CariesNCT03224962
Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion
An observational study of Caries, run by Cairo University.
Trial summary
This study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- fluorescence camera
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Mar 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult populations suffering from occlusal caries.
Who may be able to join
- Patients should be over 18 Years old
- Patient should have good oral hygiene and general health
- patients With at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible
Who cannot join
- Known allergy to any component of the dyes used.
- Patients having caries at proximal, buccal, lingual surface.
- Previously placed sealants or restorations.
- Bruxism or malocclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reliability of Fluorescent Camera and Caries Detection Dye Versus Visual- Assessment in Diagnosis of Occlusal Carious Lesion in Adult Patients: Invivo Diagnostic Study
This study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion.
Read the detailed description
A total of 43 volunteer patients will be assigned in this study. Each patient must have at least two occlusal carious lesions. Each lesion will be evaluated by three diagnostic methods (D), where D1 represents light induced fluorescence camera, D2 represents Caries detection dye. And D3 represents visual assessment method (ICDAS criteria)
- Conditions
- Caries
- Being tested
- fluorescence camera
- Keywords
- pit and fissure caries
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence cameraDevice
Also called Caries detection dye., visual assessment method (ICDAS criteria)
drug - diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| diagnostic tool | Light induced fluorescence camera Caries detection dye. visual assessment method (ICDAS criteria) Receives: Device: fluorescence camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability and level of agreement between operators for all diagnostic methods.
It will be assessed using reliability \& reproducibility by kappa strength measuring unit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Maher Zenhom Abd El Rahman, Cairo University
- Investigators
- Mona I Riad, Professor, Principal investigator, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224962
- Sponsor's protocol ID
- CEBC-CU-2017-07-28
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 25 Jul 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 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Fluorescent Camera and Caries Detection Dye Versus Visual- Assessment in Diagnosis of Occlusal Carious Lesion in Adult Patients: Invivo Diagnostic Study
- ClinicalTrials.gov ID
- NCT03224962
- Acronym / sponsor ID
- CEBC-CU-2017-07-28
- Conditions
- Caries
- Keywords
- pit and fissure caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 Jul 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 compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion.
Detailed description
A total of 43 volunteer patients will be assigned in this study. Each patient must have at least two occlusal carious lesions. Each lesion will be evaluated by three diagnostic methods (D), where D1 represents light induced fluorescence camera, D2 represents Caries detection dye. And D3 represents visual assessment method (ICDAS criteria)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic tool | – | Device: fluorescence cameraLight induced fluorescence camera Caries detection dye. visual assessment method (ICDAS criteria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult populations suffering from occlusal caries.
Key inclusion criteria (3 listed)
- Patients should be over 18 Years old
- Patient should have good oral hygiene and general health
- patients With at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible
Key exclusion criteria (4 listed)
- Known allergy to any component of the dyes used.
- Patients having caries at proximal, buccal, lingual surface.
- Previously placed sealants or restorations.
- Bruxism or malocclusion
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 |
|---|---|---|
| fluorescence cameraAlso: Caries detection dye., visual assessment method (ICDAS criteria)drug - diagnostic test | Device | diagnostic tool |
Primary outcome
Reliability and level of agreement between operators for all diagnostic methods.
Time frame: 3 months
It will be assessed using reliability \& reproducibility by kappa strength measuring unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Caries
Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental 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.
Mona I Riad, Professor principal investigator
Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries, run by Cairo University.
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 4 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 shimaa M Zenhom Abd El Rahman, B A ((002)01001036094, shimaa-maher@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and level of agreement between operators for all diagnostic methods. (time frame: 3 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 25 Jul 2017.