Nctid:
NCT06611865
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M7542", "name"=>"Dry Socket", "relevance"=>"LOW"}, {"id"=>"T4202", "name"=>"Oculocerebral Syndrome With Hypopigmentation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000777", "term"=>"Anesthetics"}], "ancestors"=>[{"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "asFound"=>"Saline", "relevance"=>"HIGH"}, {"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"A split-mouth group was included with 70 teeth extracted from 35 patients. In such cases, involving bilaterally indicated teeth, ILA and IANB were used on opposite sides, but the second tooth was anesthetized only after the first extraction had completed and had been recorded. The second group had 500 patients with unilateral extractions. ILA was compared with IANB in each group separately, and the results in group I were then compared descriptively with those in group II."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>535}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-03-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-06-17", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-15", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Injection pain", "timeFrame"=>"Through the duration of injection (within a few seconds to 1 minute)", "description"=>"Rating of injection administration pain from 0-10."}, {"measure"=>"Pain during extraction procedure", "timeFrame"=>"For the duration of treatment (estimated within 1 hour)", "description"=>"Pain during extraction procedure on a scale of 0-10."}, {"measure"=>"Unpleasantness of treatment", "timeFrame"=>"For the duration of treatment (estimated within 1 hour)", "description"=>"A rating of 0-10 for overall discomfort felt by the patient during the treatment."}, {"measure"=>"Latency time of anesthesia (minutes)", "timeFrame"=>"Anesthesia was tested with a dental probe on the marginal gingiva at: 1) immediately after the injection and 2) every 10 seconds (ILA) / every 30 seconds (IANB) until complete painlessness was achieved.", "description"=>"The onset of anesthesia after injection"}, {"measure"=>"Anesthetic effect", "timeFrame"=>"For the duration of treatment (estimated within 2 hours)", "description"=>"4 categories: Complete, sufficient, insufficient or no effect."}, {"measure"=>"Amount of anesthetic solution (mL)", "timeFrame"=>"For the duration of treatment (estimated within 1 hour)", "description"=>"The average amount of anaesthetic solution injected per procedure."}, {"measure"=>"Duration of treatment (minutes)", "timeFrame"=>"For the duration of treatment (estimated up to 1 to 2 hours)", "description"=>"Time in minutes taken from the injection to the complete extraction of tooth."}, {"measure"=>"Duration of local numbness (minutes)", "timeFrame"=>"For the duration of treatment (estimated up to 1 to 2 hours)", "description"=>"Total duration of local numbness reported by the patient"}], "secondaryOutcomes"=>[{"measure"=>"Incidence of Dry socket", "timeFrame"=>"From the complete extraction of tooth to 14 days after the extraction of tooth", "description"=>"Dry socket incidence reported by the patient int he recovery period of 14 days"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Intraligamentary Anaesthesia", "Inferior Alveolar Nerve Block", "Tooth Extraction", "Dry Socket"], "conditions"=>["Tooth Extraction", "Tooth Extraction Site Healing"]}, "descriptionModule"=>{"briefSummary"=>"Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. It will help dentists better understand the benefits of the two techniques, and their usage case to case.", "detailedDescription"=>"The study was designed as a randomized controlled trial. The purpose of this study was to examine the differences in efficacy of the intraligamentary anaesthetic technique and the inferior alveolar nerve block for mandibular posterior tooth extraction cases. Pain intensity, duration of anaesthesia, incidence of post-operative dry socket, success rates, onset of anaesthesia were examined. It was done in a split-mouth method so that two different techniques were used in the same patient, thus minimizing individual variations."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients of both sexes who were more than 18 years of age; they had indications of non-surgical extraction of one or multiple mandibular posterior teeth.\n\nExclusion Criteria:\n\n* For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.\n* The exclusion criteria for individual teeth were: acutely infected teeth or any teeth with the instances of expression of pus through sinus tracts or the gingival sulcus were excluded. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study."}, "identificationModule"=>{"nctId"=>"NCT06611865", "briefTitle"=>"Comparison of Intraligamentary Anesthesia With the Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars.", "organization"=>{"class"=>"OTHER", "fullName"=>"Nishtar Medical University"}, "officialTitle"=>"Cross-sectional Study Documenting the Relative Efficacy of Intraligamentary Anesthesia and the Inferior Alveolar Nerve Block for the Extraction of Posterior Mandibular Teeth.", "orgStudyIdInfo"=>{"id"=>"642/NID"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Split-mouth group", "description"=>"It includes bilaterally indicated teeth. ILA and IANB were used on opposite sides in the same person; the second tooth was anesthetized only after the first extraction had completed and had been recorded.", "interventionNames"=>["Procedure: Intraligamentary anaesthesia", "Procedure: Inferior alveolar nerve block"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group 2 ILA", "description"=>"The patients in group 2, with unilateral extractions, that were only administered Intraligamentary anaesthesia.", "interventionNames"=>["Procedure: Intraligamentary anaesthesia"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group 2 IANB", "description"=>"The patients in group 2, with unilateral extractions, that were only administered the Inferior Alveolar Nerve Block. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study.", "interventionNames"=>["Procedure: Inferior alveolar nerve block"]}], "interventions"=>[{"name"=>"Intraligamentary anaesthesia", "type"=>"PROCEDURE", "description"=>"Injection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe.", "armGroupLabels"=>["Group 2 ILA", "Split-mouth group"]}, {"name"=>"Inferior alveolar nerve block", "type"=>"PROCEDURE", "description"=>"Anaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point.", "armGroupLabels"=>["Group 2 IANB", "Split-mouth group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60000", "city"=>"Multan", "state"=>"Punjab", "country"=>"Pakistan", "facility"=>"Nishtar Institute of Dentistry", "geoPoint"=>{"lat"=>30.19679, "lon"=>71.47824}}], "overallOfficials"=>[{"name"=>"Amjad Bari, MDS", "role"=>"STUDY_CHAIR", "affiliation"=>"Nishtar Institute of Dentistry"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hamza Zia Ahmed", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Hamza Zia Ahmed", "investigatorAffiliation"=>"Nishtar Medical University"}}}}
