Salivary Cystatin S Levels in a Group of Egyptian Children

NCT05716867 | Active Not Recruiting

• 1 other identifier: PEDO 1-2-1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study

1. 1.Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries.
2. 2.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

Keywords

early childhood caries, salivary cystatin S protein, salivary buffer capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Buffer Capacity

  2 months

• Demographic, clinical and nutrition habits characteristics of participants Interview

  2 months

Study Arms (2)

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

Interventions

Measurement of salivary cystatin S protein levels in saliva BIOLOGICAL

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; Children with early childhood caries aged between 36-71 month

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine Cairo University

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva samples

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: December 1, 2023
• Primary Completion: December 15, 2024
• Study Completion: May 10, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

EG (1)