Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study
NCT ID: NCT02873585
Last Updated: 2020-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2018-04-19
2019-09-30
Brief Summary
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Detailed Description
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Fifty adult patients who have been referred to the Section of Oral and Maxillofacial Radiology (OMR) at the University of North Carolina (UNC) School of Dentistry (SOD) for horizontal bitewing (BW) radiographs or a Full Mouth Series (FMX) with horizontal bitewing radiographs will be recruited for the study.
Participants will receive an experimental s-IOT bitewing radiograph on each side of their mouth and a visual exam to look for caries. Experienced observers will assess the presence or absence of caries using the two imaging modalities. The results of their analysis will be evaluated to determine statistical difference. Participants completed questionnaires will be tabulated and the data will be analyzed using descriptive statistics.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Stationary intraoral tomosynthesis
Stationary intraoral tomosynthesis after standard conventional bitewing radiography
Stationary intraoral tomosynthesis
Bitewing radiographs using a stationary intraoral tomosynthesis unit
Standard conventional bitewing radiography
Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
Interventions
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Stationary intraoral tomosynthesis
Bitewing radiographs using a stationary intraoral tomosynthesis unit
Standard conventional bitewing radiography
Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for horizontal BW or Full (FMX) with horizontal BWs
* Patients who have in the right and left maxilla and mandible at least a canine and two posterior teeth that are in contact
* At least one proximal caries lesion in a surface of a posterior tooth (premolar or molar) that is in contact with another tooth. Lesion depth can be incipient (outer half enamel), moderate (inner half enamel) or advanced (outer half dentin) as determined by conventional BW radiography.
* At least one non-carious proximal surface of a posterior tooth (premolar or molar) that is in contact with another tooth.
* Patients should be able to provide informed consent
Exclusion Criteria
* Critically ill or mentally unstable patients (identified by medical record)
* Patients with no radiographic caries of the posterior teeth as determined by conventional BW radiographs
* Patients with only severe caries lesions as determined by conventional BW radiographs
18 Years
ALL
Yes
Sponsors
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XinVivo, Inc.
INDUSTRY
North Carolina Translational and Clinical Sciences Institute
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Angela Broome, DDS
Role: PRINCIPAL_INVESTIGATOR
UNC-School of Dentistry
Locations
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UNC School of Dentistry
Chapel Hill, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-0194
Identifier Type: -
Identifier Source: org_study_id
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