Accuracy of Dynamic Navigation System on Zygomatic Implant Placement

December 2, 2023 updated by: Adrià Jorba García, University of Barcelona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain
        • Recruiting
        • Hospital Odontológic de Barcelona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angular deviation
Time Frame: 1 month
Angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
1 month
Platform 3D deviation
Time Frame: 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).
1 month
Apex 3D deviation
Time Frame: 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).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcome measures questionnaire
Time Frame: 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.
One week post operative
Time of surgery
Time Frame: 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.
24 hours
Complications
Time Frame: 6 months
Number of intra and postoperative complications and what kind of complication it was.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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