Klotho Gene, Red Complex Bacteria and Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome

April 1, 2026 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Evaluation of the Expression of Klotho Gene and Its Protein Level, Determination of Red Complex Bacteria, and the Estimation of Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome

The Klotho gene was initially identified as an aging suppressor gene, but subsequent research revealed its multifaceted functions, encompassing antioxidant defense, anti-inflammatory effects, calcium and phosphorus balance, metabolic regulation, and anti-apoptotic activity. It encodes a single pass transmembrane protein and is expressed primarily in renal tubules. The Klotho protein exists in two forms: membrane-bound and secreted. Membrane Klotho acts as a co-receptor for FGF23, a bone-derived hormone, while secreted Klotho regulates various cell surface glycoproteins, including ion channels and growth factor receptors. Klotho has recently emerged as a potential biomarker for coronary heart disease, with evidence suggesting its involvement in the disease's pathophysiology.

The red complex, comprising Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia harbors key pathogens in adult periodontal disease. These bacteria possess various virulence factors, including fimbriae, lipopolysaccharides, and proteases in P. gingivalis, which disrupt inflammatory and immune responses and degrade connective tissue proteins. T. forsythia produces a trypsin-like protease, sialidase, hemagglutinin, and BspA, contributing to alveolar bone loss. Meanwhile, T. denticola disrupts the host cell extracellular matrix, penetrates tissue, and dysregulates immunoregulatory factors, further exacerbating periodontal disease. Similarly, Herpes Simplex Virus 1 (HSV-1), human Cytomegalovirus (HCMV) and Epstein Barr Virus (EBV) have been implicated in the pathogenesis of periodontal disease. The expressions of viruses along the red complex bacteria would provide further evidence of periodontal risk in progression of acute coronary artery disease.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The selected subjects will be categorized into the following groups:

GROUP I: Healthy volunteers. GROUP II: Periodontitis patients without acute coronary syndrome. GROUP III: Acute coronary syndrome without periodontitis GROUP IV: Periodontitis and acute coronary syndrome

Study Type

Observational

Enrollment (Estimated)

108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

GROUP I

  • Systemically healthy subjects with healthy periodontium having probing pocket depth (PPD) ≤ 3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites. GROUP II
  • Systemically healthy subjects with periodontitis having interdental clinical attachment loss ≥ 3-5mm (stage II/III periodontitis) and probing pocket depth (PPD) ≥ 5mm (stage I/III periodontitis) and bleeding on probing ≥ 10% of sites. GROUP III
  • Patients diagnosed with acute coronary syndrome with healthy periodontium having probing pocket depth (PPD) ≤ 3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites GROUP IV
  • Acute coronary syndrome patients with periodontitis having interdental clinical attachment loss ≥ 3-5mm (stage II/III periodontitis) and probing pocket depth (PPD) ≥ 5mm (stage II/III periodontitis) and bleeding on probing ≥ 10%.

Description

Inclusion Criteria:

  1. Patients willing to participate in the study.
  2. Male and female patients within the age group of 30-65 years.
  3. Patients having ≥ 10 remaining natural teeth.
  4. No history of long-term antibiotic use in past 6 months.

Exclusion Criteria:

  1. Subjects with systemic conditions such as type I and type I diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
  2. Subjects on drugs such as corticosteroids or antibiotics within 6 months of investigation or antiepileptic drugs (phenytoin or cyclosporine) having an impact on periodontal tissues will be excluded.
  3. Pregnant women (pregnancy may alter the oral flora).
  4. Current smokers and individuals who quit smoking less than 6 months.
  5. Patients who have undergone periodontal therapy within the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Periodontitis patients without acute coronary syndrome
Acute coronary syndrome patients without periodontitis
Periodontitis and acute coronary syndrome patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in periodontal parameters
Time Frame: Baseline-24 months
Change in periodontal probing depth (measured in mm higher value indicate disease progression)
Baseline-24 months
Change in periodontal variables
Time Frame: Baseline - 2 years
Change in Clinical attachment level (measured in mm higher value indicate disease progression)
Baseline - 2 years
Change in periodontal criteria
Time Frame: Baseline - 2 years
Change in plaque index (measured as a ratio, range: 0 to 3, maximum value indicates worse outcome and minimum value indicates better outcome)
Baseline - 2 years
Change in periodontal variables
Time Frame: Baseline - 2 years
Changes in Gingival index (measure as a ratio, (0-3)higher value indicates severity of gingival inflammation)
Baseline - 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meenakshi Ammal Dental College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

October 3, 2026

Study Completion (Estimated)

November 9, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADC/IEC/I/28/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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