NCT04344808

Dynamic Navigation System in Implantology

Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Surgery, Computer-Assisted
• Dental Implants

Interventions

Type	Name	Description
DEVICE	Dynamic navigation system	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.
DEVICE	Freehand implant placement	Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-04-14
• Last updated: 2020-04-14

Locations

1 site across 1 country: Spain