Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.
Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro|
- Implant survival [ Time Frame: Continuously during 5,5 years after implant placement ] [ Designated as safety issue: No ]
|Study Start Date:||January 1999|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Device: Fixture MicroThread (Micro-Macro)
Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.
|United States, Louisiana|
|Louisiana State University Medical Center, School of Dentistry|
|New Orleans, Louisiana, United States, 70119-2799|
|Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität|
|Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia|
|Madrid, Spain, 28040|
|Käkkirurgiska kliniken, Universitetssjukhuset MAS|
|Malmö, Sweden, 205 02|
|Principal Investigator:||Bo Sunzel, Dr||Käkkirurgiska kliniken, Universitetssjukhuset MAS|