Accuracy of ICCMS Versus Simplified Cariogram

Not yet recruiting

• Conditions: Caries,Dental

• Registration Number: NCT06448884
• Lead Sponsor: Kirolos Hisham Nadi Sedek

Brief 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.

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 Timeline

• Study First Submitted: 2024-05-29
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Study Start: 2024-06-15
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 323

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity	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.

Secondary Outcome Measures

Name	Time	Method
Reproducibility	At baseline Immediately after collecting the data.	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.