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Study on OsseoSpeed™ TX Implants in the Upper 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: NCT01389245
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
Dentsply Sirona Implants

Brief Summary:
The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX implants 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 posterior maxilla is a safe and predictable procedure.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
Study Start Date : June 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: OsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 mm
Device: OsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 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 placement, loading and at 6, 12, 24 and 36 months follow-up. ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)

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

  3. Implant survival [ Time Frame: From implant placement to 36 months after loading. ]
    Implant survival rate will be evaluated by clinically and radiographically.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 enrollment
  3. History of edentulism in the posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
  4. Neighboring tooth to the planned bridge must have natural root.
  5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
  6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
  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. Earlier graft procedures in the study area
  3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
  4. Uncontrolled pathologic processes in the oral cavity
  5. Known or suspected current malignancy
  6. History of radiation therapy in the head and neck region
  7. History of chemotherapy within 5 years prior to surgery
  8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
  9. Uncontrolled diabetes mellitus
  10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  11. Smoking more than 10 cigarettes/day
  12. Present alcohol and/or drug abuse
  13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  14. Previous enrollment in the present study.
  15. Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.
  16. Subjects that are unable to give informed consent

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): NCT01389245

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Capital Medical University School of Stomatology, Centre of Oral Implantation
Beijing, China, 100050
Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, China, 510055
Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
Nanjing City, China, 210008
Sponsors and Collaborators
Dentsply Sirona Implants
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Principal Investigator: Deng Feilong, MD Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou

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Responsible Party: Dentsply Sirona Implants Identifier: NCT01389245     History of Changes
Other Study ID Numbers: CHN-0001
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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