Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06270693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004708', 'term': 'Endodontics'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2024-01-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum hsCRP', 'timeFrame': '12 months', 'description': 'Systemic inflammatory burden assessed'}, {'measure': 'complete hemogram indices', 'timeFrame': '12 months', 'description': 'Systemic inflammatory burden assessed'}], 'secondaryOutcomes': [{'measure': 'Periapical index SCORE CHANGE', 'timeFrame': '12 months', 'description': '1-5 ordinal scale,5 worse outconpme \\& HEALING ASSESSED'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apical periodontitis', 'coronary artery disease'], 'conditions': ['Apical Periodontitis', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure.', 'detailedDescription': 'Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure. Systemic inflammatory burden is assessed before and after endodontic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease patients with and without chronic pulp exposure\n\nExclusion Criteria:\n\n* Other systemic diseases\n* Antibiotics for More than 1 month\n* Smoking\n* Analgesics more than 1 week'}, 'identificationModule': {'nctId': 'NCT06270693', 'briefTitle': 'hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Effect of Endodontic Treatment on Serum High Sensitivity C-reactive Protein and Complete Hemogram Indices in Patients With Cardiovascular Disease With and Without Apical Periodontitis: A Prospective Interventional Study', 'orgStudyIdInfo': {'id': 'Dr Sushma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAD WITH AP', 'description': 'CORONARY ARTERY DISEASE WITH APICAL PERIODONTITIS', 'interventionNames': ['Procedure: Endodontic treatment']}, {'type': 'NO_INTERVENTION', 'label': 'CAD WITHOUT AP', 'description': 'CORONARY ARTERY DISEASE WITHOUT AP'}], 'interventions': [{'name': 'Endodontic treatment', 'type': 'PROCEDURE', 'description': 'Root canal treatment', 'armGroupLabels': ['CAD WITH AP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'PGIDS', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'overallOfficials': [{'name': 'DR SANJAY TEWARI, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Post Graduate Institute Of Dental Sciences,Rohtak'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}