Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions

Completed

• Conditions: Benign Radiolucent Lesions

• Registration Number: NCT02121236
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-23
• Primary Completion: 2015-02
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-14
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lesion Contents	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	Three possible categories for this variable: Solid, liquid, mixed.

Secondary Outcome Measures

Name	Time	Method
3D measurements of the lesion	One time assessment once sample recruitment has completed.

Trial Locations

Locations (1)

Department of Oral Medicine, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic