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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657538
• Other study ID #: 110/13
• Status: Completed
• Phase: N/A
• First received: January 5, 2016
• Last updated: April 11, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Non invasive caries treatment
If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
• Invasive caries treatment
If the active comparator does detect cavitation, a composite restauration is placed

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries extension according to Diagnocam codes 0-4	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	One year	Yes
Secondary	lesion activity	active lesions: 1; inactive lesions: 0	One year	Yes