Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02084433
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-11-20', 'releaseDate': '2018-04-19'}], 'estimatedResultsFirstSubmitDate': '2018-04-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reported by the patient according to the visual analogue scale (VAS)', 'timeFrame': 'up to 10 minutes', 'description': 'Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at the end of the injection / infiltration. The assessment will concern the insertion of the needle and the injection / infiltration'}], 'secondaryOutcomes': [{'measure': 'latency', 'timeFrame': 'up to 15 minutes', 'description': 'latency (in minutes) evaluated by examining the sensitivity of the sulcus using a probe (an exam will be conducted every minute until the sulcus is insensitive to the probe)'}, {'measure': 'need for additional anesthesia during the treatment', 'timeFrame': '1 hour'}, {'measure': 'pain felt during the treatment', 'timeFrame': '1 hour', 'description': 'need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MIH of the first permanent molar'], 'conditions': ['Deep Caries', 'Molar Incisor Hypomineralisation']}, 'referencesModule': {'references': [{'pmid': '30883951', 'type': 'DERIVED', 'citation': 'Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.'}, {'pmid': '26163031', 'type': 'DERIVED', 'citation': 'Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration.\n\nDesign: split-mouth design AND parallel-arm design', 'detailedDescription': 'Local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal of anxiety because of the fear of the injection. The latter can be painful if the product is delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia systems allow reducing pain during the injection. In particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. Moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* split-mouth randomized controlled trial: patients with at least two first permanent molars requiring the same treatment with anesthesia\n* parallel-arm radnomized controlled trial: patients with first permanent molar requiring treatment with anesthesia\n* vital pulp\n* patient did not take any pain medication 48 hours before randomization\n* non-opposition of the child and two holders of parental participation in the study\n* Treatments can be conservative treatment or endodontic treatment limited to pulpotomy.\n\nExclusion Criteria:\n\n* Patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency)\n* Disabled or autistic patients\n* Patients with cancer, heart disease or sickle cell anemia'}, 'identificationModule': {'nctId': 'NCT02084433', 'acronym': 'QUICK', 'briefTitle': 'Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia', 'orgStudyIdInfo': {'id': '75018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional anasthesia', 'description': 'para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia', 'interventionNames': ['Procedure: conventional anasthesia']}, {'type': 'EXPERIMENTAL', 'label': 'intraosseous anaesthesia', 'description': 'intraosseous anaesthesia using a computerized system (Quicksleeper) "1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "', 'interventionNames': ['Procedure: intraosseous anaesthesia using a computerized system']}], 'interventions': [{'name': 'intraosseous anaesthesia using a computerized system', 'type': 'PROCEDURE', 'description': '"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "', 'armGroupLabels': ['intraosseous anaesthesia']}, {'name': 'conventional anasthesia', 'type': 'PROCEDURE', 'description': 'para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia', 'armGroupLabels': ['conventional anasthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Bretonneau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Frédéric Courson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor, hospital practitionner', 'investigatorFullName': 'Frederic COURSON', 'investigatorAffiliation': 'Assistance Publique - Hôpitaux de Paris'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-04-19', 'type': 'RELEASE'}, {'date': '2018-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Frederic COURSON, assistant professor, hospital practitionner, Assistance Publique - Hôpitaux de Paris'}}}}