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

NCT ID: NCT02657538

Last Updated: 2016-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Near infrared transillumination

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

Group Type ACTIVE_COMPARATOR

Non invasive caries treatment

Intervention Type OTHER

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

Invasive caries treatment

Intervention Type OTHER

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

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

Intervention Type DEVICE

Visual caries detection + BW

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

Group Type ACTIVE_COMPARATOR

Non invasive caries treatment

Intervention Type OTHER

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

Invasive caries treatment

Intervention Type OTHER

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

Visual examination and bitewing (BW) radiography

Intervention Type OTHER

established diagnostic methods

Interventions

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Non invasive caries treatment

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

Intervention Type OTHER

Invasive caries treatment

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

Intervention Type OTHER

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

Intervention Type DEVICE

Visual examination and bitewing (BW) radiography

established diagnostic methods

Intervention Type OTHER

Other Intervention Names

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Fluoridation Filling

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus W Neuhaus, PD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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110/13

Identifier Type: -

Identifier Source: org_study_id

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