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).
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)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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
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.
- Conditions
- Stable Angina, Periodontitis
- 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 group | Role | What they receive |
|---|---|---|
| Stable angina and periodontitis group (SAP group) | Experimental | Individuals 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) | Experimental | Cardiovascularly 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 comparator | Periodontally 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.
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)
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.
- First posted17 Feb 2026
- Study start20 Feb 2026
- Primary completion5 Jun 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Altintas, Ondokuz Mayıs University
- Investigators
- Sena Altintas, DDS, Principal investigator, Ondokuz Mayis University Department of PeriodontologyFeyza Otan Ozden, Professor, Study director, Ondokuz Mayis University Department of Periodontology
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 40211225Yilmaz 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Ischemia-Modified Albumin and Soluble ST2 in Patients With Stable Angina
- ClinicalTrials.gov ID
- NCT07412795
- Acronym / sponsor ID
- OMU-BAP-5673
- Conditions
- Stable Angina, Periodontitis
- Keywords
- Non-surgical Periodontal Treatment, Cardiovascular Disease, Cardiovascular Biomarkers, stable angina, soluble ST2, periodontitis, IMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stable angina and periodontitis group (SAP group) | Experimental | Procedure: Non-surgical periodontal therapy (scaling and root planing)Individuals diagnosed with stable angina and periodontitis who will receive non-surgical |
| Periodontitis group (P group) | Experimental | Procedure: Non-surgical periodontal therapy (scaling and root planing)Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing. |
| Control group (C group) | Active comparator | Procedure: Non-surgical periodontal therapy (Professional dental cleaning)Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal therapy (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. | Procedure or surgery | Periodontitis group (P group), Stable angina and periodontitis group (SAP group) |
| Non-surgical periodontal therapy (Professional dental cleaning)Supragingival calculus and plaque removal with standardized oral hygiene instruction. | Procedure or surgery | Control group (C group) |
Primary outcome
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.
1 secondary outcome
Change in serum soluble suppression of tumorigenicity 2(sST2) concentration after non-surgical periodontal therapy
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 40211225Karci 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.
- Background: PubMed 37427857Yilmaz 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sena Altintas, DDS principal investigator
Ondokuz Mayis University Department of Periodontology
Feyza Otan Ozden, Professor study director
Ondokuz Mayis University Department of Periodontology
1 site in 1 country: see every site and its status.
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.