Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04748913
Enrollment
153
Registered
2021-02-10
Start date
2020-11-09
Completion date
2023-11-09
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Initial Proximal Caries

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.

Interventions

Standardized bitewing radiographs will be performed by the principal investigator

DEVICEScanning with DIAGNOcam

The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device

DEVICEScan with DIAGNOcam and Indocyanine

One the dye has been applied, a new series of images will be taken with Diagnocam

DIAGNOSTIC_TESTVisual-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

Universidad Rey Juan Carlos
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Near infrared transillumination2 yearsAbility to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026