Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns

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.

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Key information

Conditions

Saliva Dental Crown Nickel Sensitivity

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yüzüncü Yil University

Van, Tuşba, 65080, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

**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.

Treatment and study plan

Salivary Collection

Genetic

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 3 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.

Ph and ion level measurement of saliva

Diagnostic Test

Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer.

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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jun 3, 2024
Registry last updated: Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed