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NCT06116487 Clinical Trial

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

Periodontitis Clinical Trial

Official title:
Evaluation of Magnetic Resonance Imaging as Alternative to Cone Beam Computed Tomography for the Assessment of Furcation Involvement in Molars

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06116487
Other study ID # 1208/2023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 20, 2023
Est. completion date December 20, 2024

Study information
Verified date October 2023
Source Medical University of Vienna
Contact Elias Salzmann
Phone 0043 1 40070 4720
Email elias.salzmann@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 140
Est. completion date December 20, 2024
Est. primary completion date September 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medical University of Vienna, Clinic of Dentistry Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary horizontal furcation defects according to Hamp 1975 Grad 0, I, II, III day 1
Secondary horizontal bone loss measured in mm day 1
Secondary vertical bone loss measured in mm day 1
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