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

Not Applicable

• Conditions: Initial Proximal Caries
• Interventions: Device: Radiographic examination; Device: Scanning with DIAGNOcam; Device: Scan with DIAGNOcam and Indocyanine; Diagnostic Test: Visual-tactile exploration with separation

• Registration Number: NCT04748913
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-11-09
• Study Completion: 2022-11-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remineralization	Scan with DIAGNOcam and Indocyanine	-
Remineralization	Visual-tactile exploration with separation	-
Remineralization	Radiographic examination	-
Remineralization	Scanning with DIAGNOcam	-

Primary Outcome Measures

Name	Time	Method
Near infrared transillumination	2 years	Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine

Trial Locations

Locations (1)

Santiago De Vega Calleja; 🇪🇸 Alcorcón, Madrid, Spain