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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00545818
First received: October 16, 2007
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention
Jaw, Edentulous, Partially
Device: OsseoSpeed™

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Radiological assessments of marginal bone level alteration [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implant survival (on implant and patient level) Condition of periimplant mucosa Overall safety [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2007
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: OsseoSpeed™
OsseoSpeed™ implant, length: 6 mm
Active Comparator: 2 Device: OsseoSpeed™
OsseoSpeed™ implant, length: 11 mm

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545818

Locations
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
Netherlands
Praktijk De Mondhoek
Apeldoorn, Netherlands, 7315
Sweden
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 Implants
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00545818     History of Changes
Other Study ID Numbers: YA-SHO-0001
Study First Received: October 16, 2007
Last Updated: January 9, 2014
Health Authority: Australia: National Health and Medical Research Council
The Netherlands: Independent Review Board, Nijmegen
Sweden: Regional Ethical Review Board, Göteborg
United States: Institutional Review Board
United Kingdom: Guy's & St Thomas' NHS Foundation Trust

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on September 18, 2014