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

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.

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

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

Responsible Party:	Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research )
Study ID Numbers:	YA-MIC-0002
First Received:	September 5, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00748241
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:

Jaw Diseases

ClinicalTrials.gov processed this record on November 05, 2008