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

NCT06439095 | Completed Results

• 1 other identifier: YYU-BAVCI-01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Saliva; Dental Crown; Nickel Sensitivity

Keywords

Saliva; Dental crown; Gene expression

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (1)

Stainless Steel Crown Group

Participants in this group received stainless steel crowns on posterior teeth. Salivary samples were collected before treatment (pre-treatment) and 7 days after treatment. IL-2, IL-5, and IL-17 gene expression levels were measured using Real-Time PCR. Additionally, salivary pH and the concentration of nickel, chrome ions were analyzed using atomic absorption spectrophotometry.

Genetic: Salivary Collection; Diagnostic Test: Ph and ion level measurement of saliva

Interventions

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.

Stainless Steel Crown Group

Ph and ion level measurement of saliva DIAGNOSTIC_TEST

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

Stainless Steel Crown Group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The patients living in Van city

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yüzüncü Yil University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

Related Publications (1)

• Avci B, Koc A, Kaya S. Evaluation of Salivary IL-2, IL-5, and IL-17 Levels in Paediatric Patients Treated With Stainless Steel Crowns. Int J Paediatr Dent. 2025 Dec 30. doi: 10.1111/ipd.70071. Online ahead of print.

  PMID: 41469209 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva of patients using stainless steel crown

MeSH Terms

Interventions

Hydrogen-Ion Concentration

Intervention Hierarchy (Ancestors)

Chemical Phenomena

Limitations and Caveats

The small sample size and short 7-day follow-up limit the generalizability and long-term interpretation of the results. The before-and-after design reduces variability but does not fully control for genetic, immune, or environmental factors. Larger randomized studies are needed to confirm these findings.

Results Point of Contact

• Title: Dr. Burçin Avcı, Assistant Professor
• Organization: Van Yuzuncu Yil University Faculty of Dentistry

burcinavci@yyu.edu.tr

+90 5359558140

Study Officials

• Burçin Avcı, DDS, MSc

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: September 10, 2024
• Primary Completion: November 1, 2024
• Study Completion: April 15, 2025
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)