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

Sponsor

University of Aarhus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05439330

Collaborator

Siemens Corporation, Corporate Technology (Industry), Dentsply Sirona Implants (Industry)

470

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
TMJ Apical Periodontitis Periodontal Inflammation Retained Tooth MRI	Device: MRI of teeth and surrounding structures	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

470 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each person has a MRI scan done following the requested radiograph. MRI and radiographs are compared for diagnostic purposes.Each person has a MRI scan done following the requested radiograph. MRI and radiographs are compared for diagnostic purposes.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Application of a dental-dedicated MRI in the diagnosis of temporomandibular joint disorders, tissue alterations related to third molars, and periapical and periodontal inflammatory diseases. [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)), 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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