Dental CariesNCT02873585

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

A study testing Stationary intraoral tomosynthesis and Standard conventional bitewing radiography in people with Dental Caries, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: Stationary intraoral tomosynthesis and Standard conventional bitewing radiography
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 19 Apr 2018to 30 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC School of Dentistry
Chapel Hill, North Carolina, 27510

Other trials in United States

About this study

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

Read the 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.

Conditions: Dental Caries
Being tested: Stationary intraoral tomosynthesis, Standard conventional bitewing radiography
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stationary intraoral tomosynthesisDevice
Also called Dental tomosynthesis
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

Study groups in NCT02873585
Study group	Role	What they receive
Stationary intraoral tomosynthesis	Experimental	Stationary intraoral tomosynthesis after standard conventional bitewing radiography Receives: Device: Stationary intraoral tomosynthesis; Device: Standard conventional bitewing radiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: Within 7 months of last participants imaging

Secondary outcomes (2)

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.
Measured: During a single 2-hour visit
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.
Measured: During a single 2-hour visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 201830 Sep 2019

First posted19 Aug 2016 (estimated)
Study start19 Apr 2018
Primary completion30 Sep 2019
Study completion30 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental CariesStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02873585
Sponsor's protocol ID: 16-0194
Status last verified: Jan 2020
First submitted: 16 Aug 2016
Last updated: 2 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gupta R, Kumar R, Kumar N, Singh P. Reimagining Brain Drug Delivery: Mechanistic and Translational Advances in Carbon Nanotube Nanomedicine. J Appl Toxicol. 2026 Jul;46(7):2250-2274. doi: 10.1002/jat.70154. Epub 2026 Mar 24.
PubMed 41873211

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation and Patient Experience of a Stationary Intraoral Tomosynthesis (s-IOT) Unit Using a Carbon Nanotube X-ray Source Array
ClinicalTrials.gov ID: NCT02873585
Acronym / sponsor ID: 16-0194
Conditions: Dental Caries
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: XinVivo, Inc., North Carolina Translational and Clinical Sciences Institute
Study start: 19 Apr 2018 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 30 Sep 2019 (actual)
First posted: 19 Aug 2016 (estimated)
Results: Posted 19 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Stationary intraoral tomosynthesis	Experimental	Device: Stationary intraoral tomosynthesis, Device: Standard conventional bitewing radiographyStationary intraoral tomosynthesis after standard conventional bitewing radiography

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stationary intraoral tomosynthesisAlso: Dental tomosynthesisBitewing radiographs using a stationary intraoral tomosynthesis unit	Device	Stationary intraoral tomosynthesis
Standard conventional bitewing radiographyBitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography	Device	Stationary intraoral tomosynthesis

Primary outcome

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).
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.
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.

2 secondary outcomes

Number of Participants With a Positive Experience
Time frame: During a single 2-hour visit
Overall Investigator Confidence Survey
Time frame: During a single 2-hour visit

Results and safety

Results posted to the registry on 19 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stationary Intraoral Tomosynthesis	32	32

Primary outcome: ROC Using the Area Under the Curve (AUC)

Time frame: Within 7 months of last participants imaging. Mean (Standard Deviation). Unit: probability

Measure	Standard Conventional Bitewing Radiography n = 32	Stationary Intraoral Tomosynthesis n = 32
Value	0.5427 (0.0473)	0.5173 (0.0200)

Primary outcome: Proportion of Healthy Tooth Surfaces

Time frame: Within 7 months of last participants imaging. Mean (Standard Deviation). Unit: proportion of tooth surfaces

Measure	Standard Conventional Bitewing Radiography n = 32	Stationary Intraoral Tomosynthesis n = 32
Value	0.7308 (0.099)	0.7657 (0.045)

Primary outcome: Proportion of Carious Tooth Surfaces

Time frame: Within 7 months of last participants imaging. Mean (Standard Deviation). Unit: proportion of carious tooth surfaces

Measure	Standard Conventional Bitewing Radiography n = 32	Stationary Intraoral Tomosynthesis n = 32
Value	0.3601 (0.1006)	0.2768 (0.0401)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During a single 2-hour visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Conventional Bitewing Radiography	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Stationary Intraoral Tomosynthesis	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41873211Gupta R, Kumar R, Kumar N, Singh P. Reimagining Brain Drug Delivery: Mechanistic and Translational Advances in Carbon Nanotube Nanomedicine. J Appl Toxicol. 2026 Jul;46(7):2250-2274. doi: 10.1002/jat.70154. Epub 2026 Mar 24.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angela Broome, DDS principal investigator

UNC-School of Dentistry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ROC Using the Area Under the Curve (AUC) (time frame: Within 7 months of last participants imaging). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873585, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.