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临床试验/NCT07427069
NCT07427069尚未招募不适用

The Role of Pro-Inflammatory Diet in Periodontal Tissue Destruction in Chronic Kidney Disease

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4月20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 investigate the relationship between chronic kidney disease (CKD) and periodontitis, and to evaluate the potential mediating role of dietary inflammatory potential, measured by the Dietary Inflammatory Index (DII), in this association.

The main question it aims to answer is:

Does a pro-inflammatory diet, as reflected by a higher DII score, exacerbate periodontal inflammation in individuals with chronic kidney disease?

Participants will include adults diagnosed with CKD at various stages. Periodontal status will be assessed through clinical parameters such as probing depth, clinical attachment loss, and bleeding on probing. Dietary intake will be evaluated using a validated food frequency questionnaire, and DII scores will be calculated accordingly. The study will aim to observe and analyze whether dietary inflammation contributes to increased periodontal disease severity in CKD patients, potentially offering insight into modifiable risk factors relevant to both systemic and oral health.

详细描述

This observational study will aim to investigate the association between chronic kidney disease (CKD) and periodontitis, with a specific focus on the potential role of dietary inflammatory potential measured by the Dietary Inflammatory Index (DII). Adult participants diagnosed with CKD will be enrolled and their periodontal status will be evaluated using standard clinical parameters, including plaque index, probing depth, clinical attachment loss, and bleeding on probing. Dietary intake data will be collected through a validated food frequency questionnaire, and individual DII scores will be calculated to estimate the inflammatory potential of each participant's diet. The study will analyze whether higher dietary inflammatory load is associated with increased periodontal disease severity in individuals with CKD. Findings from this study are expected to contribute to a better understanding of the interplay between systemic disease, oral health, and modifiable lifestyle factors such as diet.

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
  • Being diagnosed with Chronic Kidney Disease (having an eGFR below 60 ml/min/1.73 m² for at least 3 months or a urine albumin-to-creatinine ratio above 30 mg/g (proteinuria))
  • 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 chronic kidney disease

Chronic kidney disease is diagnosed if the eGFR is below 60 ml/min/1.73 m2 for at least 3 months or if the urine albumin-creatinine ratio is above 30 mg/g (proteinuria).

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 antiinflammatory diet, while a higher score indicates a more proinflammatory 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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