Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-03-02 @ 10:35 PM
Study NCT ID:
NCT03737357
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2018-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dental Implants With a SLActive® vs. SLA® Surface
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anais.robert@straumann.com', 'phone': '+41799258750', 'title': 'Anaïs Robert, Clinical Trial Leader', 'organization': 'Institut Straumann'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 26, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 26, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Mechanical complications', 'notes': "Including fracture/chipping of prosthesis; loosening of Abutment/Occlusal screw; Loss/failure of a healing cap; the crown doesn't fit", 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biological Complications', 'notes': 'Including bruising, local irritation and pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other complications', 'notes': 'Including facial traumatism, loss of composite covering the crown, and transitory dizziness/nausea during procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biological Complications - hard tissue related', 'notes': 'Including Early Loss/Failure Of Implant (I.E. Before Osseointegration); Implant Mobility (Tactile Horizontal Or Vertical; Late Loss/Failure Of Implant (I.E. After Osseointegration); Low Primary Stability (At Surgery)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bone Level Change 12 Months After Implant Loading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'OG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.214', 'spread': '0.391', 'groupId': 'OG000'}, {'value': '0.056', 'spread': '0.093', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'paired difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.01', 'estimateComment': 'The paired difference is (SLActive® bone level change from baseline (CFB) - SLA® CFB (i.e. resorption))', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Non-inferiority one-sided paired t-tests using a non-inferiority margin of -0.10mm.', 'nonInferiorityComment': 'The tolerance range or non-inferiority margin characterizes the largest absolute difference which is considered to be dismissible. A MBL of less than 0.5mm within the first year after implant loading constitutes an acceptable clinical standard(10, 18, 19). In this clinical trial, a non-inferiority margin of 20% of the acceptable clinical standard was chosen, which amounts to 0.1mm.', 'otherAnalysisDescription': 'In the PP population, the paired difference between SLActive® and SLA® bone level change from baseline (CFB) was estimated at 0.01 mm with a standard deviation of 0.444 mm (95% CI: -Inf, 0.11; p = 0.074), based on a one-sided paired t-test with a non-inferiority margin of 0.10 mm.'}], 'paramType': 'MEAN', 'timeFrame': '12 months after implant loading', 'description': 'The primary efficacy objective of this study was to confirm the performance of the SLActive® implants by means of bone level change 12 months after implant loading, as described in the CIP (CR2017-05, v03).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol Population: defined as each eligible study subject with one study control and one study test implant and who performed all follow-up visits.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'OG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}], 'classes': [{'title': 'Number of ADE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Number of DD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after implant loading', 'description': 'Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF populations defined as all patients who were enrolled in the study and who received a study device'}, {'type': 'SECONDARY', 'title': 'Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'OG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}], 'classes': [{'title': 'Inflammation (IL-6) at implant placement', 'categories': [{'measurements': [{'value': '437.4', 'spread': '1056.2', 'groupId': 'OG000'}, {'value': '508.3', 'spread': '1296.7', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (IL-6) at implant Week 4', 'categories': [{'measurements': [{'value': '17.2', 'spread': '77.4', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '38.5', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (IL-1B) at implant placement', 'categories': [{'measurements': [{'value': '11.3', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (IL-1B) at Week 4', 'categories': [{'measurements': [{'value': '29.2', 'spread': '65.8', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '88.1', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (TNF-a) at implant placement', 'categories': [{'measurements': [{'value': '13.3', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '30.1', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (TNF-a) at Week 4', 'categories': [{'measurements': [{'value': '14.2', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '46.3', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (IL-2) at implant placement', 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Inflammation (IL-2) at Week 1', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Anti-inflammation (IL-10) at implant placement', 'categories': [{'measurements': [{'value': '18.3', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '44.4', 'groupId': 'OG001'}]}]}, {'title': 'Anti-inflammation (IL-10) at Week 4', 'categories': [{'measurements': [{'value': '22.5', 'spread': '40.0', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '51.3', 'groupId': 'OG001'}]}]}, {'title': 'Anti-inflammation (IL-4) at implant placement', 'categories': [{'measurements': [{'value': '3.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Anti-inflammation (IL-4) at Week 4', 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At implant placement, 1 and 4 weeks after implant placement', 'description': 'Change in inflammatory and anti-inflammatory biomarkers (IL-10, IL-4, IL-6, IL-1beta, TNF-alpha, IL-2) concentrations in gingival crevicular fluid samples.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention To Treat (ITT) population: each eligible and randomized study patient who received control and test implants in two different quadrants and from whom at least one follow-up measurement after placement is available.'}, {'type': 'SECONDARY', 'title': 'Change in Osseointegration Biomarkers Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'OG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}], 'classes': [{'title': 'VEGF-a at implant placement', 'categories': [{'measurements': [{'value': '39.3', 'spread': '295.2', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '272.7', 'groupId': 'OG001'}]}]}, {'title': 'VEGF-a at 4 weeks', 'categories': [{'measurements': [{'value': '73.6', 'spread': '504.4', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '573.5', 'groupId': 'OG001'}]}]}, {'title': 'OCN at implant placement', 'categories': [{'measurements': [{'value': '760.3', 'spread': '1394.5', 'groupId': 'OG000'}, {'value': '2408.6', 'spread': '8935.4', 'groupId': 'OG001'}]}]}, {'title': 'OCN at 8 weeks', 'categories': [{'measurements': [{'value': '159.8', 'spread': '79.6', 'groupId': 'OG000'}, {'value': '117.7', 'spread': '76.3', 'groupId': 'OG001'}]}]}, {'title': 'OPN at implant placement', 'categories': [{'measurements': [{'value': '6064.2', 'spread': '11713.2', 'groupId': 'OG000'}, {'value': '4419.0', 'spread': '7887.0', 'groupId': 'OG001'}]}]}, {'title': 'OPN at 8 weeks', 'categories': [{'measurements': [{'value': '939.3', 'spread': '1677.1', 'groupId': 'OG000'}, {'value': '876.6', 'spread': '1789.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2, 4 and 8 weeks after implant placement', 'description': 'Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: each eligible and randomized study patient who received control and test implants in two different quadrants and from whom at least one follow-up measurement after placement is available.'}, {'type': 'SECONDARY', 'title': 'Implant Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'OG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after implant loading', 'description': 'Implant survival at 12 months after implant loading', 'unitOfMeasure': 'number of lost implants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population - defined as each eligible and randomized study patient who received control and test implants in two different quadrants and from whom at least one follow-up measurement after placement is available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'FG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '68'}, {'groupId': 'FG001', 'numUnits': '68', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '61', 'numSubjects': '61'}, {'groupId': 'FG001', 'numUnits': '61', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '7'}, {'groupId': 'FG001', 'numUnits': '7', 'numSubjects': '7'}]}]}], 'typeUnitsAnalyzed': 'Implants', 'recruitmentDetails': 'Patients were screened at 2 investigational centers in Spain', 'preAssignmentDetails': 'A total of 70 patients were screened. Of those, 68 subjects were enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'units': 'Implants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SLActive® Implant', 'description': 'SLActive® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'BG001', 'title': 'SLA® Implant', 'description': 'SLA® implant: One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '79'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '79'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'European', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Smoking status (never, past, current)', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Past smoker (<10 years since cessation)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Past smoker (>=10 years since cessation)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker (<= 10 cigarettes per day)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker (1 cigar per day)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker (> 10 cigarettes per day)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker (>1 cigar per day)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker (e-cigs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Number of missing teeth', 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '10.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Teeth', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Number of Implants', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Implants', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Implants'}, {'title': 'Number of planned implants', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Implants', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Implants'}], 'typeUnitsAnalyzed': 'Implants', 'populationDescription': 'This study used a split-mouth design. Each participant received both SLActive® and SLA® implants. As a result, the same 68 participants appear under both arms. The Total column reflects the number of unique participants (N=68).