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Not yet recruitingNCT06932939Updated Apr 20, 2025

Comparison of CAMBRA123 and AAPD (CAT) for Caries Risk in Egyptian Children

An observational study in Caries Experience, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
376
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

Read the detailed description

This study will ensure that patients receive precise evaluations and guide early, appropriate preventive measures or treatments. Over time, this will contribute to reducing caries progression and related complications. Also, Parents become more aware of their children's dental health status, emphasizing the importance of early detection and intervention. Furthermore, Comparing the indices will provide insights into which tool is most efficient and reliable for detecting caries in children 3-6 years old.

02

Conditions studied

  • Caries Experience
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Uncooperative patient.
  • Children with cognitive impairments that prevent understanding the study procedures.
  • Parents refused.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
376 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: baseline (single visit)

  2. 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

    Time frame: baseline (single visit)

Secondary outcomes

  1. Time For index Application

    The time required to apply each caries assessment index (CAMBRA123 and AAPD) will be measured in seconds for each child during the clinical examination

    Time frame: baseline (single visit)

07

Study locations

1 site
  • Faculty of Dentistry Cairo University
    Cairo, Giza 12613, Egypt
08

References and documents

Publications

  • 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. PubMed 35048004 ↗
  • 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. PubMed 38616421 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06932939
Lead sponsor
Cairo University
Responsible party
Hanaa AlKarib (principal investigator, Cairo University) — Principal investigator
First posted
Apr 17, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Apr 20, 2025

Study contacts

Hanaa Mohamed AlKarib, master degree
Contact
hanaa.elkarib@gmail.com
+201096790172 ext. +201055151391

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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