Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: Non invasive caries treatment; Other: Invasive caries treatment; Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany); Other: Visual examination and bitewing (BW) radiography

• Registration Number: NCT02657538
• Lead Sponsor: University of Bern

Brief Summary

The aim of this study is to validate a near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany) for interproximal enamel caries detection and compare it with the established diagnostic methods (visual examination and bitewing radiography). The aim is to avoid/reduce ionizing radiation for caries diagnostic purposes.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2014-12
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-18
• Study Completion: 2016-03
• Results First Submitted: 2016-05-25
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-07
• Last Update Submitted: 2016-07-07
• Results First Posted: 2016-08-18
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• ASA-Status 1
• Complete permanent dentition
• Bitewing radiography already existing (< 4 months)
• Minimum of one cavitation-free approximal surface, symptomless, interproximal enamel or dentin caries lesion in the posterior teeth without restorations and/or sound tooth surface.

Exclusion Criteria

• Children younger than 15 Years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Near infrared transillumination	Invasive caries treatment	Near infrared transillumination is applied for initial enamel caries lesion detection.
Visual caries detection + BW	Non invasive caries treatment	visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.
Visual caries detection + BW	Invasive caries treatment	visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.
Near infrared transillumination	Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)	Near infrared transillumination is applied for initial enamel caries lesion detection.
Near infrared transillumination	Non invasive caries treatment	Near infrared transillumination is applied for initial enamel caries lesion detection.
Visual caries detection + BW	Visual examination and bitewing (BW) radiography	visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.

Primary Outcome Measures

Name	Time	Method
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)	One year	The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine; Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions.; Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them

Secondary Outcome Measures

Name	Time	Method
Lesion Activity	One year	active lesions: 1; inactive lesions: 0