Klotho Gene, Red Complex Bacteria and 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.

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Key information

Conditions

Periodontal Diseases Acute Coronary Artery Disease Mouth Diseases Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.
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.
Pregnant women (pregnancy may alter the oral flora).
Current smokers and individuals who quit smoking less than 6 months.
Patients who have undergone periodontal therapy within the previous 6 months

Treatment and study plan

Primary outcomes

Changes in periodontal parameters

Time frame: Baseline-24 months

Change in periodontal probing depth (measured in mm higher value indicate disease progression)
Change in periodontal variables

Time frame: Baseline - 2 years

Change in Clinical attachment level (measured in mm higher value indicate disease progression)
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)
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)

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 1, 2026
Registry last updated: Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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