Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03106168
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-05-08', 'releaseDate': '2019-04-16'}, {'resetDate': '2019-08-12', 'releaseDate': '2019-07-23'}], 'estimatedResultsFirstSubmitDate': '2019-04-16'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anesthetic efficacy', 'timeFrame': '10 minutes after anesthetic technique', 'description': 'The anesthetic efficacy will be analyzed through the use of a verbal numerical scale used during the pulpectomy procedure'}], 'secondaryOutcomes': [{'measure': 'Pulpal Anesthesia', 'timeFrame': '10 minutes after anesthetic technique', 'description': 'Pulp anesthesia was defined as the absence of a positive response to the Pulptest after 10 minutes of the inferior alveolar nerve block in the teeth adjacent to the one selected for extraction'}, {'measure': 'Postoperative pain', 'timeFrame': 'seven days after the extraction', 'description': 'A postoperative evaluation of pain and discomfort was carried out by the patient in the first seven days after the surgery through the analysis of a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extraction', 'Local Anesthetic', 'Mepivacaine', 'Mandibular Molar'], 'conditions': ['Local Anesthetics', 'Tooth Extraction']}, 'descriptionModule': {'briefSummary': 'To evaluate subjectively and objectively the quality and efficacy of local anesthetic block with mepivacaine in simple extraction of mandibular molar. Provide and collect information such as: signs and symptoms, quality of anesthetic block, quantify pain and / or discomfort, as well as medication used, both preoperatively and postoperatively.', 'detailedDescription': 'Anamnesis and clinical diagnosis of patients, with indication of extraction, will be performed by the Emergency Department of the School of Dentistry of the University of São Paulo (SDUSP). Of these, 80 patients with mandibular molar teeth extraction, with and without apparent apical lesion radiographically identified in the initial imaging examination will be included. They must be over 16 years old, with good judgment and good general health, who have availability of return to the clinic for postoperative follow-up and aware of the Term of Consent.\n\nAfter the anamnesis, clinical and radiographic examinations for diagnosis and inclusion in the study, they will receive information on the procedure to be submitted, mainly on the quality of the local anesthetic block, quantification of pain and / or discomfort, and what will occur on the days after the procedure, such as guidelines and post-operative care (PO).\n\nThe clinical procedure (extraction) will follow the protocol of attendance of the Emergency Department of SDUSP, which is consistent with the surgical practice in force in this School and in other Dentistry Schools. In clinical care, patients will be questioned about the presence of discomfort and / or pain, indicated on the visual analogue scale (VAS score 0, score 1, score 2 or pain score 3). They will be informed about the effects of anesthesia, the use of the pulptest sensitivity test, absence of sensitivity in soft tissue and pulp after anesthesia, and the need for complementation with more local anesthetic (Mepivacaine and Noradrenaline) and / or incorporation of other anesthetic techniques.\n\nTo obtain basal tooth responsiveness patterns, prior to anesthesia, the pulptest will be applied to vital teeth of the quadrant that will receive intervention. The same will be reapplied after the injection of the anesthetic, in order to verify the installation of the blockade. Only after the anesthetic blockade has been confirmed and installed, both pulp ("Pulptest"), and soft tissues, the patient will be included in the research, initiating the surgical procedure. Any discomfort or complaint that the patient may have during the transoperatory period will be considered and, if necessary, we will use anesthetic complementation, which is recorded. In the postoperative period, these patients will have the opportunity to report some discomfort and pain, through a questionnaire, which will be filled and returned on the day of removal of suture, as well as intercurrence and / or need to use the suggested medication in case of pain.\n\nThe information obtained in this study will be inserted in Excel spreadsheet for descriptive analysis, statistics and comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that need extraction of one or more dental elements, older than or equal to sixteen and less than sixty, will be included, obligatorily with local surgical and systemic need and opportunity. They should be literate, able to read and understand, with discernment and able to answer the survey questionnaire. The indication for extraction should be attributed to caries destruction, periodontal impairment, large trauma damage, root fractures, orthodontic indication, prosthetic / rehabilitative or presence of residual roots.\n\nExclusion Criteria:\n\n* Patients over sixty, smokers, pregnant women, immunosuppressed, users of steroids, antidepressive and / or other psychiatric medications, users of illicit drugs, carriers of hemorrhagic disorders, with previous history of radiotherapy in the oral cavity, patients with metabolic and / or glandular bone disorders of chronic renal failure. Patients in whom the initial anesthesia does not install after a tube, without analgesia of part of the lip and tongue, or without numerical alteration in the pulp test, will also be excluded, characterizing failure in the anesthetic technique.'}, 'identificationModule': {'nctId': 'NCT03106168', 'briefTitle': 'Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of Anesthetic Efficacy in Extraction on Mandibular Molars With Periapical Granuloma', 'orgStudyIdInfo': {'id': 'Extraction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With periapical granuloma', 'description': 'Patients presenting periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography', 'interventionNames': ['Procedure: Extraction of mandibular molar']}, {'type': 'EXPERIMENTAL', 'label': 'Without periapical granuloma', 'description': 'Patients without periapical granuloma in mandibular molar teeth, diagnosed by periapical radiography', 'interventionNames': ['Procedure: Extraction of mandibular molar']}], 'interventions': [{'name': 'Extraction of mandibular molar', 'type': 'PROCEDURE', 'description': 'Patients who require extraction of mandibular molars will be submitted to surgery', 'armGroupLabels': ['With periapical granuloma', 'Without periapical granuloma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508000', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ines Buscariolo, PhD', 'role': 'CONTACT', 'email': 'iabuscar@usp.br'}, {'name': 'Bruno K Carrocini, Ms', 'role': 'CONTACT', 'email': 'bruno.carrocini@usp.br'}, {'name': 'Bruno K Carrocini, Ms', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Serviço de Urgência da Faculdade de Odontologia de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Bruno K Carrocini, Ms', 'role': 'CONTACT', 'email': 'bruno.carrocini@usp.br', 'phone': '5511994331906'}, {'name': 'Ines A Buscariolo, PhD', 'role': 'CONTACT', 'email': 'iabuscar@usp.br', 'phone': '5511982618190'}], 'overallOfficials': [{'name': 'Bruno k Carrocini, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bruno Klouczek Carrocini', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-04-16', 'type': 'RELEASE'}, {'date': '2019-05-08', 'type': 'RESET'}, {'date': '2019-07-23', 'type': 'RELEASE'}, {'date': '2019-08-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ines Buscariolo, Principal Investigator, University of Sao Paulo'}}}}