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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
32
Bitewing radiographs using a stationary intraoral tomosynthesis unit
Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
UNC School of Dentistry
Chapel Hill, North Carolina, United States
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).
Time frame: 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.
Time frame: 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.
Time frame: Within 7 months of last participants imaging
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.
Time frame: 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.
Time frame: During a single 2-hour visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.