Clinical trial

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

Name

YYU-BAVCI-01

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2024-08-01

Trial end

2024-08-01

Status

Recruiting

Treatment

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.

Arms:

Follow-up patients after placement of stainless steel crowns, Patients prior to placement of stainless steel crowns

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

Arms:

Follow-up patients after placement of stainless steel crowns, Patients prior to placement of stainless steel crowns

Size

Primary endpoint

Level of salivary gene expression

Sample collection during 1 day examination, approximately a week later second sample collection

Eligibility criteria

\*\*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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CROSSOVER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva of patients using stainless steel crown'}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

Updated at

2024-06-03

1 organization

1 product

2 indications

Organization

Yuzuncu Yıl University

Product

Salivary Collection

Indication

Saliva

Indication

Dental Crown