Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 4:52 AM
Study NCT ID:
NCT06342869
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of complementary palatinal anesthesia with VAS', 'timeFrame': '10 minutes after anesthesia is performed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['articaine, lidocaine, irreversible pulpitis, infiltration anesthesia'], 'conditions': ['Fist and Second Molars With ırreversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '22341059', 'type': 'BACKGROUND', 'citation': 'Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.'}, {'pmid': '39923048', 'type': 'DERIVED', 'citation': 'Kolay D, Kirici D. Comparison of the effects of lidocaine and articaine used for buccal infiltration and supplemental palatinal infiltration anesthesia in maxillary molars with irreversible pulpitis: a prospective randomized study. BMC Oral Health. 2025 Feb 8;25(1):207. doi: 10.1186/s12903-025-05552-y.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.\n\nMethod: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient must be a healthy individual between the ages of 18 and 65 who is classified as ASA I and II.\n2. No allergy to local anesthetic substances to be used in the study\n3. Upper maxillary molars with irreversible pulpitis whose vitality has been proven by pulp tests, with no radiolucency at the root tip\n4. Not having used any painkillers, antibiotics, antidepressants and sedative drugs in the last 12 hours\n5. Being capable of understanding the Pain scale\n\nExclusion Criteria:\n\n1. Allergy to local anesthetics\n2. Failure to respond to the cold test and electric pulp test performed on the relevant tooth\n3. Radiolucent lesion in the apical part of the relevant tooth on periapical radiography\n4. No vital tissue is encountered when the pulp chamber is opened'}, 'identificationModule': {'nctId': 'NCT06342869', 'briefTitle': 'Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis', 'orgStudyIdInfo': {'id': '690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'buccal infiltration with 4% articaine containing 1:100,000 epinephrine', 'interventionNames': ['Procedure: Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'buccal infiltration with 2% lidocaine containing 80,000 epinephrine', 'interventionNames': ['Procedure: Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine', 'interventionNames': ['Procedure: Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine', 'interventionNames': ['Procedure: Anesthesia']}], 'interventions': [{'name': 'Anesthesia', 'type': 'PROCEDURE', 'description': 'application of different anesthesia techniques', 'armGroupLabels': ['buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine', 'buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine', 'buccal infiltration with 2% lidocaine containing 80,000 epinephrine', 'buccal infiltration with 4% articaine containing 1:100,000 epinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Damla Kırıcı', 'investigatorAffiliation': 'Akdeniz University'}}}}