Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-11 @ 9:03 AM
Study NCT ID:
NCT04839458
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2021-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relation between occlusal force and scanning time', 'timeFrame': 'immediately after the intervention', 'description': 'After Dental Prescale II is used and cleaned, the first time of scanning will be defined as 0 min. The pressure sensitive sheet will be scanned every minute during 0\\~15 minutes, and at 30, 60, 90 and 120 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Prescale II,Scan Delay'], 'conditions': ['Bite Force', 'Scan Delay']}, 'descriptionModule': {'briefSummary': 'Dental Prescale II (GC Corp., Tokyo) is a pressure sensitive sheet for occlusal force measurement. According to the instruction, the patient need to bite the sheet for about 3 seconds and then the sheet will be scanned. But the delay response of coloring agent will influence the data collected and was noticed in vitro. To have a standard procedure, we need to know the time for scanning. This study will scan the sheet up to 2 hours and try to find the relation between the time the sheet scanned and the data collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusive criteria:\n\n * full dentition except third molar\n * healthy periodontal condition\n * can sign consent\n2. Exclusive criteria:\n\n * history of temporomandibular disorders'}, 'identificationModule': {'nctId': 'NCT04839458', 'briefTitle': 'Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II', 'orgStudyIdInfo': {'id': '202102052RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dental Prescale II used', 'interventionNames': ['Device: Dental Prescale II']}], 'interventions': [{'name': 'Dental Prescale II', 'type': 'DEVICE', 'description': 'The participant will bite Dental Prescale II for about 3 seconds, using a force for " chewing beef ". And the Dental Prescale II will be taken out from the mouth. Then the trial is end.', 'armGroupLabels': ['Dental Prescale II used']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Zhongzheng District', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'TongMei Wang Wang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dentistry, National Taiwan University College of Medicine.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}