NCT01878331

Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants

Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study. No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. Patients will not receive an investigational treatment in this study. Patients will be followed at 5 to 10 years from the date of the original implant loading

Detailed description

The primary study objective is to compare implant survival with the Titanium Zirconium (Roxolid™) implant compared the Titanium grade IV (SLActive®) implant between baseline (surgery) and 10 years. The following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types Straumann® Bone Level SLActive, diameter 3.3 mm, Titanium-Zirconium (Roxolid®) vs. Straumann® Bone Level SLActive implant, diameter 3.3 mm, Titanium Grade IV: * Implant survival * Implant success according to Buser et al. (1990) * Crestal bone level change measured by Orthopantomogram (OPT) * Soft tissue health * Clinical measurements * Prosthetic parts assessments: Success and maintenance * Oral Health Related Quality of Life (OHRQoL) * Product Safety (Adverse events and device deficiencies)

Conditions

• Jaw, Edentulous

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2013-06-14
• Last updated: 2020-01-07

Locations

1 site across 1 country: Switzerland