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临床试验/NCT07287553
NCT07287553已完成不适用

The Relationship Between Dietary Inflammatory Index and Periodontal Status in Obese Patients

Recep Tayyip Erdogan University Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Periodontal pocket depth

研究概览

简要总结

In this study aimed to investigate the effect of nutrition on periodontal status in individuals diagnosed with obesity and without any other systemic disease, and to investigate the relationship between DII and periodontal disease risk. A total of 200 participants will be included in the study. Participants' overall daily Dietary Inflammatory Index (DII) scores will be calculated. The obtained scores will be divided into four groups, from low to high: Q1 (n=50), Q2 (n=50), Q3 (n=50), and Q4 (n=50). According to the DII, groups Q1 and Q2, which include lower scores, represent individuals on an anti-inflammatory diet, while groups Q3 and Q4, which include higher scores, represent individuals on a pro-inflammatory diet. Interleukin (IL)-1β, IL-10, total oxidant status (TOS), and total antioxidant status (TAS) were collected from gingival crevicular fluid (GCF) and serum samples. The levels of biomarkers such as malondialdehyde (MDA), glutathione (GSH), leptin, adiponectin, tumor necrosis factor (TNF)-α and C-reactive protein (CRP) from serum samples alone will be analyzed by ELISA method at the Recep Tayyip Erdoğan University Medical Biochemistry Laboratory.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with obesity,
  • Not having any systemic conditions other than obesity (systemic diseases that may affect periodontal health, such as cardiovascular disease, chronic kidney disease, Type 1 diabetes, Type 2 diabetes, and hypertension (>130/85 mmHg)),
  • Being between the ages of 18 and 65,
  • Not smoking or consuming alcohol,
  • Not having used anti-inflammatory medications in the last 3 months, or antibiotics or systemic corticosteroids in the last 6 months,
  • Not being pregnant or lactating,
  • Not having received periodontal treatment in the last 6 months,
  • Not having received nutritional advice in the last 3 months,
  • Obesity diagnosis: BMI > 30 kg/m2 or waist circumference: > 100 cm for men and > 90 cm for women.

排除标准

  • Non-obese
  • Having any systemic disease other than obesity (such as cardiovascular disease, chronic kidney disease, Type 1 diabetes, Type 2 diabetes, and hypertension (>130/85 mmHg) that may affect periodontal health)
  • Being over 65 years old and under 18 years old
  • Smoking and alcohol use
  • Having used anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 6 months
  • Being pregnant or lactating
  • Having received periodontal treatment in the last 6 months
  • Having received nutritional advice in the last 3 months

结局指标

主要结局

Periodontal pocket depth

时间窗: baseline

The distance between the pocket base and the gingival margin will be measured. 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

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)
  • interleukin (IL)-10 level(baseline)
  • total oxidant status (TOS) level(baseline)
  • total antioxidant status (TAS) level(baseline)
  • serum leptin level(baseline)
  • serum tumor necrosis factor (TNF)-α level(baseline)
  • serum adiponectin level(baseline)
  • serum C-reactive protein (CRP) level(baseline)
  • serum malondialdehyde (MDA) level(baseline)
  • serum glutathione (GSH) level(baseline)

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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