Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-13 @ 3:37 AM
Study NCT ID:
NCT02416869
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2015-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone in Lower Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial swelling (using 3 facial measurements (in millimeters)', 'timeFrame': '1 day, 3 day, 7 day', 'description': 'We followed facial swelling 1, 3 and 7 days after intervention.\n\nSwelling in the operation site will be evaluated using 3 facial measurements (in millimeters):\n\n1. Tragus - Midline.\n2. Tragus - Corner of the mouth\n3. Gonion - Lateral canthus.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain (visual analog scale)', 'timeFrame': '1 day, 3 day, 7 day', 'description': 'Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain".'}, {'measure': 'Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)', 'timeFrame': '1 day, 3 day, 7 day', 'description': 'Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.'}, {'measure': 'Postoperative discomfort (25-items custom made questionnaire)', 'timeFrame': '4 day, 7 day', 'description': "Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexamethasone', 'Lower third molar surgery'], 'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy patients (ASA I)\n* Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification\n\nExclusion Criteria:\n\n* Heavy tobacco smokers\n* Drug and / or alcohol abusers"}, 'identificationModule': {'nctId': 'NCT02416869', 'briefTitle': 'Dexamethasone in Lower Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery', 'orgStudyIdInfo': {'id': '36/11-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intramuscular application', 'description': 'Intramuscular application of 4mg Dexamethasone', 'interventionNames': ['Procedure: Intramuscular application']}, {'type': 'EXPERIMENTAL', 'label': 'Submucosal application', 'description': 'Submucosal application of 4mg Dexamethasone', 'interventionNames': ['Procedure: Submucosal application']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4mg Dexamethasone submucosal', 'description': '4mg Dexamethasone submucosal application', 'interventionNames': ['Drug: 4mg Dexamethasone submucosal']}, {'type': 'EXPERIMENTAL', 'label': '8mg Dexamethasone submucosal', 'description': '8mg Dexamethasone submucosal application', 'interventionNames': ['Drug: 8mg Dexamethasone submucosal']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4mg Dexamethasone postoperative', 'description': '4mg Dexamethasone postoperative application', 'interventionNames': ['Procedure: 4mg Dexamethasone preoperative']}, {'type': 'EXPERIMENTAL', 'label': '4mg Dexamethasone preoperative', 'description': '4mg Dexamethasone postoperative application', 'interventionNames': ['Procedure: 4mg Dexamethasone postoperative']}], 'interventions': [{'name': 'Intramuscular application', 'type': 'PROCEDURE', 'description': 'Patient receive 4mg of Dexamethasone by intramuscular application', 'armGroupLabels': ['Intramuscular application']}, {'name': 'Submucosal application', 'type': 'PROCEDURE', 'description': 'Patients receive 4mg of Dexamethasone by submucosal application', 'armGroupLabels': ['Submucosal application']}, {'name': '4mg Dexamethasone submucosal', 'type': 'DRUG', 'otherNames': ['Dexasone'], 'description': 'Patients receive 4mg of submucosal Dexamethasone', 'armGroupLabels': ['4mg Dexamethasone submucosal']}, {'name': '8mg Dexamethasone submucosal', 'type': 'DRUG', 'otherNames': ['Dexasone'], 'description': 'Patients receive 8mg of submucosal Dexamethasone', 'armGroupLabels': ['8mg Dexamethasone submucosal']}, {'name': '4mg Dexamethasone preoperative', 'type': 'PROCEDURE', 'description': 'Patients receive 4mg of Dexamethasone preoperatively', 'armGroupLabels': ['4mg Dexamethasone postoperative']}, {'name': '4mg Dexamethasone postoperative', 'type': 'PROCEDURE', 'description': 'Patients receive 4mg of Dexamethasone postoperatively', 'armGroupLabels': ['4mg Dexamethasone preoperative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'School of Dental Medicine', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Miroslav M Andric, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zagreb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Miroslav Andric', 'investigatorAffiliation': 'University of Belgrade'}}}}