Status:

COMPLETED

Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

Lead Sponsor:

Dentsply Sirona Implants and Consumables

Conditions:

Jaw, Edentulous, Partially

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

47 Patients enrolled

Trial Details

Trial ID

NCT00711113

Start Date

December 1 2003

Last Update

February 7 2014

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Iowa, College of Dentistry, Dow's Institute for Dental Research

Iowa City, Iowa, United States, 52242-1010

2

UTHSCSA

San Antonio, Texas, United States, 78229

3

Universitetsklinik Mainz, Klinik fur ZMK

Mainz, Germany, D-551 31