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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04426604

Collaborator

(none)

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Caries Around Resin Composite Restorations	Diagnostic Test: Light induced fluorescence intraoral camera Diagnostic Test: Laser-induced fluorescence device Diagnostic Test: Visual-tactile assessment method according to FDI criteria	N/A

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 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:

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

Actual Study Start Date :

Sep 21, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Light induced fluorescence intraoral camera	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
Experimental: Laser-induced fluorescence device	Diagnostic Test: 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
Active Comparator: Visual-tactile assessment method according to FDI criteria	Diagnostic Test: 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

Arm

Intervention/Treatment

Experimental: Light induced fluorescence intraoral camera

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

Experimental: Laser-induced fluorescence device

Diagnostic Test: 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

Active Comparator: Visual-tactile assessment method according to FDI criteria

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

Validity of Fluorescence-based Devices versus Visual-tactile method [Through study completion, an average of 5 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Mohamed Adly, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT04426604

Other Study ID Numbers:

AMAI-CU-2020-06-07

First Posted:

Jun 11, 2020

Last Update Posted:

Aug 6, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Aug 6, 2021