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PeriodontitisNCT06755372

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

An observational study of Periodontitis and End-stage Renal Disease, run by Ain Shams University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis, End-stage Renal Disease
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 1 Aug 2025
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 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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
  • Age: 30 to 60 years
Show all 11Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Asmaa Bakr elshaf3y, PHD contact

01000093885

Asmaa.AbdAlRaouf@gu.edu.eg

Egypt1 site, 1 recruiting
  • hemodialysis center at Benha University Hospital.

    Al Fayyum, Faiyum Governorate

    Nermeen Nagi assistant lecturer of Fixed Prosthodontics, Faculty of Dentis, msc, 01000093885, dr.nermeennagi@hotmail.com

    Recruiting

Other trials in Egypt

About this study

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.

Read the detailed description

Chronic kidney disease (CKD), which ranks sixth among the top causes of death from 2009 to 2019, has become 36% more prevalent in Egypt, following the global trend (The Center for Economic and Social Rights: 2021).

Since untreated CKD can lead to end-stage renal disease (ESRD), which is the complete loss of renal function when patients are dialysis-dependent and require a kidney transplant, CKD has emerged as a significant public health issue in Egypt (Chen et al., 2024).

According to the most recent data available, the prevalence of dialysis in Egypt was 0.61 per 1000 persons in 2019; the incidence was estimated to be 0.19 per 1000 people (Bello et al., 2029; Farag et al., 2022).

ESRD patients exhibit a variety of oral abnormalities, as the disease and the medications taken by those patients might exacerbate or cause the development of caries, periodontal disease, mucosal lesions, decreased saliva production, and other oral disorders (Trzcionka et al., 2020).

Periodontitis is a widely prevalent inflammatory and infectious disease affecting the supporting structure of the teeth. In the past few decades, the association between periodontitis and systemic diseases has received much attention (Abou-Bakr et al., 2022; Mainas et al., 2022).

There is increasing evidence to suggest that renal disease and periodontitis are strongly correlated (Kapellas et al., 2019; Li et al., 2021). Furthermore, periodontitis has been implicated in the decline in renal function, cardiovascular outcomes, and also mortality of CKD patients (Lertpimonchai et al., 2019; Tai et al., 2021).

Apart from inadequate oral hygiene and the prevalence of inflammatory diseases, renal osteodystrophy, elevated urea levels, alterations in salivary composition, and host factors linked to underlying systemic diseases that modify the host's reaction to periodontal infection are additional factors that accelerate periodontal disease in patients with ESRD (Pakpour et al., 2015).

While CKD susceptibility is known to be influenced by traditional risk factors, such as age, hypertension, diabetes, and dyslipidemia, emerging evidence indicates that nontraditional risk factors, such as chronic inflammation-mediated activation of the innate immune system, also contribute to the pathogenesis of CKD and diabetic nephropathy (DN) (Lin and Tang, 2014; Verzola et al., 2014).

Toll-like receptor 4 (TLR4) is one of the key components of the mammalian innate immune system. Binding of exogenous and endogenous ligands activates TLR4, which in turn triggers a signaling cascade, leading to initiation of an adaptive and innate immune response. Genetic variations in TLR4 are thought to alter the ligand-binding capacity and contribute to the chronic inflammation-mediated pathogenesis of many diseases (Noreen and Arshad, 2015).

TLR4 binds to the exogenous ligands, such as hyaluronan, heparan sulfate, or fibrinogen, and promotes renal injury by increasing inflammation (Lin and Tang, 2014). Chronic inflammation-mediated activation of the innate immune system has been implicated in the pathogenesis of CKD/DN. In diabetes, TLR4 may sense high glucose, free fatty acids, and advanced glycation end products as signal molecules and trigger the inflammatory signaling cascade to contribute to DN (Verzola et al., 2014).

In DN patients, TLR4 expression was found to be upregulated in glomeruli with a subsequent decline in eGFR. TLR4 expression was associated with increased expression of TGF-β1 in kidney biopsies from patients with CKD/DN (Lepenies et al., 2011). In summary, it is evident that TLR4 activation likely contributes to DN (Thameem et al., 2016).

According to Murphy et al. (1993), genetic predisposition is the difference in immune-related DNA molecules within the host that influences the development and occurrence of disease. Investigating the variations in immune-related molecules responsible for susceptibility and prevention of periodontitis is crucial because a set of host genetic variants may contribute to the occurrence and development of chronic periodontitis by selectively engaging in the pathophysiological process (Gordon et al., 2002).

Immunologically competent cells express a class of trans membrane proteins known as Toll-like Receptors (TLRs) (Medzhitov et al., 1997). They identify and bind MAMPs, or microorganism-associated molecular patterns, which are produced by bacteria and are important molecules for the eradication of microbes (Takeda et al., 2003).

TLR4 is also expressed in gingival epithelial keratinocytes, fibroblasts, and antigen-presenting cells. Lipopolysaccharide (LPS) of Gram-negative bacteria periopathogens, such as Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, and Veillonella parvula, has been demonstrated to be specifically recognized by TLR4. These bacteria collaborate with multiple protein components, including lipopolysaccharide binding protein (LBP) and CD14 (Yoshimora et al., 2002; Mori et al., 2003).

