Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-09 @ 1:24 AM
Study NCT ID:
NCT06538233
Status:
RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain After Buffered Vs Non Buffered Articaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rate Scale (NRS)', 'timeFrame': 'Immediate', 'description': 'Pain during injection of buffered versus non-buffered articaine local anesthetic will be measured using NRS from 0 to 10, where 0 is no pain and 10 is the most unbearable pain .'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Pain after buffered versus non buffered articaine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, age- 18 to 60 yrs.\n* Medically free.\n* Need a dental treatment in the upper anterior region.\n\nExclusion Criteria:\n\n* Periodontally affected teeth.\n* Radiographic bone loss.\n* Upnormal length of the teeth.'}, 'identificationModule': {'nctId': 'NCT06538233', 'briefTitle': 'Pain After Buffered Vs Non Buffered Articaine', 'organization': {'class': 'OTHER', 'fullName': 'Cleveland Dental Institute'}, 'officialTitle': 'A Comparison of Pain Response During Administration of Buffered Articaine Versus Non-buffered Articaine Local Anesthetics for Dental Treatment in Adult', 'orgStudyIdInfo': {'id': 'CDIOS00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buffered articaine', 'interventionNames': ['Drug: Buffered articaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non buffered articaine', 'interventionNames': ['Drug: Non buffered articaine']}], 'interventions': [{'name': 'Buffered articaine', 'type': 'DRUG', 'description': 'Injecting buffered articaine in maxillary anterior region and evaluate pain response.', 'armGroupLabels': ['Buffered articaine']}, {'name': 'Non buffered articaine', 'type': 'DRUG', 'description': 'Injecting non buffered articaine in maxillary anterior region and evaluate pain response.', 'armGroupLabels': ['non buffered articaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44128', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pavanpreet Kaur, Resident', 'role': 'CONTACT', 'email': 'p.kaur@cdiohio.org', 'phone': '216-355-1155'}], 'facility': 'Clevland Dental Institute', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Pavanpreet Kaur, Resident', 'role': 'CONTACT', 'email': 'p.kaur@cdiohio.org', 'phone': '2163551155'}, {'name': 'Jana Aboul-Hassan, Resident', 'role': 'CONTACT', 'email': 'j.aboulhassan@cdiohio.org', 'phone': '7262054266'}], 'overallOfficials': [{'name': 'Ahmed H Khalifa, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cleveland Dental Institute'}, {'name': 'Waleed Elmallah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Dental Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleveland Dental Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}