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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Gingival crevicular fluid TNF-α levels [Срок оценки: Baseline]
• Gingival crevicular fluid IL-1β levels [Срок оценки: Baseline]
• Gingival crevicular fluid IL-10 levels [Срок оценки: Baseline]
• Gingival crevicular fluid MMP-8 levels [Срок оценки: Baseline]

Вторичные конечные точки (4)

• Gingival Index [Срок оценки: Baseline]
• Plaque Index [Срок оценки: Baseline]
• Bleeding on Probing Scores Assessed by Periodontal Probing [Срок оценки: Baseline]
• Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Individuals aged 8-12 years (child group) or 15-24 years (young adult group)
• Clinical diagnosis of gingivitis
• Presence of fully erupted tooth #31 with closed apex
• Systemically healthy individuals
• No history of periodontal treatment in the last 3 months
• No antibiotic or anti-inflammatory drug use in the last 3 months
• Good cooperation and willingness to participate
• Written informed consent from participants or legal guardians (for minors)

Критерии исключения

• Age 13-14 years (transitional pubertal period)
• Presence of periodontitis or other periodontal diseases
• Systemic, genetic, or immunological diseases
• Acute oral infections or conditions requiring emergency treatment
• Orthodontic appliances in the sampling region
• Smokers
• Pregnant or lactating individuals
• Individuals with cognitive, psychological, or physical disabilities affecting cooperation
• Inadequate eruption or incomplete root development of tooth #31
• Refusal to participate or withdrawal of consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Niğde Ömer Halisdemir University Faculty of Dentistry — Niğde

Идентификаторы

NCT: NCT07607639 · NigdeOHU-GingivitisDOS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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