The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery: a Randomized Clinical Trial

Conditions
-----------------
Dental Implant

Intervention / Treatment
-----------------
* Procedure: dental implant robot
* Procedure: Freehand surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single missing teeth with adjacent and opposing healthy natural teeth; Healthy patients; Sufficient alveolar bone available for implant placement. Exclusion Criteria: Pregnancy or intention to become pregnant at any point during the study duration With any systemic diseases/conditions that are contraindications to dental implant...

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-guided<br>Implant placement by robot-guided based on a digital plan | Procedure: dental implant robot<br>* Implant placement will be navigated by a dental implant robot based on a digital plan.<br>|
| Active Comparator: Freehand surgery<br>Implant placement by freehand based on a digital plan | Procedure: Freehand surgery<br>* Implant will be placed under freehand surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery complication | Complication related to implant placement surgery. | Immediately and seven days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robot-guided surgery, dental implant robot, accuracy, freehand