Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-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. Identifier: NCT00748397
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
Information provided by:
Dentsply Sirona Implants

Brief Summary:

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 or disease Intervention/treatment Phase
Jaw, Edentulous Device: Fixture MicroThread (Micro-Macro) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : January 1999
Actual Primary Completion Date : December 2007

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00748397

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

Responsible Party: Head of Therapeutic Area Dental, Clinical Research, Astra Tech AB Identifier: NCT00748397     History of Changes
Other Study ID Numbers: YA-MMF-0002
First Posted: September 8, 2008    Key Record Dates
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