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.
Primary Purpose
TMJ, Apical Periodontitis, Periodontal Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MRI of teeth and surrounding structures
Sponsored by
About this trial
This is an interventional diagnostic trial for TMJ
Eligibility Criteria
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
Sites / Locations
- IOOSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Application of a dental-dedicated MRI
Arm Description
MRI of conditions related to teeth and surrounding structures
Outcomes
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05439330
First Posted
June 20, 2022
Last Updated
November 1, 2022
Sponsor
University of Aarhus
Collaborators
Siemens Corporation, Corporate Technology, Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT05439330
Brief 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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Siemens Corporation, Corporate Technology, Dentsply Sirona Implants and Consumables
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ, Apical Periodontitis, Periodontal Inflammation, Retained Tooth, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each person has a MRI scan done following the requested radiograph. MRI and radiographs are compared for diagnostic purposes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Application of a dental-dedicated MRI
Arm Type
Experimental
Arm Description
MRI of conditions related to teeth and surrounding structures
Intervention Type
Device
Intervention Name(s)
MRI of teeth and surrounding structures
Intervention Description
included above
Primary Outcome Measure Information:
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.
Description
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.
Time Frame
2½ years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens Spin-Neto, ph.D
Phone
+4587159713
Email
rsn@dent.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Spin-Neto, ph.D
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
IOOS
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens Spin Neto, dr.odont
Email
rsn@dent.au.dk
First Name & Middle Initial & Last Name & Degree
Jennifer Christensen, ph.d.
Email
jchristensen@dent.au.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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