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

NCT ID: NCT04426604

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Secondary Caries Around Resin Composite Restorations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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Light induced fluorescence intraoral camera

Group Type EXPERIMENTAL

Light induced fluorescence intraoral camera

Intervention Type DIAGNOSTIC_TEST

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

Group Type EXPERIMENTAL

Laser-induced fluorescence device

Intervention Type DIAGNOSTIC_TEST

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

Group Type ACTIVE_COMPARATOR

Visual-tactile assessment method according to FDI criteria

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Mohamed Adly

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya Mohamed Adly Ibrahim, Master's Degree

Role: CONTACT

+201221528843

Shereen Hafez Ibrahim, Associate Professor (PhD)

Role: CONTACT

+201099296591

Facility Contacts

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Aya Mohamed Adly Ibrahim, Master's Degree

Role: primary

+201221528843

Shereen Hafez Ibrahim, Associate Professor (PhD)

Role: backup

+201099296591

References

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Adly AM, Ibrahim SH, El-Zoghbi AF. Clinical validity of fluorescence-based devices versus visual-tactile method in detection of secondary caries around resin composite restorations: diagnostic accuracy study. BDJ Open. 2025 Jan 6;11(1):2. doi: 10.1038/s41405-024-00284-7.

Reference Type DERIVED
PMID: 39762230 (View on PubMed)

Other Identifiers

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AMAI-CU-2020-06-07

Identifier Type: -

Identifier Source: org_study_id

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