Study on OsseoSpeed™ TX Implants in a Chinese Population

Inclusion criteria

• Provision of informed consent
• Aged 20-75 years at enrolment
• History of edentulism in the posterior mandible, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
• Neighboring tooth to the planned bridge must have natural root.
• 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 adequate bone height and a bone width of minimum 5.5 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
• Current need for pre-surgical bone or soft tissue augmentation in the planned implant 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.
• Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.
• Subjects that are unable to give informed consent