PeriodontitisNCT07506590
Association Between Periodontitis and Chronic Kidney Disease
An observational study of Periodontitis and Chronic Kidney Diseases, run by Yu Tang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Chronic Kidney Diseases
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Chronic Kidney Diseases
- Medical subject headings
- Periodontitis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Oral microbiota composition
Oral microbiota composition assessed by sequencing-based analysis of oral samples to explore its association with periodontitis and chronic kidney disease.
Measured: At baseline
Secondary outcomes (3)
Periodontal status
Periodontal status assessed by probing pocket depth (PPD) to evaluate the severity of periodontitis and its association with chronic kidney disease.
Measured: 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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Tang, Xi'an Jiaotong University
- Investigators
- Yu Tang, Principal investigator, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506590
- Sponsor's protocol ID
- 2025-XJKQIEC-KY-QT-0003-003
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Periodontitis and Chronic Kidney Disease: An Oral-Renal Axis Study With Exploratory Gut Microbiota Analysis
- ClinicalTrials.gov ID
- NCT07506590
- Acronym / sponsor ID
- 2025-XJKQIEC-KY-QT-0003-003
- Conditions
- Periodontitis, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yu TangUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Periodontal status
Time frame: At baseline
Renal function
Time frame: At baseline
Gut microbiota composition
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu Tang principal investigator
Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Chronic Kidney Diseases, run by Yu Tang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Tang (+8618821788560, 18821788560@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbiota composition (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.