An interventional study of Dynamic navigation system and Freehand implant placement in Surgery, Computer-Assisted and Dental Implants, sponsored by University of Barcelona. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by University of Barcelona · Not applicable, Interventional, and Treatment
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.
University of Barcelona is the lead sponsor of 95 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dental implants will be placed using a dynamic computer assisted surgery system
Device: Dynamic navigation system
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
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.
Also known as: Dynamic computer assisted surgery
Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
Also known as: Non-guided implant placement
Angular deviation
angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 3 months post operative
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.
Time frame: One week post operative.
Plan to share: No
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University of Barcelona