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Not yet recruiting NCT07427069

Chronic Kidney Disease Associated Diet

— Observational Chronic Kidney Disease Periodontitis Diet, Food and Nutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease, Periodontitis, Diet, Food and Nutrition. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Dietary Inflammatory Index [Time frame: Day 1]
Secondary outcome measures (5)
  • Clinical Periodontal Parameters (Plaque Index) [Time frame: Day 1]
  • Clinical Periodontal Parameters (Gingival Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Bleeding on Probing Index) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Probing Pocket Depth) [Time frame: Day 1]
  • Periodontal Clinical Parametres (Clinical Attachment Loss) [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan Universit — Rize

Identifiers

NCT: NCT07427069 · KBHDiet09/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