Dental Caries
Conditions
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.
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.
Interventions
DEVICEStationary intraoral tomosynthesis
Bitewing radiographs using a stationary intraoral tomosynthesis unit
DEVICEStandard conventional bitewing radiography
Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
Sponsors
XinVivo, Inc.
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ROC Using the Area Under the Curve (AUC) | 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 | 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 | Within 7 months of last participants imaging | Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Positive Experience | During a single 2-hour visit | 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. |
| Overall Investigator Confidence Survey | During a single 2-hour visit | The investigators were to complete a brief survey regarding the overall confidence in diagnosis, time, and the number of required radiographic re-takes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| 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 | 217 |
| Total | 249 |
Baseline characteristics
| Characteristic | Stationary Intraoral Tomosynthesis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Proportion of Carious Tooth Surfaces
Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion.
Time frame: Within 7 months of last participants imaging
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Conventional Bitewing Radiography | Proportion of Carious Tooth Surfaces | 0.3601 proportion of carious tooth surfaces | Standard Deviation 0.1006 |
| Stationary Intraoral Tomosynthesis | Proportion of Carious Tooth Surfaces | 0.2768 proportion of carious tooth surfaces | Standard Deviation 0.0401 |
Primary
Proportion of Healthy Tooth Surfaces
Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion.
Time frame: Within 7 months of last participants imaging
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Conventional Bitewing Radiography | Proportion of Healthy Tooth Surfaces | 0.7308 proportion of tooth surfaces | Standard Deviation 0.099 |
| Stationary Intraoral Tomosynthesis | Proportion of Healthy Tooth Surfaces | 0.7657 proportion of tooth surfaces | Standard Deviation 0.045 |
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).
Time frame: Within 7 months of last participants imaging
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Conventional Bitewing Radiography | ROC Using the Area Under the Curve (AUC) | 0.5427 probability | Standard Deviation 0.0473 |
| Stationary Intraoral Tomosynthesis | ROC Using the Area Under the Curve (AUC) | 0.5173 probability | Standard Deviation 0.02 |
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.
Time frame: During a single 2-hour visit
Population: Responses reported for all that were received
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | More Difficult to Perform | 14 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | Noticeably Different | 18 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | Recommended Without Reservation | 27 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | Reported No Issues with Either System | 18 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | Equally Comfortable | 13 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | More Comfortable | 8 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | Requires More Time | 6 Participants |
| Standard Conventional Bitewing Radiography | Number of Participants With a Positive Experience | Equally Easy to Perform | 16 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | Equally Easy to Perform | 16 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | More Difficult to Perform | 18 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | Equally Comfortable | 19 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | Noticeably Different | 14 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | Requires More Time | 25 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | Recommended Without Reservation | 5 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | More Comfortable | 18 Participants |
| Stationary Intraoral Tomosynthesis | Number of Participants With a Positive Experience | Reported No Issues with Either System | 10 Participants |
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.
Time frame: During a single 2-hour visit
Population: This survey tool was not developed or executed; therefore, these data were not collected.