3-Year Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-Stage Surgery and Early Loading.

This study has been completed.

First Received: September 5, 2008 No Changes Posted

Sponsored by:	Astra Tech AB
Information provided by:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00748241

Purpose

The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.

Condition	Intervention
Jaw, Edentulous, Partially	Device: Astra Tech Fixture ST

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Implant survival rate [ Time Frame: At follow-up visits: 6 months, 1 year, 2 and 3 years after implants have been loaded ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	September 2000
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: Astra Tech Fixture ST Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 - 75
Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
Willing to give informed consent

Exclusion Criteria:

Bone height < 5 mm, in the planned implant area
Bone width < 5 mm, in the planned implant area
Previous bone augmentation procedure in the planned implant area
Previous failures of endosseous implants
Untreated caries and/or periodontal disease of residual dentition
History or presence of any systemic or local 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
Current alcohol or drug abuse
Unable or unwilling to return for follow-up visits for 3 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748241

Locations

United States, New York
Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center
New York, New York, United States, 10010
Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center
New York, New York, United States, 10010

Sponsors and Collaborators

Astra Tech AB

Investigators

Principal Investigator:	Bruce G Valauri, D.D.S.	New York Dept of Veterans Affairs Medical Center
Principal Investigator:	Michael Toffler, D.D.S.	New York Dept of Veterans Affairs Medical Center

More Information

No publications provided

Responsible Party:	Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research )
Study ID Numbers:	YA-MIC-0002
Study First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00748241 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases
Musculoskeletal Diseases

Stomatognathic Diseases
Jaw, Edentulous
Tooth Loss
Jaw, Edentulous, Partially

Additional relevant MeSH terms:

Mouth Diseases
Mouth, Edentulous
Tooth Diseases
Musculoskeletal Diseases

Jaw Diseases
Stomatognathic Diseases
Jaw, Edentulous
Jaw, Edentulous, Partially

ClinicalTrials.gov processed this record on May 07, 2009