Study of Astra Tech Implants in Patients Missing 2-5 Teeth in the Posterior Upper Jaw, With Provisional Teeth Attached 6-7 Weeks Later

This study is ongoing, but not recruiting participants.

First Received: July 7, 2008 Last Updated: January 8, 2009 History of Changes

Sponsored by:	Astra Tech AB
Information provided by:	Astra Tech AB
ClinicalTrials.gov Identifier:	NCT00711113

Purpose

The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Condition	Intervention
Jaw, Edentulous, Partially	Device: OsseoSpeed™

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Maxilla in an Early Loading Protocol.

Further study details as provided by Astra Tech AB:

Primary Outcome Measures:

Implant Survival Rate [ Time Frame: From implant placement until 5-year follow-up ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	December 2003
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: OsseoSpeed™ OsseoSpeed™, all dimensions

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent
18 years of age and over
Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

Exclusion Criteria:

Untreated caries and/or periodontal disease of residual dentition
History of edentulism in the area of implant placement of less than two months
Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
Present alcohol or drug abuse
Unable or unwilling to return for follow-up visits for a period of 5 years
Current use of smoking tobacco
Pregnancy or lactation at the time of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711113

Locations

United States, Iowa
University of Iowa, College of Dentistry, Dow's Institute for Dental Research
Iowa City, Iowa, United States, 52242-1010
United States, Texas
UTHSCSA
San Antonio, Texas, United States, 78229
Germany
Universitetsklinik Mainz, Klinik fur ZMK
Mainz, Germany, D-551 31

Sponsors and Collaborators

Astra Tech AB

Investigators

Principal Investigator:

James T Mellonig, D.D.S., M.S

UTHSCSA

More Information

No publications provided

Responsible Party:	Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research )
Study ID Numbers:	YA-OSS-0001
Study First Received:	July 7, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00711113 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Germany: Ethics Commission

Keywords provided by Astra Tech AB:

Jaw, Edentulous, Partially (posterior maxilla)

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