Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-01 @ 2:42 AM
Study NCT ID:
NCT02708433
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2016-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ray_white@unc.edu', 'phone': '919-537-3944', 'title': 'Raymond P. White, Jr. DDS, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected for 24 hours after active component of the trial', 'eventGroups': [{'id': 'EG000', 'title': 'Buffered 1% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Buffered 2% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Time to Pulpal Response After Mandibular Molar Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.'}, {'id': 'OG001', 'title': 'Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'spread': '49', 'groupId': 'OG000'}, {'value': '98', 'spread': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.57', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '49', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Every 30 minutes up to 120 minutes total', 'description': 'Subject\'s Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no."', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Time to Pulpal Response After Mandibular Canine Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.'}, {'id': 'OG001', 'title': 'Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'spread': '48', 'groupId': 'OG000'}, {'value': '85', 'spread': '48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.52', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '48', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Every 30 minutes up to 120 minutes total', 'description': 'Subject\'s Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants "yes" or "no."', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buffered 1% Lidocaine, Then Non-buffered 2% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Buffered 1% Lidocaine followed by a 1-week washout, then Non-buffered 2% Lidocaine.'}, {'id': 'FG001', 'title': 'Non-Buffered 2% Lidocaine, Then Buffered 1% Lidocaine', 'description': 'At each treatment visit, participants were injected orally for mandibular block (inferior alveolar, lingual, buccal nerves).\n\nFor this arm, participants first received Non-Buffered 2% Lidocaine followed by a 1-week washout, then Buffered 1% Lidocaine.'}], 'periods': [{'title': 'First Intervention (Visit 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (at Least 1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Visit 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who were randomized to received either Buffered 1% Lidocaine or Non-buffered 2% Lidocaine'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-01', 'size': 241066, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-26T13:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2016-03-03', 'resultsFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Time to Pulpal Response After Mandibular Molar Anesthesia', 'timeFrame': 'Every 30 minutes up to 120 minutes total', 'description': 'Subject\'s Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no."'}, {'measure': 'Mean Time to Pulpal Response After Mandibular Canine Anesthesia', 'timeFrame': 'Every 30 minutes up to 120 minutes total', 'description': 'Subject\'s Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants "yes" or "no."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lidocaine, jaw'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures', 'detailedDescription': 'Specific Aims:\n\nCompare clinical depths of pulpal anesthesia (cold, Electronic Pulp Test) for mandibular molar, and canine teeth at 30 minute intervals post injection for mandibular block anesthesia with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.\n\nHypotheses:\n\nNo differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for mandibular block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.\n\nStudy Time Frame: 6 months Month One: Recruit 24 volunteers as subjects. Prepare case-books. Months Two-Three: Clinical Study, Months Four-Five: Analyze data Month Six: Prepare Abstracts, Papers Methods: Blinded, Randomized Clinical Design Recruit subjects with Institutional Review Board approved consent at UNC Subjects will serve as their own controls in a cross-over AB/BA study design which is uniform within sequences, uniform within periods, and balanced Randomized subjects to be injected orally for mandibular block (inferior alveolar, lingual, buccal nerves) alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine.\n\nAssessment: pre, and post-anesthetic administration for pulpal anesthesia with cold, Electronic Pulp Test: Mandibular molar, canine at 30 minute intervals Inclusion Criteria: Age 18-30 years, American Society Anesthesiologists (ASA) I Exclusion Criteria Allergy to lidocaine class of anesthetic drugs, Local anesthetic drug past week Current symptoms teeth or oral mucosa. SAS will be used for database management and statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-30 years, ASA I\n\nExclusion Criteria:\n\n* Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa'}, 'identificationModule': {'nctId': 'NCT02708433', 'briefTitle': 'Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Pilot Study: Comparison of Buffered 1% vs. Non-Buffered 2% Lidocaine Used in Dental and Oral Surgical Procedures: Clinical Outcomes', 'orgStudyIdInfo': {'id': '16-0068a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Buffered 1% lidocaine', 'description': 'In week one each subject would receive either anesthetic (Buffered 1% lidocaine with 1/100,000 Epinephrine) or (Non-Buffered 2% lidocaine with 1/100,000 Epinephrine) to block the inferior alveolar, lingual, buccal nerves.\n\nIn week two the alternate anesthetic would be administered.\n\nMandibular molar and canine tested for pulpal anesthesia', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Buffered lidocaine', 'description': 'In week two each subject would receive the alternate anesthetic (Buffered 1% lidocaine with 1/100,000 Epinephrine) or (Non-Buffered 2% lidocaine with 1/100,000 Epinephrine) to block the inferior alveolar, lingual, buccal nerves.\n\nMandibular molar and canine tested for pulpal anesthesia', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['xylocaine'], 'description': 'Lidocaine', 'armGroupLabels': ['Buffered 1% lidocaine', 'Non-Buffered lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7450', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC School of Dentistry', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Raymond P White, Jr., DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Dept Oral and Maxillofacial Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}