The Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area

Study Overview
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Brief Summary
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The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Detailed Description
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Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Official Title
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Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial

Conditions
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Dental Implant

Intervention / Treatment
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* Procedure: robotic system
* Procedure: Static navigation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form signed voluntarily. Aged at least 18 years. Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row). Sufficient bone volume for implant placement without bone augmentation; The minimum number of residual teeth was seven teeth. Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene. Exclusion criteria: Systemic disease that would interfere with dental implant surgery. Bisphosphonate treatment. Untreated, uncontrolled periodontal disease. Heavy smoker (more than 10 cigarettes per day). Poor oral hygiene.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic system<br>implant placement by robotic surgery | Procedure: robotic system<br>* Implant placement will be navigated by robotic system based on a digital plan<br>|
| Active Comparator: Static system<br>implant placement by static navigation surgery | Procedure: Static navigation system<br>* Implant placement will be navigated by static navigation system based on a digital plan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant positional accuracy | The implant placement accuracy was measured by overlapping the planned position of the implant in the preoperative CBCT and its final position assessed through a postoperative CBCT. | immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | patient pain perception after surgery will recorded by visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience) | immediately after surgery, and 1 to 7 days after surgery. | 
| Surgery complication | Complication related to implant placement surgery. | Immediately and 7 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implant, Robotic system, Static navigation system