Dental Implants, Surgery, Computer-Assisted
Conditions
Keywords
Surgery, Computer-Assisted, Dental Implants, Navigation system, Dynamic computer-assisted surgery, Implantology
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.
Interventions
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.
DEVICEFreehand implant placement
Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
Sponsors
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angular deviation | 3 months post operative | angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees |
| 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). |
| 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). |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
Primary ContactAdrià Jorba-García, DDS
Backup ContactRui Figueiredo
Outcome results
None listed