Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions

NCT ID: NCT02121236

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Benign Radiolucent Lesions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with benign radiolucent lesions

No interventions assigned to this group

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...

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Obai Zainedeen, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus

Iyad Al-Haffar, DDS MSc Phd

Role: STUDY_CHAIR

Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus

Nabeel Kushaji, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School

Locations

Department of Oral Medicine, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Countries

Syria

References

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Reference Type: BACKGROUND

PMID: 8884838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8456714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1313327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14710764 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15898566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16940480 (View on PubMed)

Other Identifiers

UDDS-OraMed-02-2014

Identifier Type: -

Identifier Source: org_study_id