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

E

Ege University

Status

Enrolling

Conditions

Saliva
Procalcitonin
Children, Only
Bacterial Infections

Treatments

Diagnostic Test: Sliva Procalcitonin

Study type

Interventional

Funder types

Other

Identifiers

NCT06354205
24-3.1T/98

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

160 participants in 1 patient group

Patients selection
Other group
Description:
Children under 1 year of age will be recruited for saliva and blood sample collection in the study
Treatment:
Diagnostic Test: Sliva Procalcitonin

Trial contacts and locations

1

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Central trial contact

Caner Turan, PhD; Sercan Cinarli

Data sourced from clinicaltrials.gov

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