Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-06 @ 6:39 PM
Study NCT ID:
NCT01951820
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2013-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D013748', 'term': 'Tetracaine'}, {'id': 'D001566', 'term': 'Benzocaine'}, {'id': 'D002355', 'term': 'Carticaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carlosgc@umich.edu', 'phone': '734-763-3391', 'title': 'Dr. Carlos Gonzalez', 'organization': 'University of Michigan School of Dentistry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Benzocaine', 'description': 'benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nBenzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pliaglis', 'description': 'Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nPliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benzocaine', 'description': 'Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nBenzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed'}, {'id': 'OG001', 'title': 'Pliaglis', 'description': 'Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nPliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '170'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '170'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 minutes', 'description': 'The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Benzocaine', 'description': 'benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nBenzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed'}, {'id': 'FG001', 'title': 'Pliaglis', 'description': 'Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nPliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Benzocaine', 'description': 'benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nBenzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed'}, {'id': 'BG001', 'title': 'Pliaglis', 'description': 'Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.\n\nPliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.\n\nArticaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>18 Years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-12', 'studyFirstSubmitDate': '2013-08-22', 'resultsFirstSubmitDate': '2016-04-09', 'studyFirstSubmitQcDate': '2013-09-24', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-12', 'studyFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale', 'timeFrame': '2.5 minutes', 'description': 'The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia of Mucous Membrane']}, 'descriptionModule': {'briefSummary': 'The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.', 'detailedDescription': 'This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.\n\nIn order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.\n\nThe purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars\n* Patients with healthy mucosal tissues, and who do not have pain on palpation at injection site\n* Ability to use and understand a VAS score\n* Ability to use and understand a VAS score\n* No know allergies to topical anesthetics being used\n\nExclusion Criteria:\n\n* Allergy or other contraindications to topical anesthetics\n* Allergy to epinephrine or local anesthetics\n* Broken/unhealthy mucosal tissues and pain on palpation at injection site\n* Patients needing endodontic therapy on maxillary anterior teeth\n* Inability to consent to participate in the study\n* Patients who have used analgesics within 6 hours of appointment time\n* Pregnant and nursing women'}, 'identificationModule': {'nctId': 'NCT01951820', 'briefTitle': 'Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Comparison of Efficacy of Two Topical Anesthetics: Benzocaine Versus Pliaglis for Control of Pain Associated With Dental Needle Insertion in the Palate, A Double Blind Study', 'orgStudyIdInfo': {'id': 'HUM00075036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Benzocaine', 'description': 'Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.', 'interventionNames': ['Drug: Benzocaine', 'Drug: Articaine']}, {'type': 'EXPERIMENTAL', 'label': 'Pliaglis', 'description': 'Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.', 'interventionNames': ['Drug: Pliaglis', 'Drug: Articaine']}], 'interventions': [{'name': 'Pliaglis', 'type': 'DRUG', 'otherNames': ['lidocaine and tetracaine'], 'description': 'Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.', 'armGroupLabels': ['Pliaglis']}, {'name': 'Benzocaine', 'type': 'DRUG', 'otherNames': ['Hurricaine'], 'description': 'Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.', 'armGroupLabels': ['Benzocaine']}, {'name': 'Articaine', 'type': 'DRUG', 'otherNames': ['Septocaine'], 'description': 'Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed', 'armGroupLabels': ['Benzocaine', 'Pliaglis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Dental School', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Brian l Royle, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan department of Endodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Association of Endodontists', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Endodontic Resident', 'investigatorFullName': 'Brian Royle', 'investigatorAffiliation': 'University of Michigan'}}}}