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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

October 16, 2007
January 9, 2014
November 2007
May 2016   (final data collection date for primary outcome measure)
Radiological assessments of marginal bone level alteration [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]
The primary objective of this study is to compare marginal bone level alteration, by radiological assessments, between OsseoSpeed™ implant 6 mm and OsseoSpeed™ implant 11 mm. [ Time Frame: 5 year follow-up ]
Complete list of historical versions of study NCT00545818 on ClinicalTrials.gov Archive Site
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 ]
Secondary objectives are to evaluate implant survival (on implant and patient level), condition of periimplant mucosa, and overall safety. [ Time Frame: 5 year follow-up ]
Not Provided
Not Provided
 
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Jaw, Edentulous, Partially
  • Device: OsseoSpeed™
    OsseoSpeed™ implant, length: 6 mm
  • Device: OsseoSpeed™
    OsseoSpeed™ implant, length: 11 mm
  • Experimental: 1
    Intervention: Device: OsseoSpeed™
  • Active Comparator: 2
    Intervention: Device: OsseoSpeed™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
May 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Netherlands,   Sweden,   United Kingdom
 
NCT00545818
YA-SHO-0001
No
Dentsply Implants
Dentsply Implants
Not Provided
Not Provided
Dentsply Implants
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP