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

Not Applicable

Completed

Interventions: Device: Stationary intraoral tomosynthesis
Device: Standard conventional bitewing radiography

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Stationary intraoral tomosynthesis	Stationary intraoral tomosynthesis	Stationary intraoral tomosynthesis after standard conventional bitewing radiography
Stationary intraoral tomosynthesis	Standard conventional bitewing radiography	Stationary intraoral tomosynthesis after standard conventional bitewing radiography

Primary Outcome Measures

Name	Time	Method
ROC Using the Area Under the Curve (AUC)	Within 7 months of last participants imaging	This prospective study is to compare the diagnostic performance (accuracy) of a stationary intraoral tomosynthesis device using a Carbon Nanotube X-ray source array and a conventional intraoral X-ray device in the diagnosis of interproximal caries. receiver operating characteristic (ROC) analysis will be used to compare the areas under the curve (AUC).
Proportion of Healthy Tooth Surfaces	Within 7 months of last participants imaging	Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion.
Proportion of Carious Tooth Surfaces	Within 7 months of last participants imaging	Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Positive Experience	During a single 2-hour visit	Questionnaire used a five point Likert scale for evaluating participants' comfort with the experimental tomosynthesis unit (s-IOT) when compared to the standard intraoral unit used for bitewing radiography. Survey was distributed immediately after the examination using the experimental tomosynthesis unit. A score of 1 reflects "strongly disagree" and a score of 5 reflects "strongly disagree." A "positive experience" was defined as a score greater than 3.
Overall Investigator Confidence Survey	During a single 2-hour visit	The investigators were to complete a brief survey regarding the overall confidence in diagnosis, time, and the number of required radiographic re-takes.