Salivary Cystatin S Levels in a Group of Egyptian Children

Active, not recruiting

• Conditions: Early Childhood Caries
• Interventions: Biological: Measurement of salivary cystatin S protein levels in saliva

• Registration Number: NCT05716867
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Study First Posted: 2023-02-08
• Study Start: 2023-12-01
• Primary Completion: 2024-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Levels of salivary cystatin S protein	2 months	Levels of salivary cystatin S protein measured by Human cystatin S enzyme linked immunosorbent assay (ELISA) kit (unit ng/ml)

Secondary Outcome Measures

Name	Time	Method
Buffer Capacity	2 months	Buffer Capacity measured by PH meter
Demographic, clinical and nutrition habits characteristics of participants Interview	2 months	Demographic, clinical and nutrition habits characteristics of participants, using interview

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine Cairo University; 🇪🇬 Cairo, Egypt