Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions

Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions Compared to CBCT Imaging and Histological Examination

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.

Study Overview

• Status: Completed
• Conditions: Benign Radiolucent Lesions

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Oral Medicine, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 A database of these referred patients will be created and a random sample from this database will be withdrawn.

Description

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...

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with benign radiolucent lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Contents	Three possible categories for this variable: Solid, liquid, mixed.	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 Outcome Measures

Outcome Measure	Time Frame
3D measurements of the lesion	One time assessment once sample recruitment has completed.

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Obai Zainedeen, DDS MSc, PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus; Study Chair: Iyad Al-Haffar, DDS MSc Phd, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus; Study Director: Nabeel Kushaji, DDS MSc PhD, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: April 21, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 14, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: CBCT; Histopathology; Ultrasonic diagnosis; Benign radiolucent lesions
• Other Study ID Numbers: UDDS-OraMed-02-2014