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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873585
• Other study ID #: 16-0194
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Stationary intraoral tomosynthesis
Bitewing radiographs using a stationary intraoral tomosynthesis unit
• Standard conventional bitewing radiography
Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography

Locations

Country	Name	City	State
United States	UNC School of Dentistry	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute, XinVivo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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