MedPath

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

Completed
Conditions
Dental Crown
Saliva
Interventions
Genetic: Salivary Collection
Diagnostic Test: Ph and ion level measurement of saliva
Registration Number
NCT06439095
Lead Sponsor
Yuzuncu Yıl University
Brief Summary

The aim of this study is to investigate whether nickel hypersensitivity following stainless steel crown treatment in children aged 7-13 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 7-13 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. Also ph value and ion levels of saliva will be measured

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria

**

  • Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.
  • Pediatric patients between 7-13 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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients prior to placement of stainless steel crownsPh and ion level measurement of salivaSalivary IL-2, IL-5 and IL-17 expression levels of patients will be recorded
Follow-up patients after placement of stainless steel crownsPh and ion level measurement of salivaSalivary IL-2, IL-5 and IL-17 expression levels of patients will be recorded
Patients prior to placement of stainless steel crownsSalivary CollectionSalivary IL-2, IL-5 and IL-17 expression levels of patients will be recorded
Follow-up patients after placement of stainless steel crownsSalivary CollectionSalivary IL-2, IL-5 and IL-17 expression levels of patients will be recorded
Primary Outcome Measures
NameTimeMethod
Level of salivary gene expressionSample collection during 1 day examination, approximately a week later second sample collection

Relative gene expression analysis will be performed. Quantitative polymerase chain reaction (qPCR) Master Mix will be used for this purpose. Primers to be used in polymerase chain reaction (PCR) analysis and their properties are given below. The total volume of each PCR reaction will be set to 25 µL consisting of 12.5 µL qPCR Master Mix, 1 µL forward and reverse primers, 6.5 µL ultrapure water and 5 µL complementary DNA (cDNA). In the first step of the PCR protocol, after an initial incubation step at 95 °C for 10 minutes, PCR cycles will be performed at 94 °C for 15 seconds and 60 °C for 30 seconds in 40 replicates. The threshold for gene expression analysis will be set as auto-detection. According to the housekeeping gene, IL-2, IL-5, IL-17 gene expression values will be determined.

Secondary Outcome Measures
NameTimeMethod
Level of salivary ionsSample collection during 1 day examination, approximately a week later second sample collection

Salivary concentration of nickel, chrome, cobalt and palladium ions will be measured using an atomic absorption spectrophotometer

Level of salivary potential of hydrogen (pH)Sample collection during 1 day examination, approximately a week later second sample collection

Salivary pH will be measured with the help of a digital pH meter

Trial Locations

Locations (1)

Yüzüncü Yil University

🇹🇷

Van, Tuşba, Turkey

© Copyright 2025. All Rights Reserved by MedPath