Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 12:22 PM
Study NCT ID:
NCT00820235
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2009-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper 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-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.', 'otherNumAtRisk': 48, 'otherNumAffected': 8, 'seriousNumAtRisk': 48, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed', 'otherNumAtRisk': 49, 'otherNumAffected': 23, 'seriousNumAtRisk': 49, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed', 'otherNumAtRisk': 44, 'otherNumAffected': 10, 'seriousNumAtRisk': 44, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Study implant failled to osseointegrate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Study implant temporary mobile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restoration failure', 'notes': 'Fractured/mobile/de-bonded dental crown on the study implant.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose abutments', 'notes': 'Abutment screws temporarily loose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'notes': 'Mixed Adverse Events Pain (less the 5% per category). Including: swelling of soft tissue, bone loss around implant, fistula, infection, food impaction in tooth etc., etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized due to fever after mastectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for partial nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalised for gall bladder surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for follow-up on chest pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for spine fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for gastric surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for surgery of infected appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for knee replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization after heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death caused by heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized due to episode of bi-polar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for fractured leg after an accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized due to pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for treatment of infection after vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized due to menstrual hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'units': 'Implants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.'}, {'id': 'OG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed'}, {'id': 'OG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading', 'description': 'Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading.\n\nThe vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'A total of 88 subjects completed the 5-year follow-up visit. Five radiographs (two in group A, two in group B and one in group C) were not possible to evaluate, giving an overall number of 83 subjects (83 implants) as basis for the analysis of Gingival Zenith score change.'}, {'type': 'SECONDARY', 'title': 'Marginal Bone Level Alterations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.'}, {'id': 'OG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed'}, {'id': 'OG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '1.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Evaluated at time of implant installation and at the 5-year follow-up visit.', '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. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 88 subjects completed the 5-year follow-up visit. Three radiographs (all in group C) were not possible to evaluate, giving an overall number of 85 subjects (85 implants) as basis for the analysis of marginal bone level change.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.'}, {'id': 'OG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed'}, {'id': 'OG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at time of loading of permanent restoration and at the 5-year follow-up.', 'description': 'Condition of the periimplant mucosa by assessment of 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': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the PPD assessment.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}, {'units': 'Surfaces', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.'}, {'id': 'OG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed'}, {'id': 'OG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the implant loading and at the 5-year follow-up after loading.', 'description': 'Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.', 'unitOfMeasure': 'Change in proportion of surfaces', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surfaces', 'denomUnitsSelected': 'Surfaces', 'populationDescription': 'A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the assessment of BoP change.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.'}, {'id': 'FG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed'}, {'id': 'FG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '48', 'numSubjects': '48'}, {'groupId': 'FG001', 'numUnits': '49', 'numSubjects': '49'}, {'groupId': 'FG002', 'numUnits': '44', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '33', 'numSubjects': '33'}, {'groupId': 'FG001', 'numUnits': '28', 'numSubjects': '28'}, {'groupId': 'FG002', 'numUnits': '27', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '15', 'numSubjects': '15'}, {'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '21'}, {'groupId': 'FG002', 'numUnits': '17', 'numSubjects': '17'}]}]}], 'typeUnitsAnalyzed': 'Implants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group-A. OsseoSpeed™ Implant', 'description': 'Subjects that had OsseoSpeed™ implants installed.'