Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting

NCT02699866 | Completed Results

• 1 other identifier: CR02/15
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

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. During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.

Conditions

Tooth Loss

Keywords

Small diameter implant

Outcome Measures

Primary Outcomes (1)

• Implant Survival Rate at 12 Months After Implant Placement

  A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.

  12 months after implant placement

Secondary Outcomes (1)

• Pink Esthetic Score (PES) at 6 Months After Implant Placement

  6 months after implant placement

Other Outcomes (3)

• Implant Success Rate at 12 Months After Implant Placement

  12 months after implant placement

• Marginal Bone Level Changes at 12 Months After Implant Placement

  Baseline and 12 months after implant placement

• Incidence of Adverse Events and Adverse Device Effects

  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

Study Arms (1)

BLT Implant Ø 2.9 mm

EXPERIMENTAL

The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.

Device: BLT Implant Ø 2.9 mm

Interventions

BLT Implant Ø 2.9 mm DEVICE

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.

Also known as: Short Diameter Implant (SDI)

BLT Implant Ø 2.9 mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients with inadequate bone volume and / or quality or metabolic bone disorder.
• 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.

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (5)

Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen

Düsseldorf, 40210, Germany

Location

Medi+

Mainz, 55128, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen

Mainz, 55131, Germany

Location

Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie

Münster, 48149, Germany

Location

Kieferchirurgische Praxen Hentschel & Herrmann

Zwickau, 08056, Germany

Location

Related Publications (14)

• 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: 10337309 BACKGROUND

• 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: 20586785 BACKGROUND

• 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: 7593037 BACKGROUND

• 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: 21414131 BACKGROUND

• 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: 24015975 BACKGROUND

• 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: 24666383 BACKGROUND

• 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: 24713048 BACKGROUND

• 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: 24660189 BACKGROUND

• 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: 15635943 BACKGROUND

• 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: 3507627 BACKGROUND

• 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: 15635945 BACKGROUND

• 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: 16307569 BACKGROUND

• 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: 19681932 BACKGROUND

• 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.

  PMID: 37725234 DERIVED

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Results Point of Contact

• Title: Dr. Michael McCaskey, Team Leader Clinical Research
• Organization: Institut Straumann AG

michael.mccaskey@straumann.com

+41619651741

Study Officials

• Keyvan Sagheb, Dr.

  Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: February 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 31, 2021
• Results First Posted: September 17, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)