Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT02054767
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2013-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthetic Efficacy in Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-31', 'studyFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'lip anesthesia', 'timeFrame': 'ten minutes after the inferior alveolar nerve block', 'description': 'The investigators evaluated the subjective lip anethesia by asking the patient whether his/her lip was numb'}], 'primaryOutcomes': [{'measure': 'pulpal anesthesia', 'timeFrame': 'Ten minutes after the inferior alveolar nerve block', 'description': 'pulpal anesthesia was tested with an electric pulp stimulator'}], 'secondaryOutcomes': [{'measure': 'analgesia', 'timeFrame': 'the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal', 'description': 'To evaluate the intensity of pain during the pulpectomy a verbal analogic scale was adopted'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['articaine', 'lidocaine', 'mepivacaine', 'inferior alveolar nerve block', 'irreversible pulpitis'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.', 'detailedDescription': 'Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of irreversible pulpitis\n* good health\n* had at least 1 adjacent tooth plus a healthy canine\n\nExclusion Criteria:\n\n* took medication could be interacting with any of the anesthetics used'}, 'identificationModule': {'nctId': 'NCT02054767', 'briefTitle': 'Anesthetic Efficacy in Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar', 'orgStudyIdInfo': {'id': 'FDAAA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine', 'description': 'injections of 3.6 mL of 2% lidocaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection', 'interventionNames': ['Drug: Intervention: inferior alveolar nerve block injection']}, {'type': 'EXPERIMENTAL', 'label': 'mepivacaine', 'description': 'injections of 3.6 mL of 2% mepivacaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection', 'interventionNames': ['Drug: Intervention: inferior alveolar nerve block injection']}, {'type': 'EXPERIMENTAL', 'label': 'articaine', 'description': 'injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection', 'interventionNames': ['Drug: Intervention: inferior alveolar nerve block injection']}], 'interventions': [{'name': 'Intervention: inferior alveolar nerve block injection', 'type': 'DRUG', 'description': '-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)', 'armGroupLabels': ['articaine', 'lidocaine', 'mepivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Emergency Center of the School of Dentistry at the University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Isabel P Tortamano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USão Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Isabel Peixoto Tortamano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}