Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw (NCT00545818) | Clinical Trial Compass
CompletedNot Applicable
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
United States, Australia, Netherlands97 participantsStarted 2007-11
Plain-language summary
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.
Who can participate
Age range20 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Radiological Assessments of Marginal Bone Level Alteration
Timeframe: Evaluated from implant installation to 5 years follow-up after implant placement