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

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 Overview

• Status: Recruiting
• Conditions: Initial Proximal Caries
• Intervention / Treatment: Device: Radiographic examination; Device: Scanning with DIAGNOcam; Device: Scan with DIAGNOcam and Indocyanine; Diagnostic test: Visual-tactile exploration with separation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Santiago De Vega Calleja
      • Contact: Santiago De V Calleja, Dentist; Phone Number: 617702800; Email: santi_5_59@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Other: Remineralization	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Anticipated): November 9, 2022
• Study Completion (Anticipated): November 9, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Universidad Rey Juan Carlos

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No