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

NCT02873585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-09-02

Study results available
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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.

Conditions

  • Dental Caries

Interventions

DEVICE

Stationary intraoral tomosynthesis

Bitewing radiographs using a stationary intraoral tomosynthesis unit

DEVICE

Standard conventional bitewing radiography

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

Sponsors & Collaborators

  • XinVivo, Inc.

    collaborator INDUSTRY

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Angela Broome, DDS · UNC-School of Dentistry

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02873585 on ClinicalTrials.gov