Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-04-22 @ 10:39 AM
Study NCT ID:
NCT02699866
Status:
COMPLETED
Last Update Posted:
2021-08-31
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.mccaskey@straumann.com', 'phone': '+41619651741', 'title': 'Dr. Michael McCaskey, Team Leader Clinical Research', 'organization': 'Institut Straumann AG'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse Events were recorded at every patient visit and monitored during IMV. Safety Board meetings were conducted to assess the reported and monitored AEs from a Sponsor-Perspective.', 'eventGroups': [{'id': 'EG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 10, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Implant lost', 'notes': 'Implant lost on pos. 22, subject discontinued.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO14155'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO14155'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Implant Survival Rate at 12 Months After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.68', 'groupId': 'OG000', 'lowerLimit': '79.00', 'upperLimit': '97.58'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after implant placement', 'description': 'A "surviving implant" is an implant stably inserted in the subject\'s jaw bone at the time of assessment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pink Esthetic Score (PES) at 6 Months After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '11.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after implant placement', 'description': 'The Pink esthetic score allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14. The higher the value, the better the outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '11 missing values.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Implant Success Rate at 12 Months After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '97.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after implant placement', 'description': 'A "successful implant" is an implant where all of the following success criteria (according to Buser et al., 1992) apply:\n\n1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation);\n2. Absence of recurrent peri-implant infection with suppuration;\n3. Absence of tactile implant mobility;\n4. Absence of a continuous peri-implant radiolucency.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '2 missing values.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Marginal Bone Level Changes at 12 Months After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '-0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months after implant placement', 'description': 'An independent expert is contracted to perform the bone level measurements from the X-rays. The vertical bone level is evaluated by measuring the distance from the implant shoulder to the first visible bone contact on the implant. Measurements are taken at the mesial and distal aspects of the implant, and an average value is calculated. Mean bone level changes are computed by subtracting the average bone level at 12 months after implant placement from the average bone level at baseline (implant placement). Hence, negative bone level changes are representing bone loss; vice versa positive changes representing bone gain. Measurements take into account distortion based on changes on the radiograph from the true dimension of the implant.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Adverse Events and Adverse Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'classes': [{'categories': [{'title': 'Adverse Events (AE)', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Adverse Device Effects (ADE)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Serious Adverse Events', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Serious Adverse Device Effects', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unanticipated Serious Adv. Device Effect (USADE)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No AEs', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, Baseline, 7-14 days after implant placement, 6 weeks after implant placement, 4 months after implant placement, 6 months after implant placement and 12 months after implant placement', 'description': 'At each visit the Investigator should determine if any adverse events occurred since the last study visit by speaking with the patient and reviewing any dental and medical records. These AEs, along with any AEs from the current study visit, should be documented and reported as described in Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing AEs throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'First study centre initiation.', 'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'Included', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Last study centre close-out.', 'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'First site was initiated on 11th DEC 2015 (Mainz University). The first patient was included on 12 FEB 2016 and the last patient out was on 07 JUN 2019 (last 1-year follow-up). The last centre was closed on 10 DEC 2019 (Münster).', 'preAssignmentDetails': 'This was a non-randomized study (N/A).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.\n\nBLT Implant Ø 2.9 mm: Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.53', 'spread': '18.