Trial Outcomes & Findings for Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns (NCT NCT06439095)

NCT ID: NCT06439095

Last Updated: 2025-06-18

Results Overview

Relative gene expression analysis was performed using quantitative PCR (qPCR) with appropriate primers. The results were reported as fold change relative to baseline values.

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

Sample collection at baseline (Day 0) and 7 days after treatment

Results posted on

2025-06-18

Participant Flow

Participants were recruited from pediatric dental clinics and selected based on the need for stainless steel crown placement.

Twelve patients were enrolled according to the study protocol and all twelve commenced the study.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
12
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
Lost to Follow-up
2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Stainless Steel Crown Group
n=10 Participants
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.
Age, Continuous
6.4 Years
STANDARD_DEVIATION 1.0 • n=10 Participants
Sex: Female, Male
Female
6 Participants
n=10 Participants
Sex: Female, Male
Male
4 Participants
n=10 Participants
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 • n=10 Participants
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 • n=10 Participants
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 • n=10 Participants

PRIMARY outcome

Timeframe: 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.

Relative gene expression analysis was performed using quantitative PCR (qPCR) with appropriate primers. The results were reported as fold change relative to baseline values.

Outcome measures

Outcome measures
Measure
Stainless Steel Crown Group
n=10 Participants
Patients received stainless steel crowns on posterior teeth. Salivary IL-2, IL-5, and IL-17 gene expression levels were measured before treatment and 7 days after.
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
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
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

Adverse Events

Stainless Steel Crown Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Burçin Avcı, Assistant Professor

Van Yuzuncu Yil University Faculty of Dentistry

Phone: +90 5359558140

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place