Secondary CariesNCT03558113
Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence
A study testing light induced fluorescence intraoral camera in people with Secondary Caries, run by Cairo University at 1 site in Egypt.
Trial summary
A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Secondary Caries
- What is being tested?
- light induced fluorescence intraoral camera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2018to Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Official title: Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study
A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera
Read the detailed description
Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. 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, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera
- Conditions
- Secondary Caries
- Being tested
- light induced fluorescence intraoral camera
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
Also called soprolife camera
intraoral oral light induced fluorescence diagnostic camera
| Study group | Role | What they receive |
|---|---|---|
| visual tactile method | Other | visual tactile method using the modified USHPS critiria Receives: Diagnostic Test: light induced fluorescence intraoral camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability and reproducibility of intra oral light fluorescence camera using kappa strength
in secondary craies diagnosis around composite restorations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startAug 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary CariesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' restorations will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haneen ahmed shafik elmoselhy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558113
- Sponsor's protocol ID
- CEBD-CU-2018-06-04
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 13 Aug 2018
- 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 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence in Comparison to Visual Tactile Method: Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03558113
- Acronym / sponsor ID
- CEBD-CU-2018-06-04
- Conditions
- Secondary Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 15 Jun 2018 (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.
A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera
Detailed description
Three operators, the researcher and the 2 supervisors, from the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, will be the examiners in this study. 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, probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' restorations will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.
| Arm | Type | Receives |
|---|---|---|
| visual tactile method | Other | Diagnostic Test: light induced fluorescence intraoral cameravisual tactile method using the modified USHPS critiria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 (1 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 cameraAlso: soprolife cameraintraoral oral light induced fluorescence diagnostic camera | Diagnostic test | visual tactile method |
Primary outcome
reliability and reproducibility of intra oral light fluorescence camera using kappa strength
Time frame: 6 months
in secondary craies diagnosis around composite restorations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Secondary Caries
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.
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 in people with Secondary Caries, 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 1 inclusion and 1 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 13 Aug 2018. 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 Haneen elmoselhy, master (01003778829, noonyelmoselhy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reliability and reproducibility of intra oral light fluorescence camera using kappa strength (time frame: 6 months). 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 13 Aug 2018.