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

Not Applicable

• Conditions: Secondary Caries Around Resin Composite Restorations
• Interventions: Diagnostic Test: Laser-induced fluorescence device; Diagnostic Test: Visual-tactile assessment method according to FDI criteria; Diagnostic Test: Light induced fluorescence intraoral camera

• Registration Number: NCT04426604
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-09-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-31
• Last Update Posted: 2021-08-06
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser-induced fluorescence device	Laser-induced fluorescence device	-
Visual-tactile assessment method according to FDI criteria	Visual-tactile assessment method according to FDI criteria	-
Light induced fluorescence intraoral camera	Light induced fluorescence intraoral camera	-

Primary Outcome Measures

Name	Time	Method
Validity of Fluorescence-based Devices versus Visual-tactile method	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt