Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 6, 2021
July 1, 2021
12 months
June 8, 2020
July 31, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Light induced fluorescence intraoral camera
EXPERIMENTALLaser-induced fluorescence device
EXPERIMENTALVisual-tactile assessment method according to FDI criteria
ACTIVE COMPARATORInterventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with a compromised medical history.
- Patients with active severe periodontal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, Egypt
Related Publications (1)
Adly AM, Ibrahim SH, El-Zoghbi AF. Clinical validity of fluorescence-based devices versus visual-tactile method in detection of secondary caries around resin composite restorations: diagnostic accuracy study. BDJ Open. 2025 Jan 6;11(1):2. doi: 10.1038/s41405-024-00284-7.
PMID: 39762230DERIVED
Central Study Contacts
Shereen Hafez Ibrahim, Associate Professor (PhD)
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 11, 2020
Study Start
September 21, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
August 6, 2021
Record last verified: 2021-07