Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-25 @ 2:46 PM
Study NCT ID:
NCT05875350
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain using visual analogue scale', 'timeFrame': 'immediately after injection', 'description': 'visual analogue scale (VAS) was used in which a pain score was recorded for each patient just after local anesthetic adminstration. The VAS score ranges from 0 (no pain) to 10 (extreme unbearable pain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy patients (class I category according to American society of anesthesiologists )\n* Age range: 20 - 60 years of age,\n* Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.\n\nExclusion Criteria:\n\n* Patients with tooth that require trans osseous extraction\n* Badly broken down coronal structure of the tooth to be extracted\n* Patients with significant medical conditions\n* Alcoh intake\n* Patients on drugs that affect the central nervous systems\n* Patients who reported the use of drugs that might interfere with pain sensitivity\n* Pregnant or lactating women\n* Patients who suffer from hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).'}, 'identificationModule': {'nctId': 'NCT05875350', 'briefTitle': 'Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Efficacy of Low Dose Intraligamental Local Anesthesia as an Alternative for Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars: Double Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraligamental local anesthetic injection', 'interventionNames': ['Procedure: Intraligamental local anesthetic injection']}, {'type': 'NO_INTERVENTION', 'label': 'Buccal infiltration local anesthetic injection'}], 'interventions': [{'name': 'Intraligamental local anesthetic injection', 'type': 'PROCEDURE', 'description': 'The intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt)', 'armGroupLabels': ['Intraligamental local anesthetic injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2431412', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Tarek Abdelbarry', 'investigatorAffiliation': 'Minia University'}}}}