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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
OsseoSpeed TX implants of lengths 8-17 mm
Department of Prosthodontics, School of Stomatology, Beijing University
Beijing, China
Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, China
Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University
Shanghai, China
Marginal Bone Level Alteration
Marginal Bone Level 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 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Time frame: Evaluated 3 years after implant loading
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Time frame: From implant placement to the follow-up 36 months after loading.
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no)
Time frame: Measured from loading of implants to the follow-up 36 months after loading.
Soft Tissue Status (PPD).
Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth.
Time frame: Measured from loading of implants to the follow-up 36 months after loading.
Soft Tissue Status (BoP)
Soft tissue status measured by assessment of bleeding on probing (BoP).
Time frame: Measured from loading of implants to the follow-up 36 months after loading.
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