Clinical trial NCT02121236: Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions
Official title: Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions Compared to CBCT Imaging and Histological Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Radiolucent Lesions
Keywords: CBCT
Ultrasonic diagnosis
Benign radiolucent lesions
Histopathology
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are primarily diagnosed as having a benign lesion in one of the two jaws are going to be included in the study. Patients are usually referred to the Oral and Maxillofacial Department at our University Dental School to confirm their primary diagnosis. A database of these referred patients will be created and a random sample from this database will be withdrawn.

Brief summary: This is an in vivo study which aims to evaluate the diagnostic accuracy of ultrasonography in detecting benign radiolucent lesion in the both jaws. The ultrasonography-based diagnosis of contents will be compared to those findings obtained from the histological examination (i.e. the gold standard). The second part of this study will examine the measuring accuracy by comparing ultrasonography-based 3D measurements with those obtained from CBCT images of the lesion assuming that CBCT 3D measurements are the gold standard.

Detailed description: Jaw is a common anatomical site for development of odontogenic and nonodontogenic lesions, and because of the wide variation of these lesions, the diagnosis is complex. Many techniques have been used to arrive at the final diagnosis such as conventional radiographs, computed tomography (CT), low dose cone beam CT, MRI.The use of ultrasonography has been shown to be important in evaluating the solid and cystic components of jaw lesions. Although ultrasound imaging technology is a safe and a minimally invasive procedure, and has been in use in medicine for many years, its use in dental medicine has been limited and mainly restricted to soft tissue applications. Studies evaluating the role of ultrasonography in the diagnosis of bone lesions of the jaw are limited.

Eligibility criteria: Inclusion Criteria:

* the presence of a radiolucent or mixed-appearance intraosseous lesion in the upper or lower jaw requiring surgical removal
* no previous trauma to the maxillofacial region.
* no previous surgical intervention in the same area of the lesion.

Exclusion Criteria:

* the presence of a completely radiopaque lesion indicating solid content.
* patients with systemic conditions associated with bony pathology such as hyperparathyroidism, Paget disease, ﬁbrous dysplasia, multiple myeloma, etc...

Primary outcomes:
measure: Lesion Contents
timeFrame: One time assessment once sample recruitment has completed. Ultrasonographic images will be taken before the surgical intervention of the lesion, whereas the histological examination will be performed after the surgical removal
Secondary outcomes:
measure: 3D measurements of the lesion
timeFrame: One time assessment once sample recruitment has completed.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral Medicine, University of Damascus Dental School
Study officials:
affiliation: PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus
name: Obai Zainedeen, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus
name: Iyad Al-Haffar, DDS MSc Phd
role: STUDY_CHAIR
affiliation: Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School
name: Nabeel Kushaji, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: Lauria L, Curi MM, Chammas MC, Pinto DS, Torloni H. Ultrasonography evaluation of bone lesions of the jaw. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Sep;82(3):351-7. doi: 10.1016/s1079-2104(96)80365-9.
citation: Abrahams JJ, Oliverio PJ. Odontogenic cysts: improved imaging with a dental CT software program. AJNR Am J Neuroradiol. 1993 Mar-Apr;14(2):367-74.
citation: Mast HL, Haller JO, Solomon M. Benign lesions of the mandibular and maxillary region in children: characterization by CT and MRI. Comput Med Imaging Graph. 1992 Jan-Feb;16(1):1-9. doi: 10.1016/0895-6111(92)90193-d.
citation: Tsiolis FI, Needleman IG, Griffiths GS. Periodontal ultrasonography. J Clin Periodontol. 2003 Oct;30(10):849-54. doi: 10.1034/j.1600-051x.2003.00380.x.
citation: Imbeau J. Introduction to through-transmission alveolar ultrasonography (TAU) in dental medicine. Cranio. 2005 Apr;23(2):100-12. doi: 10.1179/crn.2005.015.
citation: Gundappa M, Ng SY, Whaites EJ. Comparison of ultrasound, digital and conventional radiography in differentiating periapical lesions. Dentomaxillofac Radiol. 2006 Sep;35(5):326-33. doi: 10.1259/dmfr/60326577.