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Stable AnginaNCT07412795

Non-Surgical Periodontal Therapy and Cardiac Biomarkers in Stable Angina

A study testing Non-surgical periodontal therapy (scaling and root planing) and Non-surgical periodontal therapy (Professional dental cleaning) in people with Stable Angina and Periodontitis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stable Angina, Periodontitis
What is being tested?
Non-surgical periodontal therapy (scaling and root planing) and Non-surgical periodontal therapy (Professional dental cleaning)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2026to 5 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ondokuz Mayis University

    Samsun, Atakum, 55270

Other trials in Turkey (Türkiye)

About this study

Official title: 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:

Read more

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.

Read the 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.

Being tested
Non-surgical periodontal therapy (scaling and root planing), Non-surgical periodontal therapy (Professional dental cleaning)
Keywords
Non-surgical Periodontal Treatment, Cardiovascular Disease, Cardiovascular Biomarkers, stable angina, soluble ST2, periodontitis, IMA
Medical subject headings
Angina, Stable, Periodontitis, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-surgical periodontal therapy (scaling and root planing)Procedure or surgery

    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.

  • Non-surgical periodontal therapy (Professional dental cleaning)Procedure or surgery

    Supragingival calculus and plaque removal with standardized oral hygiene instruction.

Study groups in NCT07412795
Study groupRoleWhat they receive
Stable angina and periodontitis group (SAP group)ExperimentalIndividuals diagnosed with stable angina and periodontitis who will receive non-surgical
Receives: Procedure: Non-surgical periodontal therapy (scaling and root planing)
Periodontitis group (P group)ExperimentalCardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing.
Receives: Procedure: Non-surgical periodontal therapy (scaling and root planing)
Control group (C group)Active comparatorPeriodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.
Receives: Procedure: Non-surgical periodontal therapy (Professional dental cleaning)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy

    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.

    Measured: Baseline and 3 months

Secondary outcomes (1)
  1. Change in serum soluble suppression of tumorigenicity 2(sST2) concentration after non-surgical periodontal therapy

    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.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start20 Feb 2026
  3. Primary completion5 Jun 2026
  4. Study completion5 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stable angina and periodontitis group (SAP group): Individuals diagnosed with stable angina and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing. Periodontitis group (P group): Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing. Control group (C group): Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412795
Sponsor's protocol ID
OMU-BAP-5673
Other IDs
5673
Status last verified
Oct 2026
First submitted
27 Jan 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Karci B, Savas HB. Evaluation of thiol/disulfide homeostasis and ischemia modified albumin as potential markers for periodontitis. BMC Oral Health. 2025 Apr 10;25(1):519. doi: 10.1186/s12903-025-05875-w.

    PubMed 40211225
  • Yilmaz M, He Q, Demir E, Terasjarvi J, Gursoy UK. Salivary IL-33 and sST2 levels in relation to TLR2 rs111200466 polymorphism and periodontitis. Oral Dis. 2024 May;30(4):2254-2261. doi: 10.1111/odi.14675. Epub 2023 Jul 10.

    PubMed 37427857

Questions about this trial

What is this clinical trial studying?

A study testing Non-surgical periodontal therapy (scaling and root planing) and Non-surgical periodontal therapy (Professional dental cleaning) in people with Stable Angina and Periodontitis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412795, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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