Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

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 zygomatic implant placement in partially or total edentulous patients in the upper jaw compared with the conventional freehand method.

Detailed Description
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The present study is a prospective randomized clinical trial. Each patient enrolled in this trial will be randomly allocated to on group (Navigation group (test group) or Freehand group (control group)). Preoperative virtual planification of zygomatic an conventional implants on a prerequired cone beam computed tomography (CBCT) with radiographic markers (tooth if possible or micro implants if not possible) will be performed for each patient. The patient will be randomly allocated in one group just before the surgery, and the surgical procedure will be performed according the surgery protocol of each group. 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 European Conformity (CE) marked products and used within their intended use.

Official Title
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Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial

Conditions
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Dental Implants, Surgery, Computer-Assisted

Intervention / Treatment
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* Device: Freehand zygomatic implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partial or total edentulous maxilla Large bone atrophy that avoids possible conventional implant placement Over 18 years old patients Exclusion Criteria: Patients with facial bone disease that contraindicates conventional or zygomatic implants placement. Systemic or local conditions that contraindicates oral surgery.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation group<br>Zygomatic implant placement by dynamic computer assisted surgery system. | Device: Freehand zygomatic implant placement<br>* Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.<br>|
| Active Comparator: Freehand group<br>Zygomatic implant placement by Freehand, without any guidance. | Device: Freehand zygomatic implant placement<br>* Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.<br>|

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 | 1 month | 
| Platform 3D deviation | Global deviation at the platform of the zygomatic 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). | 1 month | 
| 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). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome measures questionnaire | Patients perception of therapy functional well-being and health status during the dental implant treatment with a navigation system. The scale goes from 0 to 4, where higher scores mean worse outcome. | One week post operative | 
| Time of surgery | Two times of surgery were recorded: time of drilling, from the first drilling of the first zygomatic implant to the last zygomatic implant placement; and time of complete surgery procedure, from first incision to suture. | 24 hours | 
| Complications | Number of intra and postoperative complications and what kind of complication it was. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Computer-Assisted, Dental implant, Navigation system