Periapical DiseasesNCT03227172
Differential Diagnosis Between Granuloma and Radicular Cyst: Effectiveness of Magnetic Resonance Imaging.
An observational study of Periapical Diseases, run by University of Bologna.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- apicoectomy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 20 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
About this study
Official title: The Accuracy of Magnetic Resonance Imaging in Diagnosing Endodontic Periapical Lesion
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
- Being tested
- apicoectomy
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apicoectomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jan 2011
- Primary completion1 Mar 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lizio, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227172
- Sponsor's protocol ID
- 15034
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Magnetic Resonance Imaging in Diagnosing Endodontic Periapical Lesion
- ClinicalTrials.gov ID
- NCT03227172
- Acronym / sponsor ID
- 15034
- Conditions
- Periapical Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apicoectomyAfter 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. | Procedure or surgery | – |
Primary outcome
The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis
Time frame: 5 years
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.
1 secondary outcome
inter-pathologist diagnoses , inter-radiologist diagnoses and internal consistency of the items used for the differential diagnosis by radiologists and pathologists.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periapical Diseases, run by University of Bologna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic accuracy of the resonance magnetic imaging, calculated in comparison with the pathologists' diagnosis with a ROC analysis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.