Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT01214369
Status:
UNKNOWN
Last Update Posted:
2010-10-27
First Post:
2010-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthetic Efficacy of X-tip Intraosseous Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-26', 'studyFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2010-10-04', 'lastUpdatePostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participant who will have the pain following X-tip or PDL as a supplementary injection', 'timeFrame': '6 months', 'description': 'All particiapant will be asked to show their pain degree on VAS for evaluation the efficacy of injections as a supplementary for anesthetising the teeth before and after the supplementary injection.'}], 'secondaryOutcomes': [{'measure': 'Heart rate monitoring', 'timeFrame': 'before block injection and after supplementary injection', 'description': 'This record will be monitored by puls oximeter device'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intraosseous injection', 'X-tip', 'PDL injection', 'Supplementary Injection'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': '* Hypothesis:\n\n * X-tip intraosseous is an effective supplementary injection in mandibular hot teeth as well as Periodontal Ligament (PDL) injection\n* Purposes:\n\n * Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar Nerve Block\n* Methods and Materials:\n\n * forty patients with mandibular hot molar or second premolar which had not been anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected for this study', 'detailedDescription': '* Randomization:\n\n * All patients will be randomly divided into two groups as follows:\n\n 1. X-tip intraosseous injection will be used as supplementary\n 2. PDL injection will be used as supplementary\n* Anesthetic evaluation:\n\n * For anesthetic evaluation we will use Visual Analog Scale (VAS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mandibular Molars and second premolars with Acute Irreversible Pulpitis\n* None of the teeth selected should have been anesthetized following 3.6 ml Lidocaine block injection\n\nExclusion Criteria:\n\n* Unhealthy patients\n* Teeth which were anesthetized following 3.6 ml nerve block injection\n* Patients who did not have any signs of lip anesthesia following 3.6 ml injection'}, 'identificationModule': {'nctId': 'NCT01214369', 'briefTitle': 'Anesthetic Efficacy of X-tip Intraosseous Injection', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Anesthetic Efficacy of X-tip Intraosseous Injection Following Mandibular Nerve Block in Molars With Acute Irreversible Pulpitis', 'orgStudyIdInfo': {'id': '88288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'X-tip intraosseous injection', 'interventionNames': ['Procedure: Type of Supplementary Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PDL injection', 'interventionNames': ['Procedure: Type of Supplementary Injection']}], 'interventions': [{'name': 'Type of Supplementary Injection', 'type': 'PROCEDURE', 'description': 'Patients will be selected from a group who were not anesthetized following 3.6 ml block injection. Half of the randomly selected patients will receive X-tip intraosseous injection and half will receive PDL injection as a supplementary for completing the anesthesia in selected hot mandibular molar teeth.', 'armGroupLabels': ['PDL injection', 'X-tip intraosseous injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91735', 'city': 'Mashhad', 'state': 'Khorasan Razavi', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Ehsan Sharifi, postgratuate student', 'role': 'CONTACT', 'email': 'sharifie@mums.ac.ir', 'phone': '+989151116448'}, {'name': 'Mina Zarei, DDS,MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'centralContacts': [{'name': 'Mina Zarei Binabaj, DDS,MSc', 'role': 'CONTACT', 'email': 'zareim@mums.ac.ir', 'phone': '00985118829525'}], 'overallOfficials': [{'name': 'Jamileh Ghoddusi, DDS,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Mohammad Ramezani', 'oldOrganization': 'Faculty of pharmacy, Mashhad University of Medical Sciences'}}}}