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临床试验/NCT07287540
NCT07287540招募中不适用

Evaluation of the Effects of Anti-inflammatory Nutrition on the Outcomes of Non-surgical Periodontal Therapy in Individuals With Periodontitis

Recep Tayyip Erdogan University Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11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
100
试验地点
2
主要终点
periodontal pocket depth

研究概览

简要总结

This study aimed to determine the effect of anti-inflammatory nutrition on non-surgical periodontal treatment in individuals with periodontitis by evaluating gingival crevicular fluid (GCF) and serum biomarkers and clinical periodontal parameters.

A total of 100 volunteers identified as having a pro-inflammatory diet (Q3 and Q4) will be included in the study. Individuals will be assigned to two groups. These groups will then be further divided into two groups based on whether or not they will receive anti-inflammatory nutrition education. Group Q3-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q3-2 (n=25) will receive only non-surgical periodontal treatment. Group Q4-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q4-2 (n=25) will receive only non-surgical periodontal treatment. After the periodontal index measurements are completed, the patients will receive non-surgical periodontal treatment. GCF and serum samples, periodontal clinical parameters and Dietary Inflammatory Index will be collected 3 times: at baseline, 1.5 and 3 months after non-surgical periodontal treatment. Levels of interleukin (IL)-1β, IL-10, tumor necrosis factor (TNF)-α, total oxidant status (TOS), total antioxidant status (TAS), and C-reactive protein (CRP) will be assessed from these samples. This will investigate the role of anti-inflammatory nutrition in reducing periodontal inflammation and increasing treatment success.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being systemically healthy
  • Not smoking
  • Not using anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 6 months
  • Not being pregnant or lactating
  • Not having received periodontal treatment in the last 6 months
  • Having at least 20 teeth in the mouth
  • Being diagnosed with periodontitis by the investigator
  • Having a dietary inflammatory index >0

排除标准

  • Having a systemic disease
  • Using anti-inflammatory drugs within the last 3 months, antibiotics within the last 6 months, or systemic corticosteroids
  • Being pregnant or lactating
  • Having received periodontal treatment within the last 6 months
  • Having fewer than 20 teeth in the mouth
  • No periodontitis

研究组 & 干预措施

Q3-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

干预措施: non surgical periodontal trearment (Other)

Q3-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

干预措施: anti-inflammatory nutrition education (Other)

Q3-2: Only nonsurgical periodontal treatment

干预措施: non surgical periodontal trearment (Other)

Q4-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

干预措施: non surgical periodontal trearment (Other)

Q4-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

干预措施: anti-inflammatory nutrition education (Other)

Q4-2: Only nonsurgical periodontal treatment

干预措施: non surgical periodontal trearment (Other)

结局指标

主要结局

periodontal pocket depth

时间窗: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

It will be calculated by measuring the distance between the gingival margin and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.

Clinical attachment loss

时间窗: baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

It will be calculated by measuring the distance between the cementoenemal border and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.

次要结局

  • interleukin (IL)-1β level(baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.)
  • interleukin (IL)-10 level(baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.)
  • tumor necrosis factor (TNF)-α level(baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.)
  • serum total oxidant status (TOS) level(baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.)
  • serum total antioxidant status (TAS) level(baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.)
  • serum C-reactive protein (CRP) level(baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.)

研究者

发起方
Recep Tayyip Erdogan University Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Yemenoğlu

Doctor

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (2)

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