CompletedNot Applicable

Differential Diagnosis Between Granuloma and Radicular Cyst: Effectiveness of Magnetic Resonance Imaging.

34 participantsStarted 2011-01-01

Plain-language summary

The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were investigated by two radiologists using MRI, based on the same six criteria, to categorize the lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded to the radiologist's diagnoses) analyzed all specimens by referring to seven specific parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater agreements between the radiologists and pathologists in terms of MRI and histological diagnoses, respectively, along with the discriminant power of the adopted criteria and the accuracy of the MRI assessments compared with the histopathologic results, were calculated. A strong inter-rater reliability was observed between the two radiologists (k-statistic = 0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was higher for the radiological (Guttmann's lambda lower bound \> 0.6) than histopathological criteria. The accuracy (true positives plus true negatives) of the radiologists was higher than that of the pathologists based on receiver operator characteristic analysis (area under the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and comparable to histopathological reliability, highlighting the usefulness of this non-invasive exam as a pre-treatment diagnostic method for periapical endodontic lesions.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patient age ≥ 18 years * the diameter of the lesion ≥ 5 mm, assessed based on periapical x-ray, * an acceptable endodontic treatment for the involved tooth. Exclusion Criteria: * general medical contraindications for classification of the patient as level III or higher according to the American Society of Anesthesiologists, * teeth involved in the lesion, the function of which could not be salvaged after enucleation of the lesion and apicoectomy. The radiological exclusion criteria were * contraindication undergoing magnetic resonance: presence of a pacemaker or any metallic devices that could interfere with the magnetic field; * severe claustrophobia, * weight ≥ 130 kg * intolerance to gadolinium-DTPA as a contrast agent;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis

Timeframe: 5 years

Trial details

NCT IDNCT03227172

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-03-01

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