Stable Angina PectorisNCT07591844
Effect of Periodontal Therapy on Asprosin 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 Pectoris and Periodontitis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of non-surgical periodontal therapy on serum asprosin levels in patients with stable angina and periodontitis. Asprosin is a novel metabolic biomarker reported to have potential protective roles in cardiovascular diseases and inflammatory processes. 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 Pectoris, 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 May 2026to 20 Oct 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 Serum Asprosin in Patients With Stable Angina
This study aims to evaluate the effect of non-surgical periodontal therapy on serum asprosin levels in patients with stable angina and periodontitis. Asprosin is a novel metabolic biomarker reported to have potential protective roles in cardiovascular diseases and inflammatory processes. The study also investigates the relationship between periodontal parameters and serum asprosin levels before and after periodontal therapy.
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues and has been associated with increased systemic inflammation and cardiovascular diseases. Stable angina, a clinical manifestation of coronary artery disease, is closely linked to inflammatory and metabolic pathways. Increasing evidence suggests that periodontal inflammation may contribute to cardiovascular pathology through systemic dissemination of inflammatory mediators and oxidative stress mechanisms.
Asprosin is a recently identified adipokine secreted mainly from white adipose tissue and is involved in glucose metabolism, inflammatory regulation, and cardiovascular homeostasis. Previous studies have reported altered serum asprosin levels in patients with atherosclerosis, myocardial infarction, and periodontitis. However, the effect of periodontal therapy on serum asprosin levels in patients with stable angina has not yet been clinically investigated.
In this clinical study, 60 individuals will be allocated into three groups: healthy controls, periodontitis patients, and patients with stable angina and periodontitis. Non-surgical periodontal therapy will be performed in periodontitis groups, while supragingival scaling and oral hygiene instructions will be provided for controls. Clinical periodontal parameters and serum asprosin levels will be evaluated at baseline and at 3-month follow-up using ELISA analysis.
The study aims to determine whether periodontal therapy may influence serum asprosin levels and to evaluate the possible relationship between periodontal inflammation and metabolic-inflammatory pathways in cardiovascular disease. To the best of our knowledge, this is the first clinical study evaluating the effect of periodontal therapy on serum asprosin levels in patients with stable angina.
- Conditions
- Stable Angina Pectoris, 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, stable angina, asprosin, periodontitis
- Medical subject headings
- Angina, Stable, Periodontitis, Cardiovascular Diseases, Arachnodactyly
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 with angiographically confirmed stable angina and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing Receives: Procedure: Non-surgical periodontal therapy (scaling and root planing) |
| Periodontitis group (P group) | Experimental | Individuals with angiographically confirmed cardiovascular health and 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 healthy individuals with angiographically confirmed absence of coronary artery disease 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 asprosin levels after non-surgical periodontal therapy
Serum asprosin concentrations (ng/mL) will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit at baseline and 3 months following 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 posted18 May 2026
- Study start20 May 2026
- Primary completion20 Aug 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies 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, Prof., Study director, Ondokuz Mayis University Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591844
- Sponsor's protocol ID
- OMU-306
- Other IDs
- 5673
- Status last verified
- Oct 2026
- First submitted
- 11 May 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
Gul SNS, Birdal O, Laloglu E. Serum asprosin levels are increased in patients with periodontitis and ST-segment elevation myocardial infarction and correlated with periodontal parameters: A case-control study. J Periodontal Res. 2024 Apr;59(2):259-266. doi: 10.1111/jre.13210. Epub 2023 Nov 20.
PubMed 37984462
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 Serum Asprosin in Patients With Stable Angina
- ClinicalTrials.gov ID
- NCT07591844
- Acronym / sponsor ID
- OMU-306
- Conditions
- Stable Angina Pectoris, Periodontitis
- Keywords
- Non-surgical periodontal treatment, cardiovascular disease, stable angina, asprosin, periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 18 May 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.
This study aims to evaluate the effect of non-surgical periodontal therapy on serum asprosin levels in patients with stable angina and periodontitis. Asprosin is a novel metabolic biomarker reported to have potential protective roles in cardiovascular diseases and inflammatory processes. The study also investigates the relationship between periodontal parameters and serum asprosin levels before and after periodontal therapy.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues and has been associated with increased systemic inflammation and cardiovascular diseases. Stable angina, a clinical manifestation of coronary artery disease, is closely linked to inflammatory and metabolic pathways. Increasing evidence suggests that periodontal inflammation may contribute to cardiovascular pathology through systemic dissemination of inflammatory mediators and oxidative stress mechanisms.
Asprosin is a recently identified adipokine secreted mainly from white adipose tissue and is involved in glucose metabolism, inflammatory regulation, and cardiovascular homeostasis. Previous studies have reported altered serum asprosin levels in patients with atherosclerosis, myocardial infarction, and periodontitis. However, the effect of periodontal therapy on serum asprosin levels in patients with stable angina has not yet been clinically investigated.
In this clinical study, 60 individuals will be allocated into three groups: healthy controls, periodontitis patients, and patients with stable angina and periodontitis. Non-surgical periodontal therapy will be performed in periodontitis groups, while supragingival scaling and oral hygiene instructions will be provided for controls. Clinical periodontal parameters and serum asprosin levels will be evaluated at baseline and at 3-month follow-up using ELISA analysis.
The study aims to determine whether periodontal therapy may influence serum asprosin levels and to evaluate the possible relationship between periodontal inflammation and metabolic-inflammatory pathways in cardiovascular disease. To the best of our knowledge, this is the first clinical study evaluating the effect of periodontal therapy on serum asprosin levels in patients with stable angina.
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 with angiographically confirmed stable angina and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing |
| Periodontitis group (P group) | Experimental | Procedure: Non-surgical periodontal therapy (scaling and root planing)Individuals with angiographically confirmed cardiovascular health and 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 healthy individuals with angiographically confirmed absence of coronary artery disease 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 (6 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
- Pregnancy or lactation (for female participants)
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 asprosin levels after non-surgical periodontal therapy
Time frame: Baseline and 3 months
Serum asprosin concentrations (ng/mL) will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit at baseline and 3 months following non-surgical periodontal therapy.
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 37984462Gul SNS, Birdal O, Laloglu E. Serum asprosin levels are increased in patients with periodontitis and ST-segment elevation myocardial infarction and correlated with periodontal parameters: A case-control study. J Periodontal Res. 2024 Apr;59(2):259-266. doi: 10.1111/jre.13210. Epub 2023 Nov 20.
- 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, Prof. 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 Pectoris 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 6 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 asprosin levels 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 NCT07591844, which also lists 1 linked publication.
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.