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

University of North Carolina (UNC)

Status

Completed

Conditions

Dental Caries

Treatments

Device: Stationary intraoral tomosynthesis

Device: Standard conventional bitewing radiography

Study type

Interventional

Funder types

Other

Identifiers

NCT02873585

16-0194

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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