The Role of Toll-like Receptor-4 in Periodontitis Patients With End-stage Renal Disease in a Sample of Egyptian Population

NCT06755372 | Recruiting

• 1 other identifier: R-625
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) is a significant public health issue in Egypt, leading to end-stage renal disease (ESRD). ESRD patients often suffer from oral abnormalities due to the disease and medications. Periodontitis is linked to systemic diseases, including renal disease, with inflammation playing a key role. TLR4 genetic variations may influence susceptibility to CKD and periodontitis. This study investigates the association between TLR4 \[Gly/Thr (rs2149356)\] polymorphism and chronic periodontal disease in ESRD patients in Egypt.

Conditions

Periodontitis; End-stage Renal Disease

Keywords

Chronic Kidney Disease; End-Stage Renal Disease; Periodontitis; Toll-like Receptor 4; Genetic Polymorphism

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level (CAL):

  Description: The CAL measures the extent of periodontal support around a tooth, from the cementoenamel junction (CEJ) to the base of the pocket, crucial for diagnosing periodontal disease. Measurement Method: CAL is recorded using a periodontal probe by measuring probing depth (PD) and distance from the gingival margin to the CEJ. CAL is calculated as follows: CEJ at gingival margin: CAL = PD Gingival margin coronal to CEJ: CAL = PD - Distance from Gingival Margin to CEJ Gingival margin apical to CEJ: CAL = PD + Distance from CEJ to Gingival Margin in non- periodontitis individuals CAL is zero

  single point "Baseline"

Secondary Outcomes (1)

• Bleeding on Probing (BOP)

  single point "Baseline"

Other Outcomes (1)

• Genetic Analysis - TLR4 SNP Genotyping

  single point "Baseline"

Study Arms (2)

Healthy Subjects with Periodontitis

Description: This group consists of 50 systemically healthy individuals diagnosed with periodontitis. Participants are of both genders, aged between 30 and 60 years. They have Periodontitis stage II and/or stage III and do not have any history of systemic diseases or long-term medication use. All smokers were excluded from this group. Interventions of Interest: Clinical assessment of periodontal parameters such as Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Clinical Attachment Level (CAL) using standard methods. Evaluation of the proportion of bleeding sites as a Bleeding on Probing (BOP) score.

ESRD Patients with Periodontitis

Description: This group includes 50 individuals diagnosed with end-stage renal disease (ESRD) who are on regular hemodialysis. Participants are of both genders, aged between 30 and 60 years, and unrelated Egyptians from similar socioeconomic statuses residing in the same geographical area. They also suffer from Periodontitis stage II and/or stage III. All participants have underlying type 2 diabetes mellitus. Exclusions include those with kidney transplants, other systemic diseases except diabetes, history of malignancy, and smokers. Interventions of Interest: Clinical assessment of periodontal parameters similar to Group I, including PI, GI, PD, and CAL. Analysis of genetic variations in the TLR4 gene through blood sample collection and DNA extraction. SNP genotyping in the TLR4 gene performed using Real Time Polymerase Chain Reaction (RT-PCR).

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Group I: Healthy Subjects with Periodontitis Number of Participants: 50 These individuals were systemically healthy but had periodontal disease. They were recruited from the Periodontology Clinic at the Faculty of Dentistry, Fayoum University. Group II: ESRD Patients with Periodontitis Number of Participants: 50 Description: These individuals had ESRD and periodontal disease. They were recruited from the hemodialysis center at Benha University Hospital.

You may qualify if:

• 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

You may not qualify if:

• Smokers
• Individuals with any systemic disease or long-term medication use
• Group II: ESRD Patients with Periodontitis
• 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
• Individuals with kidney transplants
• Individuals with systemic diseases other than diabetes
• History of malignancy
• Smokers

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

hemodialysis center at Benha University Hospital.

Al Fayyum, Faiyum Governorate, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples: Whole blood collected in EDTA-containing vacutainer tubes. This is essential for extracting genomic DNA. DNA Samples: Genomic DNA extracted from the collected blood samples. These DNA samples will be used for genetic analysis, including SNP genotyping in the TLR4 gene.

MeSH Terms

Conditions

Periodontitis; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Macular Degeneration, Age-Related, 10

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

• Fatma E. A. Hassanein, PHD

  king Salman Intwenational University University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Bakr elshaf3y, PHD

CONTACT

01000093885; Asmaa.AbdAlRaouf@gu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 1, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

EG (1)