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Completed

NCT Number: NCT02873585

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC School of Dentistry

Chapel Hill, North Carolina, 27510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stationary intraoral tomosynthesis

Device

Bitewing radiographs using a stationary intraoral tomosynthesis unit

Other names: Dental tomosynthesis

Standard conventional bitewing radiography

Device

Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography

Primary outcomes

  1. ROC Using the Area Under the Curve (AUC)

    Time frame: Within 7 months of last participants imaging

    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).

  2. Proportion of Healthy Tooth Surfaces

    Time frame: Within 7 months of last participants imaging

    Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion.

  3. Proportion of Carious Tooth Surfaces

    Time frame: Within 7 months of last participants imaging

    Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion.

Secondary outcomes

  1. Number of Participants With a Positive Experience

    Time frame: During a single 2-hour visit

    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.

  2. Overall Investigator Confidence Survey

    Time frame: During a single 2-hour visit

    The investigators were to complete a brief survey regarding the overall confidence in diagnosis, time, and the number of required radiographic re-takes.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute
  • XinVivo, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2016
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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