Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions
14. marts 2015 opdateret af: Damascus University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
25
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Damascus, Syrien Arabiske Republik, DM20AM18
- Department of Oral Medicine, University of Damascus Dental School
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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...
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patients with benign radiolucent lesions
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Lesion Contents
Tidsramme: 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
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Three possible categories for this variable: Solid, liquid, mixed.
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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
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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3D measurements of the lesion
Tidsramme: One time assessment once sample recruitment has completed.
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One time assessment once sample recruitment has completed.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Obai Zainedeen, DDS MSc, PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus
- Studiestol: Iyad Al-Haffar, DDS MSc Phd, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus
- Studieleder: Nabeel Kushaji, DDS MSc PhD, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2014
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
21. april 2014
Først indsendt, der opfyldte QC-kriterier
21. april 2014
Først opslået (Skøn)
23. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UDDS-OraMed-02-2014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .