Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-27 @ 11:44 AM
Study NCT ID:
NCT03077035
Status:
UNKNOWN
Last Update Posted:
2017-03-21
First Post:
2017-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536528', 'term': 'Van der Woude syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-19', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Decayed Surfaces (DS) of Different Fissure Sealants', 'timeFrame': 'Baseline, 6 months, 12 months and 24 months', 'description': 'Count of DS in different ICDAS cut-off( including D1-6S, D1-2S, D3-6S, D4-6S and D5-6S) in the baseline and 6-month, 12-month and 24-month follow-up.'}, {'measure': 'Change in Repaired Sealants by the baseline ICDAS', 'timeFrame': '6 months, 12 months and 24 months', 'description': 'Evaluation the numbers of tooth surface in which the fissure sealants were in the status partially retained or completely lost, and ICDAS score were increasing from the baseline to the 3 follow-ups.'}, {'measure': 'Change in DIAGNOdent Score', 'timeFrame': 'Baseline, 6 months, 12 months and 24 months', 'description': 'The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups'}]}, 'conditionsModule': {'keywords': ['ICDAS', 'DIAGNOdent', 'glass ionomer sealant', 'resin-based sealant', 'pit and fissure sealants', 'effectiveness of preventing caries'], 'conditions': ['Dental Caries on Pit and Fissure Surface']}, 'descriptionModule': {'briefSummary': 'The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects provided written informed consent;\n* They were 7 to 9 years old;\n* They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;\n* They were generally heallthy\n\nExclusion Criteria:\n\n* They were allergic to the constituents in pit and fissure sealants'}, 'identificationModule': {'nctId': 'NCT03077035', 'briefTitle': 'Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'orgStudyIdInfo': {'id': 'GJ-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glass ionomer sealant', 'interventionNames': ['Other: glass ionomer sealants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'resin-based sealant', 'interventionNames': ['Other: resin-based sealant']}], 'interventions': [{'name': 'glass ionomer sealants', 'type': 'OTHER', 'armGroupLabels': ['glass ionomer sealant']}, {'name': 'resin-based sealant', 'type': 'OTHER', 'armGroupLabels': ['resin-based sealant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengchao Wang, PHD', 'role': 'CONTACT', 'email': 'wangshengchao@fmmu.edu.cn', 'phone': '86-29-84776159'}], 'facility': 'School of Stomatology The Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jing Guo, MM', 'role': 'CONTACT', 'email': 'lucyjing@126.com', 'phone': '86-29-84776479'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheng-Chao Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Preventive Dentistry Department, Clinical Professor', 'investigatorFullName': 'Sheng-Chao Wang', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}