Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-03 @ 8:19 PM
Study NCT ID:
NCT06934512
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Comparison of Pain Score of Needleless Jet Injector and Conventional Needle Injection for Teeth Extraction Anesthesia (Split Mouth Technique).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CLINICAL COMPARISON OF PAIN SCORE OF NEEDLELESS JET INJECTOR AND CONVENTIONAL NEEDLE INJECTION FOR TEETH EXTRACTION ANESTHESIA (SPLIT MOUTH TECHNIQUE)', 'timeFrame': 'Peri operative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain score'], 'conditions': ['Pain Score']}, 'descriptionModule': {'briefSummary': 'Dental anesthesia with needle injection cause fear and anxiety in patients about the dental procedures. Therefore, less painful anesthesia alternatives like needleless anesthesia devices to reduce the negative sensation of pain and fear that is always associated with traditional local anesthesia needle injection.\n\nThe jet injector with INJEX is a needleless injector system that injects the local anesthesia solution into the tissues through a pressure. This research aims to compare the pain score of jet injector with INJEX and traditional local anesthesia needle injection for teeth extraction.\n\nMethod:\n\n50 patients visiting DOW Ojha Hospital, who needs extraction of bilateral teeth will be included in this study. Data collection approval will be taken from Institutional Review Board (IRB) of DUHS.\n\nComplete procedure, study purpose and pain scale will be explained to patients and they will be told that information will be utilized for only research purpose and after that permission will be taken from participants.\n\nAfter taking history, quadrants will be divided; one for local anesthesia by the Jet Injector with INJEX and one for traditional local anesthesia needle injection.\n\nAfter that local anesthesia with Jet Injector INJEX will be given to one side and traditional local anesthesia needle injection will be given to other site for teeth extraction. Then principle investigator will examine the patient pain through the pain scale (Visual Analog Scale) of this study and supervisor will confirm it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* 18-24 years old patient\n* Patients having permanent dentition who require bilateral anterior or premolar teeth extraction\n* Orthodontic patients who requires bilateral extraction of premolars\n* Patients who give informed consent to take part in study\n\nEXCLUSION CRITERIA:\n\n* Patients with local anesthesia allergy\n* Patients with localized inflammation/ localized abscess/tenderness at site of injection\n* Patients who do not give informed consent to take part in study'}, 'identificationModule': {'nctId': 'NCT06934512', 'briefTitle': 'Clinical Comparison of Pain Score of Needleless Jet Injector and Conventional Needle Injection for Teeth Extraction Anesthesia (Split Mouth Technique).', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Clinical Comparison of Pain Score of Needleless Jet Injector and Conventional Needle Injection for Teeth Extraction Anesthesia (Split Mouth Technique).', 'orgStudyIdInfo': {'id': 'IRB-3820/DUHS/Approval/2025/73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Needleless jet injector', 'description': 'Local anesthesia with needleless jet injector will be given on one site for the tooth extraction', 'interventionNames': ['Device: Needleless jet injector']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional needle injection', 'description': 'Local anesthesia with traditional needle will be given on another site for the tooth extraction', 'interventionNames': ['Procedure: Conventional needle injection']}], 'interventions': [{'name': 'Needleless jet injector', 'type': 'DEVICE', 'description': 'To assess the pain score through (VAS) scale of needleless jet injector for local anesthesia. Scale has minimum zero number that indicates best outcome and maximum number is ten that indicates worst outcome.', 'armGroupLabels': ['Needleless jet injector']}, {'name': 'Conventional needle injection', 'type': 'PROCEDURE', 'description': 'To assess the pain score through (VAS) scale of traditional needle injection for local anesthesia. Scale has minimum zero number that indicates best outcome and maximum number is ten that indicates worst outcome.', 'armGroupLabels': ['Conventional needle injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '775500', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dr. Ishrat-ul-Ebad Institute of Oral Health Sciences', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dow University of Health and Sciences', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Dr. Zehra Iftikhar', 'investigatorFullName': 'Zahra Iftikhar', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}