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

NCT02657538 | Completed Results

• 1 other identifier: 110/13
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Keywords

Interproximal caries; Enamel caries; Caries detection; Caries diagnostics; Near-infrared light transillumination; DIAGNOcam

Outcome Measures

Primary Outcomes (1)

• 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

  One year

Secondary Outcomes (1)

• Lesion Activity

  One year

Study Arms (2)

Near infrared transillumination

ACTIVE COMPARATOR

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

Other: Non invasive caries treatment; Other: Invasive caries treatment; Device: Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)

Visual caries detection + BW

ACTIVE COMPARATOR

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

Other: Non invasive caries treatment; Other: Invasive caries treatment; Other: Visual examination and bitewing (BW) radiography

Interventions

Non invasive caries treatment OTHER

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

Also known as: Fluoridation

Near infrared transillumination; Visual caries detection + BW

Invasive caries treatment OTHER

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

Also known as: Filling

Near infrared transillumination; Visual caries detection + BW

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

Near infrared transillumination

Visual examination and bitewing (BW) radiography OTHER

established diagnostic methods

Visual caries detection + BW

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children younger than 15 Years

Sponsors & Collaborators

• University of Bern: lead

MeSH Terms

Conditions

Dental Caries

Interventions

Fluoridation; Observation; X-Rays

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health; Methods; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: PD Dr. Klaus Neuhaus
• Organization: Department of Preventive, Restorative and Pediatric Dentistry, University of Bern

klaus.neuhaus@zmk.unibe.ch

+41 (0)31 632 49 74

Study Officials

• Klaus W Neuhaus, PD

  Department of Preventive, Restorative and Pediatric Dentistry, University of Bern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 18, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2016
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-07