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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Stationary intraoral tomosynthesis
* Device: Standard conventional bitewing radiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stationary intraoral tomosynthesis<br>Stationary intraoral tomosynthesis after standard conventional bitewing radiography | Device: Stationary intraoral tomosynthesis<br>* Bitewing radiographs using a stationary intraoral tomosynthesis unit<br>* Other names: Dental tomosynthesis;Device: Standard conventional bitewing radiography<br>* Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC Using the Area Under the Curve (AUC) | 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). | Within 7 months of last participants imaging | 
| Proportion of Healthy Tooth Surfaces | Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion. | Within 7 months of last participants imaging | 
| Proportion of Carious Tooth Surfaces | Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion. | Within 7 months of last participants imaging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Positive Experience | 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. | During a single 2-hour visit | 
| Overall Investigator Confidence Survey | The investigators were to complete a brief survey regarding the overall confidence in diagnosis, time, and the number of required radiographic re-takes. | During a single 2-hour visit |