TLR4 gene change and periodontitis in adults with end-stage kidney disease
Official title: The Role of Toll-like Receptor-4 in Periodontitis Patients With End-stage Renal Disease in a Sample of Egyptian Population
Run by Ain Shams University · NCT06755372 · Data updated 2026-11-12
This project will test whether a specific TLR4 gene change (rs2149356) is linked to periodontitis in adults aged 30–60 who are on hemodialysis for end-stage kidney disease compared with otherwise healthy adults who also have periodontitis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Al Fayyum, Faiyum Governorate) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | July 1, 2025 |
| Study ends | August 1, 2025 |
| Registry record updated | July 4, 2025 |
| Trial ID | NCT06755372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Egyptian adults 30–60 years old with stage II or III periodontitis who are either on regular hemodialysis for ESRD (including those with type 2 diabetes) or are systemically healthy controls without long-term medications.
✕Probably not a fit
People who are current smokers, have had a kidney transplant, have other systemic diseases (except diabetes in the ESRD group), or have a history of malignancy are excluded and unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares Egyptians aged 30–60 with end-stage renal disease on regular hemodialysis and stage II/III periodontitis to unrelated, systemically healthy controls who also have periodontitis. Participants will receive dental exams to confirm periodontitis staging and provide blood or saliva samples for genotyping of the TLR4 Gly/Thr (rs2149356) polymorphism. Key exclusions include current smokers, transplant recipients, people with malignancy, and those with systemic diseases other than type 2 diabetes (permitted in the ESRD group). The work is conducted at the Benha University Hospital hemodialysis center and is sponsored by Ain Shams University.
Why it matters
Potential benefit: If a link is found, testing for the TLR4 variant could help identify ESRD patients at higher risk of severe periodontitis and support earlier dental monitoring or preventive care.
How similar studies have gone: Previous studies have reported links between TLR4 variants and inflammatory conditions including periodontitis and CKD, but findings are inconsistent and the rs2149356 variant has limited prior testing in Egyptian ESRD patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Group I: Healthy Subjects with Periodontitis Inclusion Criteria: Age: 30 to 60 years Gender: Both male and female Diagnosed with Periodontitis stage II and/or stage III Systemically healthy, no history of systemic diseases Not on long-term medications Exclusion Criteria: Smokers Individuals with any systemic disease or long-term medication use Group II: ESRD Patients with Periodontitis Inclusion Criteria: Age: 30 to 60 years Gender: Both male and female Diagnosed with end-stage renal disease (ESRD) on regular hemodialysis Diagnosed with Periodontitis stage II and/or stage III Unrelated Egyptians from a similar socioeconomic status, residing in the same geographical area Underlying type 2 diabetes mellitus Exclusion Criteria: Individuals with kidney transplants Individuals with systemic diseases other than diabetes History of malignancy Smokers
Where it's running
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hemodialysis center at Benha University Hospital.
Al Fayyum, Faiyum Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Fatma E. A. Hassanein, PHD — king Salman Intwenational University University
- Study coordinator: Asmaa Bakr elshaf3y, PHD
- Email: Asmaa.AbdAlRaouf@gu.edu.eg
- Phone: 01000093885
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.