Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery

This study has been 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.)
Sponsor:
Information provided by:
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00748397
First received: September 5, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 5, 2008
September 5, 2008
January 1999
December 2007   (final data collection date for primary outcome measure)
Implant survival [ Time Frame: Continuously during 5,5 years after implant placement ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
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

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Jaw, Edentulous
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.
Experimental: A
Intervention: Device: Fixture MicroThread (Micro-Macro)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
54
Not Provided
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-75 years of age
  • Sufficient amount of bone to give good support for implants of at least 9 mm length.
  • Willing to give signed informed consent

Exclusion Criteria:

  • Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
  • Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Unable or unwilling to return for follow-up visits
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Spain,   Sweden
 
NCT00748397
YA-MMF-0002
No
Head of Therapeutic Area Dental, Clinical Research, Astra Tech AB
Dentsply Implants
Not Provided
Principal Investigator: Bo Sunzel, Dr Käkkirurgiska kliniken, Universitetssjukhuset MAS
Dentsply Implants
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP