Caries ExperienceNCT06932939
Comparison of CAMBRA123 and AAPD (CAT) for Caries Risk in Egyptian Children
An observational study of Caries Experience, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Experience
- How many people
- 376 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children aged 3 to 6 years.
- Both genders.
- No underlying medical conditions affecting oral health.
Who cannot join
- Uncooperative patient.
- Children with cognitive impairments that prevent understanding the study procedures.
- Parents refused.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry Cairo University
Cairo, Giza Governorate, 12613
Hanaa Mohamed Alkarib, master degree, +201096790172 ext. +201055151391, hanaa.elkarib@gmail.com
Sherine Ezz El-Din, PHD, +201096790172 ext. +201055151391, sherine.taha@dentistry.cu.edu.eg
About this study
Official title: 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.
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.
- Conditions
- Caries Experience
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries ExperienceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa AlKarib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932939
- Sponsor's protocol ID
- CTCRATCVA-AAGOEC-2025
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 35048004Devraj 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Caries Risk Assessment Tools CAMBRA123 Versus (CAT) AAPD Among a Group of Egyptian Children: A Cross- Sectional Study
- ClinicalTrials.gov ID
- NCT06932939
- Acronym / sponsor ID
- CTCRATCVA-AAGOEC-2025
- Conditions
- Caries Experience
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged 3 to 6 years.
- Both genders.
- No underlying medical conditions affecting oral health.
Key exclusion criteria (3 listed)
- Uncooperative patient.
- Children with cognitive impairments that prevent understanding the study procedures.
- Parents refused.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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. * Unit of Measure: Category (Low / Moderate / High)
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: * Low: -4 to -1 * Moderate: 0 to +3 * High: +4 to +13 * Very High: +14 to +18
1 secondary outcome
Time For index Application
Time frame: baseline (single visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Background: PubMed 35048004Featherstone 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.
- Background: PubMed 38616421Devraj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries Experience, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanaa Mohamed AlKarib, master degree (+201096790172 ext. +201055151391, hanaa.elkarib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries risk assessment using AAPD (time frame: baseline (single visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932939, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.