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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.
Hospital Odontológic de Barcelona
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGAngular deviation
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
Time frame: 1 month
Platform 3D deviation
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).
Time frame: 1 month
Apex 3D deviation
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).
Time frame: 1 month
Patient-reported outcome measures questionnaire
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 frame: One week post operative
Time of surgery
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.
Time frame: 24 hours
Complications
Number of intra and postoperative complications and what kind of complication it was.
Time frame: 6 months
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