Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels

Not Applicable

Recruiting

• Conditions: Bacterial Infections; Procalcitonin; Saliva; Children, Only
• Interventions: Diagnostic Test: Sliva Procalcitonin

• Registration Number: NCT06354205
• Lead Sponsor: Ege University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Study Start: 2024-06-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients selection	Sliva Procalcitonin	Children under 1 year of age will be recruited for saliva and blood sample collection in the study

Primary Outcome Measures

Name	Time	Method
Correlation	One year	the correlation between serum Procalcitonin (PCT) levels and salivary PCT levels

Secondary Outcome Measures

Name	Time	Method
Diagnose	One year	Diagnostic value of saliva PCT

Trial Locations

Locations (1)

Ege University School of Medicine; 🇹🇷 İzmir, Turkey