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临床试验/NCT07462104
NCT07462104尚未招募不适用

Pro-İnflammatory Diet as a Modifying Factor in Periodontal Tissue Destruction Associated With Metabolic Syndrome

Recep Tayyip Erdogan University Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Dietary Inflammatory Index

研究概览

简要总结

The goal of this observational study is to examine the relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate the role of the Dietary Inflammatory Index (DII) in this association.

The main question it aims to answer is:

Does a pro-inflammatory diet, as measured by the DII, increase the risk or severity of periodontitis in individuals with metabolic syndrome?

Participants will include adults who meet the diagnostic criteria for metabolic syndrome. Their periodontal health will be assessed through standard clinical parameters, and dietary data will be collected using a validated food frequency questionnaire to calculate individual DII scores. The study will observe and analyze these factors to explore potential links between diet-induced inflammation, systemic metabolic health, and periodontal outcomes.

详细描述

This study aims to investigate the potential relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate this association through the Dietary Inflammatory Index (DII), which reflects the inflammatory potential of diet. Periodontal status will be assessed using clinical parameters (plaque index, probing pocket depth, clinical attachment loss, and gingival bleeding). MetS diagnosis will be based on criteria such as waist circumference, fasting glucose level, serum triglycerides, HDL cholesterol, and blood pressure. Dietary habits of participants will be analyzed using a validated food frequency questionnaire, and individual DII scores will be calculated. The data obtained will be used to evaluate the effects of dietary inflammatory load on systemic metabolic parameters and periodontal health. This study will aim to provide scientific evidence on the role of anti-inflammatory dietary strategies in periodontal and metabolic health.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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 between 18 and 65 years of age
  • Presence of at least three of the following parameters: (For MetS diagnosis) Waist circumference: ≥ 94 cm for men, ≥ 88 cm for women Blood pressure ≥ 130/85 mmHg or taking antihypertensive medication Fasting blood glucose ≥ 100 mg/dl or diagnosed with Type 2 Diabetes Triglycerides ≥ 1.7 mmol/L HDL < 1.29 mmol/L
  • Having at least 20 teeth
  • Not having received periodontal therapy in the last 6 months
  • Not having taken antibiotics, steroids, and/or nonsteroidal anti-inflammatory drugs in the last 3 weeks
  • Not having any autoimmune disease, osteoporosis, or cancer
  • Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates
  • Not being pregnant
  • Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)
  • Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)
  • Not taking antioxidant supplements in the last 6 months

排除标准

  • Patients with an active infectious disease,
  • Those taking medications that could affect periodontal tissues,
  • History of endocarditis,
  • Recent antibiotic use (within 4 months),
  • Alcohol/drug use,
  • Psychological disorders,
  • Eating disorders,
  • Dementia,
  • Pregnancy and breastfeeding,
  • Patients who did not sign the informed consent form

研究组 & 干预措施

Patients diagnosed with metabolic syndrome

Metabolic syndrome is diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP III) criteria. Diagnosis is made by meeting three of the following five criteria: waist circumference: ≥ 94 cm in men and ≥ 88 cm in women, blood pressure ≥ 130/85 mmHg or use of antihypertensive medication, fasting blood glucose ≥ 100 mg/dL or diagnosed type 2 diabetes, triglycerides ≥ 1.7 mmol/L, and HDL < 1.29 mmol/L.

结局指标

主要结局

Dietary Inflammatory Index

时间窗: Day 1

The Dietary Inflammatory Index (DII) provides a score that measures the potential for a person's diet to cause inflammation in the body. This index is based on the pro- or anti-inflammatory effects of consumed foods and nutrients. Participants' 3-day food intake records will be entered into the system, and average daily energy intake, macronutrients, and micronutrients will be calculated. Based on the food records, average daily intake of 36 nutrients will be determined, and DII scores will be derived from these nutrient parameters. A lower score indicates a more anti-inflammatory diet, while a higher score indicates a more pro-inflammatory diet.

次要结局

  • Clinical Periodontal Parameters (Plaque Index)(Day 1)
  • Clinical Periodontal Parameters (Gingival Index)(Day 1)
  • Periodontal Clinical Parametres (Bleeding on Probing Index)(Day 1)
  • Periodontal Clinical Parametres (Probing Pocket Depth)(Day 1)
  • Periodontal Clinical Parametres (Clinical Attachment Loss)(Day 1)

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

Dilek KARADOĞAN

Assoc. Prof. Dr.

Recep Tayyip Erdogan University Training and Research Hospital

研究点 (1)

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