Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00748670|
Recruitment Status : Terminated (Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.)
First Posted : September 8, 2008
Last Update Posted : September 8, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous Poor Bone Quality||Device: Fixture MicroThread (Micro-Macro)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 1999|
|Actual Primary Completion Date :||October 2006|
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.
- Implant survival [ Time Frame: Continuously during 5,5 years after implant placement ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|