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

Initial Proximal Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748913
• Other study ID #: Universidad Rey Juan Carlos
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: November 9, 2022

Study information

• Verified date: September 2021
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Initial Proximal Caries

Intervention

Device:
• Radiographic examination
Standardized bitewing radiographs will be performed by the principal investigator
• Scanning with DIAGNOcam
The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam 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

Locations

Country	Name	City	State
Spain	Santiago De Vega Calleja	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near infrared transillumination	Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine	2 years