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Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

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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
Sponsor:
Information provided by:
Dentsply Sirona Implants

Brief Summary:

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)
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
Study Start Date : September 1999
Actual Primary Completion Date : October 2006

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 ]


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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
  • Bone quality class III or IV, (according to Lekholm & Zarb16)
  • Willing to give signed informed consent

Exclusion Criteria:

  • Need for bone augmentation of the maxilla
  • Tobacco smoking more than 5 cigarettes/day
  • 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
  • Bruxism or other parafunctional activity

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): NCT00748670


Locations
United States, Iowa
University of Iowa, College of Dentistry, Dow's Institute for Dental Research
Iowa City, Iowa, United States, 52242-1010
Sweden
Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken
Gävle, Sweden, 801 87
Odontologiska kliniken, Länssjukhuset
Halmstad, Sweden, 301 85
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
Principal Investigator: Clark Stanford, D.D.S., Ph.D. University of Iowa, College of Dentistry, Dow's Institute for Dental Research

Responsible Party: Head of Therapeutic Area Dental, Clinical Research, Astra Tech AB
ClinicalTrials.gov Identifier: NCT00748670     History of Changes
Other Study ID Numbers: YA-MMF-0003
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