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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double factor group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Factor technique | Procedure | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive edentulous patients or with terminal dentition treated with full arch implant supported prostheses based on the All-on-four® concept and the computer assisted surgery "double factor" technique will be included in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Adrià Jorba-GarcÃa, DDS, MS | University of Barcelona | Principal Investigator |
| Carmen Pomares-Puig, MD, DDS | University of Valencia | Study Chair |
| M Angeles Sánchez-Garcés, MD, MS, PhD | University of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Perio&Implant | Alicante | 03007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25123770 | Background | Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056. | |
| 33810850 | Background | Pomares-Puig C, Sanchez-Garces MA, Jorba-Garcia A. Dynamic and static computer-guided surgery using the double-factor technique for completely edentulous patients: A dental technique. J Prosthet Dent. 2022 Nov;128(5):852-857. doi: 10.1016/j.prosdent.2021.02.022. Epub 2021 Mar 31. |
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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. |
| 20623040 | Background | Pomares C. A retrospective study of edentulous patients rehabilitated according to the 'all-on-four' or the 'all-on-six' immediate function concept using flapless computer-guided implant surgery. Eur J Oral Implantol. 2010 Summer;3(2):155-63. |
| 33635397 | Background | Jorba-Garcia A, Gonzalez-Barnadas A, Camps-Font O, Figueiredo R, Valmaseda-Castellon E. Accuracy assessment of dynamic computer-aided implant placement: a systematic review and meta-analysis. Clin Oral Investig. 2021 May;25(5):2479-2494. doi: 10.1007/s00784-021-03833-8. Epub 2021 Feb 26. |