Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 3:54 AM
Study NCT ID:
NCT03605095
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2018-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence of Spreading Vasodilation in Human Gingiva
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood flow change after application of NO agonist', 'timeFrame': '30 min', 'description': 'The change in blood flow will be measured after locally applied nitroglycerin at the site fo application and at the remote sites'}], 'secondaryOutcomes': [{'measure': 'Comparsion of the change in blood flow between genders', 'timeFrame': '30min', 'description': 'The maximal blood flow changed assessed in primary outcome will be split into two groups based on gender. The change will be compared between males and females.'}, {'measure': 'Correlation between the change in blood flow and gingival thickness', 'timeFrame': '30min', 'description': 'The biotpye will be assessed by measurement of gingival thickness by an ultrasonic devices. The correlation between thickness and maximal vasodilation will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spreading vasodilation', 'gingival microcirculation'], 'conditions': ['Nitric Oxide', 'Vasodilation', 'Oral Soft Tissue Conditions']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to observe the mechanism of spreading vasodilatation on human healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to trigger the vasoactivity.', 'detailedDescription': 'Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasodilation such as spreading vasodilation in human gingiva.\n\nThe vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva. NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the test well with surrounding gingival area spanning 3 tooth and at the contralateral side by LSCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* general health\n* minimum 5 mm keratinized gingiva at upper front teeth\n\nExclusion Criteria:\n\n* pregnancy and breast-feeding\n* medication (except contraceptives)\n* smoking\n* periodontitis\n* caries\n* insufficient marginal integrity'}, 'identificationModule': {'nctId': 'NCT03605095', 'briefTitle': 'Evidence of Spreading Vasodilation in Human Gingiva', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Non-invasive Imaging of Human Gingival Microcirculation: Effect of Nitric Oxide', 'orgStudyIdInfo': {'id': '5/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '8 mg/ml nitroglycerin', 'description': 'Higher concentration of NO donor (Nitromint) vs dilution', 'interventionNames': ['Drug: nitroglycerin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 mg/ml nitroglycerin', 'description': 'Lower concentration of NO donor (Nitropohl) vs physiological saline', 'interventionNames': ['Drug: nitroglycerin']}], 'interventions': [{'name': 'nitroglycerin', 'type': 'DRUG', 'description': 'Vasodilatator solution is dropped on the gingiva.', 'armGroupLabels': ['1 mg/ml nitroglycerin', '8 mg/ml nitroglycerin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Janos Vag', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Vag Janos', 'investigatorAffiliation': 'Semmelweis University'}}}}