Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 7:16 PM
Study NCT ID:
NCT07048834
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2025-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Articaine Local Infusion and Lidocaine Nerve Block in Lower Posterior Tooth Extraction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale (VAS)', 'timeFrame': 'five minutes', 'description': 'It usually is a horizontal line, 100 mm in length, anchored by word descriptors at each end, for example, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '27663614', 'type': 'BACKGROUND', 'citation': 'Webster S Jr, Drum M, Reader A, Fowler S, Nusstein J, Beck M. How Effective Is Supplemental Intraseptal Anesthesia in Patients with Symptomatic Irreversible Pulpitis? J Endod. 2016 Oct;42(10):1453-7. doi: 10.1016/j.joen.2016.07.002.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/22822998/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34395896/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/28127498/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "In this study 60 adult patients will participate and divided into two groups (30 for each). The first group will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, while the second group will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.\n\nAfter that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction.\n\nFemale patients who are breastfeeding or pregnant, those allergic to local anesthetics, lacking full mental ability, currently taking opioids, having an infection at the extraction site, or those under the influence of medicines that alter their perception of pain will be excluded from the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically healthy patients\n\nExclusion Criteria:\n\n* Breastfeeding or pregnant\n* Allergic to local anaesthetics drugs\n* Lack full mental ability\n* Infection at the extraction site\n* Patient who currently taking opioids or under the influence of medicines that alter their perception of pain are not candidates for tooth extraction'}, 'identificationModule': {'nctId': 'NCT07048834', 'briefTitle': 'Comparison of the Effectiveness of Articaine Local Infusion and Lidocaine Nerve Block in Lower Posterior Tooth Extraction.', 'organization': {'class': 'OTHER', 'fullName': 'Ahl al-Bayt University'}, 'officialTitle': 'Comparison of the Effectiveness of Articaine Local Infusion and Lidocaine Nerve Block in Lower Posterior Tooth Extraction.', 'orgStudyIdInfo': {'id': '1419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block.', 'description': "This group of (30 patients) will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.\n\nAfter that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction", 'interventionNames': ['Other: lidocaine local anesthetic drug']}, {'type': 'OTHER', 'label': 'anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration.', 'description': "This group (of 30 patients) will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin.\n\nAfter that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction.", 'interventionNames': ['Other: articaine local anesthetic drug']}], 'interventions': [{'name': 'lidocaine local anesthetic drug', 'type': 'OTHER', 'description': 'Lidocaine Nerve Block technique', 'armGroupLabels': ['patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block.']}, {'name': 'articaine local anesthetic drug', 'type': 'OTHER', 'description': 'Articaine Local Infusion technique', 'armGroupLabels': ['anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karbala', 'country': 'Iraq', 'facility': 'Ahl Al Bayt University', 'geoPoint': {'lat': 32.61603, 'lon': 44.02488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to lack of participant consent for data Sharing. so, Individual participant data will not be shared due to the absence of specific provisions for broad external data sharing within the original informed consent documents signed by participants. Retrospective consent for such sharing is not feasible for this study population.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amjed Fouad Hussein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Amjed Fouad Hussein', 'investigatorAffiliation': 'Ahl al-Bayt University'}}}}