NCT02873585

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	Stationary intraoral tomosynthesis	Bitewing radiographs using a stationary intraoral tomosynthesis unit
DEVICE	Standard conventional bitewing radiography	Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography

Timeline

• Start date: 2018-04-19
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2016-08-19
• Last updated: 2020-09-02
• Results posted: 2020-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study