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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
OsseoSpeed™ TX implants of lengths 8-17 mm
Capital Medical University School of Stomatology, Centre of Oral Implantation
Beijing, China
Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, China
Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
Nanjing, China
Marginal Bone Level Alteration
Marginal bone level 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 the 3-year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Time frame: Measured at implant loading and at the 3-year follow-up after implant loading.
Number of Stable Implants
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: Measured at the 3-year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Time frame: Measured at the 3-year follow-up after implant loading.
Number of Survived Implants
Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.
Time frame: Measured at the 3-year follow-up after implant loading.
Presence of Plaque
Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3-year follow-up visit after implant loading.
Time frame: Measured at the 3-year follow-up after implant loading.
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