Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery, Computer-Assisted
- Sponsor
- University of Barcelona
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Platform 3D deviation
- Last Updated
- 6 years ago
Overview
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.
Investigators
Rui Figueiredo
Associate Professor. PhD, MD, DDS
University of Barcelona
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Platform 3D deviation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Patient-reported outcome measures (PROMs) questionnaire(One week post operative.)