Microleakage Around Resin Composite RestorationsNCT03090061
Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
A study testing Light induced fluorescence intraoral camera and Visual-tactile assessment method according to FDI criteria in people with Microleakage Around Resin Composite Restorations, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the 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
- Microleakage Around Resin Composite Restorations
- What is being tested?
- Light induced fluorescence intraoral camera and Visual-tactile assessment method according to FDI criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to Jan 2018
- 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 must have at least one posterior resin composite restoration.
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease.
- Heavy bruxism or a traumatic occlusion.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the 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 two diagnostic methods.
Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.
- Being tested
- Light induced fluorescence intraoral camera, 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
assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera
Visual-tactile assessment method according to FDI criteriaDiagnostic test
assessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition,
| Study group | Role | What they receive |
|---|---|---|
| Light induced fluorescence intraoral camera | Experimental | Not described Receives: Diagnostic Test: Light induced fluorescence intraoral camera |
| 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.
Repeatability for both diagnostic methods
Three examiners will record the dental findings of 29 resin composte restorations using both the intervention and control assessment methods. Each method will be repeated twice to calculate the repeatability. The intra-operator agreement will be evaluated using the kappa statistics.
Measured: 20 minutes
Reproducibility for both diagnostic methods
Three examiners will record the dental findings of 29 resin composite restorations using both the intervention and control assessment methods. Each method will be repeated after one week interval to calculate the reproducibility. The inter-operator agreement will be evaluated using the kappa statistics.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jul 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microleakage 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
- 29 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
- NCT03090061
- Sponsor's protocol ID
- CEBC-CU-2017-03-14
- Status last verified
- Aug 2017
- First submitted
- 13 Mar 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study
- ClinicalTrials.gov ID
- NCT03090061
- Acronym / sponsor ID
- CEBC-CU-2017-03-14
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Mar 2017 (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 assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the margins of resin composite restorations
Detailed description
Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods.
Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light induced fluorescence intraoral camera | Experimental | Diagnostic Test: Light induced fluorescence intraoral camera |
| 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 must have at least one posterior resin composite restoration.
Key exclusion criteria (3 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease.
- Heavy bruxism or a traumatic occlusion.
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 cameraassessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera | Diagnostic test | Light induced fluorescence intraoral camera |
| Visual-tactile assessment method according to FDI criteriaassessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition, | Diagnostic test | Visual-tactile assessment method according to FDI criteria |
Primary outcome
Repeatability for both diagnostic methods
Time frame: 20 minutes
Three examiners will record the dental findings of 29 resin composte restorations using both the intervention and control assessment methods. Each method will be repeated twice to calculate the repeatability. The intra-operator agreement will be evaluated using the kappa statistics.
Reproducibility for both diagnostic methods
Time frame: 1 week
Three examiners will record the dental findings of 29 resin composite restorations using both the intervention and control assessment methods. Each method will be repeated after one week interval to calculate the reproducibility. The inter-operator agreement will be evaluated using the kappa statistics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Visual-tactile assessment method according to FDI criteria in people with Microleakage 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 3 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 2 Aug 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability for both diagnostic methods (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2017.