According to Uematsu S. et al. (2008), this causes the NF-kB pathway to activate the inflammatory cells, which in turn activates the cytokine network. Bone loss symptoms are caused by cytokines such IL-6, IL-8, and TNF-α, as well as matrix metalloproteinase and prostaglandin E2. (Giannobile et al., 2008). Additionally, in a periodontal paradigm, TLR-4-deficient C3H/HeJ mice showed decreased bone resorption, suggesting that TLRs may be essential for the development and susceptibility of periodontitis (Hou et al., 2009).

The TLR4 genes' single nucleotide polymorphisms (SNPs) have been shown to result in reduced cytokine production by epithelial cells in response to LPS stimulation and impaired microbe detection (Schroder et al., 2005). Hence, after being stimulated by bacteria in periodontal tissues, TLRs take part in innate immune responses and inflammatory reactions. Nonetheless, there is disagreement on the degree to which these receptors influence individual variations in periodontitis susceptibility (Ding et al., 2015).

Through a variety of pattern-recognition receptors, the host immune system predominantly identifies invasive infections. These receptors identify pathogen-associated molecular patterns (PAMPs) that are conserved and generally shared by broad assemblages of microorganisms, such as lipopolysaccharide-producing bacteria (Folwaczny et al., 2004).

The transmembrane receptors known as Toll-like receptors belong to the evolutionary conserved interleukin-1 super-family and are capable of identifying molecular patterns linked to pathogens (Takeda K, Akira, 2003). The Toll/IL-1R (TIR) domain refers to the cytoplasmic domain of Toll-like receptors that exhibits strong similarities to the intracellular region of the interleukin-1 (IL-1) receptor family (Aderem and Ulevitch, 2000).

Leucine-rich repeats (LRRs) are present in the Toll-like receptor extracellular domain.Lipopolysaccharide is the primary cause of inflammation in gram-negative bacterial infections, and Toll-like receptor-4 plays a critical role in mediating its effects, which include activating the inflammatory molecular cascade through the NFκB pathway (Medzhitov et al., 1997). Lipopolysaccharide-binding protein (LBP), the CD14 receptor, and the MD-2 protein are three additional molecules that are necessary for the identification and transmission of the lipopolysaccharide signal through the Toll-like receptor-4. Numerous other organs, including endothelial cells, macrophages, cardiomyocytes, and airway epithelia, express the TLR-4 protein. (Zarember and Godowski 2002).

Two frequently occurring segregating missense variants that impact the extracellular domain of the TLR4 protein have been identified: Asp299Gly and Thr399Ile (Arbour et al., 2000). The two mutations cause LPS signaling to be less effective and less able to cause inflammation. Individuals with these mutations were consistently found to have an elevated risk of gram-negative infections and a much lower risk of atherosclerosis. (Agnese et al., 2002).

Since TLR4 is a crucial mediator between pathogen-produced substances and the start of host defense, variations in the TLR4 gene may play a significant role in an individual's vulnerability to bacterial infections, which in turn may have an impact on the inflammatory process (Akira et al., 2003).

TLR4 SNPs have also been demonstrated to affect the risk of various multifactorial disorders. These findings suggest that TLR4 gene sequence variants with abnormal function, may contribute to the development of various diseases, including multifactorial disorders (Shibuya et al., 2008).

In a previous study by Farouk et al., 2021, it was concluded that TLR4 SNP rs2149356 was linked with chronic periodontitis in an Egyptian sample. Thus, the aim of the present study is to investigate the association between the genetic variations of TLR-4 [Gly/Thr (rs2149356)] and chronic periodontal disease in ESRD. To the best of the authors knowledge, no published studies from the Middle East and North Africa region exist, and there's a gap of knowledge in the role of the TLR-4 [Gly/Thr (rs2149356)] gene polymorphism in relation to ESRD patients with chronic periodontitis in the North African Egyptian subjects.

Keywords
Chronic Kidney Disease, End-Stage Renal Disease, Periodontitis, Toll-like Receptor 4, Genetic Polymorphism
Medical subject headings
Periodontitis, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Macular Degeneration, Age-Related, 10

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06755372
Study groupRoleWhat they receive
Healthy Subjects with PeriodontitisDescription: 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 PeriodontitisDescription: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: single point "Baseline"

Secondary outcomes (1)
  1. Bleeding on Probing (BOP)

    Description: BOP is a clinical measurement used to assess gingival inflammation. It indicates the presence of bleeding in the gums after they are gently probed, reflecting the health of the gingival tissues.

    Measurement Method: A standardized manual probe with controlled force is used to probe the bottom of the sulcus or periodontal pocket at six locations around each tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual). The presence or absence of bleeding is recorded within 10 seconds of probing.

    Measured: single point "Baseline"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

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
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06755372
Sponsor's protocol ID
R-625
Status last verified
Jul 2025
First submitted
31 Dec 2024
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and End-stage Renal Disease, run by Ain Shams University at 1 site in Egypt.

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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Asmaa Bakr elshaf3y, PHD (01000093885, Asmaa.AbdAlRaouf@gu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Attachment Level (CAL): (time frame: single point "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 4 Jul 2025.

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