Accuracy of Dynamic Navigation System on Zygomatic Implant Placement
Study Details
Study Description
Brief Summary
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in zygomatic implant placement in partially or total edentulous patients in the upper jaw compared with the conventional freehand method.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The present study is a prospective randomized clinical trial.
Each patient enrolled in this trial will be randomly allocated to on group (Navigation group (test group) or Freehand group (control group)). Preoperative virtual planification of zygomatic an conventional implants on a prerequired cone beam computed tomography (CBCT) with radiographic markers (tooth if possible or micro implants if not possible) will be performed for each patient.
The patient will be randomly allocated in one group just before the surgery, and the surgical procedure will be performed according the surgery protocol of each group. 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 European Conformity (CE) marked products and used within their intended use.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Navigation group Zygomatic implant placement by dynamic computer assisted surgery system. |
Device: Freehand zygomatic implant placement
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
|
| Active Comparator: Freehand group Zygomatic implant placement by Freehand, without any guidance. |
Device: Freehand zygomatic implant placement
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
|
Outcome Measures
Primary Outcome Measures
- Angular deviation [1 month]
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
- Platform 3D deviation [1 month]
Global deviation at the platform of the zygomatic 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 [1 month]
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).
Secondary Outcome Measures
- Patient-reported outcome measures questionnaire [One week post operative]
Patients perception of therapy functional well-being and health status during the dental implant treatment with a navigation system. The scale goes from 0 to 4, where higher scores mean worse outcome.
- Time of surgery [24 hours]
Two times of surgery were recorded: time of drilling, from the first drilling of the first zygomatic implant to the last zygomatic implant placement; and time of complete surgery procedure, from first incision to suture.
- Complications [6 months]
Number of intra and postoperative complications and what kind of complication it was.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Partial or total edentulous maxilla
-
Large bone atrophy that avoids possible conventional implant placement
-
Over 18 years old patients
Exclusion Criteria:
-
Patients with facial bone disease that contraindicates conventional or zygomatic implants placement.
-
Systemic or local conditions that contraindicates oral surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Odontológic de Barcelona | L'Hospitalet De Llobregat | Barcelona | Spain |
Sponsors and Collaborators
- University of Barcelona
- Principal Investigator: Bassel Traboulsi-Garet. Master of Oral Surgery and Implantology. University of Barcelona
- Study Chair: Javier Bara-Casaus. Head of the Oral and Maxillofacial Surgery Institute. University Hospital Sagrat Cor, Barcelona.
- Study Chair: Eduard Valmaseda-Castellón. Full professor of Oral Surgery. University of Barcelona
- Study Chair: Octavi Camps-Font. Lecturer in Oral Surgery. University of Barcelona
- Study Director: Maria Angels Sanchez-Garces. Associate professor in Oral Surgery. University of Barcelona
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 11/2023