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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Secondary Caries Around Resin Composite Restorations

Intervention / Treatment
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* Diagnostic Test: Light induced fluorescence intraoral camera
* Diagnostic Test: Laser-induced fluorescence device
* Diagnostic Test: Visual-tactile assessment method according to FDI criteria


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light induced fluorescence intraoral camera<br> | Diagnostic Test: Light induced fluorescence intraoral camera<br>* Each restoration margins will be assessed by Light induced fluorescence intraoral camera to assess its validity in diagnosing secondary caries around margins of resin composite restorations<br>|
| Experimental: Laser-induced fluorescence device<br> | Diagnostic Test: Laser-induced fluorescence device<br>* Each restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations<br>|
| Active Comparator: Visual-tactile assessment method according to FDI criteria<br> | Diagnostic Test: Visual-tactile assessment method according to FDI criteria<br>* Each restoration margins will be assessed by visual-tactile assessment method which includes the use of mirror, probe under good illumination condition to assess its validity in diagnosing secondary caries around margins of resin composite restorations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of Fluorescence-based Devices versus Visual-tactile method | 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. | Through study completion, an average of 5 months |