Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 5:51 AM
Study NCT ID:
NCT01046435
Status:
COMPLETED
Last Update Posted:
2010-03-25
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Periodontal Therapy on Systemic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D010512', 'term': 'Periodontal Index'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-24', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count', 'timeFrame': '0, 3, 6, 9 and 12 months after therapy'}], 'secondaryOutcomes': [{'measure': 'Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level', 'timeFrame': '0, 3, 6, 9 and 12 months after therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['periodontitis', 'cardiovascular disease', 'diabetes'], 'conditions': ['Periodontal Disease', 'Cardiovascular Disease', 'Type 2 Diabetes', 'Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fondecyt.cl/578/channel.html', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.', 'detailedDescription': 'Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.\n\nMethods: The current study is a randomized, double blind clinical trial, with two treatment groups.\n\nEligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.\n\nThe study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.\n\nThe periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and \\>30 % of sites with bleeding on probing.\n\nThe outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosis of marginal periodontitis\n* No history of periodontal treatment\n* At least 14 natural teeth present\n* Dyslipidemia\n* And at least one of the following factors:\n\n * obesity\n * diabetes\n * smoking, hypertension\n\nExclusion Criteria:\n\n* Rheumatoid arthritis\n* Any type of cancer in the previous 2 years\n* Pregnancy and lactation\n* Indication of the use of antibiotic for invasive procedures\n* Use of antibiotics in previous three months.'}, 'identificationModule': {'nctId': 'NCT01046435', 'briefTitle': 'Effects of Periodontal Therapy on Systemic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk', 'orgStudyIdInfo': {'id': 'FONDECYT 1061070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Supragingival scaling plus placebo', 'description': 'Plaque control instructions, supra gingival scaling and two placebos', 'interventionNames': ['Procedure: metronidazole and amoxicillin', 'Procedure: Two placebos']}, {'type': 'EXPERIMENTAL', 'label': 'Root planing plus antibiotics', 'description': 'Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days', 'interventionNames': ['Procedure: metronidazole and amoxicillin', 'Procedure: Two placebos']}], 'interventions': [{'name': 'metronidazole and amoxicillin', 'type': 'PROCEDURE', 'otherNames': ['Non-surgical periodontal therapy'], 'description': 'Metronidazole 250 mg three times a day per 7 days', 'armGroupLabels': ['Root planing plus antibiotics', 'Supragingival scaling plus placebo']}, {'name': 'Two placebos', 'type': 'PROCEDURE', 'otherNames': ['Community periodontal treatment'], 'description': 'Two placebos 3 times a day for 7 days', 'armGroupLabels': ['Root planing plus antibiotics', 'Supragingival scaling plus placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Nestor J. Lopez, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}, {'name': 'Antonio Quintero, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chile'}, {'name': 'Carola Ibieta, DDS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Chile'}, {'name': 'Carlos Y Valenzuela, DMS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Chile'}, {'name': 'Lilian Jara, MsB, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Chile'}, {'name': 'Marcelo Llancaqueo, DMS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nestor J. Lopez', 'oldOrganization': 'University of Chile Faculty of Dentistry'}}}}