Dynamic Navigation System in Implantology

April 9, 2020 updated by: Rui Figueiredo, University of Barcelona

Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial

This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized clinical trial.

Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.

During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. 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 CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08907
        • Universitat 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Partially edentulous patients that requires at least the placement of one dental implant
  • Healthy patients ASA I and II (American Society of Anesthesiologists classification)
  • Over 18 years old patients

Exclusion Criteria:

  • Totally edentulous patients
  • Systemic or local conditions that contraindicates dental implant surgery
  • Patients with less than 3 teeth in the jaw.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navigation group
Dental implants will be placed using a dynamic computer assisted surgery system
Device: Dynamic navigation system
The navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position.
Other Names:
  • Dynamic computer assisted surgery
Active Comparator: Freehand group
Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography)
Device: Freehand implant placement
Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
Other Names:
  • Non-guided implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angular deviation
Time Frame: 3 months post operative
angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees
3 months post operative
Platform 3D deviation
Time Frame: 3 months post operative
global deviation at the platform 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).
3 months post operative
Apex 3D deviation
Time Frame: 3 months post operative
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).
3 months post operative
Platform 2D deviation
Time Frame: 3 months post operative
Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm).
3 months post operative
Apex depth deviation
Time Frame: 3 months post operative
Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm).
3 months post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcome measures (PROMs) questionnaire
Time Frame: One week post operative.
Patients perception of their functional well-being and health status during the dental implant treatment with a navigation system. We will use OHIP-14 (Oral Health Impact Profile) questionnaire.
One week post operative.

Collaborators and Investigators

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

Sponsor

University of Barcelona

Investigators

  • Principal Investigator: Adrià Jorba-García, University of Barcelona
  • Study Director: Rui Figueiredo, University of Barcelona
  • Study Chair: Eduard Valmaseda-Castellón, University of Barcelona
  • Study Chair: Octavi Camps-Font, University of Barcelona
  • Study Chair: Javier Bara-Casaus, 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

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 (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NavigationSystem

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

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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