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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants
ClinicalTrials.gov Identifier:
NCT00545818
First received: October 16, 2007
Last updated: August 21, 2017
Last verified: August 2017
October 16, 2007
August 21, 2017
November 2007
June 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 ]
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 ]
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: None (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™
Guljé F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
Not Provided
June 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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Netherlands,   Sweden,   United Kingdom,   United States
 
 
NCT00545818
YA-SHO-0001
No
Not Provided
Not Provided
Dentsply Sirona Implants
Dentsply Sirona Implants
Not Provided
Not Provided
Dentsply Sirona Implants
August 2017

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