Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
NCT ID: NCT02699866
Last Updated: 2021-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2016-02-29
2019-11-30
Brief Summary
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During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.
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Detailed Description
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Straumann 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.
In 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.
The 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.
Four 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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BLT Implant Ø 2.9 mm
The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.
BLT 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.
Interventions
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BLT 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be males or females who are a minimum of 18 years of age.
* 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).
* Presence of natural tooth or implants adjacent to the study implant position (single tooth gap).
* Patients with complete soft tissue coverage of the socket at implant placement.
Exclusion Criteria
* Patients with local root remnants.
* Patients with inadequate wound healing capacity.
* Patients with not completed maxillary and mandibular growth.
* 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.
* Patients with poor general state of health.
* Patients with drug or alcohol abuse.
* Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy.
* 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.
* A woman who is pregnant or planning to become pregnant at any point during the study duration.
18 Years
ALL
No
Sponsors
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Institut Straumann AG
INDUSTRY
Responsible Party
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Principal Investigators
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Keyvan Sagheb, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
Locations
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Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen
Düsseldorf, , Germany
Medi+
Mainz, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
Mainz, , Germany
Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie
Münster, , Germany
Kieferchirurgische Praxen Hentschel & Herrmann
Zwickau, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CR02/15
Identifier Type: -
Identifier Source: org_study_id
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