Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT07130760
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to receive either intraligamentary injection or inferior alveolar nerve block prior to endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-16', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-08-16', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain during endodontic access', 'timeFrame': 'Immediately after access cavity preparation (within 30 minutes of anesthesia)', 'description': 'Pain intensity experienced by the patient during endodontic access after the assigned anesthetic technique.'}], 'secondaryOutcomes': [{'measure': 'Need for supplementary anesthesia', 'timeFrame': 'During access or initial root canal instrumentation (within first 45 minutes)', 'description': 'Whether the initial anesthesia technique was sufficient or required additional anesthetic injection to complete the procedure pain-free.'}, {'measure': 'Patient satisfaction immediately after treatment', 'timeFrame': 'End of visit (within 1 hour)', 'description': 'Patient-reported satisfaction immediately after treatment will be measured using a 5-point Likert scale. The scale ranges from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate better satisfaction.'}, {'measure': 'Postoperative pain at 7 days', 'timeFrame': 'Day 7 post-treatment', 'description': 'Pain intensity reported by the patient at day 7 after treatment will be assessed using a 4-point ordinal scale: 1 (none), 2 (mild), 3 (moderate), 4 (severe). Higher scores indicate worse pain.'}, {'measure': 'Patient satisfaction at 7 days', 'timeFrame': 'Day 7 post-treatment', 'description': 'Patient-reported satisfaction one week after treatment will be measured using a 5-point Likert scale. The scale ranges from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate better satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inferior alveolar nerve block', 'Pulpitis Mandibular molars', 'Emergency dental treatment', 'Symptomatic irreversible pulpitis', 'Randomized clinical trial', 'Endodontics', 'Dental pain', 'Local anesthesia', 'Intraligamentary anesthesia'], 'conditions': ['Symptomatic Irreversible Pulpitis (SIP)', 'Dental Pain', 'Inferior Alveolar Nerve Block Failure', 'Local Anesthesia']}, 'descriptionModule': {'briefSummary': 'This multicenter randomized trial compares the clinical effectiveness of intraligamentary injection versus inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. The goal is to determine which technique provides better pain control during endodontic treatment.', 'detailedDescription': 'Symptomatic irreversible pulpitis in mandibular molars presents a clinical challenge due to the difficulty in achieving profound anesthesia. This prospective, randomized, controlled clinical trial evaluates two anesthetic techniques-intraligamentary injection (ILA) versus inferior alveolar nerve block (IANB)-to compare their efficacy in eliminating pain during endodontic access. Patients will be enrolled from multiple dental centers following standardized inclusion and exclusion criteria. Pain will be assessed using validated scales. Statistical analysis will be conducted to determine significant differences in anesthetic success between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Presenting with symptomatic irreversible pulpitis in a mandibular molar\n* Vital response to cold testing\n* Ability to understand and provide informed consent\n* Available for follow-up and data collection\n\nExclusion Criteria:\n\n* Known allergy to lidocaine or epinephrine\n* Pregnancy or breastfeeding\n* Use of analgesics or anti-inflammatory drugs in the previous 6 hours\n* Non-vital or previously treated teeth\n* Significant systemic disease (ASA III or above)\n* History of psychiatric or neurological disorders affecting pain perception'}, 'identificationModule': {'nctId': 'NCT07130760', 'briefTitle': 'Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Aula Dental Avanzada'}, 'officialTitle': 'Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.', 'orgStudyIdInfo': {'id': 'ILA VS AINB PULP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraligamentary Injection Group', 'description': 'Patients in this arm will receive intraligamentary anesthesia prior to endodontic access.', 'interventionNames': ['Procedure: Intraligamentary Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inferior Alveolar Nerve Block Group', 'description': 'Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access.', 'interventionNames': ['Procedure: Inferior Alveolar Nerve Block']}], 'interventions': [{'name': 'Intraligamentary Injection', 'type': 'PROCEDURE', 'otherNames': ['Intraligamental anesthesia (ILA)', 'Periodontal ligament injection (PDL injection)', 'Intraligamentary anesthetic technique'], 'description': 'Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine.', 'armGroupLabels': ['Intraligamentary Injection Group']}, {'name': 'Inferior Alveolar Nerve Block', 'type': 'PROCEDURE', 'otherNames': ['Inferior alveolar nerve anesthesia', 'Inferior dental block'], 'description': 'Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique.', 'armGroupLabels': ['Inferior Alveolar Nerve Block Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15402', 'city': 'Ferrol', 'state': 'A coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Barreiro-Gabeiras, DDS', 'role': 'CONTACT', 'email': 'clinica4dental@gmail.com', 'phone': '34981358375'}], 'facility': 'Clínica Dental 4', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '03001', 'city': 'Alicante', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Guillem Esteve-Pardo, PhD', 'role': 'CONTACT', 'email': 'guillem@clinicaesteve.com', 'phone': '34965215755'}, {'name': 'Guillem Esteve-Pardo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clínica Dental Esteve', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}], 'centralContacts': [{'name': 'Guillem Esteve-Pardo, PhD', 'role': 'CONTACT', 'email': 'guillem@clinicaesteve.com', 'phone': '34965215755'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study will not share individual participant data (IPD).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aula Dental Avanzada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - DDS, PhD (Bioengineering)', 'investigatorFullName': 'Guillem Esteve-Pardo', 'investigatorAffiliation': 'Aula Dental Avanzada'}}}}