NCT05439330

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

June 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

June 20, 2022

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Application of a dental-dedicated MRI

EXPERIMENTAL

MRI of conditions related to teeth and surrounding structures

Device: MRI of teeth and surrounding structures

Interventions

included above

Application of a dental-dedicated MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • younger than 18 years
  • unable to give consent
  • pregnant
  • pronounced claustrophobia
  • pacemakers or implanted defibrillators
  • non-removable piercings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IOOS

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Periapical PeriodontitisTooth, Impacted

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisTooth Diseases

Study Officials

  • Rubens Spin-Neto, ph.D

    University of Aarhus

    STUDY CHAIR

Central Study Contacts

Rubens Spin-Neto, ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Each person has a MRI scan done following the requested radiograph. MRI and radiographs are compared for diagnostic purposes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, ph.d.

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 30, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations