Dynamic Navigation System in Implantology

Not Applicable

• Conditions: Dental Implants; Surgery, Computer-Assisted
• Interventions: Device: Dynamic navigation system; Device: Freehand implant placement

• Registration Number: NCT04344808
• Lead Sponsor: University of Barcelona

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-30
• Status Verified: 2020-04
• Study Start: 2020-04
• Study First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-09
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Partially edentulous patients that requires at least the placement of one dental implant
• Healthy patients ASA I and II (American Society of Anesthesiologists classification)
• Over 18 years old patients

Exclusion Criteria

• Totally edentulous patients
• Systemic or local conditions that contraindicates dental implant surgery
• Patients with less than 3 teeth in the jaw.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation group	Dynamic navigation system	Dental implants will be placed using a dynamic computer assisted surgery system
Freehand group	Freehand implant placement	Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography)

Primary Outcome Measures

Name	Time	Method
Platform 3D deviation	3 months post operative	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).
Platform 2D deviation	3 months post operative	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).
Angular deviation	3 months post operative	angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Apex 3D deviation	3 months post operative	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).
Apex depth deviation	3 months post operative	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).

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome measures (PROMs) questionnaire	One week post operative.	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.

Trial Locations

Locations (1)

Universitat de Barcelona; 🇪🇸 Barcelona, Spain