Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-28 @ 9:10 PM
Study NCT ID:
NCT03786133
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2018-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial load of six main periodontal pathogens', 'timeFrame': 'November 16th 2016', 'description': 'Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count'}, {'measure': 'Prevalence of six main periodontal pathogens', 'timeFrame': 'November 16th 2016', 'description': 'Number of sites presenting a specific pathogen'}, {'measure': 'Relative bacterial load of six main periodontal pathogens', 'timeFrame': 'November 16th 2016', 'description': 'A mean percentage that derives from the comparison of the bacterial load to the total bacterial load'}, {'measure': 'Total bacterial load', 'timeFrame': 'November 16th 2016', 'description': 'A mean of all bacteria present in a periodontal site expressed as number after a polymerase chain reaction count'}], 'secondaryOutcomes': [{'measure': 'Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans', 'timeFrame': 'November 16th 2016', 'description': 'Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subgingival analysis', 'Real-time PCR', 'Comparative study', 'Chronic Periodontitis', 'Type 2 Diabetes Mellitus'], 'conditions': ['Chronic Periodontitis', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '34965620', 'type': 'DERIVED', 'citation': "Montevecchi M, Valeriani L, Gatto MR, D'Alessandro G, Piana G. Subgingival pathogens in chronic periodontitis patients affected by type 2 diabetes mellitus: a retrospective case-control study. J Periodontal Implant Sci. 2021 Dec;51(6):409-421. doi: 10.5051/jpis.2100180009."}]}, 'descriptionModule': {'briefSummary': 'This study is a retrospective comparative evaluation of six main periodontal pathogens and total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes mellitus by polymerase chain reaction analysis.', 'detailedDescription': 'The aim of this study was to compare prevalence and bacterial load of six main periodontal pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus. Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also investigated.\n\nThe recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test.\n\nFor each subject, the following data have been collected: age, gender, smoking habits, type of metabolic control of diabetes, duration of diabetes, number of missing teeth.\n\nFor each subject, four periodontal sites were studied. Probing pocket depth, sites with bleeding on probing, sites with suppuration and microbiological data were evaluated.\n\nAn individual matching on the basis of severity and extension of periodontitis was performed by pairing a diabetic patient with another non-diabetic one with the same degree of severity and extension of the periodontal disease.\n\nMicrobiological data of subgingival biofilm were analysed and compared for the examined pathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, Fusobacterium nucleatum, Tannerella forsythia.\n\nDifferences in genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of chronic periodontitis\n* diagnosis of type 2 diabetes mellitus (only in the test group)\n* the presence of at least 12 teeth (except for the third molar)\n* belonging to caucasian ethnic group\n* age greater than 18 years.\n\nExclusion Criteria:\n\n* pregnant or lactating\n* history of systemic antibiotics within 3 months prior to the microbiological testing or anti-inflammatory therapy in the month before the visit\n* if they were suffering from any other systemic disease except diabetes mellitus (arthritis, ulcerative colitis, Crohn's disease, osteoporosis or osteopenia, HIV infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or pathologies that could potentially interfere with the periodontitis and/or with diabetes)\n* mental disorders\n* if they had received periodontal treatment in the 6 months before the microbiological test."}, 'identificationModule': {'nctId': 'NCT03786133', 'briefTitle': 'Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study', 'orgStudyIdInfo': {'id': 'periopathogensdiabetes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 diabetics', 'description': 'Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus', 'interventionNames': ['Diagnostic Test: Analysis of microbiological tests']}, {'label': 'non-diabetics', 'description': 'Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus', 'interventionNames': ['Diagnostic Test: Analysis of microbiological tests']}], 'interventions': [{'name': 'Analysis of microbiological tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Collection and comparison of microbiological data', 'armGroupLabels': ['non-diabetics', 'type 2 diabetics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40120', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Marco Montevecchi, DDS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bologna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available when the research will be published', 'ipdSharing': 'YES', 'description': 'Data will be available when the research will be published', 'accessCriteria': 'On request to the main investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Aggregate Professor of Periodontology', 'investigatorFullName': 'Marco Montevecchi', 'investigatorAffiliation': 'University of Bologna'}}}}