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NCT Number: NCT07506590

Association Between Periodontitis and Chronic Kidney Disease

The goal of this observational study is to explore the comorbid association between periodontitis and chronic kidney disease (CKD) based on the oral-renal axis in adults aged 18 to 75 years. The main question it aims to answer is:

Is periodontitis associated with chronic kidney disease through oral-renal axis-related mechanisms?

Participants aged 18 to 75 years will be recruited and undergo clinical assessment, sample collection, and laboratory testing as part of the study. Periodontal status, kidney function, and oral microbiota characteristics will be evaluated to investigate the association between periodontitis and CKD. Fecal samples will also be collected for exploratory analysis of gut microbiota to assess its potential relevance to the oral-renal relationship.

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Key information

Conditions

Periodontitis Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Renal Insufficiency Renal Insufficiency, Chronic Stomatognathic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

This observational case-control study with a cross-sectional design aims to investigate the association between periodontitis and chronic kidney disease in adults aged 18 to 75 years. Participants will be classified into four groups according to the presence or absence of periodontitis and chronic kidney disease: PD(+)/CKD(-), PD(+)/CKD(+), PD(-)/CKD(+), and PD(-)/CKD(-). Periodontal examination, renal function assessment, and biospecimen collection will be performed. Oral samples will be analyzed to characterize oral microbiota, and fecal samples will be collected for exploratory gut microbiota analysis. The study aims to explore the oral-renal association and the potential relevance of gut microbiota to this relationship.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Disease Group: 1. Adults aged 18 to 75 years; 2. No restrictions on sex or race; 3. Diagnosis of at least one target disease, including periodontitis or chronic kidney disease; 4. Ability and willingness to provide written informed consent; 5. Ability to understand the study procedures and comply with study requirements.

Control Group: 1. Adults aged 18 to 75 years; 2. No restrictions on sex or race; 3. No history of diagnosis of periodontitis or chronic kidney disease; 4. Ability and willingness to provide written informed consent; 5. Ability to understand the study procedures and comply with study requirements.

Exclusion criteria

  • Age <18 years or >75 years; 2. Pregnancy or lactation; 3. Current smoking, alcohol abuse, or betel nut chewing; 4. Unhealthy dietary habits, such as frequent intake of high-salt or high-fat foods; 5. Use of antibiotics or probiotics, or receipt of oral/gastrointestinal surgery, within the past 2 months; 6. Fewer than 8 natural teeth remaining; 7. Severe systemic diseases other than the target condition, mental illness, or other conditions that may affect study participation, compliance, or data interpretation; 8. Inability to understand the study procedures; 9. Current participation in another clinical trial.

Treatment and study plan

Primary outcomes

  1. Oral microbiota composition

    Time frame: At baseline

    Oral microbiota composition assessed by sequencing-based analysis of oral samples to explore its association with periodontitis and chronic kidney disease.

Secondary outcomes

  1. Periodontal status

    Time frame: At baseline

    Periodontal status assessed by probing pocket depth (PPD) to evaluate the severity of periodontitis and its association with chronic kidney disease.

  2. Renal function

    Time frame: At baseline

    Renal function assessed by estimated glomerular filtration rate (eGFR) and serum creatinine to evaluate kidney function and its association with periodontal status and oral microbiota characteristics.

  3. Gut microbiota composition

    Time frame: At baseline

    Gut microbiota composition assessed by sequencing-based analysis of fecal samples for exploratory evaluation of its potential association with periodontitis, chronic kidney disease, and the oral-renal relationship.

Study contacts

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

Yu Tang

CONTACT

[email protected]

+8618821788560

Sponsors and collaborators

Lead sponsor

Yu Tang

Other

Registry information

Official study title

Association Between Periodontitis and Chronic Kidney Disease: An Oral-Renal Axis Study With Exploratory Gut Microbiota Analysis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 1, 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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