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NCT04958005 Clinical Trial

Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children

Early Childhood Caries Clinical Trial

Official title:
Evaluation of Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children With Early Childhood Caries.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04958005
Other study ID # 2020/190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date September 30, 2021

Study information
Verified date October 2021
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to evaluate the levels of interleukin 10, interleukin 6, interleukin 32 and tumor necrosis factor-alpha (TNF-α) in saliva of children with early childhood caries.

Description:

Fifty six children ( 28 with early childhood caries and 28 without early childhood caries ; age range 3-6 years) will be recruited for the study. Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded and saliva samples will be collected. Interleukin-32, Interleukin-10, Interleukin-6 and TNF-α will be analyzed in saliva samples by ELISA.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date September 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers
Gender All
Age group 3 Years to 70 Months
Eligibility Inclusion Criteria: - Children with untreated early chilhood caries - Age between 3 and 6 years Exclusion Criteria: - Having a systemic problem or mental retardation - Children with treated caries

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ELISA
Enzim linked immunoabsorbant assay

Locations
Country Name City State
Turkey Sultan KELES Aydin

Sponsors (1)
Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary IL-32 Interleukin- 32 level Baseline
Primary IL-10 Interleukin- 10 level Baseline
Secondary IL-6 Interleukin- 6 level Baseline
Secondary Tnf-Alpha Tnf-alpha level Baseline
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