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Clinical Trials/NCT04426604
NCT04426604
Unknown
Not Applicable

Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study

Cairo University1 site in 1 country30 target enrollmentSeptember 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Secondary Caries Around Resin Composite Restorations
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Validity of Fluorescence-based Devices versus Visual-tactile method
Last Updated
4 years ago

Overview

Brief Summary

This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.

Detailed Description

Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations

Registry
clinicaltrials.gov
Start Date
September 21, 2020
End Date
September 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aya Mohamed Adly

Principal Investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients should be over 18 years of age.
  • Patients should have an acceptable oral hygiene level.
  • Patients should have at least one resin composite restoration.

Exclusion Criteria

  • Patients with a compromised medical history.
  • Patients with active severe periodontal disease.

Outcomes

Primary Outcomes

Validity of Fluorescence-based Devices versus Visual-tactile method

Time Frame: Through study completion, an average of 5 months

Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations in terms of sensitivity and specificity.

Study Sites (1)

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