Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.
Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Prospective, Multicenter Study to Evaluate the Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants, in Patients With Totally Edentulous Maxillas and Poor Bone Quality and Quantity in an Immediate Loading Protocol.|
- Implant Survival Rate [ Time Frame: At 5-year follow-up ] [ Designated as safety issue: No ]An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
|Study Start Date:||May 2005|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: OsseoSpeed||Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711022
|United States, Illinois|
|The University of Chicago, MC-2108|
|Chicago, Illinois, United States, 60637|
|Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine|
|Uppsala, Sweden, SE-751 85|
|Principal Investigator:||Joseph A Toljanic, Prof.||University of Chicago|