Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:20 - 70
Updated:8/9/2018
Start Date:November 2007
End Date:May 2016

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An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.

The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for
rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long.
The primary hypothesis is that the alteration in bone level is equal in patients randomized
to 6 mm as to patients randomized to 11 mm implants.


Inclusion Criteria:

- Provision of informed consent

- Aged 20-70 years at enrolment

- History of edentulism in the study area of at least four months

- Neighboring tooth/teeth to the planned bridge must have natural root(s)

- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in
contact with the planned bridge.

- Deemed by the investigator to have a bone height of at least 11 mm and a bone width of
minimum 6 mm

- Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

- Unlikely to be able to comply with study procedures, as judged by the investigator

- Earlier graft procedures in the study area

- Uncontrolled pathologic processes in the oral cavity

- Known or suspected current malignancy

- History of radiation therapy in the head and neck region

- History of chemotherapy within 5 years prior to surgery

- Systemic or local disease or condition that could compromise post-operative healing
and/or osseointegration

- Uncontrolled diabetes mellitus

- Corticosteroids or any other medication that could influence post-operative healing
and/or osseointegration

- Smoking more than 10 cigarettes/day

- Present alcohol and/or drug abuse

- Involvement in the planning and conduct of the study (applies to both Astra Tech staff
and staff at the study site)

- Previous enrolment in the present study.

- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

- Simultaneous participation in another clinical study, or participation in a clinical
study during the last 6 months
We found this trial at
3
sites
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from
Melbourne,
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Iowa City, IA
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Los Angeles, California 90089
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from
Los Angeles, CA
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