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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Stationary intraoral tomosynthesis; Device: Standard conventional bitewing radiography

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27510
      • UNC School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stationary intraoral tomosynthesis; Stationary intraoral tomosynthesis after standard conventional bitewing radiography	Device: Stationary intraoral tomosynthesis; Bitewing radiographs using a stationary intraoral tomosynthesis unit; Other Names: Dental tomosynthesis; Device: Standard conventional bitewing radiography; Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute; XinVivo, Inc.
• Investigators: Principal Investigator: Angela Broome, DDS, UNC-School of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 16-0194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No