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

Dentsply

Status

Completed

Conditions

Jaw, Edentulous, Partially

Treatments

Device: OsseoSpeed™ length 11 mm

Device: OsseoSpeed™ length 6 mm

Study type

Interventional

Funder types

Industry

Identifiers

NCT00545818

YA-SHO-0001

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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