Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT02150005
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2014-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-25', 'studyFirstSubmitDate': '2014-05-18', 'studyFirstSubmitQcDate': '2014-05-25', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in probing depth in sites with PPD>3mm', 'timeFrame': 'Baseline and 90 days after the initial exam', 'description': 'Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth\\>3mm'}, {'measure': 'Reduction in probing depth in sites with PPD>5mm', 'timeFrame': 'Baseline and 90 days after the initial exam', 'description': 'Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth\\>5mm'}, {'measure': 'Reduction in probing depth in sites with CAL>3mm', 'timeFrame': 'Baseline and 90 days after the initial exam', 'description': 'Reduction of 4.6% in probing depth in sites with Clinical Attachment Level \\>3mm.'}, {'measure': 'Reduction in probing depth in sites with CAL >5mm', 'timeFrame': 'Baseline and 90 days after the initial exam', 'description': 'Reduction of 3.6% in probing depth in sites with Clinical Attachment Level \\>5mm.'}, {'measure': 'Leukocyte count', 'timeFrame': 'Baseline and 90 days after the initial exam', 'description': 'Non-significant reduction of leukocyte count in the test group. Mean difference of 74.6 m/mcL.'}, {'measure': 'Glucose', 'timeFrame': 'Baseline and 90 days after the initial exam', 'description': 'Glucose showed a non-significant increase in the test group. Mean difference of 24.2 mg/dL.'}, {'measure': 'Hemocyte', 'timeFrame': 'Baseline and 90 days after initial exam', 'description': 'Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL'}, {'measure': 'Hemoglobin', 'timeFrame': 'Baseline and 90 days after initial exam', 'description': 'Non-significant reduction in test group. Mean difference of 0.2 g/dL'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline and 90 days after initial exam', 'description': 'Significant reduction in the test group. Mean reduction of 27.4 mg/dL.'}, {'measure': 'High density lipid', 'timeFrame': 'Baseline and 90 days after initial exam', 'description': 'Significant reduction in test group. Mean difference of 8.2 mg/dL.'}, {'measure': 'Low density lipid', 'timeFrame': 'Baseline and 90 days after initial exam', 'description': 'Non-significant reduction in test group. Mean difference of 8.9 mg/dL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['periodontal diseases', 'cardiovascular diseases', 'periodontitis treatment'], 'conditions': ['Periodontitis', 'Coronariopathy']}, 'descriptionModule': {'briefSummary': 'Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization.\n\nMaterials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing cardiovascular treatment;\n* Eight viable teeth in the oral cavity;\n* Four periodontal sites with periodontal probing depths ≥5mm in different teeth.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02150005', 'briefTitle': 'Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Veiga de Almeida'}, 'officialTitle': 'Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization', 'orgStudyIdInfo': {'id': 'UVA71/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Periodontal treatment', 'description': 'The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance.', 'interventionNames': ['Procedure: Periodontal treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Periodontal treatment', 'type': 'PROCEDURE', 'armGroupLabels': ['Periodontal treatment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Veiga de Almeida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rio de Janeiro State Research Supporting Foundation (FAPERJ)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Walmir Júnio de Pinho Reis Rodrigues', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}