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NCT Number: NCT07427069

Chronic Kidney Disease Associated Diet

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dietary Inflammatory Index

    Time frame: 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.

Secondary outcomes

  1. Clinical Periodontal Parameters (Plaque Index)

    Time frame: Day 1

    Plaque Index (PI) (Silness and Löe, 1964) This index is used to evaluate the amount of dental plaque accumulation on tooth surfaces. Each tooth's four surfaces (buccal, lingual, mesial, distal) are examined using a probe or visually. Each surface is scored from 0 to 3. The average score is calculated for each tooth. The overall plaque index is obtained by averaging the scores from all examined teeth.

    Score Description 0 No plaque.

    • No visible plaque, but a slight film of plaque is detected when a probe is run along the gingival margin.
    • Visible plaque along the gingival margin, forming a continuous band.
    • Abundant plaque covering the gingival area and extending toward the middle of the tooth surface, including the interproximal spaces.
  2. Clinical Periodontal Parameters (Gingival Index)

    Time frame: Day 1

    The Gingival Index is used to assess the presence and severity of gingival inflammation (gingivitis). Four surfaces of each tooth (buccal, lingual, mesial, distal) are examined visually and with a periodontal probe. The evaluation considers color changes, edema (swelling), tissue consistency, and bleeding on probing. Each surface is scored from 0 to 3. The average score per tooth is calculated, and then the overall average is used to determine the individual's GI score.

    Score Description 0 Healthy gingiva: normal color and texture, no bleeding

    • Mild inflammation: slight color change and swelling, no bleeding on probing
    • Moderate inflammation: redness, edema, soft tissue, bleeding on probing
    • Severe inflammation: marked redness and swelling, ulceration, possible spontaneous bleeding
  3. Periodontal Clinical Parametres (Bleeding on Probing Index)

    Time frame: Day 1

    This index is used to assess the presence and severity of gingival inflammation by observing bleeding after gentle pressure is applied to the gingival sulcus using a periodontal probe. A thin periodontal probe is gently inserted into the gingival sulcus with light pressure (approximately 20-25 grams). Bleeding occurring within 10-30 seconds is observed. Each measurement site is recorded as either "bleeding present" or "bleeding absent." Presence of bleeding is an early and sensitive indicator of gingival inflammation.

    Score Description: 0 No bleeding 1 Bleeding present (mild or severe)

  4. Periodontal Clinical Parametres (Probing Pocket Depth)

    Time frame: Day 1

    Using a Williams periodontal probe, the distance between the gingival margin and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.

    Measurement Interpretation 1-3 mm Healthy sulcus 4-5 mm Shallow to moderate pocket

    ≥6 mm Deep periodontal pocket (advanced disease)

  5. Periodontal Clinical Parametres (Clinical Attachment Loss)

    Time frame: Day 1

    Using a Williams periodontal probe, the distance between the enamel-cementum junction and the base of the periodontal pocket is measured in millimeters at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual. All teeth are measured. The values obtained from each site are summed and then divided by the total number of sites measured. This gives the average probing depth for the individual.

    CAL Value Interpretation 0-1 mm Healthy / minimal loss 2-3 mm Mild attachment loss 4-5 mm Moderate attachment loss

    ≥6 mm Severe attachment loss

Other outcomes

  1. Creatinine

    Time frame: Day 1

    Creatinine is a waste product generated from muscle metabolism and excreted by the kidneys; its serum level is used to assess renal function.

  2. Albumin

    Time frame: Day 1

    Albumin is the main serum protein synthesized by the liver that maintains plasma oncotic pressure; it provides information about nutritional status and kidney function.

  3. Blood urea nitrogen

    Time frame: Day 1

    Blood urea nitrogen (BUN) represents the amount of nitrogen in the blood derived from urea, a byproduct of protein metabolism, and is an indicator of renal function.

  4. Glomerular filtration rate

    Time frame: Day 1

    Glomerular filtration rate (GFR) indicates the volume of blood filtered by the kidneys per minute and is a key parameter for evaluating renal function.

  5. High-sensitivity C-reactive protein

    Time frame: Day 1

    High-sensitivity C-reactive protein (hsCRP) is a sensitive marker used to detect low-grade systemic inflammation.

  6. Vitamin D

    Time frame: Day 1

    Vitamin D is a fat-soluble vitamin that regulates calcium-phosphorus metabolism and plays a role in bone health and immune function.

  7. Uric acid

    Time frame: Day 1

    Uric acid is the end product of purine metabolism, and elevated levels are associated with gout and kidney disease.

  8. Ferritin

    Time frame: Day 1

    Ferritin is a protein responsible for iron storage in the body, and its serum level reflects iron stores.

  9. Iron

    Time frame: Day 1

    Iron is an essential trace element involved in hemoglobin synthesis and oxygen transport.

  10. Phosphorus

    Time frame: Day 1

    Phosphorus is an essential mineral involved in bone mineralization and cellular energy metabolism.

  11. Calcium

    Time frame: Day 1

    Calcium is a vital mineral required for bone and dental health, muscle contraction, and nerve transmission.

  12. Parathyroid hormone

    Time frame: Day 1

    Parathyroid hormone (PTH) is a hormone secreted by the parathyroid glands that regulates calcium and phosphorus balance.

  13. Platelet

    Time frame: Day 1

    Platelets are anucleate blood cell fragments derived from megakaryocytes in the bone marrow, and their primary function is to participate in blood clot formation (hemostasis) to prevent bleeding.

  14. Lymphocyte

    Time frame: Day 1

    Lymphocytes are key cells of the adaptive immune system and mainly consist of T cells, B cells, and natural killer (NK) cells; they generate specific immune responses against infections and foreign antigens.

  15. Neutrophil

    Time frame: Day 1

    Neutrophils are the most abundant leukocytes in the innate immune system and constitute the first line of defense against bacterial infections by destroying microorganisms through phagocytosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Oguz KOSE, Professor Dr.

CONTACT

[email protected]

+90 541 348 64 65

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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