Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the margins of resin composite restorations

Detailed Description
-----------------
Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods. Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.

Official Title
-----------------
Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study

Conditions
-----------------
Microleakage Around Resin Composite Restorations

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be over 18 years of age. Patients should have an acceptable oral hygiene level. Patients must have at least one posterior resin composite restoration. Exclusion Criteria: Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>* assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera<br>|
| Active Comparator: Visual-tactile assessment method according to FDI criteria<br> | Diagnostic Test: Visual-tactile assessment method according to FDI criteria<br>* assessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition,<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability for both diagnostic methods | Three examiners will record the dental findings of 29 resin composte restorations using both the intervention and control assessment methods. Each method will be repeated twice to calculate the repeatability. The intra-operator agreement will be evaluated using the kappa statistics. | 20 minutes | 
| Reproducibility for both diagnostic methods | Three examiners will record the dental findings of 29 resin composite restorations using both the intervention and control assessment methods. Each method will be repeated after one week interval to calculate the reproducibility. The inter-operator agreement will be evaluated using the kappa statistics. | 1 week |