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

NCT07504744 | Not Yet Recruiting

• 1 other identifier: MADC/IEC/I/28/2025
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontal Diseases; Acute Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• Changes in periodontal parameters

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

  Baseline-24 months

• Change in periodontal variables

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

  Baseline - 2 years

• Change in periodontal criteria

  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

  Changes in Gingival index (measure as a ratio, (0-3)higher value indicates severity of gingival inflammation)

  Baseline - 2 years

Study Arms (4)

Healthy volunteers

Periodontitis patients without acute coronary syndrome

Acute coronary syndrome patients without periodontitis

Periodontitis and acute coronary syndrome patients

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and Professor, Department of Periodontics

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): November 9, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08