Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-04-02 @ 9:51 AM
Study NCT ID:
NCT01389258
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2011-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalResearchMolndal@dentsplysirona.com', 'phone': '0046313763500', 'title': 'Manager Global Clinical Research', 'organization': 'Dentsply Sirona Implants, Mölndal, SWEDEN'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Implant Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Implant survival rate evaluated clinically and radiographically.', 'unitOfMeasure': 'Implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Intention to treat (ITT), including all participants that received at least one implant, a total of 45 subjects (47 implants).\n\nA total of 5 subjects (5 implants) had been lost to follow-up at time of the 3-year follow-up visit, giving an overall number of 40 subjects (42 implants) as basis for the analysis of three year survival rate.'}, {'type': 'SECONDARY', 'title': 'Implant Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}, {'units': 'implants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Implant stability evaluated clinically/manually (recorded as stable yes/no).', 'unitOfMeasure': 'implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': '40 subjects (42 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the All Patients Treated (APT) population.'}, {'type': 'SECONDARY', 'title': 'Marginal Bone Level Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Marginal Bone Level (mm) determined from radiographs and expressed as a difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.\n\nMarginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': '40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).'}, {'type': 'SECONDARY', 'title': 'Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at implant loading and at the 3-year follow-up visit after loading.', 'description': 'Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).\n\nNegative value = increased pocket depth.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': '40 subjects (42 implants) completed the 3 years follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).'}, {'type': 'SECONDARY', 'title': 'Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'implants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Measured at implant loading and at the 3-year follow-up visit after loading.', 'description': 'Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.', 'unitOfMeasure': 'implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': '40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).'}, {'type': 'SECONDARY', 'title': 'Presence of Plaque', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'implants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.', 'unitOfMeasure': 'implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': '40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).'}, {'type': 'SECONDARY', 'title': 'Gingival Zenith Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}, {'units': 'implants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at implant loading and at the 3-year follow-up visit after loading.', 'description': 'Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.\n\nPresented as change from loading of permanent restoration to time of the 3-year follow-up visit.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': '40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '47', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'typeUnitsAnalyzed': 'Implants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '14.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2011-07-06', 'resultsFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-16', 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Survival', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Implant survival rate evaluated clinically and radiographically.'}], 'secondaryOutcomes': [{'measure': 'Implant Stability', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Implant stability evaluated clinically/manually (recorded as stable yes/no).'}, {'measure': 'Marginal Bone Level Alteration', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Marginal Bone Level (mm) determined from radiographs and expressed as a difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.\n\nMarginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).'}, {'measure': 'Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).', 'timeFrame': 'Measured at implant loading and at the 3-year follow-up visit after loading.', 'description': 'Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).\n\nNegative value = increased pocket depth.'}, {'measure': 'Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).', 'timeFrame': 'Measured at implant loading and at the 3-year follow-up visit after loading.', 'description': 'Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.'}, {'measure': 'Presence of Plaque', 'timeFrame': 'Measured at the 3-year follow-up visit after implant loading.', 'description': 'Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.'}, {'measure': 'Gingival Zenith Score', 'timeFrame': 'Measured at implant loading and at the 3-year follow-up visit after loading.', 'description': 'Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.\n\nPresented as change from loading of permanent restoration to time of the 3-year follow-up visit.'}]}, 'conditionsModule': {'conditions': ['Partially Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Provision of informed consent\n2. Aged 20-75 years at enrollment\n3. History of edentulism in the study area of at least two months\n4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)\n5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns\n6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant\n7. Deemed by the investigator as likely to present an initially stable implant situation\n\nExclusion Criteria:\n\n1. Unlikely to be able to comply with study procedures, as judged by the investigator\n2. Uncontrolled pathologic processes in the oral cavity\n3. Known or suspected current malignancy\n4. History of radiation therapy in the head and neck region\n5. History of chemotherapy within 5 years prior to surgery\n6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator\n7. Uncontrolled diabetes mellitus\n8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration\n9. Smoking more than 10 cigarettes per day\n10. Present alcohol and/or drug abuse\n11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)\n12. Previous enrollment in the present study\n13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01389258', 'briefTitle': 'Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dentsply Sirona Implants and Consumables'}, 'officialTitle': 'An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.', 'orgStudyIdInfo': {'id': 'CHN-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OsseoSpeed™ TX', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm', 'interventionNames': ['Device: OsseoSpeed™ TX']}], 'interventions': [{'name': 'OsseoSpeed™ TX', 'type': 'DEVICE', 'description': 'OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm', 'armGroupLabels': ['OsseoSpeed™ TX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Tong Ji University, Oral Implants Department', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '430079', 'city': 'Wuhan', 'country': 'China', 'facility': 'School of Stomatology Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '710032', 'city': "Xi'an", 'country': 'China', 'facility': 'Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Li Dehua, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dentsply Sirona Implants and Consumables', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}