Dynamic Navigation System in Implantology

Study Overview
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Brief Summary
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This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.

Detailed Description
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This is a prospective randomized clinical trial. Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system. During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. Then after the surgical procedure a PROMs questionnaire will be asked to the patients. Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured. The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Official Title
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Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial

Conditions
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Surgery, Computer-Assisted, Dental Implants

Intervention / Treatment
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* Device: Dynamic navigation system
* Device: Freehand implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partially edentulous patients that requires at least the placement of one dental implant Healthy patients ASA I and II (American Society of Anesthesiologists classification) Over 18 years old patients Exclusion Criteria: Totally edentulous patients Systemic or local conditions that contraindicates dental implant surgery Patients with less than 3 teeth in the jaw.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation group<br>Dental implants will be placed using a dynamic computer assisted surgery system | Device: Dynamic navigation system<br>* The navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position.<br>* Other names: Dynamic computer assisted surgery;|
| Active Comparator: Freehand group<br>Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography) | Device: Freehand implant placement<br>* Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done<br>* Other names: Non-guided implant placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angular deviation | angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees | 3 months post operative | 
| Platform 3D deviation | global deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm). | 3 months post operative | 
| Apex 3D deviation | global deviation at the apex of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm). | 3 months post operative | 
| Platform 2D deviation | Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm). | 3 months post operative | 
| Apex depth deviation | Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm). | 3 months post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome measures (PROMs) questionnaire | Patients perception of their functional well-being and health status during the dental implant treatment with a navigation system. We will use OHIP-14 (Oral Health Impact Profile) questionnaire. | One week post operative. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Computer-Assisted, Dental Implants, Navigation system, Dynamic computer-assisted surgery, Implantology