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Clinical Trials/NCT04748913
NCT04748913CompletedNot Applicable

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

Universidad Rey Juan Carlos1 site in 1 country153 target enrollmentStarted: November 9, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
153
Locations
1
Primary Endpoint
Near infrared transillumination

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

No intervention

No Intervention

Remineralization

Other

Intervention: Radiographic examination (Device)

Remineralization

Other

Intervention: Scanning with DIAGNOcam (Device)

Remineralization

Other

Intervention: Scan with DIAGNOcam and Indocyanine (Device)

Remineralization

Other

Intervention: Visual-tactile exploration with separation (Diagnostic Test)

Outcomes

Primary Outcomes

Near infrared transillumination

Time Frame: 2 years

Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Santiago Miguel de Vega Calleja

Principal investigator

Universidad Rey Juan Carlos

Study Sites (1)

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