search
Back to results

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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non invasive caries treatment
Invasive caries treatment
Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)
Visual examination and bitewing (BW) radiography
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Caries focused on measuring Interproximal caries, Enamel caries, Caries detection, Caries diagnostics, Near-infrared light transillumination, DIAGNOcam

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Near infrared transillumination

    Visual caries detection + BW

    Arm Description

    Near infrared transillumination is applied for initial enamel caries lesion detection.

    visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Lesion Activity
    active lesions: 1; inactive lesions: 0

    Full Information

    First Posted
    January 5, 2016
    Last Updated
    July 7, 2016
    Sponsor
    University of Bern
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02657538
    Brief Title
    Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection
    Official Title
    Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection: A Clinical Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Bern

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    Interproximal caries, Enamel caries, Caries detection, Caries diagnostics, Near-infrared light transillumination, DIAGNOcam

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Near infrared transillumination
    Arm Type
    Active Comparator
    Arm Description
    Near infrared transillumination is applied for initial enamel caries lesion detection.
    Arm Title
    Visual caries detection + BW
    Arm Type
    Active Comparator
    Arm Description
    visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.
    Intervention Type
    Other
    Intervention Name(s)
    Non invasive caries treatment
    Other Intervention Name(s)
    Fluoridation
    Intervention Description
    If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
    Intervention Type
    Other
    Intervention Name(s)
    Invasive caries treatment
    Other Intervention Name(s)
    Filling
    Intervention Description
    If the active comparator does detect cavitation, a composite restauration is placed
    Intervention Type
    Device
    Intervention Name(s)
    Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)
    Intervention Type
    Other
    Intervention Name(s)
    Visual examination and bitewing (BW) radiography
    Intervention Description
    established diagnostic methods
    Primary Outcome Measure Information:
    Title
    Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)
    Description
    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
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Lesion Activity
    Description
    active lesions: 1; inactive lesions: 0
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Klaus W Neuhaus, PD
    Organizational Affiliation
    Department of Preventive, Restorative and Pediatric Dentistry, University of Bern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs