Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT05857033
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain scores', 'timeFrame': 'Baseline and up to 1 hour', 'description': "Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain."}, {'measure': "Change in child's behavior", 'timeFrame': 'During the procedure', 'description': "Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections.\n\nTotal scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental injection', 'Palatal injection', 'Indirect palatal injection'], 'conditions': ['Anesthesia, Local']}, 'referencesModule': {'references': [{'pmid': '40462040', 'type': 'DERIVED', 'citation': 'Hambouta HM, Sharaf DA, Wahba NA. Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):900. doi: 10.1186/s12903-025-06170-4.'}]}, 'descriptionModule': {'briefSummary': 'Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are in need of extraction of maxillary posterior teeth.\n* Children free of any systemic disease or special health care needs (ASA I).\n* Children with no learning disabilities.\n* Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.\n* Patients whose parents will give consent to participate.\n\nExclusion Criteria:\n\n* Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.\n* Signs of reversible pulpitis.\n* Restorable tooth.\n* Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.\n* Patients with acute oral or facial infection (swelling and/or cellulites )'}, 'identificationModule': {'nctId': 'NCT05857033', 'briefTitle': 'Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '0568-12/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct local anesthesia with Buzzy', 'interventionNames': ['Other: Buccal and direct palatal injection with the aid of Buzzy']}, {'type': 'EXPERIMENTAL', 'label': 'Indirect local anesthesia with Buzzy', 'interventionNames': ['Other: Buccal and indirect palatal injection with the aid of Buzzy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct local anesthesia', 'interventionNames': ['Other: Buccal and direct palatal injection without Buzzy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indirect local anesthesia', 'interventionNames': ['Other: Buccal and indirect palatal injection without Buzzy']}], 'interventions': [{'name': 'Buccal and direct palatal injection with the aid of Buzzy', 'type': 'OTHER', 'description': 'Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection', 'armGroupLabels': ['Direct local anesthesia with Buzzy']}, {'name': 'Buccal and indirect palatal injection with the aid of Buzzy', 'type': 'OTHER', 'description': 'Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection', 'armGroupLabels': ['Indirect local anesthesia with Buzzy']}, {'name': 'Buccal and direct palatal injection without Buzzy', 'type': 'OTHER', 'description': 'Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection', 'armGroupLabels': ['Direct local anesthesia']}, {'name': 'Buccal and indirect palatal injection without Buzzy', 'type': 'OTHER', 'description': 'Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection', 'armGroupLabels': ['Indirect local anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}