NCT04748913

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Universidad Rey Juan Carlos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Initial Proximal Caries

Interventions

Type	Name	Description
DEVICE	Radiographic examination	Standardized bitewing radiographs will be performed by the principal investigator
DEVICE	Scanning with DIAGNOcam	The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device
DEVICE	Scan with DIAGNOcam and Indocyanine	One the dye has been applied, a new series of images will be taken with Diagnocam
DIAGNOSTIC_TEST	Visual-tactile exploration with separation	The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator

Timeline

• Start date: 2020-11-09
• Primary completion: 2022-11-09
• Completion: 2022-11-09
• First posted: 2021-02-10
• Last updated: 2021-09-28

Locations

1 site across 1 country: Spain