Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
1 other identifier
interventional
29
1 country
1
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
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 Jul 2017
Shorter than P25 for not_applicable
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
March 13, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedAugust 2, 2017
August 1, 2017
6 months
March 13, 2017
August 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Repeatability for both diagnostic methods
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.
20 minutes
Reproducibility for both diagnostic methods
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.
1 week
Study Arms (2)
Light induced fluorescence intraoral camera
EXPERIMENTALVisual-tactile assessment method according to FDI criteria
ACTIVE COMPARATORInterventions
assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera
assessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition,
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with a compromised medical history.
- Severe or active periodontal disease.
- Heavy bruxism or a traumatic occlusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and Dental Medicine, Cairo University
Cairo, Egypt
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
- internal resident
Study Record Dates
First Submitted
March 13, 2017
First Posted
March 24, 2017
Study Start
July 1, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
August 2, 2017
Record last verified: 2017-08