The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Department of Periodontology, School of Stomatology, Peking University
Beijing, China
Department of Implantology, School of Stomatology, Peking University
Beijing, China
Second Dental and Periodontal Center, School of Stomatology, Peking University
Beijing, 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.
Time frame: Evaluated from implant installation to 12 months after implant loading
Marginal Bone Level Alteration After 36 Months
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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading. Positive value = bone gain, Negative values = bone loss.
Time frame: Evaluated from implant loading to 36 months after implant loading.
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Time frame: Evaluated from implant installation to 36 months after implant loading.
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: Evaluated 36 months after implant loading.
Condition of the Periimplant Mucosa (PPD).
Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Negative value = increased pocket depth
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Evaluated from implant loading to 36 months after implant loading.
Condition of the Periimplant Mucosa (BoP).
Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP). Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.
Time frame: Evaluated from implant loading to 36 months after implant loading.
Plaque
Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.
Time frame: Evaluated 36 months after implant loading.
Crown-to-implant Ratio
Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs
Time frame: 12 months after implant loading