Dental Crown, Nickel Sensitivity, Saliva
Conditions
Keywords
Saliva, Dental crown, Gene expression
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.
Detailed description
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.
Interventions
GENETICSalivary Collection
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.
DIAGNOSTIC_TESTPh and ion level measurement of saliva
Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer.
Sponsors
Yuzuncu Yil University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Inclusion criteria
\*\*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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-2, IL-5, IL-17 Expression Level (Fold Change) | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were recruited from pediatric dental clinics and selected based on the need for stainless steel crown placement.
Pre-assignment details
Twelve patients were enrolled according to the study protocol and all twelve commenced the study.
Participants by arm
| Arm | Count |
|---|---|
| Stainless Steel Crown Group Patients received stainless steel crowns, and salivary IL-2, IL-5, and IL-17 gene expression levels were measured at baseline and after 7 days. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Stainless Steel Crown Group | — |
|---|---|---|
| Age, Continuous | 6.4 Years STANDARD_DEVIATION 1 | — |
| Baseline IL-2, IL-5, and IL-17 Expression Status Baseline IL-17 Expression (Relative Units) | 1.0 Relative Expression Units STANDARD_DEVIATION 0.2 | — |
| Baseline IL-2, IL-5, and IL-17 Expression Status Baseline IL-2 Expression (Relative Units) | 1.0 Relative Expression Units STANDARD_DEVIATION 0.1 | — |
| Baseline IL-2, IL-5, and IL-17 Expression Status Baseline IL-5 Expression (Relative Units) | 1.0 Relative Expression Units STANDARD_DEVIATION 0.15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: Sample collection at baseline (Day 0) and 7 days after treatment
Population: Of 12 enrolled participants, data from 10 participants were included in the final analysis due to complete sample availability.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stainless Steel Crown Group | IL-2, IL-5, IL-17 Expression Level (Fold Change) | Day 7 IL-2 Expression (Fold Change) | 1.2 Fold Change | Standard Deviation 0.4 |
| Stainless Steel Crown Group | IL-2, IL-5, IL-17 Expression Level (Fold Change) | Day 7 IL-5 Expression (Fold Change) | 1.8 Fold Change | Standard Deviation 0.3 |
| Stainless Steel Crown Group | IL-2, IL-5, IL-17 Expression Level (Fold Change) | Day 7 IL-17 Expression (Fold Change) | 4.5 Fold Change | Standard Deviation 1.7 |