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

Comparison of Gingival Crevicular Fluid Biomarkers Between Childhood Gingivitis and Adolescent Gingivitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07607639
Enrollment
80
Registered
2026-05-26
Start date
2026-05-22
Completion date
2027-11-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

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.

Detailed description

Gingivitis is the most common reversible periodontal disease in children and young adults and is characterized by gingival inflammation without periodontal attachment loss. Gingival crevicular fluid (GCF) contains inflammatory mediators and biomarkers that reflect periodontal tissue response and disease activity. This prospective observational case-control study aims to compare GCF biomarker profiles between children and young adults diagnosed with gingivitis. 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 due to pubertal hormonal variability that may affect inflammatory biomarker levels. Clinical periodontal parameters including Gingival Index, Plaque Index, Bleeding on Probing, and Probing Depth will be recorded. GCF samples will be collected from tooth #31 using standardized paper strips and analyzed for IL-1β, TNF-α, IL-10, and MMP-8 levels using ELISA. The findings may contribute to understanding age-related differences in gingival inflammatory responses and biomarker expression in gingivitis.

Interventions

DIAGNOSTIC_TESTGingival 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.

Sponsors

Nigde Omer Halisdemir University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Gingival crevicular fluid TNF-α levelsBaseline
Gingival crevicular fluid IL-1β levelsBaseline
Gingival crevicular fluid IL-10 levelsBaseline
Gingival crevicular fluid MMP-8 levelsBaseline

Secondary

MeasureTime frameDescription
Gingival IndexBaselineGingival inflammation will be assessed using the Löe and Silness Gingival Index. Each surface will be scored between 0 and 3: 0 = normal gingiva 1. = mild inflammation 2. = moderate inflammation with bleeding on probing 3. = severe inflammation with spontaneous bleeding Higher scores indicate worse gingival inflammation.
Plaque IndexBaselineDental plaque accumulation will be evaluated using the Silness and Löe Plaque Index. Each surface will be scored between 0 and 3: 0 = no plaque 1. = plaque detectable by probe 2. = visible plaque accumulation 3. = abundant plaque accumulation Higher scores indicate poorer oral hygiene and greater plaque accumulation.
Bleeding on Probing Scores Assessed by Periodontal ProbingBaselineBleeding on probing will be evaluated using a periodontal probe after gentle probing of the gingival sulcus. Bleeding presence will be recorded dichotomously: 0 = absence of bleeding 1 = presence of bleeding Higher scores indicate greater gingival inflammation.
Periodontal Probing Depth Measurements Assessed With Williams Periodontal ProbeBaselinePeriodontal probing depth will be measured in millimeters using a Williams periodontal probe at six sites per tooth. Higher values indicate deeper periodontal pockets and worse periodontal condition.

Countries

Turkey (Türkiye)

Contacts

CONTACTAycan Dal Dönertaş
aycandal@outlook.com+903382252595
CONTACTSelcen Özcan Bulut
selcen_ozcan@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026