Accuracy of ICCMS Versus Simplified Cariogram

Caries,Dental Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448884
• Other study ID #: 29607210104331
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: Kirolos Sedek, BDS
• Phone: 00201023353383
• Email: kiroloshisham[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 323
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• Age ranging from 18 to 29 years.

• The presence of dental caries or restoration.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirolos Hisham Nadi Sedek

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline Immediately after collecting the data.
Secondary	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.	At baseline Immediately after collecting the data.