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Association Between Periodontitis and Chronic Kidney Disease

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07506590
Enrollment
80
Registered
2026-04-01
Start date
2026-05-01
Completion date
2026-12-31
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Periodontitis

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.

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.

Interventions

None listed

Sponsors

Yu Tang
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Periodontal statusAt baselinePeriodontal status assessed by probing pocket depth (PPD) to evaluate the severity of periodontitis and its association with chronic kidney disease.
Renal functionAt baselineRenal 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.
Gut microbiota compositionAt baselineGut 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.

Contacts

CONTACTYu Tang
18821788560@163.com+8618821788560
PRINCIPAL_INVESTIGATORYu Tang

Xi'an Jiaotong University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026