N/A
N=32
Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02873585 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: ROC Using the Area Under the Curve (AUC) — 0.5427; 0.5173 probability
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stationary intraoral tomosynthesis (Device); Standard conventional bitewing radiography (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ROC Using the Area Under the Curve (AUC) |
0.5427; 0.5173 | — |
| PRIMARY Proportion of Healthy Tooth Surfaces |
0.7308; 0.7657 | — |
| PRIMARY Proportion of Carious Tooth Surfaces |
0.3601; 0.2768 | — |
| SECONDARY Number of Participants With a Positive Experience |
13; 19; 8; 18; 6; 25 | — |
| SECONDARY Overall Investigator Confidence Survey |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02873585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.