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Clinical Trials/NCT03090061
NCT03090061UnknownNot Applicable

Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study

Cairo University1 site in 1 country29 target enrollmentStarted: July 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
29
Locations
1
Primary Endpoint
Repeatability for both diagnostic methods

Study Overview

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

Detailed Description

Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods.

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, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (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

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Light induced fluorescence intraoral camera

Experimental

Intervention: Light induced fluorescence intraoral camera (Diagnostic Test)

Visual-tactile assessment method according to FDI criteria

Active Comparator

Intervention: Visual-tactile assessment method according to FDI criteria (Diagnostic Test)

Outcomes

Primary Outcomes

Repeatability for both diagnostic methods

Time Frame: 20 minutes

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.

Reproducibility for both diagnostic methods

Time Frame: 1 week

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aya Mohamed Adly

internal resident

Cairo University

Study Sites (1)

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