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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Secondary Caries Around Resin Composite Restorations

Treatments

Diagnostic Test: Light induced fluorescence intraoral camera
Diagnostic Test: Laser-induced fluorescence device
Diagnostic Test: Visual-tactile assessment method according to FDI criteria

Study type

Interventional

Funder types

Other

Identifiers

NCT04426604
AMAI-CU-2020-06-07

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Shereen Hafez Ibrahim, Associate Professor (PhD); Aya Mohamed Adly Ibrahim, Master's Degree

Data sourced from clinicaltrials.gov

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