NCT02873585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 19, 2020

Completed
Last Updated

September 2, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

August 16, 2016

Results QC Date

August 5, 2020

Last Update Submit

August 20, 2020

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (3)

  • 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).

    Within 7 months of last participants imaging

  • Proportion of Healthy Tooth Surfaces

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

    Within 7 months of last participants imaging

  • Proportion of Carious Tooth Surfaces

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

    Within 7 months of last participants imaging

Secondary Outcomes (2)

  • Number of Participants With a Positive Experience

    During a single 2-hour visit

  • Overall Investigator Confidence Survey

    During a single 2-hour visit

Study Arms (1)

Stationary intraoral tomosynthesis

EXPERIMENTAL

Stationary intraoral tomosynthesis after standard conventional bitewing radiography

Device: Stationary intraoral tomosynthesisDevice: Standard conventional bitewing radiography

Interventions

Stationary intraoral tomosynthesisDEVICE

Bitewing radiographs using a stationary intraoral tomosynthesis unit

Also known as: Dental tomosynthesis
Stationary intraoral tomosynthesis
Standard conventional bitewing radiographyDEVICE

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

Stationary intraoral tomosynthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC School of Dentistry

Chapel Hill, North Carolina, 27510, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Angela Broome, DDS, MS
Organization
University of North Carolina at Chapel Hill
abroome@unc.edu
9195373160

Study Officials

  • Angela Broome, DDS

    UNC-School of Dentistry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

April 19, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 2, 2020

Results First Posted

August 19, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)