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Study on OsseoSpeed™ TX Implants in a Chinese Population

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ClinicalTrials.gov Identifier: NCT01346683
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):

May 2, 2011
May 3, 2011
September 16, 2016
February 2011
March 2016   (Final data collection date for primary outcome measure)
Marginal bone level alteration [ Time Frame: At 12 months after implant loading ]
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).
Same as current
Complete list of historical versions of study NCT01346683 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 bleeding on probing and measurement of probing pocket depth.
  • Plaque [ Time Frame: At 6, 12, 24 and 36 months follow-up. ]
    Occurrence of plaque around the study implant will be recorded.
  • Implant survival [ Time Frame: From implant placement to 36 months after loading. ]
    Implant survival rate will be evaluated clinically and radiographically.
  • Implant stability [ Time Frame: At implant placement (inclusion) ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • 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)
  • Implant stability [ Time Frame: At 12 months after implant loading ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)
  • Implant survival [ Time Frame: At 12 months after implant loading ]
    Implant survival rate will be evaluated clinically and radiographically and will be defined as number of implants remaining in function
Not Provided
Not Provided
 
Study on OsseoSpeed™ TX Implants in a Chinese Population
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.
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Partially Edentulous Jaw
Device: OsseoSpeed TX
OsseoSpeed TX implants of lengths 8-17 mm
Experimental: OsseoSpeed TX
OsseoSpeed TX implants of lengths 8-17 mm
Intervention: Device: OsseoSpeed TX
Zhou J, Huang Q, Wang X, Peng D, Li Y, Zhang L, Liu J, Zhang S, Zhao K, Jiang X, Zhou Y. Early loading of splinted implants in the posterior mandible: a prospective multicentre case series. J Clin Periodontol. 2016 Mar;43(3):298-304. doi: 10.1111/jcpe.12513. Epub 2016 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01346683
CHN-0002
Not Provided
Not Provided
Not Provided
Dentsply Sirona Implants
Dentsply Sirona Implants
Not Provided
Principal Investigator: Yongsheng Zhou, Prof Department of Prosthodontics, School of Stomatology, Beijing University
Dentsply Sirona Implants
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP