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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473355
First Posted: November 17, 2011
Last Update Posted: August 22, 2017
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.
Information provided by (Responsible Party):
Dentsply Sirona Implants
November 15, 2011
November 17, 2011
August 22, 2017
October 2011
September 2014   (Final data collection date for primary outcome measure)
Marginal bone level alteration [ Time Frame: At 12 months after implant loading ]
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) ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant stability [ Time Frame: At 36 months after implant loading ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant survival [ Time Frame: At 36 months after implant loading ]
    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) ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant stability [ Time Frame: At 12 months after implant loading ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant survival [ Time Frame: At 12 months after implant loading ]
    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: None (Open Label)
Primary Purpose: Treatment
Partially Edentulous Jaw
Device: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Experimental: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Intervention: Device: OsseoSpeed™ TX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
October 2016
September 2014   (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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01473355
CHN-0003
Not Provided
Not Provided
Not Provided
Dentsply Sirona Implants
Dentsply Sirona Implants
Not Provided
Principal Investigator: Ping Gong, Prof Sichuan University
Dentsply Sirona Implants
August 2017

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