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NCT05439330 Clinical Trial

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

MRI Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05439330
Other study ID # 91340
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2024

Study information
Verified date November 2023
Source University of Aarhus
Contact Rubens Spin-Neto, ph.D
Phone +4587159713
Email rsn@dent.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 470
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MRI of teeth and surrounding structures
included above

Locations
Country Name City State
Denmark IOOS Aarhus

Sponsors (3)
Lead Sponsor Collaborator
University of Aarhus Dentsply Sirona Implants and Consumables, Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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