Light Fluorescence DeviceNCT03940170
Clinical Effectiveness of(VistaProof)in Comparison With ICDAS-II & Histological Validation for Detecting Occlusal Caries
An observational study of Light Fluorescence Device, run by Mohamed samy El-sayed at 1 site in Egypt.
Trial summary
a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Light Fluorescence Device
- What is being tested?
- vistacam proof, ICDASII and fissurotomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 9 Aug 2021
- Phase
- Observational
- 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 15 to 50 years
- All sexes
- Child, Adult
Study population: Egyptian population
Who may be able to join
- Patients aged from 15 to 50 years.
- Patient at least has one posterior pits and fissure occlusal caries.
- No gender restriction
- Co-operative patients who signed the informed consent.
- Good general health
- Acceptable oral health
Who cannot join
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of Quantitative Light Fluorescence Based Device (Vistacam Proof) in Comparison With ICDAS-II and Histological Validation in Detection of Initial Pits and Fissures Caries:: Diagnostic Accuracy Study
a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries
- Conditions
- Light Fluorescence Device
- Being tested
- vistacam proof, ICDASII, fissurotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vistacam proofDevice
Light fluorescence device
ICDASIIOther
visual examination
fissurotomyProcedure or surgery
histological validation
| Study group | Role | What they receive |
|---|---|---|
| vistacam | Not described Receives: Device: vistacam proof | |
| ICDAS II | Not described Receives: Other: ICDASII | |
| Fissurotomy | Not described Receives: Device: vistacam proof; Other: ICDASII; Procedure: fissurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pits and fissure caries
occlusal pits and fissure caries in posterior teeth non-cavitated
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2020
- Primary completion13 May 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Fluorescence DeviceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed samy El-sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed samy El-sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940170
- Sponsor's protocol ID
- 2222
- Status last verified
- Aug 2021
- First submitted
- 25 Apr 2019
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Quantitative Light Fluorescence Based Device (Vistacam Proof) in Comparison With ICDAS-II and Histological Validation in Detection of Initial Pits and Fissures Caries:: Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03940170
- Acronym / sponsor ID
- 2222
- Conditions
- Light Fluorescence Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mohamed samy El-sayedUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 7 May 2019 (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 diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vistacam | – | Device: vistacam proof |
| ICDAS II | – | Other: ICDASII |
| Fissurotomy | – | Device: vistacam proof, Other: ICDASII, Procedure: fissurotomy |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Egyptian population
Key inclusion criteria (6 listed)
- Patients aged from 15 to 50 years.
- Patient at least has one posterior pits and fissure occlusal caries.
- No gender restriction
- Co-operative patients who signed the informed consent.
- Good general health
Key exclusion criteria (5 listed)
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
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 |
|---|---|---|
| vistacam proofLight fluorescence device | Device | Fissurotomy, vistacam |
| ICDASIIvisual examination | Other | Fissurotomy, ICDAS II |
| fissurotomyhistological validation | Procedure or surgery | Fissurotomy |
Primary outcome
pits and fissure caries
Time frame: through study completion, an average of 1 year
occlusal pits and fissure caries in posterior teeth non-cavitated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Light Fluorescence Device, run by Mohamed samy El-sayed 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pits and fissure caries (time frame: through study completion, an average of 1 year). 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 19 Aug 2021.