}, {'id': 'BG001', 'title': 'Group-B. NobelSpeedy™ Replace® Implant', 'description': 'Subjects that had NobelSpeedy™ Replace® implants installed'}, {'id': 'BG002', 'title': 'Group-C. NanoTite™ Certain® PREVAIL® Implant', 'description': 'Subjects that had NanoTite™ Certain® PREVAIL® implants installed'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '15', 'groupId': 'BG000'}, {'value': '46', 'spread': '17', 'groupId': 'BG001'}, {'value': '46', 'spread': '16', 'groupId': 'BG002'}, {'value': '45', 'spread': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-24', 'studyFirstSubmitDate': '2009-01-09', 'resultsFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-24', 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.', 'timeFrame': 'Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading', 'description': 'Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading.\n\nThe vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.'}], 'secondaryOutcomes': [{'measure': 'Marginal Bone Level Alterations', 'timeFrame': 'Evaluated at time of implant installation and at the 5-year follow-up visit.', '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. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement.'}, {'measure': 'Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD', 'timeFrame': 'Measured at time of loading of permanent restoration and at the 5-year follow-up.', 'description': 'Condition of the periimplant mucosa by assessment of 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': 'Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.', 'timeFrame': 'Measured at the implant loading and at the 5-year follow-up after loading.', 'description': 'Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Jaw, Edentulous, Partially']}, 'referencesModule': {'references': [{'pmid': '25738335', 'type': 'RESULT', 'citation': 'McGuire MK, Scheyer T, Ho DK, Stanford CM, Feine JS, Cooper LF. Esthetic outcomes in relation to implant-abutment interface design following a standardized treatment protocol in a multicenter randomized controlled trial--a cohort of 12 cases at 1-year follow-up. Int J Periodontics Restorative Dent. 2015 Mar-Apr;35(2):149-59. doi: 10.11607/prd.2341.'}, {'pmid': '26009913', 'type': 'RESULT', 'citation': 'Cooper LF, Reside G, Stanford C, Barwacz C, Feine J, Abi Nader S, Scheyer ET, McGuire M. A multicenter randomized comparative trial of implants with different abutment interfaces to replace anterior maxillary single teeth. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):622-32. doi: 10.11607/jomi.3772.'}, {'pmid': '26096162', 'type': 'RESULT', 'citation': 'Barwacz CA, Stanford CM, Diehl UA, Qian F, Cooper LF, Feine J, McGuire M. Electronic assessment of peri-implant mucosal esthetics around three implant-abutment configurations: a randomized clinical trial. Clin Oral Implants Res. 2016 Jun;27(6):707-15. doi: 10.1111/clr.12640. Epub 2015 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* At least 18 years\n* In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24\n\nThe following should be considered at inclusion but can not be fulfilled until at Visit 2:\n\n* Edentulous for at least 5 months at study site\n* A buccal-lingual bone width at study site of at least 5.5 mm\n* A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm\n* A keratinized mid-buccal mucosal height of at least 2 mm at study site\n* Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (\\>1 mm) and/or significant soft tissue loss\n* Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions\n* An opposing dentition with teeth, implants or prosthesis\n\nExclusion Criteria:\n\n* Insufficient interocclusal distance for implant placement and restoration at study site\n* Tooth adjacent (mesial and/or distal) to study site is ankylosed\n* More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth\n* Site development (bone tissue) performed at less than 5 months before Visit 2 at study site\n* Untreated rampant caries and/or uncontrolled periodontal disease\n* Class II division 2 malocclusion (Edward Hartley Angle)\n* Use of tobacco within last 6 months\n* Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)\n* Current alcohol or drug abuse\n* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration\n* Use of any substance that will influence bone metabolism\n* Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration\n* History of radiation in the head and neck region\n* Known pregnancy, pregnancy tests will be performed as per local requirements.\n* Unable or unwilling to return for follow-up visits for a period of 5 years\n* Unlikely to be able to comply with study procedures according to Investigators judgement\n* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)\n* Previous enrollment or randomization of treatment in the present study.'}, 'identificationModule': {'nctId': 'NCT00820235', 'briefTitle': 'Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dentsply Sirona Implants and Consumables'}, 'officialTitle': 'Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings', 'orgStudyIdInfo': {'id': 'YA-OSS-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Device: OsseoSpeed™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Device: NobelSpeedy™ Replace®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'interventionNames': ['Device: NanoTite™ Certain® PREVAIL®']}], 'interventions': [{'name': 'OsseoSpeed™', 'type': 'DEVICE', 'description': 'OsseoSpeed™ implant', 'armGroupLabels': ['A']}, {'name': 'NobelSpeedy™ Replace®', 'type': 'DEVICE', 'description': 'NobelSpeedy™ Replace® implant', 'armGroupLabels': ['B']}, {'name': 'NanoTite™ Certain® PREVAIL®', 'type': 'DEVICE', 'description': 'NanoTite™ Certain® PREVAIL® implant', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242-1010', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa, College of Dentistry', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '27599-7450', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, School of Dentistry', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Perio Health Clinical Research Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'H3A 2K6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Faculty of Dentistry, McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Lyndon Cooper, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Illinois College of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dentsply Sirona Implants and Consumables', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}