Jaw, Edentulous Clinical Trial
Official title:
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
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
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)
;
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