NCT07607639 Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis
| NCT ID | NCT07607639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nigde Omer Halisdemir University |
| Condition | Gingivitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-05-22 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels. Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.
Eligibility Criteria
Inclusion Criteria: 1. Individuals aged 8-12 years (child group) or 15-24 years (young adult group) 2. Clinical diagnosis of gingivitis 3. Presence of fully erupted tooth #31 with closed apex 4. Systemically healthy individuals 5. No history of periodontal treatment in the last 3 months 6. No antibiotic or anti-inflammatory drug use in the last 3 months 7. Good cooperation and willingness to participate 8. Written informed consent from participants or legal guardians (for minors) Exclusion Criteria: 1. Age 13-14 years (transitional pubertal period) 2. Presence of periodontitis or other periodontal diseases 3. Systemic, genetic, or immunological diseases 4. Acute oral infections or conditions requiring emergency treatment 5. Orthodontic appliances in the sampling region 6. Smokers 7. Pregnant or lactating individuals 8. Individuals with cognitive, psychological, or physical disabilities affecting cooperation 9. Inadequate eruption or incomplete root development of tooth #31 10. Refusal to participate or withdrawal of consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07607639 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 24 Years, studying Gingivitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07607639 currently recruiting?
Yes, NCT07607639 is actively recruiting participants. Contact the research team at aycandal@outlook.com for enrollment information.
Where is the NCT07607639 trial being conducted?
This trial is being conducted at Niğde, Turkey (Türkiye).
Who is sponsoring the NCT07607639 clinical trial?
NCT07607639 is sponsored by Nigde Omer Halisdemir University. The trial plans to enroll 80 participants.