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
NCT number | NCT06439095 |
Other study ID # | YYU-BAVCI-01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | August 2024 |
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Yüzüncü Yil University | Van | Tusba |
Lead Sponsor | Collaborator |
---|---|
Yuzuncu Yil University |
Turkey,
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 |
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