Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study



Status:Active, not recruiting
Conditions:Other Indications, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Other
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:April 19, 2018
End Date:June 2019

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Clinical Evaluation and Patient Experience of a Stationary Intraoral Tomosynthesis (s-IOT) Unit Using a Carbon Nanotube X-ray Source Array

A comparison of caries detection rates between conventional intraoral bitewing radiography
and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source
array. The secondary objective is to assess participants experience with the s-IOT device.

The primary purpose of this study is to compare caries detection rates between conventional
intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using
a carbon nanotube X-ray source array. Patient experience with the s-IOT device will be assess
using a short questionnaire.

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.

Inclusion Criteria:

- 18 years and older

- 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:

- Institutionalized subject (prisoners, nursing home, etc.) (identified by medical
record)

- 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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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