoration Examination
Multidimensional clinical assessment of implants and prostheses following the ID-COSM (implant dentistry core outcome set and measurement)
Measured: 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Rinse Sample Inflammation
Collection of oral rinse fluid for analysis of inflammatory markers
Measured: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Edentulism Class IIStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Maurizio S. Tonetti, Professor, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577245
- Sponsor's protocol ID
- SH9H-2026-T177-2
- Other IDs
- JYXK-2026-047
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shi JY, Wu XY, Lv XL, Liu M, Fu XJ, Liu BL, Lai HC, Tonetti MS. Comparison of Implant Precision with Robots, Navigation, or Static Guides. J Dent Res. 2025 Jan;104(1):37-44. doi: 10.1177/00220345241285566. Epub 2024 Nov 25.
PubMed 39586816
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07577245
- Acronym / sponsor ID
- SH9H-2026-T177-2
- Conditions
- Partial Edentulism Class II
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Robot assisted dental implant placement surgery | Experimental | Procedure: Robot assisted dental implant placement surgeryNovel robotic implant placement |
| 3D printed static guide assisted dental implant placement surgery | Active comparator | Procedure: 3D printed static guide assisted dental implant placement surgerystandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted dental implant placement surgeryThe 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. | Procedure or surgery | Robot assisted dental implant placement surgery |
| 3D printed static guide assisted dental implant placement surgeryThe 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. | Procedure or surgery | 3D printed static guide assisted dental implant placement surgery |
Primary outcome
Degrees of Implant misangulation
Time frame: 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.
12 secondary outcomes
Implant positioning error
Time frame: 3 months after implant surgery
Food Frequency Questionnaire (FFQ)
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Health-Related Quality of Life (OHIP-14)
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Rinse Sample Microbiome
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Stool Metagenome
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Blood Sample
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Masticatory Function
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Postoperative Diary (First 2 Weeks)
Time frame: From immediately after surgery to 14 days postoperatively (diary returned at 2-week follow-up).
Clinician-Reported Outcomes
Time frame: Immediately after surgery.
Treatment Planning and Surgical Procedure Times
Time frame: Planning time: recorded preoperatively; Surgical time: recorded intraoperatively.
Implant-Supported Restoration Examination
Time frame: 3 months after prothesis delivery; 12 months after prothesis delivery.
Oral Rinse Sample Inflammation
Time frame: Preoperative; 3 months after prothesis delivery; 12 months after prothesis delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 39586816Shi JY, Wu XY, Lv XL, Liu M, Fu XJ, Liu BL, Lai HC, Tonetti MS. Comparison of Implant Precision with Robots, Navigation, or Static Guides. J Dent Res. 2025 Jan;104(1):37-44. doi: 10.1177/00220345241285566. Epub 2024 Nov 25.
- Individual participant dataSharing planned: Undecided
Related trials for Partial Edentulism Class II
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Internal Irrigation Surgery
Dental Implant Healing, Partial Edentulism Class 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
International Medical Department Shanghai Ninth People's Hospital affiliated to the Shanghai Jiao TOng University School of Medicine
Shanghai, China
Maurizio S. Tonetti, Professor principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted dental implant placement surgery and 3D printed static guide assisted dental implant placement surgery in people with Partial Edentulism Class II, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degrees of Implant misangulation (time frame: 3 months after implant surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07577245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.