NCT02569671

Bone Level Tapered Multi-Center Study

Immediate Placement of the Straumann® Bone Level Tapered Implant With Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed Placement

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized, controlled, multi-center study is to assess the clinical and radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites (control).

Detailed description

The primary objective is to demonstrate that the change in mean peri-implant marginal bone level changes (mesial and distal) from loading to 12 months post-loading of the test treatment will not be worse than the control treatments. The secondary objectives of the study are to assess differences in clinical and radiographic outcomes between the test and control treatments at 12 months post-loading by looking at implant success and survival, buccal bone dimensional changes, implant stability, soft tissue changes, subject satisfaction, and adverse events. An additional objective is to assess long-term differences in clinical and radiographic outcomes, as measured in the primary and secondary objectives, over the span of two, three, four, and five years.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
DEVICE	Straumann Bone Level Tapered Implant - Immediate Placement	Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
DEVICE	Straumann Bone Level Tapered Implant - Delayed Placement	Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-11-12
• Completion: 2025-09-01
• First posted: 2015-10-07
• Last updated: 2025-07-08
• Results posted: 2025-07-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study