Non-Surgical Periodontal Therapy and Cardiac Biomarkers in Stable Angina

February 13, 2026 updated by: Sena Altintas, Ondokuz Mayıs University

Effect of Non-Surgical Periodontal Therapy on Ischemia-Modified Albumin and Soluble ST2 in Patients With Stable Angina

The goal of this clinical study is to learn whether gum treatment can improve heart health. Researchers will compare blood markers related to heart disease before and after routine gum treatment.

The main questions this study aims to answer are:

Is gum disease a risk factor for heart disease? Can treating gum disease lower the risk of heart disease? Adults with stable angina (a type of heart disease) and adults without heart disease may take part in this study.

All participants will receive routine, non-surgical gum treatment, which is a standard dental care procedure. This includes professional cleaning to remove plaque and tartar from the teeth and practical education on tooth brushing and cleaning between the teeth. The treatment will be performed by a single researcher and completed in one visit within about one hour.

Participants will:

Provide a blood sample before gum treatment Receive routine, non-surgical gum treatment Return after three months for a follow-up visit Provide a second blood sample This study does not involve experimental drugs or devices. Participation is voluntary, and there is no cost to participants. The results may help researchers better understand how gum health is related to heart health.

Study Overview

Detailed Description

Periodontitis is a chronic, multifactorial inflammatory disease characterized by progressive destruction of the periodontal tissues and alveolar bone surrounding the teeth. It develops as a result of dysbiosis of the oral microbiota and an altered host immune response. Dental plaque is the primary etiological factor, and anaerobic periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola play a major role in disease progression.

Atherosclerotic cardiovascular disease and periodontitis are both major global health problems and share several common risk factors, including smoking, diabetes mellitus, obesity, poor oral hygiene, and chronic inflammation. Although establishing a direct causal relationship between the two conditions is challenging, increasing evidence suggests that periodontitis may contribute to endothelial dysfunction, atherosclerotic plaque instability, and an increased risk of cardiovascular events.

Two main biological mechanisms have been proposed to explain the association between periodontitis and cardiovascular disease. The first is a direct mechanism involving the translocation of periodontal pathogens into the bloodstream and their interaction with vascular endothelial cells. Periodontal bacteria and their components have been detected in atherosclerotic plaques, suggesting a potential role in plaque formation and progression. The second mechanism is indirect and involves systemic inflammation. Periodontitis induces a chronic inflammatory response characterized by elevated levels of proinflammatory cytokines and acute-phase proteins, which may promote atherosclerosis through endothelial dysfunction, altered lipid metabolism, and increased oxidative stress.

Stable angina pectoris is a clinical manifestation of coronary artery disease caused by reduced blood flow to the myocardium, typically due to atherosclerosis of the coronary arteries. It is characterized by predictable chest pain or discomfort that occurs during physical exertion or emotional stress and is relieved by rest or medication. Although stable angina is generally less acute than unstable angina, it remains a serious condition requiring appropriate management to reduce the risk of adverse cardiovascular outcomes.

Non-surgical periodontal therapy is the first-line treatment for periodontal disease and includes scaling and root planing to remove supragingival and subgingival plaque and calculus. This treatment aims to reduce the periodontal inflammatory burden, improve periodontal clinical parameters, and restore periodontal tissue health. Previous studies have shown that effective non-surgical periodontal therapy may also reduce systemic inflammatory markers and improve surrogate markers of early atherosclerosis.

In the present study, cardiovascular-related biomarkers are evaluated to explore the systemic effects of periodontal therapy. Ischemia-modified albumin(IMA) is a circulating biomarker that reflects ischemia-related structural changes in albumin and has been associated with oxidative stress, inflammation, and cardiovascular disease risk. Elevated serum IMA levels have been reported in individuals with periodontitis and have been shown to decrease following periodontal treatment.

Soluble ST2 is a member of the interleukin-1 receptor family and acts as a decoy receptor for interleukin-33, thereby modulating inflammatory and cardioprotective signaling pathways. Increased serum sST2 levels have been associated with adverse outcomes in cardiovascular disease and heart failure. While limited data exist on the relationship between periodontitis and sST2 levels, preliminary evidence suggests that periodontal inflammation and its treatment may influence sST2 expression.

This clinical study aims to evaluate changes in cardiovascular biomarkers, including IMA and sST2, before and after routine non-surgical periodontal therapy in adults with stable angina and in cardiovascularly healthy individuals. By comparing biomarker levels and periodontal clinical parameters at baseline and after treatment, the study seeks to improve understanding of the potential role of periodontal therapy in cardiovascular health.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Contact Backup

Study Locations

    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55270
        • Ondokuz Mayis University
        • Contact:
          • Ondokuz Mayis University Faculty of Dentistry
          • Phone Number: +90362 312 19 19 / 8121
          • Email: disinfo@omu.edu.tr
        • Principal Investigator:
          • Sena Altintas, DDS

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:

  • Willingness to participate in the study and provide written informed consent
  • Age 18 years or older
  • No periodontal treatment within the past 6 months
  • No use of local or systemic antibiotics within the past 3 months

Exclusion Criteria:

  • Unwillingness to participate in the study or to provide informed consent
  • Age under 18 years
  • Use of local or systemic antibiotics for the treatment of widespread infection
  • within the past 3 months
  • Receipt of periodontal treatment within the past 6 months
  • Pregnancy or lactation (for female participants)
  • History of acute myocardial infarction within the past 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stable angina and periodontitis group (SAP group)
Individuals diagnosed with stable angina and periodontitis who will receive non-surgical
Non-surgical periodontal therapy will include full-mouth scaling and root planing performed using hand instruments and/or ultrasonic devices to remove supra- and subgingival plaque and calculus.
Experimental: Periodontitis group (P group)
Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing.
Non-surgical periodontal therapy will include full-mouth scaling and root planing performed using hand instruments and/or ultrasonic devices to remove supra- and subgingival plaque and calculus.
Active Comparator: Control group (C group)
Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.
Supragingival calculus and plaque removal with standardized oral hygiene instruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy
Time Frame: Baseline and 3 months

Serum ischemia-modified albumin (IMA) concentration measured in nanograms per milliliter (ng/mL) using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.

Assessed at baseline and 3 months after non-surgical periodontal therapy.

Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum soluble suppression of tumorigenicity 2(sST2) concentration after non-surgical periodontal therapy
Time Frame: Baseline and 3 months
Serum soluble suppression of tumorigenicity 2 (sST2) concentration measured in picograms per milliliter (pg/mL) using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Assessed at baseline and 3 months after non-surgical periodontal therapy.
Baseline and 3 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sena Altintas, DDS, Ondokuz Mayis University Department of Periodontology
  • Study Director: Feyza Otan Ozden, Professor, Ondokuz Mayis University Department of Periodontology

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.

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)

February 20, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

August 5, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The decision to not share individual participant data (IPD) is based on ethical considerations, institutional policies, and the need to protect participant privacy and confidentiality. The collected data will only be used for the purposes of this study and will not be made available for external use.

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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