- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07591844
Effect of Periodontal Therapy on Asprosin in Stable Angina
Effect of Non-Surgical Periodontal Therapy on Serum Asprosin in Patients With Stable Angina
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sena Altintas, DDS
- Phone Number: +905540270097
- Email: senaltintas144@gmail.com
Study Contact Backup
- Name: Feyza Otan Ozden, Prof.
- Email: feyza_otan@yahoo.com
Study Locations
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Atakum
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Samsun, Atakum, Turkey (Türkiye), 55270
- Ondokuz Mayis University
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Contact:
- Ondokuz Mayis University Faculty of Dentistry
- Phone Number: +90362 312 19 19 / 8121
- Email: disinfo@omu.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 with angiographically confirmed stable angina and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing
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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)
Individuals with angiographically confirmed cardiovascular health and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing
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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 healthy individuals with angiographically confirmed absence of coronary artery disease who will receive routine professional dental cleaning and standardized oral hygiene instruction
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Supragingival calculus and plaque removal with standardized oral hygiene instruction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum asprosin levels after non-surgical periodontal therapy
Time Frame: Baseline and 3 months
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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.
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Baseline and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sena Altintas, DDS, Ondokuz Mayis University Department of Periodontology
- Study Director: Feyza Otan Ozden, Prof., Ondokuz Mayis University Department of Periodontology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Vascular Diseases
- Heart Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Myocardial Ischemia
- Chest Pain
- Limb Deformities, Congenital
- Angina Pectoris
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Periodontitis
- Cardiovascular Diseases
- Angina, Stable
- Arachnodactyly
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Scaling
- Dental Prophylaxis
- Periodontics
- Subgingival Curettage
- Preventive Dentistry
- Root Planing
- Tooth Exfoliation
Other Study ID Numbers
- OMU-306
- 5673 (Other Grant/Funding Number: Grantor or Funder Organization: Ondokuz Mayıs University - Scientific Research Projects Coordination Unit (BAP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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