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

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. Identifier: NCT01473355
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Dentsply Sirona Implants

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Partially Edentulous Jaw Device: OsseoSpeed™ TX Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Device: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

  2. Implant stability [ Time Frame: At 36 months after implant loading ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)

  3. 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

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473355

School of Stomatology, JiLin University, Hospital of Stomatology
ChangChun City, China
Sichuan University
Chengdu, China, 610041
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China, 310003
Sponsors and Collaborators
Dentsply Sirona Implants
Principal Investigator: Ping Gong, Prof Sichuan University

Responsible Party: Dentsply Sirona Implants Identifier: NCT01473355     History of Changes
Other Study ID Numbers: CHN-0003
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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