Study on OsseoSpeed™ TX Implants in a Chinese Population
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.
|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.|
- 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).
- 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.
|Study Start Date:||February 2011|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Device: OsseoSpeed TX
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346683
|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|
|Principal Investigator:||Yongsheng Zhou, Prof||Department of Prosthodontics, School of Stomatology, Beijing University|