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

8 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

80

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

      • Niğde, Turquia (Türkiye), 51240
        • Recrutamento
        • Niğde Ömer Halisdemir University Faculty of Dentistry
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

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.

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Gingival crevicular fluid TNF-α levels
Prazo: Baseline
Baseline
Gingival crevicular fluid IL-1β levels
Prazo: Baseline
Baseline
Gingival crevicular fluid IL-10 levels
Prazo: Baseline
Baseline
Gingival crevicular fluid MMP-8 levels
Prazo: Baseline
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Gingival Index
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de maio de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • NigdeOHU-GingivitisDOS

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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