Salivary Cystatin S Levels in a Group of Egyptian Children

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Evidence of Early Childhood Caries Prediction by Salivary Cystatin S Levels in a Group of Egyptian Children: A Case Control Study

Conditions
-----------------
Early Childhood Caries

Intervention / Treatment
-----------------
* Biological: Measurement of salivary cystatin S protein levels in saliva


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 71 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with early childhood caries aged between 36-71 month<br> | Biological: Measurement of salivary cystatin S protein levels in saliva<br>* 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<br>|
| Caries free children aged between 36-71 month<br> | Biological: Measurement of salivary cystatin S protein levels in saliva<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early childhood caries, salivary cystatin S protein, salivary buffer capacity