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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06354205
Other study ID # 24-3.1T/98
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Ege University
Contact Caner Turan, PhD
Phone +902323901510
Email drcanerturan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections. The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date April 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 1 Year
Eligibility Inclusion Criteria: - Being under one year of age - Having serum Procalcitonin (PCT) requested due to suspicion of systemic infection Exclusion Criteria: - Being over one year of age - Having a chronic illness that could cause elevation in inflammatory biomarkers - Taking any medication (such as antibiotics, immunomodulatory, or immunosuppressive drugs, etc.) that could affect inflammatory biomarkers - Diagnosis of gingivostomatitis

Study Design


Intervention

Diagnostic Test:
Sliva Procalcitonin
Sliva Procalcitonin vs Blood procalcitonin

Locations

Country Name City State
Turkey Ege University School of Medicine Izmir

Sponsors (2)

Lead Sponsor Collaborator
Ege University THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKIYE

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation the correlation between serum Procalcitonin (PCT) levels and salivary PCT levels One year
Secondary Diagnose Diagnostic value of saliva PCT One year
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