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Recruiting Observational

Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis

NCT07607639 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-05-22
Last updated
2026-06-10

Condition(s) studied

Gingivitis

Investigational drug(s) / intervention(s)

Gingival Crevicular Fluid Biomarker Assessment

Gingival Crevicular Fluid Biomarker Assessment: Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only.

Study 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

Sex
ALL
Min age
8 Years
Max age
24 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Gingival crevicular fluid TNF-α levels — Baseline
  • Gingival crevicular fluid IL-1β levels — Baseline
  • Gingival crevicular fluid IL-10 levels — Baseline
  • Gingival crevicular fluid MMP-8 levels — Baseline

Trial sites (1)

FacilityCityRegionStatus
Niğde Ömer Halisdemir University Faculty of Dentistry Niğde Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07607639 on ClinicalTrials.gov ↗ ← All trials in Turkey