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 maxilla 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
Tong Ji University, Oral Implants Department
Shanghai, China
School of Stomatology Wuhan University
Wuhan, China
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
Xi'an, China
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Time frame: Measured at the 3-year follow-up visit after implant loading.
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: Measured at the 3-year follow-up visit after implant loading.
Marginal Bone Level Alteration
Marginal Bone Level (mm) determined from radiographs and expressed as a 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 obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).
Time frame: Measured at the 3-year follow-up visit after implant loading.
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
Change in pocket depth expressed in millimeters at time of the 3 years 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 implant loading and at the 3-year follow-up visit after loading.
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (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 implant loading and at the 3-year follow-up visit after loading.
Presence of Plaque
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Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.
Time frame: Measured at the 3-year follow-up visit after implant loading.
Gingival Zenith Score
Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm. Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.
Time frame: Measured at implant loading and at the 3-year follow-up visit after loading.