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Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01473355
First received: November 15, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes

November 15, 2011
February 20, 2013
October 2011
January 2016   (final data collection date for primary outcome measure)
Marginal bone level alteration [ Time Frame: At 12 months after implant loading ] [ Designated as safety issue: No ]
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Same as current
Complete list of historical versions of study NCT01473355 on ClinicalTrials.gov Archive Site
  • Implant stability [ Time Frame: At implant loading (6-8 weeks after implant placement) ] [ Designated as safety issue: No ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant stability [ Time Frame: At 36 months after implant loading ] [ Designated as safety issue: No ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant survival [ Time Frame: At 36 months after implant loading ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated by clinically and radiographically count the number of implants remaining in function
  • Implant stability [ Time Frame: At implant loading (6-8 weeks after implant placement) ] [ Designated as safety issue: No ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant stability [ Time Frame: At 12 months after implant loading ] [ Designated as safety issue: No ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant survival [ Time Frame: At 12 months after implant loading ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated by clinically and radiographically count the number of implants remaining in function
Not Provided
Not Provided
 
Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. A 3-years Follow-up Study.

The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Partially Edentulous Jaw
Device: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Not Provided
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
45
Not Provided
January 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Provision of informed consent
  2. Aged 20-75 years at enrolment
  3. History of edentulism in the study area of at least two months
  4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
  5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  6. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

  1. Unlikely to be able to comply with study procedures, as judged by the investigator
  2. Uncontrolled pathologic processes in the oral cavity
  3. Known or suspected current malignancy
  4. History of radiation therapy in the head and neck region
  5. History of chemotherapy within 5 years prior to surgery
  6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
  7. Uncontrolled diabetes mellitus
  8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  9. Smoking more than 10 cigarettes per day
  10. Present alcohol and/or drug abuse
  11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  12. Previous enrollment in the present study
  13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01473355
CHN-0003
Not Provided
Dentsply Implants
Dentsply Implants
Not Provided
Principal Investigator: Ping Gong, Prof Sichuan University
Dentsply Implants
February 2013

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