Skip to main content
OpenTrials
Completed

NCT Number: NCT02657538

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non invasive caries treatment

Other

If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.

Other names: Fluoridation

Invasive caries treatment

Other

If the active comparator does detect cavitation, a composite restauration is placed

Other names: Filling

Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)

Device

Visual examination and bitewing (BW) radiography

Other

established diagnostic methods

Primary outcomes

  1. 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 outcomes

  1. Lesion Activity

    Time frame: One year

    active lesions: 1; inactive lesions: 0

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Jan 18, 2016
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.