Benign Radiolucent LesionsNCT02121236
Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions
An observational study of Benign Radiolucent Lesions, run by Damascus University at 1 site in Syria.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Benign Radiolucent Lesions
- How many people
- 25 participants
- Where
- 1 siteSyria
- Study dates
- Apr 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
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 A database of these referred patients will be created and a random sample from this database will be withdrawn.
Who may be able to join
- 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.
Who cannot join
- 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...
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Oral Medicine, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
About this study
Official title: 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.
Read the 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
- Keywords
- CBCT, Ultrasonic diagnosis, Benign radiolucent lesions, Histopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with benign radiolucent lesions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Contents
Three possible categories for this variable: Solid, liquid, mixed.
Measured: 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 (1)
3D measurements of the lesion
Measured: One time assessment once sample recruitment has completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Radiolucent LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Obai Zainedeen, DDS MSc, Principal investigator, PhD student, Department of Oral Medicine, University of Damascus Dental School, DamascusIyad Al-Haffar, DDS MSc Phd, Study chair, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, DamascusNabeel Kushaji, DDS MSc PhD, Study director, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121236
- Sponsor's protocol ID
- UDDS-OraMed-02-2014
- Status last verified
- Mar 2015
- First submitted
- 21 Apr 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8884838Abrahams JJ, Oliverio PJ. Odontogenic cysts: improved imaging with a dental CT software program. AJNR Am J Neuroradiol. 1993 Mar-Apr;14(2):367-74.
PubMed 8456714Mast 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.
PubMed 1313327Tsiolis 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.
PubMed 14710764Imbeau J. Introduction to through-transmission alveolar ultrasonography (TAU) in dental medicine. Cranio. 2005 Apr;23(2):100-12. doi: 10.1179/crn.2005.015.
PubMed 15898566Gundappa 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.
PubMed 16940480
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Ultrasonography in Detecting Benign Radiolucent Lesions Compared to CBCT Imaging and Histological Examination
- ClinicalTrials.gov ID
- NCT02121236
- Acronym / sponsor ID
- UDDS-OraMed-02-2014
- Conditions
- Benign Radiolucent Lesions
- Keywords
- CBCT, Ultrasonic diagnosis, Benign radiolucent lesions, Histopathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with benign radiolucent lesions | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lesion Contents
Time frame: 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.
1 secondary outcome
3D measurements of the lesion
Time frame: One time assessment once sample recruitment has completed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Background: PubMed 8884838Lauria 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.
- Background: PubMed 8456714Abrahams JJ, Oliverio PJ. Odontogenic cysts: improved imaging with a dental CT software program. AJNR Am J Neuroradiol. 1993 Mar-Apr;14(2):367-74.
- Background: PubMed 1313327Mast 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.
- Background: PubMed 14710764Tsiolis 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.
- Background: PubMed 15898566Imbeau J. Introduction to through-transmission alveolar ultrasonography (TAU) in dental medicine. Cranio. 2005 Apr;23(2):100-12. doi: 10.1179/crn.2005.015.
- Background: PubMed 16940480Gundappa 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Obai Zainedeen, DDS MSc principal investigator
PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus
Iyad Al-Haffar, DDS MSc Phd study chair
Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus
Nabeel Kushaji, DDS MSc PhD study director
Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Radiolucent Lesions, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Contents (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121236, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.