Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090061
Recruitment Status : Unknown
Verified August 2017 by Aya Mohamed Adly, Cairo University.
Recruitment status was:  Enrolling by invitation
First Posted : March 24, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Aya Mohamed Adly, Cairo University

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

Condition or disease Intervention/treatment Phase
Microleakage Around Resin Composite Restorations Diagnostic Test: Light induced fluorescence intraoral camera Diagnostic Test: Visual-tactile assessment method according to FDI criteria Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Primary Purpose: Diagnostic
Official Title: Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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,




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090061


Locations
Layout table for location information
Egypt
Faculty of Oral and Dental Medicine, Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University

Layout table for additonal information
Responsible Party: Aya Mohamed Adly, internal resident, Cairo University
ClinicalTrials.gov Identifier: NCT03090061     History of Changes
Other Study ID Numbers: CEBC-CU-2017-03-14
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No