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

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ClinicalTrials.gov Identifier: NCT02657538
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dental Caries 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection: A Clinical Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Near infrared transillumination
Near infrared transillumination is applied for initial enamel caries lesion detection.
Other: Non invasive caries treatment
If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Other Name: Fluoridation

Other: Invasive caries treatment
If the active comparator does detect cavitation, a composite restauration is placed
Other Name: Filling

Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)
Active Comparator: Visual caries detection + BW
visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.
Other: Non invasive caries treatment
If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
Other Name: Fluoridation

Other: Invasive caries treatment
If the active comparator does detect cavitation, a composite restauration is placed
Other Name: Filling

Other: Visual examination and bitewing (BW) radiography
established diagnostic methods




Primary Outcome Measures :
  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 Outcome Measures :
  1. Lesion Activity [ Time Frame: One year ]
    active lesions: 1; inactive lesions: 0



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657538


Sponsors and Collaborators
University of Bern
Investigators
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Principal Investigator: Klaus W Neuhaus, PD Department of Preventive, Restorative and Pediatric Dentistry, University of Bern

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02657538     History of Changes
Other Study ID Numbers: 110/13
First Posted: January 18, 2016    Key Record Dates
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016

Keywords provided by University of Bern:
Interproximal caries
Enamel caries
Caries detection
Caries diagnostics
Near-infrared light transillumination
DIAGNOcam

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases