Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 7:47 AM
Study NCT ID:
NCT05599269
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2022-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ronny.Watzke@ivoclar.com', 'phone': '+423 235 3401', 'title': 'Dr. med. dent. Ronny Watzke', 'organization': 'Ivoclar Vivadent AG'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'retrospective study after 10 years of dentures wear, participants assessed for a maximum of 90 minutes', 'description': "As it's a retrospective study and patients were examined after 10 years in one recall, it's not possible to define a time frame over which adverse event data were collected. Recall takes a maximum of 90 minutes for each patient.", 'eventGroups': [{'id': 'EG000', 'title': 'Examination of dentures with SR Phonares II teeth', 'description': 'Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Rate of Dentures With SR Phonares II Teeth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Examination of dentures with SR Phonares II teeth', 'description': 'Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years', 'description': 'After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Examination of dentures with SR Phonares II teeth', 'description': 'Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.'}], 'classes': [{'title': 'surface lustre teeth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'staining teeth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'plaque accumulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 2', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'color match', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'marginal adaptation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 2', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'occlusal contour/wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 3', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'patients view', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'adjacent mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'oral health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 1', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade 4', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years', 'description': "After a wearing time of 10 years dentures with SR Phonares II teeth were evaluated by a dentist according to adopted FDI criteria.\n\nAesthetic properties (surface luster, surface staining, plaque accumulation, color match (to a reference), functional properties (fracture of material, marginal adaption, occlusal contour and wear, patient's view (evaluated during discussion) and biological properties (adjacent mucosa, oral health) were eveluated according the following FDI grades:\n\n* FDI grade 1: clinically excellent\n* FDI grade 2: clinically good\n* FDI grade 3: clinically satisfactory\n* FDI grade 4: clinically unsatisfactory", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As only the denture was made available for some examinations in the clinical investigation, it was not possible to examine the oral health of these patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Examination of dentures with SR Phonares II teeth', 'description': 'Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Examination of dentures with SR Phonares II teeth', 'description': 'Examination of dentures with SR Phonares II teeth: The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Liechtenstein', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-19', 'size': 769615, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-26T03:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'retrospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2022-10-20', 'resultsFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate of Dentures With SR Phonares II Teeth', 'timeFrame': '10 years', 'description': 'After a wearing time of 10 years dentures with SR Phonares II teeth were examined by a dentist'}], 'secondaryOutcomes': [{'measure': 'Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties', 'timeFrame': '10 years', 'description': "After a wearing time of 10 years dentures with SR Phonares II teeth were evaluated by a dentist according to adopted FDI criteria.\n\nAesthetic properties (surface luster, surface staining, plaque accumulation, color match (to a reference), functional properties (fracture of material, marginal adaption, occlusal contour and wear, patient's view (evaluated during discussion) and biological properties (adjacent mucosa, oral health) were eveluated according the following FDI grades:\n\n* FDI grade 1: clinically excellent\n* FDI grade 2: clinically good\n* FDI grade 3: clinically satisfactory\n* FDI grade 4: clinically unsatisfactory"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Mouth', 'Dental Prosthesis Failure']}, 'descriptionModule': {'briefSummary': 'This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years.\n\nThe primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent signed and understood by the subject\n* partial or full denture with SR Phonares II teeth\n* dentures delivered in the internal clinic between August 2010 and August 2012\n* to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.)\n\nExclusion Criteria:\n\n* patient does not wear the dentures regularly\n* health status (physical and mental) does not allow participation.'}, 'identificationModule': {'nctId': 'NCT05599269', 'briefTitle': 'Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivoclar Vivadent AG'}, 'officialTitle': 'Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II', 'orgStudyIdInfo': {'id': 'LL5267725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Examination of dentures with SR Phonares II teeth', 'interventionNames': ['Device: Examination of dentures with SR Phonares II teeth']}], 'interventions': [{'name': 'Examination of dentures with SR Phonares II teeth', 'type': 'DEVICE', 'description': 'The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.', 'armGroupLabels': ['Examination of dentures with SR Phonares II teeth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9494', 'city': 'Schaan', 'country': 'Liechtenstein', 'facility': 'Ivoclar Vivadent AG', 'geoPoint': {'lat': 47.16498, 'lon': 9.50867}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivoclar Vivadent AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}