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临床试验/NCT07607639
NCT07607639招募中不适用

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

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
8 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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
  • 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

研究组 & 干预措施

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.

干预措施: Gingival Crevicular Fluid Biomarker Assessment (Diagnostic Test)

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.

干预措施: Gingival Crevicular Fluid Biomarker Assessment (Diagnostic Test)

结局指标

主要结局

未指定

次要结局

  • Gingival Index(Baseline)
  • Plaque Index(Baseline)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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