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-26', 'size': 997800, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-17T05:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2018-10-25', 'resultsFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-26', 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Level Change 12 Months After Implant Loading', 'timeFrame': '12 months after implant loading', 'description': 'The primary efficacy objective of this study was to confirm the performance of the SLActive® implants by means of bone level change 12 months after implant loading, as described in the CIP (CR2017-05, v03).'}, {'measure': 'Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect', 'timeFrame': '12 months after implant loading', 'description': 'Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect'}], 'secondaryOutcomes': [{'measure': 'Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations', 'timeFrame': 'At implant placement, 1 and 4 weeks after implant placement', 'description': 'Change in inflammatory and anti-inflammatory biomarkers (IL-10, IL-4, IL-6, IL-1beta, TNF-alpha, IL-2) concentrations in gingival crevicular fluid samples.'}, {'measure': 'Change in Osseointegration Biomarkers Concentrations', 'timeFrame': '1, 2, 4 and 8 weeks after implant placement', 'description': 'Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.'}, {'measure': 'Implant Survival', 'timeFrame': '12 months after implant loading', 'description': 'Implant survival at 12 months after implant loading'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implants', 'SLActive® surface', 'biomarkers', 'BLT implant'], 'conditions': ['Partially Edentulous Patients']}, 'descriptionModule': {'briefSummary': 'This post-market study is to show that dental implants with a SLActive® surface (SLActive® implants) show non-inferior clinical performance compared to dental implants with a SLA® surface (SLA® implants). The primary hypothesis is that 12 months after implant loading, the bone loss around the SLActive® implants will not be appreciably greater than around the SLA® implants.\n\nThe occurrence of adverse events and device deficiencies will also be recorded to confirm once more the safety of the Straumann® Bone Level Tapered (BLT), Roxolid® implant.\n\nOsseointegration and anti-inflammatory potential of SLActive® implants will be evaluated in the study as secondary endpoints.', 'detailedDescription': 'This is a prospective, single-blinded, randomized, paired sample, multi-center clinical study. Eight visits per patient are scheduled in this study. The final analysis will be conducted after all patients completed the 12-month visit.\n\nThe study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.\n\nTwo centers in Spain will participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females, at least 18 years old\n* partially edentulous patients in need of two or more dental implants (canine to molars) placed in two different quadrants in healed sites (3 months post extraction)\n* subject must have voluntarily signed the informed consent, is willing and able to attend scheduled follow-up visits, and agrees that the encoded data will be collected and analyzed\n\nExclusion Criteria:\n\n* any contraindications for oral surgical procedures\n* dental implant placement contraindicated according to Instructions for Use (IFU)\n* subjects with inadequate oral hygiene (FMPS ≥ 20%)\n* subjects who are currently heavy smokers (defined \\>10 cigarettes per day or \\>1 cigar per day) or who use chewing tobacco\n* subjects with drug or alcohol abuse\n* patients requiring soft tissue and bone grafting procedures\n* inadequate bone volume\n* severe bruxism or clenching habits\n* women who are pregnant or planning to become pregnant at any point during the study duration.\n* patients who have systemic factors that could interfere with the healing process of either bone or soft tissue or the osseointegration process (e.g. bone metabolism disturbances, uncontrolled diabetes mellitus, anticoagulation drugs/ hemorrhagic diatheses)\n* patients with local factors that could interfere with the healing process, such as untreated periodontal diseases, acute infection of implant site, temporomandibular joint disorders, treatable pathologic diseases of the jaw and changes in the oral mucosa)\n* conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.'}, 'identificationModule': {'nctId': 'NCT03737357', 'briefTitle': 'Dental Implants With a SLActive® vs. SLA® Surface', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Straumann AG'}, 'officialTitle': 'A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface', 'orgStudyIdInfo': {'id': 'CR 2017-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLActive® implant', 'interventionNames': ['Device: SLActive® implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLA® implant', 'interventionNames': ['Device: SLA® implant']}], 'interventions': [{'name': 'SLActive® implant', 'type': 'DEVICE', 'description': 'One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.', 'armGroupLabels': ['SLActive® implant']}, {'name': 'SLA® implant', 'type': 'DEVICE', 'description': 'One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.', 'armGroupLabels': ['SLA® implant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Complutense', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Universidad de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}], 'overallOfficials': [{'name': 'Mariano Sanz, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Chairman of Periodontology'}, {'name': 'Juan Blanco-Carrión, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor in Periodontology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}