NCT02699866

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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

• Tooth Loss

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-06-30
• Completion: 2019-11-30
• First posted: 2016-03-04
• Last updated: 2021-08-31
• Results posted: 2020-09-17

Locations

5 sites across 1 country: Germany