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

Completed · Not applicable

Conditions studied: Jaw, Edentulous, Partially

In brief

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.

Key facts

Study ID

NCT00545818

Run by

Dentsply Sirona Implants and Consumables

People needed

97

Starts

2007-11-01

Expected to finish

2016-05-01

Last updated by the study team

2020-05-19

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC School of Dentistry — Los Angeles, California, United States
• The University of Iowa, College of Dentistry — Iowa City, Iowa, United States
• School of Dental Science, University of Melbourne — Melbourne, Victoria, Australia
• Praktijk De Mondhoek — Apeldoorn, Netherlands
• Dept. of Parodontology, Göteborg University — Gothenburg, Sweden
• King's College London Dental Institute at Guy's King's and St Thomas' Hospitals — London, United Kingdom

Full record on ClinicalTrials.gov

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