CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Stationary intraoral tomosynthesis +1 moredevice
Likely dose
Bitewing radiographs using stationary intraoral tomosynthesis unit with carbon nanotube x-ray source arrayAI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Scheduled for horizontal bitewing or full mouth radiographs with horizontal bitewings
  • ✓Canine and two posterior teeth in contact in all four quadrants (right/left maxilla and mandible)
  • ✓At least one proximal caries lesion in a posterior tooth (premolar or molar) in contact with another tooth, with lesion depth incipient (outer half enamel), moderate (inner half enamel), or advanced (outer half dentin)
Key exclusion· 4
  • ✕Institutionalized subjects (prisoners, nursing home residents, etc.)
  • ✕Critically ill or mentally unstable patients
  • ✕No radiographic caries detected in posterior teeth on conventional bitewing radiographs
  • ✕Only severe caries lesions present on conventional bitewing radiographs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02873585
NCT02873585N/ACompleted
CompareCT.gov

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

University of North Carolina, Chapel Hill·interventional·Posted Aug 19, 2016·Updated Sep 2, 2020

In Brief

A clinical study evaluating Stationary intraoral tomosynthesis and Standard conventional bitewing radiography for Dental Caries. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
CollaboratorsXinVivo, Inc., North Carolina Translational and Clinical Sciences Institute

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 19, 2016
Enrollment StartApr 19, 2018
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.9 years ago

Interventions

Stationary intraoral tomosynthesisdevice

Bitewing radiographs using a stationary intraoral tomosynthesis unit

Standard conventional bitewing radiographydevice

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