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

8. juni 2026 oppdatert av: Nigde Omer Halisdemir University

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
      • Niğde, Tyrkia (Türkiye), 51240
        • Rekruttering
        • Niğde Ömer Halisdemir University Faculty of Dentistry
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants will be recruited from the Pedodontics and Periodontology Clinics of Niğde Ömer Halisdemir University Faculty of Dentistry. The study population will consist of systemically healthy children and young adults diagnosed with gingivitis. Participants will be divided into two age-based groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded due to being in a transitional pubertal stage associated with significant hormonal variability that may influence gingival inflammatory responses and confound biomarker levels. All participants will undergo clinical periodontal examination and gingival crevicular fluid sampling for biomarker analysis.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Childhood gingivitis group
Systemically healthy children aged 8-12 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
Diagnostisk test: 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.
Young adult gingivitis group
Systemically healthy young adults aged 15-24 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
Diagnostisk test: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Gingival crevicular fluid TNF-α levels
Tidsramme: Baseline
Baseline
Gingival crevicular fluid IL-1β levels
Tidsramme: Baseline
Baseline
Gingival crevicular fluid IL-10 levels
Tidsramme: Baseline
Baseline
Gingival crevicular fluid MMP-8 levels
Tidsramme: Baseline
Baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gingival Index
Tidsramme: Baseline

Gingival 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.
Baseline
Plaque Index
Tidsramme: Baseline

Dental 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.
Baseline
Bleeding on Probing Scores Assessed by Periodontal Probing
Tidsramme: Baseline

Bleeding 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.
Baseline
Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe
Tidsramme: Baseline
Periodontal 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.
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nigde Omer Halisdemir University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. mai 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NigdeOHU-GingivitisDOS

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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