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

Periapical Diseases Clinical Trial

Official title:

The Accuracy of Magnetic Resonance Imaging in Diagnosing Endodontic Periapical Lesion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227172
• Other study ID #: 15034
• Status: Completed
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 21, 2017
• Start date: January 1, 2011
• Est. completion date: December 20, 2016

Study information

• Verified date: July 2017
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 20, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Periapical Diseases

Intervention

Procedure:
• apicoectomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	inter-pathologist diagnoses , inter-radiologist diagnoses and internal consistency of the items used for the differential diagnosis by radiologists and pathologists.	To examine inter-rater agreement between the two radiologists and two pathologists, we calculated Cohen's kappa.; The sensitivity and specificity were determined to assess the ability of MRI to differentially diagnose cysts and granulomas. Sensitivity was calculated as the proportion of true-positive test results (cyst diagnosed consistently by both MRI and biopsy) among the patients with the "disease" (cyst diagnosed by biopsy). Specificity was calculated as the proportion of true-negative results (granuloma diagnosed consistently by both MRI and biopsy) among the "disease-free" subjects (granuloma diagnosed by biopsy) .; Guttman's lambda coefficient was computed to account for the reliability of the used criteria.	5 years