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

NCT04748913 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universidad Rey Juan Carlos

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2022-11-09
Completion
2022-11-09

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04748913 on ClinicalTrials.gov