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

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stationary intraoral tomosynthesis

Standard conventional bitewing radiography

About this trial

This is an interventional diagnostic trial for Dental Caries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UNC School of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stationary intraoral tomosynthesis

Arm Description

Stationary intraoral tomosynthesis after standard conventional bitewing radiography

Outcomes

Primary Outcome Measures

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).

Proportion of Healthy Tooth Surfaces

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

Proportion of Carious Tooth Surfaces

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02873585

First Posted

August 16, 2016

Last Updated

August 20, 2020

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02873585

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

April 19, 2018 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stationary intraoral tomosynthesis

Arm Type

Experimental

Arm Description

Stationary intraoral tomosynthesis after standard conventional bitewing radiography

Intervention Type

Device

Intervention Name(s)

Stationary intraoral tomosynthesis

Other Intervention Name(s)

Dental tomosynthesis

Intervention Description

Bitewing radiographs using a stationary intraoral tomosynthesis unit

Intervention Type

Device

Intervention Name(s)

Standard conventional bitewing radiography

Intervention Description

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

Primary Outcome Measure Information:

Title

ROC Using the Area Under the Curve (AUC)

Description

Time Frame

Within 7 months of last participants imaging

Title

Proportion of Healthy Tooth Surfaces

Description

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

Time Frame

Within 7 months of last participants imaging

Title

Proportion of Carious Tooth Surfaces

Description

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

Time Frame

Within 7 months of last participants imaging

Secondary Outcome Measure Information:

Title

Number of Participants With a Positive Experience

Description

Time Frame

During a single 2-hour visit

Title

Overall Investigator Confidence Survey

Description

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

Time Frame

During a single 2-hour visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Broome, DDS

Organizational Affiliation

UNC-School of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC School of Dentistry

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27510

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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