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We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.
Oral implants have become a widely used treatment modality for patients with missing or edentulous teeth. Previous studies have shown that implant accuracy is associated with implant success and long-term outcomes. Therefore, we plant to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery. By comparing the preoperative planned implant position with the actual postoperative implant position using CBCT, we will evaluate the accuracy of implant in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-guided | Experimental | Implant placement by robot-guided based on a digital plan |
|
| Freehand surgery | Active Comparator | Implant placement by freehand based on a digital plan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental implant robot | Procedure | Implant placement will be navigated by a dental implant robot based on a digital plan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant positional accuracy | Implant accuracy will be measured as distance discrepancy at implant platform and implant apex, and angular discrepancy of implant axis between the digital plan and the actual position of the implant assessed digitally at the end of the procedure. Pre- and post-operative CBCT will be used for measurement. | immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery complication | Complication related to implant placement surgery. | Immediately and seven days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenqi Chen, MD | Contact | +86 13995544537 | 1635156040@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Qi Yan, PhD | School & Hospital of Stomatology, Wuhan University | Principal Investigator |
| Yufeng Zhang, PhD | School & Hospital of Stomatology, Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School & Hospital of Stomatology, Wuhan University | Recruiting | Wuhan | Hubei | 430070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42210518 | Derived | Luo Z, Zhou W, Wang M, Xu L, Du X, Cao Y, Song K. Accuracy, Efficiency, and Patient- and Surgeon-Reported Outcomes of Static Versus Robotic Computer-Assisted Implant Surgery: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 May 28. doi: 10.1111/clr.70138. Online ahead of print. |
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| Freehand surgery | Procedure | Implant will be placed under freehand surgery. |
|