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
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Aycan Dal Dönertaş
- 电话号码:+903382252595
- 邮箱:aycandal@outlook.com
研究联系人备份
- 姓名:Selcen Özcan Bulut
- 邮箱:selcen_ozcan@hotmail.com
学习地点
-
-
-
Niğde、土耳其(türkiye)、51240
- 招聘中
- Niğde Ömer Halisdemir University Faculty of Dentistry
-
接触:
- Merdan Doğan
- 电话号码:905422076565
- 邮箱:merdan@ohu.edu.tr
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Gingival crevicular fluid TNF-α levels
大体时间:Baseline
|
Baseline
|
|
Gingival crevicular fluid IL-1β levels
大体时间:Baseline
|
Baseline
|
|
Gingival crevicular fluid IL-10 levels
大体时间:Baseline
|
Baseline
|
|
Gingival crevicular fluid MMP-8 levels
大体时间:Baseline
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gingival Index
大体时间: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
|
Baseline
|
|
Plaque Index
大体时间: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
|
Baseline
|
|
Bleeding on Probing Scores Assessed by Periodontal Probing
大体时间: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
大体时间: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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.