Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-04-16 @ 12:32 PM
Study NCT ID:
NCT01866761
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2013-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010512', 'term': 'Periodontal Index'}], 'ancestors': [{'id': 'D003753', 'term': 'Dental Health Surveys'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-27', 'studyFirstSubmitDate': '2013-05-20', 'studyFirstSubmitQcDate': '2013-05-27', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relation between probing pocket depth and anti-periodontopathic bacteria IgG antibody titer for periodontitis and the MAX intima-media thickness, urea sugar, urea protein, urea occult blood, creatinine, and eGFR for atherosclerosis', 'timeFrame': 'an expected average of 1.5 year', 'description': 'At following 3-time points; Baseline, After initial preparation of periodontal treatment, Starting point of supportive periodontal therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontal Disease', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services.\n\nMaterials and methods:\n\n* A prospective multi-center case cohort study was conducted on 37 ambulatory medical patients (with lifestyle-related diseases under consultation in either of the medical clinics registered as collaborative investigation facilities) and 79 periodontal patients (who were seen by the dental clinics registered as collaborative investigation facilities).\n* Medical treatment and clinical periodontal treatment were provided on the subjects under medical and dental care across borders by each internal medicine and dental clinics.\n* Systemic examination of lifestyle-related disease and periodontal examination were performed before and after periodontal treatment, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed before and after periodontal treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This clinical study was performed by the local clinics which belonged to Tokyo Medical Practitioners Association, Tokyo Dental Practitioners Association, and Chiba Medical Practitioners Association. 37 patients (with lifestyle-related diseases under consultation in either of 16 medical clinics), and 79 periodontal patients (not undergoing treatment at a medical clinic,) were enrolled. The subjects constituted a broad cross-section of the local society. Medical treatment at an internal medicine clinic and clinical periodontal treatment including periodontal surgery at a dental clinic were performed on all the subjects. Twenty-six patients dropped out of the study and medical treatment and periodontal treatment were provided to the remaining 90 subjects (mean ages: 59.2 ± 12.3 yrs).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Periodontal disease: inflamed gingiva with positive for bleeding on probing or teeth with probing pocket depth more than 4 mm Lifestyle-related disease: Plaques are included when maximum IMT is measured. Furthermore, hypertension was defined as systolic blood pressure of more than 140 mm Hg or diastolic pressure of more than 90 mm Hg, or both, or patients already being treated by anti-hypertensive agents. Hypercholesterolemia was defined by serum concentration of LDL-C of more than 140 mg/dL, or patients already being treated by lipid-lowering agents. Diabetes mellitus was defined by HbA1c of more than 6.9 % (NGSP value) or fasting blood sugar of more than 126 mg/dl or both, or patients already being treated by agents for diabetes.\n\nExclusion Criteria:\n\n* At initial consultation and examination (Baseline), patients with less than 6 months after the onset of acute myocardial infarction (AMI), and with a past history or complication of serious heart disease were excluded. Similarly, those with less than 6 months after cardiovascular revascularization surgery, less than 6 months after the onset of cerebrovascular disorder, or serious liver disease or renal disease were also excluded.'}, 'identificationModule': {'nctId': 'NCT01866761', 'acronym': 'RAPA-JMCS', 'briefTitle': 'Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services', 'organization': {'class': 'OTHER', 'fullName': 'Okayama University'}, 'officialTitle': 'Analysis of the Relationship Between Periodontal Disease and Atherosclerosis Within a Local Cooperation System of Japanese Medical Services', 'orgStudyIdInfo': {'id': 'TCHK_OU-RN605'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Periodontitis, Lifestyle-related disease', 'interventionNames': ['Procedure: Periodontal treatment']}], 'interventions': [{'name': 'Periodontal treatment', 'type': 'PROCEDURE', 'armGroupLabels': ['Periodontitis, Lifestyle-related disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-8525', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Okayama University of Graduate School of Medicine, Dentistry and Pharmaceutical Sciences', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okayama University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shogo Takashiba, DDS, PhD, Professor of Periodontal Science', 'investigatorAffiliation': 'Okayama University'}}}}