The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients

Study Overview
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Brief Summary
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To overcome the limitations of the current dynamic and static Computer Assisted surgery protocols in fully edentulous patients, and combine the advantages of both approaches, a new technique has been developed, referred to as the double factor technique. This study consists in a single arm observational prospective clinical study and the aim was to assess the accuracy and patient's perception and quality of life of the double factor technique in treating fully edentulous patients.

Detailed Description
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This is a prospective observational clinical study. Each patient enrolled in this study will be treated using the all on four concept using the double factor technique. 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, four dental implant will be placed in a fully guided approach using the double factor technique. This technique merges the static and dynamic computer-guided surgical approach in the same surgery. 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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The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients

Conditions
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Surgery, Computer-Assisted, Dental Implants

Intervention / Treatment
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* Procedure: Double Factor technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully edentulous patients or with terminal dentition that requires an implant supported rehabilitation Healthy patients ASA I and II (American Society of Anesthesiologists classification) Over 18 years old patients Exclusion Criteria: Partially edentulous patients Systemic or local conditions that contraindicates dental implant 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Double factor group<br>Patients treated with full arch implant supported prostheses based on the All-on-four® concept. All implants were placed using the double factor computer assisted surgery technique, which involves combination of the static and dynamic computer assisted surgery protocols. | Procedure: Double Factor technique<br>* The double factor computer assisted surgery technique, involves the combination of the static and dynamic computer assisted surgery protocols to place dental implants in the same surgery.<br>* Other names: Dynamic and static computer assisted surgery;|

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 | The day of the surgery | 
| 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). | The day of the surgery | 
| 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). | The day of the surgery | 
| 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). | The day of the surgery | 
| 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). | The day of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome measures (PROMs). | Patients perception of their functional well-being and health status during the dental implant treatment with a the double factor technique. We will use OHIP-14 (Oral Health Impact Profile) questionnaire. | Seven postoperative days. | 
| Patient-reported outcome measures (PROMs). | Patients perception during the surgery will be assessed using a designed questionnaire (Likert scale) | Seven postoperative days. | 
| Postoperative pain | A registration of the postoperative pain using a Visual Analog Scale (VAS) from 0mm to 100mm, meaning 0mm no pain and 100mm the maximum pain. | Seven postoperative days. | 
| Analgesic medication consumption record | The patient will be asked to record all the analgesic medication intake during the first 7 postoperative days. | Seven postoperative days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implants, Surgery, Computer-Assisted, Fully edentulous