Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT05334433
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2022-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Child Behavior After Local Anesthetic Injection Using Needless Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-09', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child behavior (Feeling pain during injection) (Binary Yes/No)', 'timeFrame': 'During injection (Immediate) (No follow up)', 'description': 'Pain perception during LA injection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Behavior']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.\n* Children who are medically fit.\n* Children who are capable of interacting on a mental level.\n* Children between the ages of 6 to 8.\n* First dental visit.\n\nExclusion Criteria:\n\n* Children who struggle with behavioral control (uncooperative).\n* Children who have a history of allergic reaction to local anesthetic drugs.\n* Parental rejection for participation."}, 'identificationModule': {'nctId': 'NCT05334433', 'briefTitle': 'Child Behavior After Local Anesthetic Injection Using Needless Systems', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Child Behavior and Soft Tissue Reaction After Local Anesthetic Injection Using Needle Versus Needless Systems', 'orgStudyIdInfo': {'id': '3399444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Local anesthesia injection with the comfort in jet (Needless system)', 'description': 'A needle-less injection approach will be used to administer the local anesthetic solution', 'interventionNames': ['Procedure: Local anesthesia injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local anesthesia injection with needle injection (conventional technique).', 'description': 'A conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution.', 'interventionNames': ['Procedure: Local anesthesia injection']}], 'interventions': [{'name': 'Local anesthesia injection', 'type': 'PROCEDURE', 'description': 'Local anesthesia administration', 'armGroupLabels': ['Local anesthesia injection with needle injection (conventional technique).', 'Local anesthesia injection with the comfort in jet (Needless system)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Cairo University, Cairo, Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ayatallah Elsayed Mohamed Aly Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}