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

July 7, 2016 updated by: University of Bern

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Fluoridation
Other: Invasive caries treatment
If the active comparator does detect cavitation, a composite restauration is placed
Other Names:
  • 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 Names:
  • Fluoridation
Other: Invasive caries treatment
If the active comparator does detect cavitation, a composite restauration is placed
Other Names:
  • Filling
Other: Visual examination and bitewing (BW) radiography
established diagnostic methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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