Association Between Periodontitis and Chronic Kidney Disease

NCT07506590 | Not Yet Recruiting

• 1 other identifier: 2025-XJKQIEC-KY-QT-0003-003
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontitis; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Periodontal status

  At baseline

• Renal function

  At baseline

• Gut microbiota composition

  At baseline

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Yu Tang: lead

Biospecimen

Retention: SAMPLES WITH DNA

Oral samples and fecal samples will be collected for microbiota analysis.

MeSH Terms

Conditions

Periodontitis; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Yu Tang

  Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Tang

CONTACT

+8618821788560; 18821788560@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share