Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment Planning

November 29, 2023 updated by: Jennifer Christensen, University of Aarhus

Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Planning

The aim of the present study is to show that the use of 0.55T MRI combined with a "dental" coil produces images of sufficient diagnostic value to assess areas of interest in dentistry, and to compare MR images to traditional, dental-oriented radiographic images for diagnostic purposes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

470

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

  • Name: Rubens Spin-Neto, ph.D
  • Phone Number: +4587159713
  • Email: rsn@dent.au.dk

Study Locations

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

Yes

Description

Inclusion Criteria (one of the following):

  • referred for CBCT imaging of at least one tooth for endodontic reasons
  • referred for intra-oral and/or panoramic imaging covering at least one molar tooth for periodontal reasons
  • referred for CBCT imaging of the TMJ (bilaterally)
  • referred for panoramic imaging of the third molar (retained/semi-retained, uni- or bilateral), prior to treatment planning
  • referred for CBCT imaging prior to implant treatment

Exclusion Criteria:

  • younger than 18 years
  • unable to give consent
  • pregnant
  • pronounced claustrophobia
  • pacemakers or implanted defibrillators
  • metal shrapnel injuries of the eyes or MRI incompatible metallic inclusions or implants large tatoos
  • non-removable piercings

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application of a dental-dedicated MRI
MRI of conditions related to teeth and surrounding structures
Device: MRI of teeth and surrounding structures
included above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application of a dental-dedicated MRI in the diagnosis of temporomandibular joint disorders, tissue alterations related to third molars, periapical and periodontal inflammatory diseases, and implant treatment planning
Time Frame: 2½ years
Diagnosis of pathologies in the TMJ (e.g. disc displacement (anterior/posterior/lateral), inflammation (yes/no), bone changes (yes/no)), periodontal defects (e.g. bone defects (mm), inflammation (yes/no)), periapical pathology (e.g. inflammation (yes/no), apical periodontitis (yes/no)), bone measurements in edentulous areas, and third molars (e.g. relation to surrounding structures (over/same level/under nerve), resorption of neighboring teeth (yes/no)) seen on MRI compared to diagnosis obtained in radiographs. Observations seen on MRI will be compared to observations seen in radiographs.
2½ years

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Siemens Corporation, Corporate Technology
Dentsply Sirona Implants and Consumables

Investigators

  • Study Chair: Rubens Spin-Neto, ph.D, University of Aarhus

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)

September 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91340

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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