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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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**Inclusion Criteria:**
**Exclusion Criteria:**
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The patients living in Van city
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| Name | Affiliation | Role |
|---|---|---|
| Burçin Avcı, DDS, MSc | Yuzuncu Yil University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yüzüncü Yil University | Van | Tuşba | 65080 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41469209 | Derived | 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. 2026 May;36(3):459-467. doi: 10.1111/ipd.70071. Epub 2025 Dec 30. |
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Twelve patients were enrolled according to the study protocol and all twelve commenced the study.
Participants were recruited from pediatric dental clinics and selected based on the need for stainless steel crown placement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 1, 2025 |
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Saliva of patients using stainless steel crown
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| Ph and ion level measurement of saliva | Diagnostic Test | Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer. |
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Baseline data was collected from all 12 participants before 2 participants were withdrawn due to loss to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Baseline IL-2, IL-5, and IL-17 Expression Status | Average baseline IL-2, IL-5, and IL-17 expression levels measured in saliva before SSC procedure. | Mean | Standard Deviation | Relative Expression Units |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of 12 enrolled participants, data from 10 participants were included in the final analysis due to complete sample availability. | Posted | Mean | Standard Deviation | Fold Change | Sample collection at baseline (Day 0) and 7 days after treatment |
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Baseline until 7 days post-treatment
Adverse events were monitored through systematic clinical examination and parental interviews.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Salivary 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. Ph and ion level measurement of saliva: Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer. | 0 | 10 | 0 | 10 | 0 | 10 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Burçin Avcı, Assistant Professor | Van Yuzuncu Yil University Faculty of Dentistry | +90 5359558140 | burcinavci@yyu.edu.tr |
| Jun 3, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D006863 | Hydrogen-Ion Concentration |
| ID | Term |
|---|---|
| D055598 | Chemical Phenomena |
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| Baseline IL-5 Expression (Relative Units) |
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| Baseline IL-17 Expression (Relative Units) |
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