Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT00545818
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2007-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
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': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm', 'otherNumAtRisk': 49, 'otherNumAffected': 13, 'seriousNumAtRisk': 49, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm', 'otherNumAtRisk': 46, 'otherNumAffected': 12, 'seriousNumAtRisk': 46, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Study implant failure', 'notes': 'Study implant failure (including implant mobility, excessive bone loss around implant and, implant related pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bridge screw loosening', 'notes': 'Loosening of the screw attaching the restoration (the bridge) to the implant abutment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abutment fracture', 'notes': 'Fracture of the abutment connecting the implant with the restoration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture of temporary bridge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteopaenia, trauma - fractured toes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insufficient renal function (30%)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Undefined heart problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure knee-prosthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip function failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallbladder removed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right hip replacement, post-op infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Armpit abscess due to spider bite.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral toe infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis - Non Hodgkin disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture due to car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye cancer (basal cell carcinoma)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiological Assessments of Marginal Bone Level Alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'OG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated from implant installation to 5 years follow-up after implant placement', 'description': 'Marginal Bone Level determined from radiographs and expressed as the 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 at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline).\n\nPositive value = bone gain, Negative value = bone loss.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'A total of 85 subjects (184 implants) completed the study. For a total of 10 implants (in 5 subjects) the quality of the radiographs were not sufficient for reading, giving a total of 80 subjects (174 implants) for the analysis of MBL change.'}, {'type': 'SECONDARY', 'title': 'Overall Implant Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'implants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'OG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Evaluated 5 years after implant placement', 'description': 'Overall implant survival, measured on implant level', 'unitOfMeasure': 'implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': 'Group-1. A total of 49 subjects (108 positions) underwent surgery. Three positions were not implanted due to complications during surgery. Giving a total 105 implants installed.\n\nGroup-2. A total of 46 subjects (101 positions) underwent surgery. Giving a total of 101 implants installed.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Periimplant Mucosa Condition - By Assessment BoP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'implants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'OG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Measured at the 5-year follow-up visit after loading', 'description': 'Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.', 'unitOfMeasure': 'implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': 'A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of BoP.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'implants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'OG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '1.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated at implant loading and at the 5-year follow-up visit.', 'description': 'Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD).\n\nChange in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).\n\nNegative value = increased pocket depth.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': 'A total of 85 subjects (184 implants) completed the 5-year follow-up visit. Group-1. For 3 subjects (7 implants) the radiographs were not possible to evaluate, giving a total of 43 subjects (91 implants) being available for evaluation of change in PPD.\n\nGroup-2. All radiographs readable, giving 39 subjects (86 positions) for the evaluation.'}, {'type': 'SECONDARY', 'title': 'Presence of Plaque', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'implants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'OG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Evaluated at the 5-year follow-up visit after loading.', 'description': 'Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.\n\nA study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.', 'unitOfMeasure': 'implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implants', 'denomUnitsSelected': 'implants', 'populationDescription': 'A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of presence of plaque.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'FG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '108', 'numSubjects': '49'}, {'groupId': 'FG001', 'numUnits': '101', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '98', 'numSubjects': '46'}, {'groupId': 'FG001', 'numUnits': '86', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'typeUnitsAnalyzed': 'Implants', 'recruitmentDetails': '97 subjects were enrolled in the study (singed informed consent).Two of those subjects fulfilled exclusion criteria and were removed from the study population before randomization.\n\nAs a consequence a total of 95 subjects were randomised (assigned to groups) and received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group-1, Implant Length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm'}, {'id': 'BG001', 'title': 'Group-2, Implant Length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '9.39', 'groupId': 'BG000'}, {'value': '54.1', 'spread': '10.04', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '9.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2007-10-16', 'resultsFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2007-10-16', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-07', 'studyFirstPostDateStruct': {'date': '2007-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological Assessments of Marginal Bone Level Alteration', 'timeFrame': 'Evaluated from implant installation to 5 years follow-up after implant placement', 'description': 'Marginal Bone Level determined from radiographs and expressed as the 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 at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline).\n\nPositive value = bone gain, Negative value = bone loss.'}], 'secondaryOutcomes': [{'measure': 'Overall Implant Survival', 'timeFrame': 'Evaluated 5 years after implant placement', 'description': 'Overall implant survival, measured on implant level'}, {'measure': 'Evaluation of the Periimplant Mucosa Condition - By Assessment BoP', 'timeFrame': 'Measured at the 5-year follow-up visit after loading', 'description': 'Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.'}, {'measure': 'Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD', 'timeFrame': 'Evaluated at implant loading and at the 5-year follow-up visit.', 'description': 'Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD).\n\nChange in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).\n\nNegative value = increased pocket depth.'}, {'measure': 'Presence of Plaque', 'timeFrame': 'Evaluated at the 5-year follow-up visit after loading.', 'description': 'Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.\n\nA study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Jaw, Edentulous, Partially']}, 'referencesModule': {'references': [{'pmid': '22938573', 'type': 'RESULT', 'citation': 'Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.'}, {'pmid': '30003598', 'type': 'RESULT', 'citation': 'Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Aged 20-70 years at enrolment\n* History of edentulism in the study area of at least four months\n* Neighboring tooth/teeth to the planned bridge must have natural root(s)\n* Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.\n* Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm\n* Deemed by the investigator as likely to present an initially stable implant situation\n\nExclusion Criteria:\n\n* Unlikely to be able to comply with study procedures, as judged by the investigator\n* Earlier graft procedures in the study area\n* Uncontrolled pathologic processes in the oral cavity\n* Known or suspected current malignancy\n* History of radiation therapy in the head and neck region\n* History of chemotherapy within 5 years prior to surgery\n* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration\n* Uncontrolled diabetes mellitus\n* Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration\n* Smoking more than 10 cigarettes/day\n* Present alcohol and/or drug abuse\n* Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)\n* Previous enrolment in the present study.\n* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech\n* Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months'}, 'identificationModule': {'nctId': 'NCT00545818', 'briefTitle': 'Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dentsply Sirona Implants and Consumables'}, 'officialTitle': 'An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.', 'orgStudyIdInfo': {'id': 'YA-SHO-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-1, Implant length 6 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 6 mm', 'interventionNames': ['Device: OsseoSpeed™ length 6 mm']}, {'type': 'OTHER', 'label': 'Group-2, Implant length 11 mm', 'description': 'Subjects treated with OsseoSpeed™ implant, length: 11 mm', 'interventionNames': ['Device: OsseoSpeed™ length 11 mm']}], 'interventions': [{'name': 'OsseoSpeed™ length 6 mm', 'type': 'DEVICE', 'description': 'OsseoSpeed™ dental implant, length: 6 mm', 'armGroupLabels': ['Group-1, Implant length 6 mm']}, {'name': 'OsseoSpeed™ length 11 mm', 'type': 'DEVICE', 'description': 'OsseoSpeed™ dental implant, length: 11 mm', 'armGroupLabels': ['Group-2, Implant length 11 mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089-0641', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC School of Dentistry', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '52242-1010', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'The University of Iowa, College of Dentistry', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '3010', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'School of Dental Science, University of Melbourne', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '7315', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Praktijk De Mondhoek', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': 'SE 405 30', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Dept. of Parodontology, Göteborg University', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London Dental Institute at Guy's King's and St Thomas' Hospitals", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Anna-Karin Lundgren', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dentsply Sirona Implants and Consumables', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}