Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad Rey Juan Carlos
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Near infrared transillumination
Study Overview
Brief Summary
The aim of the study will be to make a comparison in vivo of the following techniques:
DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard.
Methodology:
During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)
Exclusion Criteria
- •estructural abnormalities
- •visible clinical cavitation
- •restorations on the proximal surfaces
- •open contact points
- •overlapping structures on the X-ray that prevent a clear view of the proximal area
Arms & Interventions
No intervention
Remineralization
Intervention: Radiographic examination (Device)
Remineralization
Intervention: Scanning with DIAGNOcam (Device)
Remineralization
Intervention: Scan with DIAGNOcam and Indocyanine (Device)
Remineralization
Intervention: Visual-tactile exploration with separation (Diagnostic Test)
Outcomes
Primary Outcomes
Near infrared transillumination
Time Frame: 2 years
Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine
Secondary Outcomes
No secondary outcomes reported
Investigators
Santiago Miguel de Vega Calleja
Principal investigator
Universidad Rey Juan Carlos
