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

Not Applicable

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

• Registration Number: NCT03090061
• Lead Sponsor: Cairo University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-18
• Study First Posted: 2017-03-24
• Study Start: 2017-07-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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.

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Exclusion Criteria

• Patients with a compromised medical history.
• Severe or active periodontal disease.
• Heavy bruxism or a traumatic occlusion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Repeatability for both diagnostic methods	20 minutes	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.
Reproducibility for both diagnostic methods	1 week	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.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University; 🇪🇬 Cairo, Egypt