NCT06155799

Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

Accuracy of Dynamic Navigation System on Zygomatic Implant Placement: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dental Implants
• Surgery, Computer-Assisted

Interventions

Type	Name	Description
DEVICE	Freehand zygomatic implant placement	Zygomatic implants will be placed without any guidance after preoperative virtual planning has been performed.

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-05-15
• Completion: 2024-07-15
• First posted: 2023-12-04
• Last updated: 2023-12-04

Locations

1 site across 1 country: Spain