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

Saliva Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439095
• Other study ID #: YYU-BAVCI-01
• Status: Recruiting
• Start date: June 2024
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Yuzuncu Yil University
• Contact: Burçin Avci, DDS, MSc
• Phone: 4322251744
• Email: burcinavci[@]yyu.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

**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.

Related Conditions & MeSH terms

• Dental Crown
• Saliva

Intervention

Genetic:
• Salivary Collection
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.

Diagnostic Test:
• Ph and ion level measurement of saliva
Salivary concentration of nickel, chrome, cobalt and palladium ions will be measured using an atomic absorption spectrophotometer. Salivary pH will be measured with the help of a digital pH meter

Locations

Country	Name	City	State
Turkey	Yüzüncü Yil University	Van	Tusba

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of salivary gene expression	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.	Sample collection during 1 day examination, approximately a week later second sample collection
Secondary	Level of salivary ions	Salivary concentration of nickel, chrome, cobalt and palladium ions will be measured using an atomic absorption spectrophotometer	Sample collection during 1 day examination, approximately a week later second sample collection
Secondary	Level of salivary potential of hydrogen (pH)	Salivary pH will be measured with the help of a digital pH meter	Sample collection during 1 day examination, approximately a week later second sample collection