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

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.

Study Overview

• Status: Recruiting
• Conditions: Secondary Caries Around Resin Composite Restorations
• Intervention / Treatment: Diagnostic test: Light induced fluorescence intraoral camera; Diagnostic test: Laser-induced fluorescence device; Diagnostic test: Visual-tactile assessment method according to FDI criteria

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya Mohamed Adly Ibrahim, Master's Degree; Phone Number: +201221528843; Email: aya.mohamed@dentistry.cu.edu.eg
• Study Contact Backup: Name: Shereen Hafez Ibrahim, Associate Professor (PhD); Phone Number: +201099296591; Email: shereen.hafez@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry, Cairo University
    • Contact: Aya Mohamed Adly Ibrahim, Master's Degree; Phone Number: +201221528843; Email: aya.mohamed@dentistry.cu.edu.eg
    • Contact: Shereen Hafez Ibrahim, Associate Professor (PhD); Phone Number: +201099296591; Email: shereen.hafez@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light induced fluorescence intraoral camera	Diagnostic test: Light induced fluorescence intraoral camera; 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
Experimental: Laser-induced fluorescence device	Diagnostic test: Laser-induced fluorescence device; 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
Active Comparator: Visual-tactile assessment method according to FDI criteria	Diagnostic test: Visual-tactile assessment method according to FDI criteria; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: AMAI-CU-2020-06-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No