Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT05406895
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of CBCT to Improve Inferior Alveolar Nerve Block Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], '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'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'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': ['PARTICIPANT'], 'maskingDescription': 'The participants will be masked to which technique they are receiving.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel model for either CBCT guided or intra-oral technique. If the patients receive a two-stage implant placement technique then a cross-over model will be used.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lingual nerve numbness', 'timeFrame': '3 minutes', 'description': 'Numbness of tongue, numbness of lingual tissue'}, {'measure': 'Lingual nerve numbness', 'timeFrame': '5 minutes', 'description': 'Numbness of tongue, numbness of lingual tissue'}, {'measure': 'Lingual nerve numbness', 'timeFrame': '8 minutes', 'description': 'Numbness of tongue, numbness of lingual tissue'}, {'measure': 'Lingual nerve numbness', 'timeFrame': '10 minutes', 'description': 'Numbness of tongue, numbness of lingual tissue'}, {'measure': 'Lingual nerve numbness', 'timeFrame': 'one hour', 'description': 'Numbness of tongue, numbness of lingual tissue'}, {'measure': 'Lingual nerve numbness', 'timeFrame': '2 hours', 'description': 'Numbness of tongue, numbness of lingual tissue'}, {'measure': 'Mental nerve numbness', 'timeFrame': '3 minutes', 'description': 'Numbness of lips, numbness of buccal gingival tissue of canine'}, {'measure': 'Mental nerve numbness', 'timeFrame': '5 minutes', 'description': 'Numbness of lips, numbness of buccal gingival tissue of canine'}, {'measure': 'Mental nerve numbness', 'timeFrame': '8 minutes', 'description': 'Numbness of lips, numbness of buccal gingival tissue of canine'}, {'measure': 'Mental nerve numbness', 'timeFrame': '10 minutes', 'description': 'Numbness of lips, numbness of buccal gingival tissue of canine'}, {'measure': 'Mental nerve numbness', 'timeFrame': '1 hour', 'description': 'Numbness of lips, numbness of buccal gingival tissue of canine'}, {'measure': 'Mental nerve numbness', 'timeFrame': '2 hours', 'description': 'Numbness of lips, numbness of buccal gingival tissue of canine'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '3 minutes', 'description': 'Numbness of buccal gingival tissue of molar'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '5 minutes', 'description': 'Numbness of buccal gingival tissue of molar'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '8 minutes', 'description': 'Numbness of buccal gingival tissue of molar'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '10 minutes', 'description': 'Numbness of buccal gingival tissue of molar'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '1 hour', 'description': 'Numbness of buccal gingival tissue of molar'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '2 hours', 'description': 'Numbness of buccal gingival tissue of molar'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '3 minutes', 'description': 'Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '5 minutes', 'description': 'Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '8 minutes', 'description': 'Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '10 minutes', 'description': 'Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '1 hour', 'description': 'Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites'}, {'measure': 'Inferior alveolar nerve numbness', 'timeFrame': '2 hours', 'description': 'Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites'}], 'secondaryOutcomes': [{'measure': 'Pain during surgery', 'timeFrame': 'At the end of the procedure', 'description': 'Pain during surgery will be measured using Visual Analog Scale (VAS) which is a linear scale from 0-100 with a lower number suggesting a more successful anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inferior Alveolar Nerve', 'Mandibular Nerve Blocks']}, 'descriptionModule': {'briefSummary': 'The study looks to compare the success rate of lower jaw anesthesia injection (inferior alveolar nerve) that is guided by pre-treatment 3D dental scan (CBCT) versus standard injection technique.', 'detailedDescription': 'A total of 200 participants will be recruited that have existing 3D dental scans (CBCT) and require an implant placement (that will be placed in a two stage procedure) in the lower jaw for which a lower jaw anesthesia injection (inferior alveolar nerve) block will be used. The participants will be randomly assigned into one of two groups. The first group will receive the injection technique that is guided by pre-treatment measurements made from the 3D dental scan (CBCT) during implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. The second group will receive the standard injection technique first at the implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the injection technique guided by the 3D dental scan (CBCT). If the implant is placed as a one-stage procedure, the second visit will not apply. Following this, subjective and objective measurements on the success of the anesthesia will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients from the age 18 to 70 years old that are assigned to the 3 clinicians of the graduating class of LSUHSC School of Dentistry Post-graduate Periodontics program.\n* Patients have been reported as an ASA I or ASA II patient that has never had an allergic reaction to lidocaine based on previous dental experience.\n* The patient must be missing one or more mandibular teeth and is treatment planned for a mandibular implant that is placed that requires an inferior alveolar nerve block during surgery.\n* Patient must have an existing CBCT scan within the last year or is planned for a CBCT scan for the purpose of dental implant treatment.\n\nExclusion Criteria:\n\n* The exclusion criteria include patients that have undergone long term use or continuous use within the last week of opioids, analgesics, medications of nerve related pathology and non-steroidal anti-inflammatory drugs.\n* Patients diagnosed with trismus.\n* Patients that request for Nitrous and IV anesthesia\n* Patients missing remaining teeth in the quadrant or having a history of endodontic treatment of the remaining teeth in the quadrant.\n* Patients having endodontic or pulpal pathology in the teeth in the quadrant.'}, 'identificationModule': {'nctId': 'NCT05406895', 'briefTitle': 'Use of CBCT to Improve Inferior Alveolar Nerve Block Success', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBCT first', 'description': 'This group will receive the injection technique that is guided by pre-treatment measurements made from the 3D dental scan (CBCT) during implant placement surgery and if the implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. If the implant is placed as a one-stage procedure, the second visit will not apply.', 'interventionNames': ['Drug: 2% Lidocaine with 1:100,000 epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard technique first', 'description': 'This group will receive the standard injection technique first at the implant placement surgery and if the implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the injection technique guided by the 3D dental scan (CBCT). If the implant is placed as a one-stage procedure, the second visit will not apply.', 'interventionNames': ['Drug: 2% Lidocaine with 1:100,000 epinephrine']}], 'interventions': [{'name': '2% Lidocaine with 1:100,000 epinephrine', 'type': 'DRUG', 'description': '2% Lidocaine with 1:100,000 epinephrine will be used for administering the lower jaw anesthesia (inferior alveolar nerve block).', 'armGroupLabels': ['CBCT first', 'Standard technique first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University School of Dentistry', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}