NCT06932939

Brief Summary

This study goal is to compare two indices in Egyptian children aged 3-6 years in caries detection and time needed for assessment which will contribute to variable data for pediatric oral health assessment locally and globally.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 10, 2025

Last Update Submit

April 16, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Caries risk assessment using AAPD

    Caries risk will be categorized as Low, Moderate, or High based on the American Academy of Pediatric Dentistry (AAPD) criteria. * Unit of Measure: Category (Low / Moderate / High)

    baseline (single visit)

  • Caries risk assessment using CAMBRA123

    Caries risk will be evaluated using the CAMBRA 123 scoring system, which assigns scores from -4 to +18, categorized as: * Low: -4 to -1 * Moderate: 0 to +3 * High: +4 to +13 * Very High: +14 to +18

    baseline (single visit)

Secondary Outcomes (1)

  • Time For index Application

    baseline (single visit)

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted at the outpatient clinics of the Pediatric and Dental Public Health Department among group of (3-6) years old- Faculty of Dentistry, Cairo University - Egypt.

You may qualify if:

  • Children aged 3 to 6 years.
  • Both genders.
  • No underlying medical conditions affecting oral health.

You may not qualify if:

  • Uncooperative patient.
  • Children with cognitive impairments that prevent understanding the study procedures.
  • Parents refused.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (2)

  • Featherstone JDB, Crystal YO, Alston P, Chaffee BW, Domejean S, Rechmann P, Zhan L, Ramos-Gomez F. A Comparison of Four Caries Risk Assessment Methods. Front Oral Health. 2021 Apr 28;2:656558. doi: 10.3389/froh.2021.656558. eCollection 2021.

    PMID: 35048004BACKGROUND
  • Devraj IM, Shankaraguru GM, Jairam LS, Dhull KS, Bhojraj N. Comparison of two different caries risk assessment tools for infants and toddlers - A cross-sectional study. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):9-14. doi: 10.4103/jisppd.jisppd_546_23. Epub 2024 Apr 15.

    PMID: 38616421BACKGROUND

Central Study Contacts

Hanaa Mohamed AlKarib, master degree

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

June 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations