Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence

Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study

A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera

Study Overview

• Status: Unknown
• Conditions: Secondary Caries
• Intervention / Treatment: Diagnostic test: light induced fluorescence intraoral camera

Detailed Description

Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. 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, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haneen elmoselhy, master; Phone Number: 01003778829; Email: noonyelmoselhy@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11221
    • Cairo University
    • Contact: haneen elmoselhy, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: visual tactile method; visual tactile method using the modified USHPS critiria	Diagnostic test: light induced fluorescence intraoral camera; intraoral oral light induced fluorescence diagnostic camera; Other Names: soprolife camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reliability and reproducibility of intra oral light fluorescence camera using kappa strength	in secondary craies diagnosis around composite restorations	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: CEBD-CU-2018-06-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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