Association Between Periodontitis and Chronic Kidney Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases; Periodontitis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Yu Tang; Phone Number: +8618821788560; Email: 18821788560@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 75 years will be recruited from the College of Stomatology, Xi'an Jiaotong University. The study population will include participants with periodontitis and/or chronic kidney disease, as well as healthy controls without a history of periodontitis or chronic kidney disease. All participants must be able to provide written informed consent and comply with study procedures.

Description

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

1. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
PD(+)/CKD(-); Participants with periodontitis but without chronic kidney disease.
PD(+)/CKD(+); Participants with both periodontitis and chronic kidney disease.
PD(-)/CKD(+); Participants with chronic kidney disease but without periodontitis.
PD(-)/CKD(-); Healthy controls without periodontitis or chronic kidney disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral microbiota composition	Oral microbiota composition assessed by sequencing-based analysis of oral samples to explore its association with periodontitis and chronic kidney disease.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal status	Periodontal status assessed by probing pocket depth (PPD) to evaluate the severity of periodontitis and its association with chronic kidney disease.	At baseline
Renal function	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.	At baseline
Gut microbiota composition	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.	At baseline

Collaborators and Investigators

• Sponsor: Yu Tang
• Investigators: Principal Investigator: Yu Tang, Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Periodontitis; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2025-XJKQIEC-KY-QT-0003-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No