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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation group | Experimental | Dental implants will be placed using a dynamic computer assisted surgery system |
|
| Freehand group | Active Comparator | Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic navigation system | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrià Jorba-García, DDS | Contact | 0034 699183949 | adriajorba@hotmail.com | |
| Rui Figueiredo | Contact | ruipfigueiredo@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adrià Jorba-García | University of Barcelona | Principal Investigator |
| Rui Figueiredo | University of Barcelona | Study Director |
| Eduard Valmaseda-Castellón |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat de Barcelona | Barcelona | 08907 | 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. | |
| 31829457 | Background | Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29. |
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Patient will be unaware of which group since during the surgical procedure patient eyes' will be covered.
Outcome assessor won't take part of the clinical process and will be blinded regarding which group is allocated each patient.
|
|
| Freehand implant placement | Device | Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done |
|
|
| University of Barcelona |
| Study Chair |
| Octavi Camps-Font | University of Barcelona | Study Chair |
| Javier Bara-Casaus | University of Barcelona | Study Chair |
| 28000275 | Background | D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175. |
| 30573712 | Background | Jorba-Garcia A, Figueiredo R, Gonzalez-Barnadas A, Camps-Font O, Valmaseda-Castellon E. Accuracy and the role of experience in dynamic computer guided dental implant surgery: An in-vitro study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e76-e83. doi: 10.4317/medoral.22785. |
| 26452429 | Background | Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30. |
| 27267658 | Background | Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6. |
| 19885437 | Background | Jung RE, Schneider D, Ganeles J, Wismeijer D, Zwahlen M, Hammerle CH, Tahmaseb A. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2009;24 Suppl:92-109. |