Caries; InitialNCT05127356
Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II
An observational study of Caries; Initial, run by Cairo University at 1 site in Egypt.
Trial summary
There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Initial
- What is being tested?
- DIAGNOdent and ICDAS II
- Type of treatment
- Medical device
- How many people
- 193 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 5 May 2022
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with non cavitated incipient carious white spot lesions
Who may be able to join
- Non cavitated white spot lesions.
- Patient compliance
Who cannot join
- Cavitated lesions.
- Medically compromised patients.
- Enrollment in another clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II in Detection of Incipient White Spot Lesions: An In-vivo Evaluation
There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.
Read the detailed description
This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious lesions for decision making during caries management
- Conditions
- Caries; Initial
- Being tested
- DIAGNOdent, ICDAS II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAGNOdentDevice
Laser fluorescence device
ICDAS IIDiagnostic test
International Caries Detection and Assessment System (ICDAS II)
| Study group | Role | What they receive |
|---|---|---|
| Laser fluorescence | DIAGNOdent is a laser fluorescence device that detects and quantify stages of development of incipient carious lesions
0-4 healthy tooth structure; 5-10 Outer half enamel caries; 11-20 Inner half enamel caries; 21+ Dentin caries Receives: Device: DIAGNOdent | |
| Visual examination | ICDAS II
Code 0: Sound tooth surface; Code 1: First visual change in enamel; Code 2:Distinct visual change in enamel when viewed wet; Code 3: Localized enamel breakdown due to caries with no visible dentin; Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown; Code 5: Distinct cavity with visible dentin; Code 6: Extensive distinct cavity with visible dentin. Receives: Diagnostic Test: ICDAS II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.
Measured: Immediate (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; InitialStudies 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
- Cross-sectional
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
- Investigators
- Omar O Shaalan, PhD, Principal investigator, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127356
- Sponsor's protocol ID
- Diagnodent
- Status last verified
- May 2022
- First submitted
- 5 Nov 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II in Detection of Incipient White Spot Lesions: An In-vivo Evaluation
- ClinicalTrials.gov ID
- NCT05127356
- Acronym / sponsor ID
- Diagnodent
- Conditions
- Caries; Initial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 19 Nov 2021 (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.
There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.
Detailed description
This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious lesions for decision making during caries management
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser fluorescence | – | Device: DIAGNOdentDIAGNOdent is a laser fluorescence device that detects and quantify stages of development of incipient carious lesions 0-4 healthy tooth structure; 5-10 Outer half enamel caries; 11-20 Inner half enamel caries; 21+ Dentin caries |
| Visual examination | – | Diagnostic Test: ICDAS IIICDAS II Code 0: Sound tooth surface; Code 1: First visual change in enamel; Code 2:Distinct visual change in enamel when viewed wet; Code 3: Localized enamel breakdown due to caries with no visible dentin; Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown; Code 5: Distinct cavity with visible dentin; Code 6: Extensive distinct cavity with visible dentin. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with non cavitated incipient carious white spot lesions
Key inclusion criteria (2 listed)
- Non cavitated white spot lesions.
- Patient compliance
Key exclusion criteria (3 listed)
- Cavitated lesions.
- Medically compromised patients.
- Enrollment in another clinical trials.
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 |
|---|---|---|
| DIAGNOdentLaser fluorescence device | Device | Laser fluorescence |
| ICDAS IIInternational Caries Detection and Assessment System (ICDAS II) | Diagnostic test | Visual examination |
Primary outcome
Diagnostic accuracy
Time frame: Immediate (cross-sectional)
Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.
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 31 May 2022.
- Individual participant dataSharing planned: No
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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.
Omar O Shaalan, PhD principal investigator
Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
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 Caries; Initial, 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 2 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: finished, as of the sponsor's last update on 31 May 2022. 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?
Diagnostic accuracy (time frame: Immediate (cross-sectional)). 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 31 May 2022.