NCT01842958

Straumann Roxolid Multi-Center Study

A Randomized, Controlled, Multi-center Clinical Study Evaluating the Crestal Bone Level Changes of Straumann BL Ø 3.3 mm NC SLActive RXD Implants Compared to Straumann BL Ø 4.1 mm RC SLActive RXD Implants for Single Tooth Replacement.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery and 12 months post-implant placement. The secondary objectives will assess differences in clinical outcomes between the test and control implants, including implant success and survival, gingival recession, subject satisfaction and additional early bone level measurements.

Detailed description

This is a randomized, controlled, multi-center clinical study. The total study duration for each patient should be 12 ± 1 months. Straumann Bone Level implants will be placed in the pre-molar or anterior region of the mandible or maxilla for single tooth replacement, followed by provisional prosthetic loading after 25 ± 4 days and by final prosthetic loading 6 ± 1 months after implant loading. In total 6 visits per patient are scheduled in this study. Bone level changes, implant success and survival, gingival recession, subject satisfaction and adverse events (AEs) will be assessed. The study devices are CE-(Conformité Européenne, meaning European Conformity) marked products. Straumann Bone Level implants Ø 3.3 mm NC SLActive Roxolid and Straumann Bone Level Ø 4.1 mm RC SLActive implants. Five centers in USA will participate.

Conditions

• Jaw, Edentulous, Partially

Interventions

Type	Name	Description
DEVICE	Straumann Bone Level Implants, 4.1 mm implant diameter	Straumann Bone Level Implants, 4.1 mm implant diameter
DEVICE	Straumann Bone Level Implants, 3.3 mm implant diameter	Straumann Bone Level Implants, 3.3 mm implant diameter

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2013-04-30
• Last updated: 2018-02-15
• Results posted: 2018-02-15

Locations

5 sites across 1 country: United States