SalivaNCT06439095
Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns
An observational study of Saliva and Dental Crown, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Saliva, Dental Crown, Nickel Sensitivity
- What is being tested?
- Salivary Collection and Ph and ion level measurement of saliva
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 15 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Child
Study population: The patients living in Van city
Who may be able to join
- Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.
- Pediatric patients between 3-9 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of IL-2, IL-5 and IL-17 Expression Levels in Saliva of Patients Treated With Stainless Steel Crowns
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:
Read more
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.
Read the 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.
- Conditions
- Saliva, Dental Crown, Nickel Sensitivity
- Being tested
- Salivary Collection, Ph and ion level measurement of saliva
- Keywords
- Saliva, Dental crown, Gene expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary CollectionGenetic
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 salivaDiagnostic test
Salivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Salivary Collection; Diagnostic Test: Ph and ion level measurement of saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sample collection at baseline (Day 0) and 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start10 Sep 2024
- Primary completion1 Nov 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SalivaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin AVCI, Yuzuncu Yil University
- Investigators
- Burçin Avcı, DDS, MSc, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439095
- Sponsor's protocol ID
- YYU-BAVCI-01
- Status last verified
- Jun 2025
- First submitted
- 27 May 2024
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41469209
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IL-2, IL-5 and IL-17 Expression Levels in Saliva of Patients Treated With Stainless Steel Crowns
- ClinicalTrials.gov ID
- NCT06439095
- Acronym / sponsor ID
- YYU-BAVCI-01
- Conditions
- Saliva, Dental Crown, Nickel Sensitivity
- Keywords
- Saliva, Dental crown, Gene expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stainless Steel Crown Group | – | Genetic: Salivary Collection, Diagnostic Test: Ph and ion level measurement of salivaParticipants 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Age groups
- Child
- Study population
- The patients living in Van city
Key inclusion criteria (2 listed)
- Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.
- Pediatric patients between 3-9 years old
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary CollectionExpression 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. | Genetic | Stainless Steel Crown Group |
| Ph and ion level measurement of salivaSalivary concentration of nickel, chrome ions will be measured using an atomic absorption spectrophotometer. | Diagnostic test | Stainless Steel Crown Group |
Primary outcome
IL-2, IL-5, IL-17 Expression Level (Fold Change)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41469209Avci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burçin Avcı, DDS, MSc principal investigator
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Saliva and Dental Crown, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-2, IL-5, IL-17 Expression Level (Fold Change) (time frame: Sample collection at baseline (Day 0) and 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.