Salivary Cystatin S Levels in a Group of Egyptian Children

February 13, 2025 updated by: Tasneem Salah Sayed Mohamed Abo Ali, Cairo University

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

  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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Oral and Dental Medicine Cairo University

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

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

the patients going to diagnosis clinic of Pediatric dentistry and Dental Public Health Department, Cairo University

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with early childhood caries aged between 36-71 month
Biological: Measurement of salivary cystatin S protein levels in saliva
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
Caries free children aged between 36-71 month
Biological: Measurement of salivary cystatin S protein levels in saliva
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buffer Capacity
Time Frame: 2 months
Buffer Capacity measured by PH meter
2 months
Demographic, clinical and nutrition habits characteristics of participants Interview
Time Frame: 2 months
Demographic, clinical and nutrition habits characteristics of participants, using interview
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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 (Actual)

December 1, 2023

Primary Completion (Actual)

December 15, 2024

Study Completion (Estimated)

May 10, 2025

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDO 1-2-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Early Childhood Caries

Clinical Trials on Measurement of salivary cystatin S protein levels in saliva

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe