Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-28 @ 4:20 PM
Study NCT ID:
NCT05427903
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-16', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'up to 24 hours', 'description': 'verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Procedural']}, 'descriptionModule': {'briefSummary': 'The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged above 18 years\n* Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis\n\nExclusion Criteria:\n\n* Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions\n* Presence of paresthesia\n* Presence of psychological problems\n* Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively'}, 'identificationModule': {'nctId': 'NCT05427903', 'briefTitle': 'Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial', 'orgStudyIdInfo': {'id': '602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryotherapy', 'interventionNames': ['Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'IANB plus buccal infiltration local anesthesia', 'interventionNames': ['Procedure: Cryotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IANB', 'interventionNames': ['Procedure: Cryotherapy', 'Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine']}], 'interventions': [{'name': 'Cryotherapy', 'type': 'PROCEDURE', 'description': 'Ice packs application for 5 minutes after IANB injection', 'armGroupLabels': ['IANB', 'IANB plus buccal infiltration local anesthesia']}, {'name': 'Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine', 'type': 'PROCEDURE', 'description': 'Buccal infiltration after IANB', 'armGroupLabels': ['Cryotherapy', 'IANB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Omar Ahmed', 'role': 'CONTACT', 'email': 'EG135.30708112400351@nies-edu.org'}], 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Ahmad Elheeny, PhD', 'role': 'CONTACT', 'email': 'ahmedelheeny@mu.edu.eg', 'phone': '00201064257135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ahmad Elheeny', 'investigatorAffiliation': 'Minia University'}}}}