Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-03-19 @ 4:17 PM
Study NCT ID:
NCT00632957
Status:
COMPLETED
Last Update Posted:
2011-04-12
First Post:
2008-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017622', 'term': 'Periodontal Attachment Loss'}], 'ancestors': [{'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, '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': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-11', 'studyFirstSubmitDate': '2008-02-29', 'studyFirstSubmitQcDate': '2008-03-10', 'lastUpdatePostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical attachment loss', 'timeFrame': 'baseline, 8, 16, 28 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Periodontal Attachment Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years of age, male or female\n2. At least 20 natural teeth present at the time of periodontal examination\n3. Be diagnosed with severe, chronic periodontitis;\n4. Be willing to participate in the study\n\nExclusion Criteria:\n\n1. \\<18 years of age\n2. Less than 20 natural teeth present at time of periodontal examination\n3. Unable or unwilling to provide informed consent or follow study protocol\n4. Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment\n5. Use of systemic antibiotics within the last 3 months\n6. Pregnancy as diagnosed by administered pregnancy test.\n7. You are nursing a baby.\n8. Are allergic to fish or fish products.\n9. You are taking any other medications, such as dietary supplements, that could affect the outcome of the study'}, 'identificationModule': {'nctId': 'NCT00632957', 'briefTitle': 'Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.', 'orgStudyIdInfo': {'id': 'UK IRB # 04-0339-F1V'}, 'secondaryIdInfos': [{'id': 'P20RR020145-04', 'link': 'https://reporter.nih.gov/quickSearch/P20RR020145-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil', 'interventionNames': ['Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Omega-3 Fatty acid (with SRP or OHI)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000mg capsules three times daily, duration 28 weeks.', 'armGroupLabels': ['Fish oil']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'corn/soybean oil capsules 1g/three times daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky College of Dentistry', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Dolph R. Dawson, DMD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky College of Dentistry'}, {'name': 'Jeff L. Ebersole, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Kentucky College of Dentistry'}, {'name': 'M J Novak, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Kentucky College of Dentistry'}, {'name': 'Gilbert A. Boissonneault, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Kentucky Division of Clinical Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Dr. Jeff L. Ebersole, PI', 'oldOrganization': 'Center for Oral Health Research'}}}}