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. )

First Received: September 5, 2008 No Changes Posted

Sponsored by:	Astra Tech AB
Information provided by:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00748670

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)

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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 Astra Tech AB:

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
A: Experimental	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

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

Astra Tech AB

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:	Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research )
Study ID Numbers:	YA-MMF-0003
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00748670 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board; United States: Institutional Review Board

Study placed in the following topic categories:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases

Musculoskeletal Diseases
Stomatognathic Diseases
Jaw, Edentulous

Additional relevant MeSH terms:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases
Musculoskeletal Diseases

Jaw Diseases
Stomatognathic Diseases
Jaw, Edentulous

ClinicalTrials.gov processed this record on May 07, 2009