Caries,DentalNCT06448884
Accuracy of ICCMS Versus Simplified Cariogram
An observational study of Caries,Dental, run by Kirolos Hisham Nadi Sedek.
Trial summary
The study aims to compare the validity of the caries risk assessment regarding the comprehensive ICCMs Caries risk and likelihood matrix versus the simplified Cariogram aiming to see if there is a significant difference in the caries risk levels between both models. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Caries,Dental
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to Apr 2025
- 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 29 years
- All sexes
- Adult
Study population: Young Adult Egyptians
Who may be able to join
- Age ranging from 18 to 29 years.
- The presence of dental caries or restoration.
Who cannot join
- Patients with no caries.
- Patients diagnosed of psychiatric disease.
- Patients not willing to be part of the study or ones who refuse to sign the informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of the Caries Risk Assessment of International Caries Classification and Management System (ICCMS) Versus Simplified Cariogram in the Egyptian Young Adult Population
The study aims to compare the validity of the caries risk assessment regarding the comprehensive ICCMs Caries risk and likelihood matrix versus the simplified Cariogram aiming to see if there is a significant difference in the caries risk levels between both models.
Read the detailed description
The simplified Cariogram has been already established as a simple computerised efficient way to categorise patients according to their risk of developing new lesions. However, since then, more comprehensive ways such as the ICCMS have risen. Such comprehensive models require much more data to be entered and more time for the assessment to be complete.
This study aims to test whether there is a significant difference between the validity of both models that would justify the extra time, effort, and recordings that have to be taken for the ICCMS.
- Conditions
- Caries,Dental
- Keywords
- Risk, Validity, Cariogram, ICCMS
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
Measured in terms of sensitivity and specificity between the data set of the intervention and the comparator using ROC analysis.
There will be no need for follow up records as we are comparing 2 Patient Caries risk classification models. The models determine the Patient's risk category immediately after the required data is inserted into them.
Measured: At baseline Immediately after collecting the data.
Secondary outcomes (1)
Reproducibility
It will be measured based on the level of agreement between the results using KAPPA analysis. There will be no need for follow up records as we are comparing 2 Patient Caries risk classification models. The models determine the Patient's risk category immediately after the required data is inserted into them.
Measured: At baseline Immediately after collecting the data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies 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
- Cross-sectional
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirolos Hisham Nadi Sedek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirolos Hisham Nadi Sedek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448884
- Sponsor's protocol ID
- 29607210104331
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Caries Risk Assessment of International Caries Classification and Management System (ICCMS) Versus Simplified Cariogram in the Egyptian Young Adult Population
- ClinicalTrials.gov ID
- NCT06448884
- Acronym / sponsor ID
- 29607210104331
- Conditions
- Caries,Dental
- Keywords
- Risk, Validity, Cariogram, ICCMS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Kirolos Hisham Nadi SedekUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 7 Jun 2024 (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.
The study aims to compare the validity of the caries risk assessment regarding the comprehensive ICCMs Caries risk and likelihood matrix versus the simplified Cariogram aiming to see if there is a significant difference in the caries risk levels between both models.
Detailed description
The simplified Cariogram has been already established as a simple computerised efficient way to categorise patients according to their risk of developing new lesions. However, since then, more comprehensive ways such as the ICCMS have risen. Such comprehensive models require much more data to be entered and more time for the assessment to be complete.
This study aims to test whether there is a significant difference between the validity of both models that would justify the extra time, effort, and recordings that have to be taken for the ICCMS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young Adult Egyptians
Key inclusion criteria (2 listed)
- Age ranging from 18 to 29 years.
- The presence of dental caries or restoration.
Key exclusion criteria (3 listed)
- Patients with no caries.
- Patients diagnosed of psychiatric disease.
- Patients not willing to be part of the study or ones who refuse to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity
Time frame: At baseline Immediately after collecting the data.
Measured in terms of sensitivity and specificity between the data set of the intervention and the comparator using ROC analysis. There will be no need for follow up records as we are comparing 2 Patient Caries risk classification models. The models determine the Patient's risk category immediately after the required data is inserted into them.
1 secondary outcome
Reproducibility
Time frame: At baseline Immediately after collecting the data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries,Dental, run by Kirolos Hisham Nadi Sedek.
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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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 Kirolos Sedek, BDS (00201023353383, kiroloshisham@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity (time frame: At baseline Immediately after collecting the data.). 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 7 Jun 2024.