Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provi… (NCT00711113) | Clinical Trial Compass
CompletedNot Applicable
Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later
United States, Germany47 participantsStarted 2003-12
Plain-language 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 implant stability, marginal bone adaptation and survival rate.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Implant Survival Rate
Timeframe: At 5 year follow-up
2
Implant Stability
Timeframe: At 1 year follow-up
3
Marginal Bone Adaptation
Timeframe: At baseline (loading) and at 5 year follow-up