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Active, Not Recruiting

NCT Number: NCT05716867

Salivary Cystatin S Levels in a Group of Egyptian Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Early Childhood Caries

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Oral and Dental Medicine Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Buffer Capacity

    Time frame: 2 months

    Buffer Capacity measured by PH meter

  2. Demographic, clinical and nutrition habits characteristics of participants Interview

    Time frame: 2 months

    Demographic, clinical and nutrition habits characteristics of participants, using interview

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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