Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05192902
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-01-01', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on Puncture (PoP)', 'timeFrame': 'Within 2 hours', 'description': 'Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)'}, {'measure': 'Pain during Delivery (PdD)', 'timeFrame': 'Within 2 hours', 'description': 'Self-reported pain intensity during delivery of the anaesthetic solution sing visual analogue scale (0 = no pain- 10 = the worse pain)'}], 'secondaryOutcomes': [{'measure': 'Dental Anxiety (DA)', 'timeFrame': 'Within 2 hours', 'description': 'Assessed by the Dental Anxiety Scale (DAS)- Four questions survey with five possible answers. Each answer has a score: a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20. Anxiety rating: 9 - 12 = moderate anxiety/ 13 - 14 = high anxiety/ 15 - 20 = severe anxiety'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Perception']}, 'descriptionModule': {'briefSummary': 'This single-blind two-arm randomized control trial (RCT) aims to evaluate the pain perception during and following administration of dental local anaesthesia using two different systems; i.e. computer-controlled (CCLA) and conventional.', 'detailedDescription': 'The administration of local anaesthesia (LA) is associated with pain, fear and anxiety. Computer-controlled LA (CCLA) aims to control the administration speed and reduce pain, fear and anxiety. This randomised control trial (RCT) aims to compare the pain perception after CCLA and conventional LA, and it uses dental students as both test and operator group versus an experienced dentist as an additional operator of the LA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.'}, 'identificationModule': {'nctId': 'NCT05192902', 'briefTitle': 'Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CCLA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Student-administered', 'interventionNames': ['Device: Computer-controlled Local Anaesthesia (CCLA)', 'Device: Conventional Local Anaesthesia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dentist-administered', 'interventionNames': ['Device: Computer-controlled Local Anaesthesia (CCLA)', 'Device: Conventional Local Anaesthesia']}], 'interventions': [{'name': 'Computer-controlled Local Anaesthesia (CCLA)', 'type': 'DEVICE', 'description': 'The computer-controlled local anesthetic injector Calaject®, (Rønvig Dental MFG, Daugaard, Denmark), which is designed to reduce the pain of performing local anaesthesia. The principle of this device is based on the fact that the less pressure and flow of a local anaesthetic injection, the less painful will be the procedure. Each device has an installed pressure sensor as well as a three-button display that allows choosing the most appropriate program in terms of different speeds and pressure. According to the anaesthesia technique, the manufacture recommends program I for intraligamentary and palatally injections, program II for infiltration and III for alveolar nerve block techniques. Conventional carpules and needles can be used in a pen-shaped part connecting to the main unit. The administration of the anaesthetic can be achieved using a foot control pedal which is adapted to the main unit, the speed of injection is related to acoustic signals.', 'armGroupLabels': ['Dentist-administered', 'Student-administered']}, {'name': 'Conventional Local Anaesthesia', 'type': 'DEVICE', 'description': 'Conventional dental local anaesthetic injections.', 'armGroupLabels': ['Dentist-administered', 'Student-administered']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University of Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Dental Polyclinic', 'investigatorFullName': 'Sameh Attia', 'investigatorAffiliation': 'University of Giessen'}}}}