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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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