Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
Primary Purpose
Secondary Caries Around Resin Composite Restorations
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Light induced fluorescence intraoral camera
Laser-induced fluorescence device
Visual-tactile assessment method according to FDI criteria
Sponsored by
About this trial
This is an interventional diagnostic trial for Secondary Caries Around Resin Composite Restorations
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Light induced fluorescence intraoral camera
Laser-induced fluorescence device
Visual-tactile assessment method according to FDI criteria
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426604
Brief Title
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
Official Title
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Caries Around Resin Composite Restorations
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Light induced fluorescence intraoral camera
Arm Type
Experimental
Arm Title
Laser-induced fluorescence device
Arm Type
Experimental
Arm Title
Visual-tactile assessment method according to FDI criteria
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Light induced fluorescence intraoral camera
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Laser-induced fluorescence device
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual-tactile assessment method according to FDI criteria
Intervention Description
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
Primary Outcome Measure Information:
Title
Validity of Fluorescence-based Devices versus Visual-tactile method
Description
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.
Time Frame
Through study completion, an average of 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Mohamed Adly Ibrahim, Master's Degree
Phone
+201221528843
Email
aya.mohamed@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen Hafez Ibrahim, Associate Professor (PhD)
Phone
+201099296591
Email
shereen.hafez@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya Mohamed Adly Ibrahim, Master's Degree
Phone
+201221528843
Email
aya.mohamed@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Shereen Hafez Ibrahim, Associate Professor (PhD)
Phone
+201099296591
Email
shereen.hafez@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
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