Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-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:
NCT00748670
First received: September 5, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention
Jaw, Edentulous
Poor Bone Quality
Device: Fixture MicroThread (Micro-Macro)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant survival [ Time Frame: Continuously during 5,5 years after implant placement ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: September 1999
Primary Completion Date: October 2006 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Implants
Investigators
Principal Investigator: Clark Stanford, D.D.S., Ph.D. University of Iowa, College of Dentistry, Dow's Institute for Dental Research
  More Information

No publications provided

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
Study First Received: September 5, 2008
Last Updated: September 5, 2008
Health Authority: Sweden: Regional Ethical Review Board
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014