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

Study Overview
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Brief Summary
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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.

Official Title
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Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection: A Clinical Controlled Trial

Conditions
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Dental Caries

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Near infrared transillumination<br>Near infrared transillumination is applied for initial enamel caries lesion detection. | Other: Non invasive caries treatment<br>* If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.<br>* Other names: Fluoridation;Other: Invasive caries treatment<br>* If the active comparator does detect cavitation, a composite restauration is placed<br>* Other names: Filling;Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)<br> <br> |
| Active Comparator: Visual caries detection + BW<br>visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics. | Other: Non invasive caries treatment<br>* If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.<br>* Other names: Fluoridation;Other: Invasive caries treatment<br>* If the active comparator does detect cavitation, a composite restauration is placed<br>* Other names: Filling;Other: Visual examination and bitewing (BW) radiography<br>* established diagnostic methods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) | 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 | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Activity | active lesions: 1; inactive lesions: 0 | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries diagnostics, Interproximal caries, Enamel caries, Caries detection, Near-infrared light transillumination, DIAGNOcam