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MRI as Alternative to CBCT for the Assessment of Furcation Involvement in Molars

Sponsor
Medical University of Vienna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06116487
Collaborator
(none)
140
Enrollment
1
Location
13
Anticipated Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of this prospective study is to compare magnetic resonance imaging (MRI) and cone beam computed tomography (CBCT) to diagnose furcation involvement (FI) in molars in patients with periodontitis. The focus is on the differentiation of grad II and III according to Hamp et al. 1975. 140 molars (70 upper and 70 lower) will be investigated with CBCT and MRI. Due to the absence of ionic radiation MRI might be a radiation free diagnostic tool to assess FI in the future without harmful radiation for the patient. Patients of the Dental Clinic, Medical University of Vienna, who need a CBCT and have a clinically diagnosed FI can be a participant of this clinical trial and do in addition to their CBCT a MRI. The accuracy of MRI will be compared to the diagnostic gold standard CBCT. If patients need additional periodontal treatment, e.g., periodontal surgery, a subgroup will also be analysed with intraoperative measurements.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Magnetic Resonance Imaging as Alternative to Cone Beam Computed Tomography for the Assessment of Furcation Involvement in Molars
    Anticipated Study Start Date :
    Nov 20, 2023
    Anticipated Primary Completion Date :
    Sep 20, 2024
    Anticipated Study Completion Date :
    Dec 20, 2024

    Outcome Measures

    Primary Outcome Measures

    1. horizontal furcation defects according to Hamp 1975 [day 1]

      Grad 0, I, II, III

    Secondary Outcome Measures

    1. horizontal bone loss [day 1]

      measured in mm

    2. vertical bone loss [day 1]

      measured in mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with FI grade II or III, patients who need a CBCT, not pregnant
    Exclusion Criteria:
    • Patients with contraindications to perform a MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna, Clinic of Dentistry Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elias Salzmann, Principal Investigator, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT06116487
    Other Study ID Numbers:
    • 1208/2023
    First Posted:
    Nov 3, 2023
    Last Update Posted:
    Nov 3, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elias Salzmann, Principal Investigator, Medical University of Vienna
    CBCT
    MRI
    Furcation involvement
    Additional relevant MeSH terms:
    Periodontitis
    Periodontal Diseases
    Furcation Defects

    Study Results

    No Results Posted as of Nov 3, 2023