Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-20 @ 11:28 AM
Study NCT ID:
NCT02935868
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2016-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity', 'timeFrame': 'one day', 'description': 'Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL (clinical attachment level) ≥ 6mm and ≥1 interproximal site with PPD (periodontal probing depth) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/BOP (bleeding on probing) extent scores \\< 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores \\>10%.'}, {'measure': 'Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter', 'timeFrame': 'one day', 'description': "Normal Salivary pH = 6 to 7. Buffering capacity: ≥ 5.6 were considered as ''high'', ranging from 4.1 to 5.5 were labelled as ''medium'' and those ≤4 were defined as ''low''"}, {'measure': 'Salivary glucose - collection of stimulated saliva in 10 minutes and measurement with a colorimetric kit', 'timeFrame': 'one day', 'description': 'Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.'}, {'measure': 'Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer.', 'timeFrame': 'one day', 'description': 'The activity of salivary peroxidase is presented in Units/mg. The detection of activity of these enzymes is associated to periodontal disease.'}], 'secondaryOutcomes': [{'measure': 'Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence)', 'timeFrame': 'One day', 'description': 'Plaque index (PI) will be registered as scores (1 for presence, 0 for absence). For control group a plaque index of 15% is considered normal.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Saliva'], 'conditions': ['Diabetes Mellitus, Type 1', 'Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '14974821', 'type': 'BACKGROUND', 'citation': 'Aren G, Sepet E, Ozdemir D, Dinccag N, Guvener B, Firatli E. Periodontal health, salivary status, and metabolic control in children with type 1 diabetes mellitus. J Periodontol. 2003 Dec;74(12):1789-95. doi: 10.1902/jop.2003.74.12.1789.'}], 'seeAlsoLinks': [{'url': 'http://www.teses.usp.br/teses/disponiveis/25/25146/tde-26042016-102416/pt-br.php', 'label': 'Master Thesis in Portuguese - abstract in english'}]}, 'descriptionModule': {'briefSummary': 'Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes in younger patients. Thus, the aim of this observational study was to evaluate the periodontal and salivary condition of a sample of patients with type 1 diabetes of a brazillian city.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Test Group: Patients diagnosed with Type 1 diabetes mellitus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnose of Type 1 diabetes mellitus\n* Age between 18 and 35 years old\n* Presenting on tooth per quadrant\n\nExclusion Criteria:\n\n* Diagnose of Type 2 diabetes mellitus\n* Edentulous patients\n* Other systemic diseases'}, 'identificationModule': {'nctId': 'NCT02935868', 'briefTitle': 'Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Periodontal and Salivary Evaluation of a Sample of Type 1 Diabetes Mellitus Patients in Brazil', 'orgStudyIdInfo': {'id': 'Bauru School of Dentistry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test group', 'description': 'Patients with Type 1 diabetes mellitus'}, {'label': 'Control Group', 'description': 'Patients without systemic diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17012-901', 'city': 'Bauru', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Bauru School of Dentistry', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Carla Andreotti Damante', 'investigatorAffiliation': 'University of Sao Paulo'}}}}