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Study on OsseoSpeed™ TX Implants in a Chinese Population

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01346683
First received: May 2, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible 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 Mandible. 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 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. Marginal Bone Level expressed in millimeters at the 12 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 bleeding on probing and measurement of probing pocket depth.

  • 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.

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


Estimated Enrollment: 45
Study Start Date: February 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OsseoSpeed TX
    OsseoSpeed TX implants of lengths 8-17 mm
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Provision of informed consent
  2. Aged 20-75 years at enrolment
  3. History of edentulism in the posterior mandible, 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 enrolment 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 ClinicalTrials.gov identifier: NCT01346683

Locations
China
Department of Prosthodontics, School of Stomatology, Beijing University
Beijing, China, 100081
Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, China, 510055
Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University
Shanghai, China, 200011
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Yongsheng Zhou, Prof Department of Prosthodontics, School of Stomatology, Beijing University
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT01346683     History of Changes
Other Study ID Numbers: CHN-0002
Study First Received: May 2, 2011
Last Updated: January 9, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on November 27, 2014