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| Name | Class |
|---|---|
| XinVivo, Inc. | INDUSTRY |
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stationary intraoral tomosynthesis | Experimental | Stationary intraoral tomosynthesis after standard conventional bitewing radiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stationary intraoral tomosynthesis | Device | Bitewing radiographs using a stationary intraoral tomosynthesis unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Broome, DDS | UNC-School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC School of Dentistry | Chapel Hill | North Carolina | 27510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41873211 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stationary Intraoral Tomosynthesis | Stationary intraoral tomosynthesis after standard conventional bitewing radiography Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stationary Intraoral Tomosynthesis | Stationary intraoral tomosynthesis after standard conventional bitewing radiography Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | probability | Within 7 months of last participants imaging | Tooth Surfaces | Tooth Surfaces |
|
During a single 2-hour visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Conventional Bitewing Radiography | Bitewing radiographs using a standard two-dimensional bitewing radiography |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Broome, DDS, MS | University of North Carolina at Chapel Hill | 9195373160 | abroome@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2017 | Jun 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Standard conventional bitewing radiography | Device | Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography |
|
| 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. | During a single 2-hour visit |
| Tooth Surfaces |
|
| Participants |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
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Stationary intraoral tomosynthesis after standard conventional bitewing radiography.
Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit
|
|
| Primary | Proportion of Healthy Tooth Surfaces | Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion. | Posted | Mean | Standard Deviation | proportion of tooth surfaces | Within 7 months of last participants imaging | tooth surfaces | tooth surfaces |
|
|
|
| Primary | Proportion of Carious Tooth Surfaces | Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion. | Posted | Mean | Standard Deviation | proportion of carious tooth surfaces | Within 7 months of last participants imaging | tooth surfaces | tooth surfaces |
|
|
|
| Secondary | 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. | Responses reported for all that were received | Posted | Count of Participants | Participants | During a single 2-hour visit |
|
|
|
| Secondary | 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. | This survey tool was not developed or executed; therefore, these data were not collected. | Posted | During a single 2-hour visit |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Stationary Intraoral Tomosynthesis | Stationary intraoral tomosynthesis after standard conventional bitewing radiography Stationary intraoral tomosynthesis: Bitewing radiographs using a stationary intraoral tomosynthesis unit Standard conventional bitewing radiography: Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography | 0 | 32 | 0 | 32 | 0 | 32 |
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| More Comfortable |
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| Requires More Time |
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| Equally Easy to Perform |
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| More Difficult to Perform |
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| Noticeably Different |
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| Recommended Without Reservation |
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| Reported No Issues with Either System |
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