Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:51 AM
Study NCT ID:
NCT07412795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Surgical Periodontal Therapy and Cardiac Biomarkers in Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nPeriodontitis group (P group): Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing.\n\nControl group (C group): Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy', 'timeFrame': 'Baseline and 3 months', 'description': 'Serum ischemia-modified albumin (IMA) concentration measured in nanograms per milliliter (ng/mL) using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.\n\nAssessed at baseline and 3 months after non-surgical periodontal therapy.'}], 'secondaryOutcomes': [{'measure': 'Change in serum soluble suppression of tumorigenicity 2(sST2) concentration after non-surgical periodontal therapy', 'timeFrame': 'Baseline and 3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-surgical Periodontal Treatment', 'Cardiovascular Disease', 'Cardiovascular Biomarkers', 'stable angina', 'soluble ST2', 'periodontitis', 'IMA'], 'conditions': ['Stable Angina', 'Periodontitis']}, 'referencesModule': {'references': [{'pmid': '40211225', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37427857', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions this study aims to answer are:\n\nIs 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.\n\nAll 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.\n\nParticipants will:\n\nProvide 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.', 'detailedDescription': '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.\n\nAtherosclerotic 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.\n\nTwo 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.\n\nStable 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.\n\nNon-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.\n\nIn 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.\n\nSoluble 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to participate in the study and provide written informed consent\n* Age 18 years or older\n* No periodontal treatment within the past 6 months\n* No use of local or systemic antibiotics within the past 3 months\n\nExclusion Criteria:\n\n* Unwillingness to participate in the study or to provide informed consent\n* Age under 18 years\n* Use of local or systemic antibiotics for the treatment of widespread infection\n* within the past 3 months\n* Receipt of periodontal treatment within the past 6 months\n* Pregnancy or lactation (for female participants)\n* History of acute myocardial infarction within the past 6 months'}, 'identificationModule': {'nctId': 'NCT07412795', 'briefTitle': 'Non-Surgical Periodontal Therapy and Cardiac Biomarkers in Stable Angina', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Effect of Non-Surgical Periodontal Therapy on Ischemia-Modified Albumin and Soluble ST2 in Patients With Stable Angina', 'orgStudyIdInfo': {'id': 'OMU-BAP-5673'}, 'secondaryIdInfos': [{'id': '5673', 'type': 'OTHER_GRANT', 'domain': 'Ondokuz Mayıs University - Scientific Research Projects Coordination Unit (BAP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stable angina and periodontitis group (SAP group)', 'description': 'Individuals diagnosed with stable angina and periodontitis who will receive non-surgical', 'interventionNames': ['Procedure: Non-surgical periodontal therapy (scaling and root planing)']}, {'type': 'EXPERIMENTAL', 'label': 'Periodontitis group (P group)', 'description': 'Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing.', 'interventionNames': ['Procedure: Non-surgical periodontal therapy (scaling and root planing)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (C group)', 'description': 'Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.', 'interventionNames': ['Procedure: Non-surgical periodontal therapy (Professional dental cleaning)']}], 'interventions': [{'name': 'Non-surgical periodontal therapy (scaling and root planing)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Periodontitis group (P group)', 'Stable angina and periodontitis group (SAP group)']}, {'name': 'Non-surgical periodontal therapy (Professional dental cleaning)', 'type': 'PROCEDURE', 'description': 'Supragingival calculus and plaque removal with standardized oral hygiene instruction.', 'armGroupLabels': ['Control group (C group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55270', 'city': 'Samsun', 'state': 'Atakum', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ondokuz Mayis University Faculty of Dentistry', 'role': 'CONTACT', 'email': 'disinfo@omu.edu.tr', 'phone': '+90362 312 19 19 / 8121'}, {'name': 'Sena Altintas, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ondokuz Mayis University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'centralContacts': [{'name': 'Sena Altintas, DDS', 'role': 'CONTACT', 'email': 'senaltintas144@gmail.com', 'phone': '+905540270097'}, {'name': 'Feyza Otan Ozden, Professor', 'role': 'CONTACT', 'email': 'feyza_otan@yahoo.com'}], 'overallOfficials': [{'name': 'Sena Altintas, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayis University Department of Periodontology'}, {'name': 'Feyza Otan Ozden, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayis University Department of Periodontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Sena Altintas', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}