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NCT05716867 Clinical Trial

Salivary Cystatin S Levels in a Group of Egyptian Children

Early Childhood Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05716867
Other study ID # PEDO 1-2-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2023
Est. completion date July 2023

Study information
Verified date January 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 2023
Est. primary completion date May 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Months to 71 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Buffer Capacity Buffer Capacity measured by PH meter 2 months
Secondary Demographic, clinical and nutrition habits characteristics of participants Interview Demographic, clinical and nutrition habits characteristics of participants, using interview 2 months
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