NCT06448884

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

May 29, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

RiskValidityCariogramICCMS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reproducibility

    At baseline Immediately after collecting the data.

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young Adult Egyptians

You may qualify if:

  • Age ranging from 18 to 29 years.
  • The presence of dental caries or restoration.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 7, 2024

Study Start

June 15, 2024

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

June 7, 2024

Record last verified: 2024-06