Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study

Secondary Caries Around Resin Composite Restorations Clinical Trial

Official title:

Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04426604
• Other study ID #: AMAI-CU-2020-06-07
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: September 2021

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: Aya Mohamed Adly Ibrahim, Master's Degree
• Phone: +201221528843
• Email: aya.mohamed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.

Description:

Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• 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 should have at least one resin composite restoration.

Exclusion Criteria:

• Patients with a compromised medical history.

• Patients with active severe periodontal disease.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Secondary Caries Around Resin Composite Restorations

Intervention

Diagnostic Test:
• Light induced fluorescence intraoral camera
Each restoration margins will be assessed by Light induced fluorescence intraoral camera to assess its validity in diagnosing secondary caries around margins of resin composite restorations
• Laser-induced fluorescence device
Each restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations
• Visual-tactile assessment method according to FDI criteria
Each restoration margins will be assessed by visual-tactile assessment method which includes the use of mirror, probe under good illumination condition to assess its validity in diagnosing secondary caries around margins of resin composite restorations

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, 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	Validity of Fluorescence-based Devices versus Visual-tactile method	Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations in terms of sensitivity and specificity.	Through study completion, an average of 5 months