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

Dentsply

Status

Completed

Conditions

Jaw, Edentulous, Partially

Treatments

Device: OsseoSpeed™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00711113

YA-OSS-0001

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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