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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:
ClinicalTrials.gov Identifier:
NCT00748397
First Posted: September 8, 2008
Last Update Posted: September 8, 2008
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.
Information provided by:
Dentsply Sirona Implants
  Purpose

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.


Condition Intervention
Jaw, Edentulous Device: Fixture MicroThread (Micro-Macro)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Dentsply Sirona Implants:

Primary Outcome Measures:
  • Implant survival [ Time Frame: Continuously during 5,5 years after implant placement ]

Enrollment: 54
Study Start Date: January 1999
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00748397


Locations
United States, Louisiana
Louisiana State University Medical Center, School of Dentistry
New Orleans, Louisiana, United States, 70119-2799
Germany
Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität
Heidelberg, Germany
Spain
Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia
Madrid, Spain, 28040
Sweden
Käkkirurgiska kliniken, Universitetssjukhuset MAS
Malmö, Sweden, 205 02
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
Principal Investigator: Bo Sunzel, Dr Käkkirurgiska kliniken, Universitetssjukhuset MAS
  More Information

Responsible Party: Head of Therapeutic Area Dental, Clinical Research, Astra Tech AB
ClinicalTrials.gov Identifier: NCT00748397     History of Changes
Other Study ID Numbers: YA-MMF-0002
First Submitted: September 5, 2008
First Posted: September 8, 2008
Last Update Posted: September 8, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Mouth, Edentulous
Jaw, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases