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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545818
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
Dentsply Sirona Implants

Brief 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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: OsseoSpeed™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2007
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 1 Device: OsseoSpeed™
OsseoSpeed™ implant, length: 6 mm

Active Comparator: 2 Device: OsseoSpeed™
OsseoSpeed™ implant, length: 11 mm

Primary Outcome Measures :
  1. Radiological assessments of marginal bone level alteration [ Time Frame: On a regular basis during 5 years follow-up ]

Secondary Outcome Measures :
  1. Implant survival (on implant and patient level) Condition of periimplant mucosa Overall safety [ Time Frame: On a regular basis during 5 years follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00545818

United States, California
USC School of Dentistry
Los Angeles, California, United States, 90089-0641
United States, Iowa
The University of Iowa, College of Dentistry
Iowa City, Iowa, United States, 52242-1010
Australia, Victoria
School of Dental Science, University of Melbourne
Melbourne, Victoria, Australia, 3010
Praktijk De Mondhoek
Apeldoorn, Netherlands, 7315
Dept. of Parodontology, Göteborg University
Göteborg, Sweden, SE 405 30
United Kingdom
King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Dentsply Sirona Implants