Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection

Conditions
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Initial Proximal Caries

Intervention / Treatment
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* Device: Radiographic examination
* Device: Scanning with DIAGNOcam
* Device: Scan with DIAGNOcam and Indocyanine
* Diagnostic Test: Visual-tactile exploration with separation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br> | |
| Other: Remineralization<br> | Device: Radiographic examination<br>* Standardized bitewing radiographs will be performed by the principal investigator<br>Device: Scanning with DIAGNOcam<br>* The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device<br>Device: Scan with DIAGNOcam and Indocyanine<br>* One the dye has been applied, a new series of images will be taken with Diagnocam<br>Diagnostic Test: Visual-tactile exploration with separation<br>* The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near infrared transillumination | Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine | 2 years |