The Effect of Non-Surgical Periodontal Therapy on Serum And Salivary Biomarker Levels in Individuals With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Examination of TIM-3 levels of periodontal disease and inflammatory bowel disease
研究概览
简要总结
Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease of the gastrointestinal tract characterised by complex interactions between genetic susceptibility, environmental factors, microbiota and host immune response. It has two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). The main mechanism of IBD pathogenesis is dysregulated host immune response to commensal microbiota and disruption of the balance of pro- and anti-inflammatory cytokines in genetically predisposed individuals. Periodontitis is a multifactorial inflammatory disease associated with dental biofilm resulting in the loss of periodontal supporting tissues and subsequently teeth. Although the occurrence of the disease depends on multifactorial factors, bacterial plaque is the primary etiological factor and various bacterial species found in plaque are responsible for initiating and maintaining the inflammatory and immune response in periodontal disease. Periodontal diseases are known to contribute to many systemic diseases/conditions or systemic disorders are known to affect periodontal disease. Although the relationship between IBD and periodontitis is based on the potential link between oral and intestinal microbiomes and host immunoinflammatory response, the pathological interactions between the two diseases have not yet been determined. From this point of view, the aim of our study was to investigate the effect of periodontal status on serum, saliva and gingival biomarkers (TIM-3, TNF-α, IL-6 and IL-17) in patients with IBD and to evaluate the relationship between these values and periodontal clinical parameters. This is the first study to examine TIM-3 levels in saliva, serum and gingival samples in patients with IBD and periodontitis with IBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be between the ages of 18-65,
- •Having at least 8 teeth excluding wisdom teeth,
- •No periodontal treatment in the last 3 months,
- •Not having used antibiotics in the last 3 months,
- •Not being pregnant or breastfeeding,
- •The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except IBD.
排除标准
- •Under 18 years of age and over 65 years of age,
- •Having less than 8 teeth,
- •Having undergone periodontal treatment in the last 3 months,
- •Having used antibiotics in the last 3 months,
- •Being pregnant or breastfeeding,
- •Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except IBD.
研究组 & 干预措施
Clinical Healthy
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. TIM-3 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the clinically healthy group.
干预措施: ELISA (Enzyme-Linked ImmunoSorbent Assay) (Other)
Periodontitis
Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. TIM-3 analysis will be performed by ELISA in saliva and serum of individuals. TIM-3 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.
干预措施: ELISA (Enzyme-Linked ImmunoSorbent Assay) (Other)
Periodontitis with İnflammatory Bowel Disease
Non-surgical periodontal treatment will be applied to individuals with periodontitis, clinical measurements, saliva collection and serum will be repeated 12 weeks after the treatment. TIM-3 analysis will be performed by ELISA in saliva and serum of individuals. TIM-3 levels will be examined to evaluate before and after treatment in periodontitis with İnflammatory Bowel Disease. Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and salivary sample will be taken from all individuals at the beginning of the study.
干预措施: ELISA (Enzyme-Linked ImmunoSorbent Assay) (Other)
Healthy individuals with İnflammatory Bowel Disease
Clinical measurements (Plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) salivary sample and serum will be taken from all individuals at the beginning of the study. TIM-3 levels will be examined to evaluate before and after treatment in periodontal health and periodontitis. A pre-treatment saliva sample and serum will be collected from the healthy individuals with İnflammatory Bowel Disease group.
干预措施: ELISA (Enzyme-Linked ImmunoSorbent Assay) (Other)
结局指标
主要结局
Examination of TIM-3 levels of periodontal disease and inflammatory bowel disease
时间窗: up to 1 year
Examination of TIM-3 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with inflammatory bowel disease.
次要结局
- Evaluation of the effect of non-surgical periodontal treatment on changes in TIM-3 level.(up to 1 year)
研究者
Burcu KARADUMAN
Profesor
Biruni University