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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389258
First Posted: July 8, 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
  Purpose
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 maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.

Condition Intervention
Partially Edentulous Jaw Device: OsseoSpeed™ TX

Study Type: Interventional
Study Design: 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 Maxilla. A 3-years Follow-up Study.

Further study details as provided by Dentsply Sirona Implants:

Primary Outcome Measures:
  • Implant survival [ Time Frame: At 12 months after implant loading ]
    Implant survival rate will be evaluated clinically and radiographically.


Secondary Outcome Measures:
  • Marginal bone level alteration [ Time Frame: At implant placement, loading and at 1, 6, 12, 24 and 36 months follow-up. ]
    Marginal Bone Level (mm) will be determined from radiographs and expressed as a difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.

  • Soft tissue status [ Time Frame: At loading and at 1, 6, 12, 24 and 36 months follow-up. ]
    Soft tissue status will be measured by assessment of bleeding and probing and measurement of probing pocket depth.

  • Implant survival [ Time Frame: At 24 and 36 months follow-up ]
    Implant survival rate will be evaluated clinically and radiographically.

  • Gingival zenith score [ Time Frame: At loading and at 1, 6, 12, 24 and 36 months follow-up. ]
    Gingival zenith score will be measured from the gingival zenith to the incisal edge of the prosthetic crown.

  • Plaque [ Time Frame: At 1, 6, 12, 24 and 36 months follow-up. ]
    Occurrence of plaque around the study implant will be recorded.


Enrollment: 45
Study Start Date: June 2011
Study Completion Date: August 2016
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

Inclusion criteria:

  1. Provision of informed consent
  2. Aged 20-75 years at enrollment
  3. History of edentulism in the study area of at least two months
  4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
  5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
  6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  7. 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01389258


Locations
China
Tong Ji University, Oral Implants Department
Shanghai, China
School of Stomatology Wuhan University
Wuhan, China, 430079
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
Xi'an, China, 710032
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
Principal Investigator: Li Dehua, Prof Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an
  More Information

Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT01389258     History of Changes
Other Study ID Numbers: CHN-0006
First Submitted: July 6, 2011
First Posted: July 8, 2011
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