- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116487
MRI as Alternative to CBCT for the Assessment of Furcation Involvement in Molars
October 31, 2023 updated by: Elias Salzmann, Medical University of Vienna
Evaluation of Magnetic Resonance Imaging as Alternative to Cone Beam Computed Tomography for the Assessment of Furcation Involvement in Molars
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elias Salzmann
- Phone Number: 0043 1 40070 4720
- Email: elias.salzmann@meduniwien.ac.at
Study Locations
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-
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Vienna, Austria, 1090
- Medical University of Vienna, Clinic of Dentistry
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Contact:
- Elias Salzmann, Dr.
- Phone Number: 0043 1 40070 4720
- Email: elias.salzmann@meduniwien.ac.at
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with clinical detected furcation involvement at the first or second molars
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
horizontal furcation defects according to Hamp 1975
Time Frame: day 1
|
Grad 0, I, II, III
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
horizontal bone loss
Time Frame: day 1
|
measured in mm
|
day 1
|
vertical bone loss
Time Frame: day 1
|
measured in mm
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 20, 2023
Primary Completion (Estimated)
September 20, 2024
Study Completion (Estimated)
December 20, 2024
Study Registration Dates
First Submitted
October 25, 2023
First Submitted That Met QC Criteria
October 31, 2023
First Posted (Estimated)
November 3, 2023
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1208/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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