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-09', 'size': 585049, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-25T08:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2016-03-01', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-25', 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implant Success Rate at 12 Months After Implant Placement', 'timeFrame': '12 months after implant placement', 'description': 'A "successful implant" is an implant where all of the following success criteria (according to Buser et al., 1992) apply:\n\n1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation);\n2. Absence of recurrent peri-implant infection with suppuration;\n3. Absence of tactile implant mobility;\n4. Absence of a continuous peri-implant radiolucency.'}, {'measure': 'Marginal Bone Level Changes at 12 Months After Implant Placement', 'timeFrame': 'Baseline and 12 months after implant placement', 'description': 'An independent expert is contracted to perform the bone level measurements from the X-rays. The vertical bone level is evaluated by measuring the distance from the implant shoulder to the first visible bone contact on the implant. Measurements are taken at the mesial and distal aspects of the implant, and an average value is calculated. Mean bone level changes are computed by subtracting the average bone level at 12 months after implant placement from the average bone level at baseline (implant placement). Hence, negative bone level changes are representing bone loss; vice versa positive changes representing bone gain. Measurements take into account distortion based on changes on the radiograph from the true dimension of the implant.'}, {'measure': 'Incidence of Adverse Events and Adverse Device Effects', 'timeFrame': 'Screening, Baseline, 7-14 days after implant placement, 6 weeks after implant placement, 4 months after implant placement, 6 months after implant placement and 12 months after implant placement', 'description': 'At each visit the Investigator should determine if any adverse events occurred since the last study visit by speaking with the patient and reviewing any dental and medical records. These AEs, along with any AEs from the current study visit, should be documented and reported as described in Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing AEs throughout the study.'}], 'primaryOutcomes': [{'measure': 'Implant Survival Rate at 12 Months After Implant Placement', 'timeFrame': '12 months after implant placement', 'description': 'A "surviving implant" is an implant stably inserted in the subject\'s jaw bone at the time of assessment.'}], 'secondaryOutcomes': [{'measure': 'Pink Esthetic Score (PES) at 6 Months After Implant Placement', 'timeFrame': '6 months after implant placement', 'description': 'The Pink esthetic score allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14. The higher the value, the better the outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Small diameter implant'], 'conditions': ['Tooth Loss']}, 'referencesModule': {'references': [{'pmid': '10337309', 'type': 'BACKGROUND', 'citation': 'Steinemann SG. Titanium--the material of choice? Periodontol 2000. 1998 Jun;17:7-21. doi: 10.1111/j.1600-0757.1998.tb00119.x. No abstract available.'}, {'pmid': '20586785', 'type': 'BACKGROUND', 'citation': 'Gottlow J, Dard M, Kjellson F, Obrecht M, Sennerby L. Evaluation of a new titanium-zirconium dental implant: a biomechanical and histological comparative study in the mini pig. Clin Implant Dent Relat Res. 2012 Aug;14(4):538-45. doi: 10.1111/j.1708-8208.2010.00289.x. Epub 2010 Jun 25.'}, {'pmid': '7593037', 'type': 'BACKGROUND', 'citation': 'Kobayashi E, Matsumoto S, Doi H, Yoneyama T, Hamanaka H. Mechanical properties of the binary titanium-zirconium alloys and their potential for biomedical materials. J Biomed Mater Res. 1995 Aug;29(8):943-50. doi: 10.1002/jbm.820290805.'}, {'pmid': '21414131', 'type': 'BACKGROUND', 'citation': 'Al-Nawas B, Bragger U, Meijer HJ, Naert I, Persson R, Perucchi A, Quirynen M, Raghoebar GM, Reichert TE, Romeo E, Santing HJ, Schimmel M, Storelli S, ten Bruggenkate C, Vandekerckhove B, Wagner W, Wismeijer D, Muller F. A double-blind randomized controlled trial (RCT) of Titanium-13Zirconium versus Titanium Grade IV small-diameter bone level implants in edentulous mandibles--results from a 1-year observation period. Clin Implant Dent Relat Res. 2012 Dec;14(6):896-904. doi: 10.1111/j.1708-8208.2010.00324.x. Epub 2011 Mar 17.'}, {'pmid': '24015975', 'type': 'BACKGROUND', 'citation': 'Benic GI, Gallucci GO, Mokti M, Hammerle CH, Weber HP, Jung RE. Titanium-zirconium narrow-diameter versus titanium regular-diameter implants for anterior and premolar single crowns: 1-year results of a randomized controlled clinical study. J Clin Periodontol. 2013 Nov;40(11):1052-61. doi: 10.1111/jcpe.12156. Epub 2013 Sep 8.'}, {'pmid': '24666383', 'type': 'BACKGROUND', 'citation': 'Al-Nawas B, Domagala P, Fragola G, Freiberger P, Ortiz-Vigon A, Rousseau P, Tondela J. A Prospective Noninterventional Study to Evaluate Survival and Success of Reduced Diameter Implants Made From Titanium-Zirconium Alloy. J Oral Implantol. 2015 Aug;41(4):e118-25. doi: 10.1563/AAID-JOI-D-13-00149. Epub 2014 Mar 25.'}, {'pmid': '24713048', 'type': 'BACKGROUND', 'citation': 'Quirynen M, Al-Nawas B, Meijer HJ, Razavi A, Reichert TE, Schimmel M, Storelli S, Romeo E; Roxolid Study Group. Small-diameter titanium Grade IV and titanium-zirconium implants in edentulous mandibles: three-year results from a double-blind, randomized controlled trial. Clin Oral Implants Res. 2015 Jul;26(7):831-40. doi: 10.1111/clr.12367. Epub 2014 Apr 9.'