Early Childhood CariesNCT05716867
Salivary Cystatin S Levels in a Group of Egyptian Children
An observational study of Early Childhood Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of the study 1. Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries. 2. Predection of early childhood caries by using salivary cystatin S levels with demographic, clinical and nutrition habits characteristics of the participants. Read more about this study
- Who is it for?
- Ages 36 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Measurement of salivary cystatin S protein levels in saliva
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 10 May 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 36 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: the patients going to diagnosis clinic of Pediatric dentistry and Dental Public Health Department, Cairo University
Who may be able to join
- Medically free children aged 36 to 71 months with one or more decayed (noncavitated or cavitated lesions), missing, or filled teeth due to caries in any primary tooth(cases).
- Medically free children aged 36 to 71 months with no decayed, missing, or filled teeth due to caries in any primary tooth(controls).
Who cannot join
- Children receiving antibiotic therapy within three month and fluoride prophylaxis within one year.
- Parents who will refuse to participate or refuse to sign the informed consent.
- Children who will not agree or cooperate with participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evidence of Early Childhood Caries Prediction by Salivary Cystatin S Levels in a Group of Egyptian Children: a Case Control Study
Aim of the study
- Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries.
- Predection of early childhood caries by using salivary cystatin S levels with demographic, clinical and nutrition habits characteristics of the participants.
- Conditions
- Early Childhood Caries
- Being tested
- Measurement of salivary cystatin S protein levels in saliva
- Keywords
- early childhood caries, salivary cystatin S protein, salivary buffer capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of salivary cystatin S protein levels in salivaBiological
The human cystatin S enzyme-linked immunosorbent assay (ELISA) kit will be used to measure the amounts of cystatin S in saliva for cases and controls
| Study group | Role | What they receive |
|---|---|---|
| Children with early childhood caries aged between 36-71 month | Not described Receives: Biological: Measurement of salivary cystatin S protein levels in saliva | |
| Caries free children aged between 36-71 month | Not described Receives: Biological: Measurement of salivary cystatin S protein levels in saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of salivary cystatin S protein
Levels of salivary cystatin S protein measured by Human cystatin S enzyme linked immunosorbent assay (ELISA) kit (unit ng/ml)
Measured: 2 months
Secondary outcomes (2)
Buffer Capacity
Buffer Capacity measured by PH meter
Measured: 2 months
Demographic, clinical and nutrition habits characteristics of participants Interview
Demographic, clinical and nutrition habits characteristics of participants, using interview
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 posted8 Feb 2023
- Study start1 Dec 2023
- Primary completion15 Dec 2024
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Salah Sayed Mohamed Abo Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716867
- Sponsor's protocol ID
- PEDO 1-2-1
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evidence of Early Childhood Caries Prediction by Salivary Cystatin S Levels in a Group of Egyptian Children: a Case Control Study
- ClinicalTrials.gov ID
- NCT05716867
- Acronym / sponsor ID
- PEDO 1-2-1
- Conditions
- Early Childhood Caries
- Keywords
- early childhood caries, salivary cystatin S protein, salivary buffer capacity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 8 Feb 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.
Aim of the study
- Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries.
- Predection of early childhood caries by using salivary cystatin S levels with demographic, clinical and nutrition habits characteristics of the participants.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with early childhood caries aged between 36-71 month | – | Biological: Measurement of salivary cystatin S protein levels in saliva |
| Caries free children aged between 36-71 month | – | Biological: Measurement of salivary cystatin S protein levels in saliva |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- the patients going to diagnosis clinic of Pediatric dentistry and Dental Public Health Department, Cairo University
Key inclusion criteria (2 listed)
- Medically free children aged 36 to 71 months with one or more decayed (noncavitated or cavitated lesions), missing, or filled teeth due to caries in any primary tooth(cases).
- Medically free children aged 36 to 71 months with no decayed, missing, or filled teeth due to caries in any primary tooth(controls).
Key exclusion criteria (3 listed)
- Children receiving antibiotic therapy within three month and fluoride prophylaxis within one year.
- Parents who will refuse to participate or refuse to sign the informed consent.
- Children who will not agree or cooperate with 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 |
|---|---|---|
| Measurement of salivary cystatin S protein levels in salivaThe human cystatin S enzyme-linked immunosorbent assay (ELISA) kit will be used to measure the amounts of cystatin S in saliva for cases and controls | Biological | Caries free children aged between 36-71 month, Children with early childhood caries aged between 36-71 month |
Primary outcome
Levels of salivary cystatin S protein
Time frame: 2 months
Levels of salivary cystatin S protein measured by Human cystatin S enzyme linked immunosorbent assay (ELISA) kit (unit ng/ml)
2 secondary outcomes
Buffer Capacity
Time frame: 2 months
Demographic, clinical and nutrition habits characteristics of participants Interview
Time frame: 2 months
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 17 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Early Childhood Caries
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.
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 Early Childhood Caries, 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 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 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?
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?
Levels of salivary cystatin S protein (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 17 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.