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

NCT03227172 | Completed

• 1 other identifier: 15034
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periapical Diseases

Outcome Measures

Primary Outcomes (1)

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

  To determine the diagnostic accuracy of the radiologists compared with the pathologists (considered the gold standard), receiver operator characteristic (ROC) analysis was performed assuming that the diagnostic test is dichotomous. This method for computing the area under curve (AUC) and its error is in agreement with fitting procedures used for diagnostic tests.

  5 years

Secondary Outcomes (1)

• inter-pathologist diagnoses , inter-radiologist diagnoses and internal consistency of the items used for the differential diagnosis by radiologists and pathologists.

  5 years

Interventions

apicoectomy PROCEDURE

After flap elevation and osteotomy , peri-apical lesion and the root tip were located: after root-end resection using a fissure bur, the resected root tip and the pathological tissue were removed and immediately preserved in 1% formaldehyde solution.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

34 patients (17 males and 17 females; mean age 41.9 (range 21-76) years) with periapical endodontic lesions diagnosed by clinical and radiological examination using 2D standard x-rays (periapical and panoramic x-rays) or multislice CT/CBCT in the Oral and Maxillofacial Unit of the University of Bologna between January 2011 and December 2015, and treated with enucleation of the lesion and apicoectomy after a pre-operative MRI exam were retrospectively enrolled in this study. The chart of these patients, that underwent a traditional and standard therapeutic protocol, the radiological imaging and the histopathological data, were analysed after the treatment by a team of two radiologists and two pathologists.

You may qualify if:

• 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.

You may not qualify if:

• general medical contraindications for classification of the patient as level III or higher according to the American Society of Anesthesiologists,
• 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;

Sponsors & Collaborators

• University of Bologna: lead

MeSH Terms

Conditions

Periapical Diseases

Interventions

Apicoectomy

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Endodontics; Dentistry

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 24, 2017
• Study Start: January 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: December 20, 2016
• Last Updated: July 24, 2017

Record last verified: 2017-07