Clinical trial NCT02873585: Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study
Official title: Clinical Evaluation and Patient Experience of a Stationary Intraoral Tomosynthesis (s-IOT) Unit Using a Carbon Nanotube X-ray Source Array
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: XinVivo, Inc.
name: North Carolina Translational and Clinical Sciences Institute
First posted: 2016-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: ROC Using the Area Under the Curve (AUC)
timeFrame: Within 7 months of last participants imaging
measure: Proportion of Healthy Tooth Surfaces
timeFrame: Within 7 months of last participants imaging
measure: Proportion of Carious Tooth Surfaces
timeFrame: Within 7 months of last participants imaging
Secondary outcomes:
measure: Number of Participants With a Positive Experience
timeFrame: During a single 2-hour visit
measure: Overall Investigator Confidence Survey
timeFrame: During a single 2-hour visit
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Dentistry
state: North Carolina
Study officials:
affiliation: UNC-School of Dentistry
name: Angela Broome, DDS
role: PRINCIPAL_INVESTIGATOR
References: