Dental Caries in ChildrenNCT05607251
Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study
An observational study of Dental Caries in Children, run by Cairo University.
Trial summary
Aim of the study: 1. Assess the correlation between salivary alkaline phosphatase levels and dental caries. 2. Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme. 3. Assess the effect of growth of children on caries experience and severity. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Apr 2023
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged between 6-8 years.
Who may be able to join
- Children aged 6 to 8 years old.
- Children with and without previous dental visits.
Who cannot join
- Children with any systemic or mental illness.
- Children whose parents refuse to sign the informed consent.
- Children who will not cooperate on participation
About this study
Aim of the study:
- Assess the correlation between salivary alkaline phosphatase levels and dental caries.
- Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme.
- Assess the effect of growth of children on caries experience and severity.
- Conditions
- Dental Caries in Children
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention as this is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Alkaline Phosphatase levels in children with and without dental caries
Measured by spectrophotometry (unit: U/L)
Measured: 2 months
Secondary outcomes (2)
Caries index
Measured by DMFT and deft (unit: scores)
Measured: 2 months
Caries severity
Measured by ICDAS (unit: scores)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startJan 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ahmed Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607251
- Sponsor's protocol ID
- CUP1/11/2022
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05607251
- Acronym / sponsor ID
- CUP1/11/2022
- Conditions
- Dental Caries in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 7 Nov 2022 (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.
Aim of the study:
- Assess the correlation between salivary alkaline phosphatase levels and dental caries.
- Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme.
- Assess the effect of growth of children on caries experience and severity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged between 6-8 years.
Key inclusion criteria (2 listed)
- Children aged 6 to 8 years old.
- Children with and without previous dental visits.
Key exclusion criteria (3 listed)
- Children with any systemic or mental illness.
- Children whose parents refuse to sign the informed consent.
- Children who will not cooperate on participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention as this is an observational study | Other | – |
Primary outcome
Salivary Alkaline Phosphatase levels in children with and without dental caries
Time frame: 2 months
Measured by spectrophotometry (unit: U/L)
2 secondary outcomes
Caries index
Time frame: 2 months
Caries severity
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children, 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 2 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Alkaline Phosphatase levels in children with and without dental caries (time frame: 2 months). 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 7 Nov 2022.