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

Overview

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.

Full Title of Study: “Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection: A Clinical Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

Interventions

  • Other: Non invasive caries treatment
    • If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
  • Other: Invasive caries treatment
    • If the active comparator does detect cavitation, a composite restauration is placed
  • Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)
  • Other: Visual examination and bitewing (BW) radiography
    • established diagnostic methods

Arms, Groups and Cohorts

  • Active Comparator: Near infrared transillumination
    • Near infrared transillumination is applied for initial enamel caries lesion detection.
  • Active Comparator: Visual caries detection + BW
    • visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.

Clinical Trial Outcome Measures

Primary Measures

  • Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)
    • Time Frame: 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 Measures

  • Lesion Activity
    • Time Frame: One year
    • active lesions: 1; inactive lesions: 0

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Bern
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Klaus W Neuhaus, PD, Principal Investigator, Department of Preventive, Restorative and Pediatric Dentistry, University of Bern

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