Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

University of Barcelona

Status: Enrolling

Conditions: Dental Implants; Surgery, Computer-Assisted

Treatments: Device: Freehand zygomatic implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06155799

11/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Navigation group

Experimental group

Description:

Zygomatic implant placement by dynamic computer assisted surgery system.

Treatment:

Device: Freehand zygomatic implant placement

Freehand group

Active Comparator group

Description:

Zygomatic implant placement by Freehand, without any guidance.

Treatment:

Device: Freehand zygomatic implant placement