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

Universidad Rey Juan Carlos

Status: Unknown

Conditions: Initial Proximal Caries

Treatments: Device: Scanning with DIAGNOcam; Device: Scan with DIAGNOcam and Indocyanine; Device: Radiographic examination; Diagnostic Test: Visual-tactile exploration with separation

Study type: Interventional

Funder types: Other

Identifiers

NCT04748913

Universidad Rey Juan Carlos

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

No intervention

No Intervention group

Remineralization

Other group

Treatment:

Device: Scanning with DIAGNOcam

Diagnostic Test: Visual-tactile exploration with separation

Device: Scan with DIAGNOcam and Indocyanine

Device: Radiographic examination