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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dentsply Implants Identifier:
First received: July 6, 2011
Last updated: March 23, 2016
Last verified: March 2016
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 Intervention
Partially Edentulous Jaw
Device: OsseoSpeed™ TX

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • Implant stability [ Time Frame: At implant placement, loading and at 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)

  • Soft tissue status [ Time Frame: At loading and at 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Soft tissue status will be measured by assessment of bleading on probing and measurement of probing pocket depth.

  • Implant survival [ Time Frame: From implant placement to 36 months after loading. ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated by clinically and radiographically.

  • Plaque [ Time Frame: At 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Occurrence of plaque around the study implant will be recorded.

Enrollment: 42
Study Start Date: June 2011
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 mm
Device: OsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 mm


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01389245

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 Implants
Principal Investigator: Deng Feilong, MD Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
  More Information

Responsible Party: Dentsply Implants Identifier: NCT01389245     History of Changes
Other Study ID Numbers: CHN-0001 
Study First Received: July 6, 2011
Last Updated: March 23, 2016
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Mouth Diseases
Mouth, Edentulous
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases processed this record on May 26, 2016