}, {'pmid': '24660189', 'type': 'BACKGROUND', 'citation': 'Klein MO, Schiegnitz E, Al-Nawas B. Systematic review on success of narrow-diameter dental implants. Int J Oral Maxillofac Implants. 2014;29 Suppl:43-54. doi: 10.11607/jomi.2014suppl.g1.3.'}, {'pmid': '15635943', 'type': 'BACKGROUND', 'citation': 'Hammerle CH, Chen ST, Wilson TG Jr. Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets. Int J Oral Maxillofac Implants. 2004;19 Suppl:26-8. No abstract available.'}, {'pmid': '3507627', 'type': 'BACKGROUND', 'citation': 'Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.'}, {'pmid': '15635945', 'type': 'BACKGROUND', 'citation': 'Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.'}, {'pmid': '16307569', 'type': 'BACKGROUND', 'citation': 'Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.'}, {'pmid': '19681932', 'type': 'BACKGROUND', 'citation': 'Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x.'}, {'pmid': '37725234', 'type': 'DERIVED', 'citation': 'Walter C, Sagheb K, Blatt S, Klein MO, Herrmann J, Kleinheinz J, Al-Nawas B. Evaluation of the clinical safety and performance of a narrow diameter (2.9 mm) bone-level implant: a 1-year prospective single-arm multicenter study. Int J Implant Dent. 2023 Sep 19;9(1):32. doi: 10.1186/s40729-023-00495-x.'}]}, 'descriptionModule': {'briefSummary': 'The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow treatment of patients with single tooth gaps of small dimensions in the lateral and central incisor positions in the mandible and in the lateral incisor positions in the maxilla. These positions are reduced-load-bearing compared to more posterior positions.\n\nDuring this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.', 'detailedDescription': 'This is a multi-center, prospective, single cohort, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 12 ± 1 months.\n\nStraumann BLT implants Ø 2.9 mm will be placed in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement, followed by provisional prosthetic loading after 6 ± 2 weeks and by final prosthetic loading 4 ± 1 months after implant placements.\n\nIn total 7 visits per patient are scheduled in this study. Implant survival, PES, implant success, bone level changes and adverse events (AEs) will be assessed.\n\nThe investigational device is a CE-(Conformité Européenne, meaning European Conformity) marked product. Straumann BLT implants Ø 2.9 mm Roxolid SLActive (sand blasted, large grit, acid etched surface) are available in lengths of 10, 12 and 14 mm.\n\nFour centers in Germany will participate. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.\n* Patients must be males or females who are a minimum of 18 years of age.\n* Patients with a minimum of 4 weeks history of edentulism in the study area, minimal interdental space and in need of a single tooth replacement with a dental implant central and lateral incisors in the mandible and lateral incisors in the maxilla (Federation Dentaire Internationale (FDI) positions 12, 22, 31, 32, 41 or 42).\n* Presence of natural tooth or implants adjacent to the study implant position (single tooth gap).\n* Patients with complete soft tissue coverage of the socket at implant placement.\n\nExclusion Criteria:\n\n* Patients with inadequate bone volume and / or quality or metabolic bone disorder.\n* Patients with local root remnants.\n* Patients with inadequate wound healing capacity.\n* Patients with not completed maxillary and mandibular growth.\n* Patients with serious internal medical problems, uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders.\n* Patients with poor general state of health.\n* Patients with drug or alcohol abuse.\n* Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy.\n* Patients with 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.\n* A woman who is pregnant or planning to become pregnant at any point during the study duration.'}, 'identificationModule': {'nctId': 'NCT02699866', 'briefTitle': 'Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Straumann AG'}, 'officialTitle': 'A Multi-Center, Prospective, Single Cohort, Post-Market Clinical Follow-Up (PMCF) Study to Assess Implant Survival After Insertion of Straumann® Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting', 'orgStudyIdInfo': {'id': 'CR02/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLT Implant Ø 2.9 mm', 'description': 'The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.', 'interventionNames': ['Device: BLT Implant Ø 2.9 mm']}], 'interventions': [{'name': 'BLT Implant Ø 2.9 mm', 'type': 'DEVICE', 'otherNames': ['Short Diameter Implant (SDI)'], 'description': 'Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.', 'armGroupLabels': ['BLT Implant Ø 2.9 mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40210', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '55128', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Medi+', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '08056', 'city': 'Zwickau', 'country': 'Germany', 'facility': 'Kieferchirurgische Praxen Hentschel & Herrmann', 'geoPoint': {'lat': 50.72724, 'lon': 12.48839}}], 'overallOfficials': [{'name': 'Keyvan Sagheb, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}