Caries Risk AssesmentNCT05948163
Caries Risk Assessment in Egyptian Children in Mixed Dentition Stage
An observational study of Caries Risk Assesment, run by Cairo University.
Trial summary
This study aim to assess the validity of ADA caries risk assessment tool on the Egyptian Children in mixed dentition stage . Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Risk Assesment
- How many people
- 296 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 6 to 12 years
Who may be able to join
- Children age range from 6 to 12 years.
- Apparently healthy children.
- Children affected by dental caries.
- Parents acceptance for their children's participation in the study.
Who cannot join
- Children on long-term medication.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Caries Risk Assessment Using ADA Tool Among A Group of Egyptian Children in Mixed Dentition Stage : A Cross-Sectional Study
This study aim to assess the validity of ADA caries risk assessment tool on the Egyptian Children in mixed dentition stage .
Read the detailed description
Dental caries is the most common chronic disease of childhood that causes health problems such as pain and infection in children reducing their quality of life.
Risk for caries includes physical, biological, environmental, behavioral, and lifestyle-related factors as insufficient fluoride exposure, poor oral hygiene,inappropriate methods of feeding infants, and poorness .
Risk is a probability that an event will occur. Caries Risk Assessment (CRA) is "prediction of future caries based on the diagnosis of current disease by evaluation of risk and protective factors for making evidence-based clinical decisions. Individual risk assessment constitutes the cornerstone of the treatment plan for the management of early childhood caries for pediatric patients. Caries risk assessment should be included in the treatment plan to facilitate The decision-making process concerning preventive care (both home and office) treatment, recall appointments.
An ideal risk assessment model should be inexpensive, easy to use and time efficient with a high degree of accuracy in caries predictive value.
American Dental Association (ADA) is a tool for caries risk assessment and Management , that when modified to meet the needs of an environment Will be of tremendous use in caries risk assessment. The ADA's mission is to help dentists succeed and support the advancement of the health of the public.
- Conditions
- Caries Risk Assesment
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Risk Assessment using ADA
Measurement Method Questions Measurement Method :Questions
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries Risk AssesmentStudies 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
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Yehia Zekry Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948163
- Sponsor's protocol ID
- ADA tool
- Status last verified
- Oct 2023
- First submitted
- 8 Jul 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Risk Assessment Using ADA Tool Among A Group of Egyptian Children in Mixed Dentition Stage : A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05948163
- Acronym / sponsor ID
- ADA tool
- Conditions
- Caries Risk Assesment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 17 Jul 2023 (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 aim to assess the validity of ADA caries risk assessment tool on the Egyptian Children in mixed dentition stage .
Detailed description
Dental caries is the most common chronic disease of childhood that causes health problems such as pain and infection in children reducing their quality of life.
Risk for caries includes physical, biological, environmental, behavioral, and lifestyle-related factors as insufficient fluoride exposure, poor oral hygiene,inappropriate methods of feeding infants, and poorness .
Risk is a probability that an event will occur. Caries Risk Assessment (CRA) is "prediction of future caries based on the diagnosis of current disease by evaluation of risk and protective factors for making evidence-based clinical decisions. Individual risk assessment constitutes the cornerstone of the treatment plan for the management of early childhood caries for pediatric patients. Caries risk assessment should be included in the treatment plan to facilitate The decision-making process concerning preventive care (both home and office) treatment, recall appointments.
An ideal risk assessment model should be inexpensive, easy to use and time efficient with a high degree of accuracy in caries predictive value.
American Dental Association (ADA) is a tool for caries risk assessment and Management , that when modified to meet the needs of an environment Will be of tremendous use in caries risk assessment. The ADA's mission is to help dentists succeed and support the advancement of the health of the public.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 6 to 12 years
Key inclusion criteria (4 listed)
- Children age range from 6 to 12 years.
- Apparently healthy children.
- Children affected by dental caries.
- Parents acceptance for their children's participation in the study.
Key exclusion criteria (1 listed)
- Children on long-term medication.
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 ADA
Time frame: one year
Measurement Method Questions Measurement Method :Questions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Caries Risk Assesment, run by Cairo University.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Y Ibrahim, Master (01064362618, drnoha080@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 ADA (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2023.