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Salivary Cystatin S Levels in a Group of Egyptian Children

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05716867
Collaborator
(none)
30
Enrollment
4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Measurement of salivary cystatin S protein levels in saliva

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The Evidence of Early Childhood Caries Prediction by Salivary Cystatin S Levels in a Group of Egyptian Children: A Case Control Study
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Children with early childhood caries aged between 36-71 month

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
Caries free children aged between 36-71 month

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Buffer Capacity [2 months]

    Buffer Capacity measured by PH meter

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
36 Months to 71 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tasneem Salah Sayed Mohamed Abo Ali, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05716867
Other Study ID Numbers:
  • PEDO 1-2-1
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tasneem Salah Sayed Mohamed Abo Ali, principle investigator, Cairo University
early childhood caries, salivary cystatin S protein, salivary buffer capacity
Additional relevant MeSH terms:
Cystatins
Salivary Cystatins

Study Results

No Results Posted as of Feb 8, 2023