Cofilin-2 (rs80358250) and Lactoferrin (rs1126478) Polymorphism and Protein Levels With Non Surgical Periodontal Therapy in Periodontitis Patients With and Without CHD

January 20, 2026 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Determination of Cofilin-2 (rs80358250) and Lactoferrin (rs1126478) Genetic Polymorphism and Change in Their Protein Levels Before and After Non-surgical Periodontal Therapy in Periodontitis Patients With and Without Coronary Heart Disease - An Interventional Study.

Periodontitis is a chronic multifactorial inflammatory disease associated with the accumulation of dental plaque and characterized by progressive destruction of the teeth-supporting apparatus, including the periodontal ligament and alveolar bone. Dental plaque accumulation at the gingival margin initiates an inflammatory response that, in turn, causes microbial alterations and may lead to drastic consequences in the periodontium of susceptible individuals. The pathophysiology of periodontitis is influenced by the relationship between the host immune system and periodontal pathogens. The presence of periodontal pathogens and their metabolic by-products in the oral cavity may get disseminated to the systemic circulation which may pose a risk for various systemic diseases such as cardiovascular disease, oral and colorectal cancer, gastrointestinal diseases, respiratory tract infection, adverse pregnancy outcomes and diabetes.

Although pathogenic bacteria and various other environmental factors are involved in pathogenesis of periodontitis, genetic factors are also known to play a pivotal role in influencing the inflammatory and immune response. Genetic polymorphisms are alterations in the DNA sequence found in general population. Most forms of periodontitis represent a life-long account of interactions between the genome and the environment. The previous literature has stated a strong association of genetic polymorphisms in periodontitis and coronary artery diseases. Identifying these polymorphisms can potentially lead to a better understanding of the mechanisms modulating the expression of inflammatory mediators as well as provides potential therapeutic targets in the prevention of periodontal disease. Two such novel polymorphisms have gained attention recently, namely the Cofilin-2 and Lactoferrin polymorphisms.

Cofilin is one of the most affluent and common actin-binding proteins and plays a role in cell motility, migration, shape, and metabolism. They also play an important role in severing actin filament, nucleating, depolymerizing and bundling activities. Cofilin is the major ADF/cofilin isoform in mammalian neurons influences the dynamics of actin assembly by severing or stabilizing actin filaments. Cofilin-2 is the only isoform present in mature skeletal muscles. It is composed of 5 α helices, 5 β sheets, and 1 C-terminal β short chain, with a molecular weight of 18 kDa. Cofilin-2 is a member of the AC group of proteins that also includes cofilin-1 and destrin, all of which regulate actin-filament dynamics. Recently, Cofilin 2 gained attention as an emerging biomarker for coronary heart diseases. Cofilin-2 has shown to play a role in pathophysiology of coronary heart disease.

Lactoferrin is a multifunctional protein of the transferrin family. Lactoferrin is a globular glycoprotein with a molecular mass of about 80 kDa that is widely represented in various secretory fluids, such as milk, saliva, tears and nasal secretions. Lactoferrin, a multifunctional iron-binding glycoprotein, is involved in coronary heart disease pathophysiology. Recent studies reported that Lactoferrin polymorphism is associated with an increased risk of coronary artery disease in the elderly population.

Studies have been done to identify Lactoferrin genetic polymorphisms, however none of the studies have explored the role of Lactoferrin (rs1126478) and its protein level in subjects with both periodontal disease and coronary heart disease occurring as a continuum. Its expression in periodontitis and coronary heart disease patients is yet to be explored. Genetic polymorphism and protein levels of Cofilin-2 (rs80358250) has been never studied in coronary heart disease and periodontitis. This may further improve our understanding of the influence of this polymorphism on the above mentioned systemic diseases.

NEED FOR THE STUDY While there are studies which have demonstrated the expression of Cofilin-2 and Lactoferrin polymorphisms in various inflammatory conditions, there are no studies to state their expression in the subgingival plaque samples of periodontitis patients with coronary artery disease, specifically before and after non-surgical therapy. Also, the correlation of both these polymorphisms and their levels with periodontal and cardiac parameters has never been investigated so far. It is suggested that these polymorphisms may play a role as putative risk indicators in periodontitis subjects with coronary heart disease which may alter following non-surgical periodontal therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600095
        • Kilpauk medical college and hospital
      • Chennai, Tamil Nadu, India, 600095
        • Meenakshi Ammal Dental College and Hospital

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

Description

Inclusion Criteria:

  1. Patient willing to participate in the study.
  2. Male and female patients with the age group of 30 to 65 years.
  3. Patient having more than or equal to 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 II 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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP I: 21 systemically healthy subjects with healthy periodontium.
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.
Procedure: Scaling and root planing
Scaling and root planing is a deep cleaning below the gumline used to treat gum disease. Gum disease is caused by a sticky film of bacteria called plaque. Plaque is always forming on your teeth, but if they aren't cleaned well, the bacteria in plaque can cause your gums to become inflammed.
Experimental: GROUP II: 21 periodontitis patients without coronary heart disease
Systemically healthy subjects 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% of sites.
Procedure: Scaling and root planing
Scaling and root planing is a deep cleaning below the gumline used to treat gum disease. Gum disease is caused by a sticky film of bacteria called plaque. Plaque is always forming on your teeth, but if they aren't cleaned well, the bacteria in plaque can cause your gums to become inflammed.
Experimental: GROUP III: 21 coronary heart disease patients without periodontitis
Patients diagnosed with coronary artery disease with healthy periodontium having probing pocket depth (PPD)≤3mm, no clinical attachment loss (CAL=0) and bleeding on probing ≤ 10% of sites (CAD).
Procedure: Scaling and root planing
Scaling and root planing is a deep cleaning below the gumline used to treat gum disease. Gum disease is caused by a sticky film of bacteria called plaque. Plaque is always forming on your teeth, but if they aren't cleaned well, the bacteria in plaque can cause your gums to become inflammed.
Experimental: Group IV: 21 periodontitis patients with coronary heart disease.
Coronary heart disease (CHD) 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%.
Procedure: Scaling and root planing
Scaling and root planing is a deep cleaning below the gumline used to treat gum disease. Gum disease is caused by a sticky film of bacteria called plaque. Plaque is always forming on your teeth, but if they aren't cleaned well, the bacteria in plaque can cause your gums to become inflammed.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 20, 2024

Primary Completion (Estimated)

April 20, 2026

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADCH/IEC-II/48/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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