Secondary Caries Around Resin Composite RestorationsNCT04426604
Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
A study testing Light induced fluorescence intraoral camera, Laser-induced fluorescence device and Visual-tactile assessment method according to FDI criteria in people with Secondary Caries Around Resin Composite Restorations, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Caries Around Resin Composite Restorations
- What is being tested?
- Light induced fluorescence intraoral camera, Laser-induced fluorescence device and Visual-tactile assessment method according to FDI criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with a compromised medical history.
- Patients with active severe periodontal disease.
Trial locations and contacts
1 site in 1 country.
Shereen Hafez Ibrahim, Associate Professor (PhD) contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Aya Mohamed Adly Ibrahim, Master's Degree, +201221528843, aya.mohamed@dentistry.cu.edu.eg
Shereen Hafez Ibrahim, Associate Professor (PhD), +201099296591, shereen.hafez@dentistry.cu.edu.eg
About this study
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.
Read the 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
- Being tested
- Light induced fluorescence intraoral camera, Laser-induced fluorescence device, Visual-tactile assessment method according to FDI criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light induced fluorescence intraoral cameraDiagnostic 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 deviceDiagnostic 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 criteriaDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Light induced fluorescence intraoral camera | Experimental | Not described Receives: Diagnostic Test: Light induced fluorescence intraoral camera |
| Laser-induced fluorescence device | Experimental | Not described Receives: Diagnostic Test: Laser-induced fluorescence device |
| Visual-tactile assessment method according to FDI criteria | Active comparator | Not described Receives: Diagnostic Test: Visual-tactile assessment method according to FDI criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 Sep 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary Caries Around Resin Composite RestorationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Adly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426604
- Sponsor's protocol ID
- AMAI-CU-2020-06-07
- Status last verified
- Jul 2021
- First submitted
- 8 Jun 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39762230
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT04426604
- Acronym / sponsor ID
- AMAI-CU-2020-06-07
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Light induced fluorescence intraoral camera | Experimental | Diagnostic Test: Light induced fluorescence intraoral camera |
| Laser-induced fluorescence device | Experimental | Diagnostic Test: Laser-induced fluorescence device |
| Visual-tactile assessment method according to FDI criteria | Active comparator | Diagnostic Test: Visual-tactile assessment method according to FDI criteria |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a compromised medical history.
- Patients with active severe periodontal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light induced fluorescence intraoral cameraEach 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 | Diagnostic test | Light induced fluorescence intraoral camera |
| Laser-induced fluorescence deviceEach restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations | Diagnostic test | Laser-induced fluorescence device |
| Visual-tactile assessment method according to FDI criteriaEach 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 | Diagnostic test | Visual-tactile assessment method according to FDI criteria |
Primary outcome
Validity of Fluorescence-based Devices versus Visual-tactile method
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 39762230Adly 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shereen Hafez Ibrahim, Associate Professor (PhD) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light induced fluorescence intraoral camera, Laser-induced fluorescence device and Visual-tactile assessment method according to FDI criteria in people with Secondary Caries Around Resin Composite Restorations, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Mohamed Adly Ibrahim, Master's Degree (+201221528843, aya.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of Fluorescence-based Devices versus Visual-tactile method (time frame: Through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.