Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
Study NCT ID:
NCT07257432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Anesthetic Efficacy Prof. Ali Rokia Ph.D. Al-Andalus University Prof . Mouetaz Kheirallah Ph.D ArabUST
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'single blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The split-mouth design was applied to the study group, with one arm for therapeutic intervention involving Smartject injection , and the other arm involving traditional injectors'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'duration of the anesthesia', 'timeFrame': '2 month', 'description': 'was asked to record the time of return to normal sensation in the lower lip'}], 'primaryOutcomes': [{'measure': 'Onset time', 'timeFrame': '2 month', 'description': 'was considered as the period between the end of the injection and the first subsequent Onset time was considered as the period between the end of the injection and the first subsequent readings without response. After this period, the tooth was tested every 10 minutes until readings returned to the baseline threshold. Each subject was asked to record the time of return to normal sensation in the lower lip'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '2 month', 'description': 'VAS uses a straight horizontal line of extent measuring 10 cm. The ends state the maximum limit of pain orientated from the best (right) to the worst (left) so that the patient can indicate the intensity of the pain (0-100). The intensity of pain is made by measuring the dimension from "no pain" to "very severe pain" based on the patient\'s signs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Anesthesia'], 'conditions': ['Pain Perception']}, 'referencesModule': {'references': [{'pmid': '7645794', 'type': 'BACKGROUND', 'citation': 'Douglas BL. Electronic dental anesthesia. Anesth Prog. 1993;40(3):99-100. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A Spilt Mouth Clinical Comparative Evaluation Of The Electronic Anesthetic Efficacy Comparison of traditional local anesthesia with electronic local anesthesia in terms of the ability to reduce pain during injection and the duration of the anesthetic effect', 'detailedDescription': 'Study Design:\n\nThe mouth will be split in half using a split mouth study. The lower anterior teeth will be injected with a conventional local anesthetic syringe on one side, and the patient will be injected with an electronic anesthetic syringe on the other side.\n\nThe study will be conducted on a sample of volunteers aged 18 to 30 years at the Faculty of Dentistry at Al-Andalus University.\n\nThe objectives and procedure will be explained to each group of patients, and informed consent will be obtained from each patient to accept the research procedures.\n\nA 2% non-vasoconstrictor lidocaine local anesthetic will be used for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:". Age ranged from 20 to 30 years , no menstrual cycle, The participants were not allergic to local anesthetics, had not used medication that would alter pain perception, none of them had not ever experienced Smartject injection before, and none of them were alcoholics or smokers, The participants were not allergic to local anesthetics.\n\nExclusion Criteria:\n\nallergic to local anesthetics ,females during menstural cycle ,bad oral care.'}, 'identificationModule': {'nctId': 'NCT07257432', 'acronym': 'ArabUST', 'briefTitle': 'Electronic Anesthetic Efficacy Prof. Ali Rokia Ph.D. Al-Andalus University Prof . Mouetaz Kheirallah Ph.D ArabUST', 'organization': {'class': 'OTHER', 'fullName': 'Arab University for Science and Technology'}, 'officialTitle': 'a Spilt Mouth Clinical Comparative Evaluation of the Electronic Anesthetic Efficacy', 'orgStudyIdInfo': {'id': 'ArabUST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic syringe therapeutic intervention arm', 'description': 'During the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side', 'interventionNames': ['Drug: Experimental group: Electronic syringe therapeutic intervention arm', 'Drug: control group: therapeutic intervention using a traditional syringe']}, {'type': 'EXPERIMENTAL', 'label': 'therapeutic intervention using a traditional syringe', 'description': 'During the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side', 'interventionNames': ['Drug: Experimental group: Electronic syringe therapeutic intervention arm', 'Drug: control group: therapeutic intervention using a traditional syringe']}], 'interventions': [{'name': 'Experimental group: Electronic syringe therapeutic intervention arm', 'type': 'DRUG', 'otherNames': ['anesthesia pen x'], 'description': 'Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side', 'armGroupLabels': ['Electronic syringe therapeutic intervention arm', 'therapeutic intervention using a traditional syringe']}, {'name': 'control group: therapeutic intervention using a traditional syringe', 'type': 'DRUG', 'otherNames': ['surgimax'], 'description': 'During the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side', 'armGroupLabels': ['Electronic syringe therapeutic intervention arm', 'therapeutic intervention using a traditional syringe']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tartus', 'state': 'Al Kadmous', 'country': 'Syria', 'facility': 'Al Andalus University', 'geoPoint': {'lat': 34.88902, 'lon': 35.88659}}, {'city': 'Hama', 'country': 'Syria', 'facility': 'Arab University', 'geoPoint': {'lat': 35.13179, 'lon': 36.75783}}], 'overallOfficials': [{'name': 'Ali G Rokia, ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Andalus University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mouetaz Kheirallah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D., OMFS, DDS, Associate Professor', 'investigatorFullName': 'Mouetaz Kheirallah', 'investigatorAffiliation': 'Arab University for Science and Technology'}}}}