Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).
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 an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality|
- Implant survival [ Time Frame: Continuously during 5,5 years after implant placement ] [ Designated as safety issue: No ]
|Study Start Date:||September 1999|
|Primary Completion Date:||October 2006 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748670
|United States, Iowa|
|University of Iowa, College of Dentistry, Dow's Institute for Dental Research|
|Iowa City, Iowa, United States, 52242-1010|
|Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken|
|Gävle, Sweden, 801 87|
|Odontologiska kliniken, Länssjukhuset|
|Halmstad, Sweden, 301 85|
|Principal Investigator:||Clark Stanford, D.D.S., Ph.D.||University of Iowa, College of Dentistry, Dow's Institute for Dental Research|