- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06932939
Comparison of CAMBRA123 and AAPD (CAT) for Caries Risk in Egyptian Children
April 16, 2025 updated by: Hanaa AlKarib, Cairo University
Comparison of Two Caries Risk Assessment Tools CAMBRA123 Versus (CAT) AAPD Among a Group of Egyptian Children: A Cross- Sectional Study
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.
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
376
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hanaa Mohamed Alkarib, master degree
- Phone Number: +201055151391 +201096790172
- Email: hanaa.elkarib@gmail.com
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 12613
- Faculty of Dentistry Cairo University
-
Contact:
- Hanaa Mohamed Alkarib, master degree
- Phone Number: +201055151391 +201096790172
- Email: hanaa.elkarib@gmail.com
-
Contact:
- Sherine Ezz El-Din, PHD
- Phone Number: +201055151391 +201096790172
- Email: sherine.taha@dentistry.cu.edu.eg
-
Contact:
- Hanaa Mohamed Alkarib, master degree
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
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.
Description
Inclusion Criteria:
- Children aged 3 to 6 years.
- Both genders.
- No underlying medical conditions affecting oral health.
Exclusion Criteria:
- Uncooperative patient.
- Children with cognitive impairments that prevent understanding the study procedures.
- Parents refused.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caries risk assessment using AAPD
Time Frame: baseline (single visit)
|
Caries risk will be categorized as Low, Moderate, or High based on the American Academy of Pediatric Dentistry (AAPD) criteria.
|
baseline (single visit)
|
|
Caries risk assessment using CAMBRA123
Time Frame: baseline (single visit)
|
Caries risk will be evaluated using the CAMBRA 123 scoring system, which assigns scores from -4 to +18, categorized as:
|
baseline (single visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time For index Application
Time Frame: baseline (single visit)
|
The time required to apply each caries assessment index (CAMBRA123 and AAPD) will be measured in seconds for each child during the clinical examination
|
baseline (single visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
April 10, 2025
First Submitted That Met QC Criteria
April 10, 2025
First Posted (Actual)
April 17, 2025
Study Record Updates
Last Update Posted (Actual)
April 20, 2025
Last Update Submitted That Met QC Criteria
April 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- CTCRATCVA-AAGOEC-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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