The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant 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 3 mm implant is a safe and predictable procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
School of Stomatology, JiLin University, Hospital of Stomatology
Changchun, China
Sichuan University
Chengdu, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
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.
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 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.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Time frame: Measured at the 3 year follow-up after implant loading.
Presence of Plaque
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Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.
Time frame: Measured at the 3 year follow-up after implant loading.