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

Microleakage Around Resin Composite Restorations Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03090061
• Other study ID #: CEBC-CU-2017-03-14
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 13, 2017
• Last updated: August 1, 2017
• Start date: July 1, 2017
• Est. completion date: January 2018

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 29
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Microleakage Around Resin Composite Restorations

Intervention

Diagnostic Test:
• Light induced fluorescence intraoral camera
assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera
• 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,

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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