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

August 1, 2017 updated by: Aya Mohamed Adly, Cairo University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • faculty of oral and dental medicine, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light induced fluorescence intraoral camera
Diagnostic test: Light induced fluorescence intraoral camera
assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera
Active Comparator: Visual-tactile assessment method according to FDI criteria
Diagnostic test: Visual-tactile assessment method according to FDI criteria
assessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 minutes
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

March 18, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CEBC-CU-2017-03-14

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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