Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT03567369
Status:
UNKNOWN
Last Update Posted:
2018-06-25
First Post:
2018-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C433370', 'term': 'Traumeel S'}], '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'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative sequelae following thir molar extraction', 'timeFrame': 'up to seven days postoperative', 'description': 'During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Third molar', 'Surgery', 'Swelling'], 'conditions': ['Molar, Third', 'Surgery']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication of asymptomatic bilateral extractions of lower third molars;\n* Aged 18 years or older;\n* Have a good health and no disease.\n\nExclusion Criteria:\n\n• Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03567369', 'briefTitle': '92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of the Valleys of Jequitinhonha and Mucuri'}, 'officialTitle': 'Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions', 'orgStudyIdInfo': {'id': '24042018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': 'Dexamethasone 4,0 mg / mL', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Traumeel S', 'description': 'Traumeel 2,2 mg / mL', 'interventionNames': ['Drug: Traumeel S']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexamethasone Acetate', 'Decadron®'], 'description': 'Dexamethasone 4,0 mg/mL', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Traumeel S', 'type': 'DRUG', 'description': 'Traummel S 2,2 mg/mL', 'armGroupLabels': ['Traumeel S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100000', 'city': 'Diamantina', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri', 'geoPoint': {'lat': -18.24692, 'lon': -43.60345}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of the Valleys of Jequitinhonha and Mucuri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcos Luciano Pimenta Pinheiro', 'investigatorAffiliation': 'Federal University of the Valleys of Jequitinhonha and Mucuri'}}}}