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 |
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.
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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