NCT07427069

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

February 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2026

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 15, 2026

Last Update Submit

February 21, 2026

Conditions

Keywords

Chronic kidney diseaseperiodontitisdietinflammation

Outcome Measures

Primary Outcomes (1)

  • Dietary Inflammatory Index

    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.

    Day 1

Secondary Outcomes (5)

  • 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

Other Outcomes (15)

  • Creatinine

    Day 1

  • Albumin

    Day 1

  • Blood urea nitrogen

    Day 1

  • +12 more other outcomes

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with chronic kidney disease who come to the Periodontology Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry for routine periodontal treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology of the Faculty of Dentistry of Recep Tayyip Erdogan University

Rize, Rize Province, 53200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood samples Routine blood tests will include biomarkers such as creatinine, albumin, blood urea nitrogen, GFR, hsCRP, vitamin D, platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), uric acid, ferritin, iron, phosphorus, calcium, and parathyroid hormone. The spot urine albumin-to-creatinine ratio (ACR) will be recorded.

MeSH Terms

Conditions

Renal Insufficiency, ChronicPeriodontitisInflammation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Oguz KOSE, Professor Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 23, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

November 16, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations