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Clinical Trials/NCT06439095
NCT06439095CompletedNot Applicable

Evaluation of IL-2, IL-5 and IL-17 Expression Levels in Saliva of Patients Treated With Stainless Steel Crowns

Yuzuncu Yıl University1 site in 1 country12 target enrollmentStarted: September 10, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
IL-2, IL-5, IL-17 Expression Level (Fold Change)

Study Overview

Brief Summary

The aim of this study is to investigate whether nickel hypersensitivity following stainless steel crown treatment in children aged 3-9 leads to an increase in IL-2, IL-5, and IL-17 levels by analyzing saliva samples. By doing so, the study seeks to prevent potential hypersensitivity reactions after stainless steel crown treatment.

The main question it aims to answer is:

Which interleukin level increases in the controls 1 week after stainless steel crowns are applied? Researchers will investigate whether there is a significant increase in interleukin levels in children's saliva before and after the procedure.

Participants will:

They will provide saliva samples before stainless steel crowns are applied They will visit the clinic after 1 week for check-ups and tests.

Detailed Description

Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 3-9 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 5 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. Also ph value and ion levels of saliva will be measured.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
3 Years to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.
  • Pediatric patients between 3-9 years old

Exclusion Criteria

  • Patients having any dental materials, such as fillings, fissure sealants, root canal treatments, or space maintainers
  • Patients with known allergies to various foods and materials.
  • Patients with systemic diseases that affect the immune system.
  • Patients with a history of chemotherapy or radiotherapy.

Outcomes

Primary Outcomes

IL-2, IL-5, IL-17 Expression Level (Fold Change)

Time Frame: Sample collection at baseline (Day 0) and 7 days after treatment

Relative gene expression analysis was performed using quantitative PCR (qPCR) with appropriate primers. The results were reported as fold change relative to baseline values.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Yuzuncu Yıl University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Burçin AVCI

Assistant Professor

Yuzuncu Yıl University

Study Sites (1)

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