Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-01 @ 10:56 PM
Study NCT ID:
NCT05614635
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-11-05', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical reproductibility of the dental impression with Plastalgin and Plastalgin Fast.', 'timeFrame': 'Immediately after the procedure.', 'description': "Dentist's opinion through a questionnaire completed by the dentist"}], 'secondaryOutcomes': [{'measure': 'Number of impressions needed per patient', 'timeFrame': 'Immediately after the procedure.', 'description': 'Number of impressions needed per patient to make a quality impression.'}, {'measure': 'Setting time of Plastalgin and Plastalgin Fast', 'timeFrame': 'During the procedure.', 'description': 'Measure of the setting time by the dentist at each use of Plastalgin and Plastalgin Fast'}, {'measure': 'Rate of adverse events', 'timeFrame': 'During and immediately after the procedure.', 'description': 'Cumulative number of adverse events and serious adverse events'}, {'measure': 'Rate of device-related adverse event', 'timeFrame': 'During and immediately after the procedure.', 'description': 'Cumulative number of adverse events and serious adverse events related to Plastalgin or Plastalgin Fast'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fabrication of prosthesis', 'Alginate Dental Impression'], 'conditions': ['Dental Malocclusion', 'Edentulous Mouth', 'Dental Misalignment']}, 'descriptionModule': {'briefSummary': "The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation. The target population for this study is the same as the intended population specified in the study device's instructions for use: children from 5 years old and adults.\n\nCollection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of participating patients during and after the study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The target population for this study is the same as the intended population specified in the study device's instructions for use: children from 5 years old and adults.\n\nMinors are eligible to participate in the study. Other vulnerable patients can be included in the study as there is no additional risk for this population.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient fulfilling all the following criteria is eligible for the clinical investigation:\n* Male or female patient ≥ 5 years of age.\n* Indication of dental impressions for the fabrication of prosthesis such as mouth guards and trays, total or partial dentures, and fixed prosthesis (crowns, bridges, dental veneers).\n* Total or partially edentulous patient or patient with disocclusion or patient with misalignment.\n* Patient affiliated or beneficiary of a social security system.\n* Written informed consent must be obtained before any study-related assessment is performed.\n\nExclusion Criteria:\n\n* The presence of any of the following exclusion criteria will lead to the exclusion of the patient:\n* Inability to comply with study procedures.\n* Patient opposing the processing of their data.'}, 'identificationModule': {'nctId': 'NCT05614635', 'briefTitle': 'Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Septodont'}, 'officialTitle': 'Prospective, Multicenter, Observational cLinical triAl Measuring Safety and Technical Performance of plAstalgin and Plastalgin Fast in Patients Requiring a Dental Impression', 'orgStudyIdInfo': {'id': 'PLAS 2022-02'}, 'secondaryIdInfos': [{'id': '2022-A00882-41', 'type': 'OTHER', 'domain': 'BRC Identification number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Plastalgin and Plastalgin Fast', 'type': 'DEVICE', 'description': 'Plastalgin and Plastalgin Fast are potassium alginate-based powders designed for dental impression. The powder is mixed with water to obtain an impression material paste, used to imprint the teeth and mouth of the patient. The product is available under two presentations: Plastalgin and Plastalgin Fast. Plastalgin Fast has a shorter mixing time.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78180', 'city': 'Montigny-le-Bretonneux', 'country': 'France', 'facility': 'Cabinet dentaire', 'geoPoint': {'lat': 48.76636, 'lon': 2.03405}}, {'zip': '75011', 'city': 'Paris', 'country': 'France', 'facility': 'Cabinet dentaire', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Stephanie INDUNI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cabinet dentaire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Septodont', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}