Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either group based on the allocation. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up CBCT scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. However, dynamic navigation faces the following deficiencies in immediate implant placement. Firstly, it has a steep learning curve. Secondly, the rigid palatal bone wall of the socket will force the direction of drill deviating buccally. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess the professional outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Surgery | Experimental | Immediate implant placement assisted by robotic surgery |
|
| Dynamic navigation | Sham Comparator | Immediate implant placement assisted by dynamic navigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dynamic navigation surgery | Procedure | immediate implant placement assisted by dynamic navigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant positional accuracy | Implant accuracy will be measured as discrepancy between the digital plan and the actual position of the implant. (Global deviation at platform and apex, Angular deviation) | immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment. | intraoperative |
| Pain perception | Patient pain perception during surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijie Zhang, Master | Contact | 13524325673 | izhangyijie@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Department of oral implantology | Shanghai | Shanghai Municipality | 200011 | China |
Individual participant data that underlie the results reported in this article, after de-identification, will be shared upon reasonable request to the corresponding author following publication.
start date: 2026.12 end date: 2027.12
De-identified individual participant data and supporting study documents (including the study protocol and statistical analysis plan) will be available to qualified researchers upon reasonable request to the corresponding author after publication of the study results. Access will be granted for scientifically sound research purposes following review and approval of the research proposal. Data will be shared through secure electronic transfer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| robotic surgery | Procedure | immediate implant placement assisted by robotic surgery |
|
| Immediately after surgery |
| Pain perception | Patient pain perception after surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience). | 7 days after surgery |
| Surgeon preference | Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option. | Immediately after surgery |
| Soft tissue changes | Assessed by midfacial recession, mesial and distal papillary recession. | immediately after crown delivery |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided