Jianfeng Zhou1, Qingfeng Huang2, Xiaodong Wang3, Dong Peng1, Yan Li3, Lei Zhang1, Jianzhang Liu1, Songmei Zhang2, Ke Zhao3, Xinquan Jiang2, Yongsheng Zhou1,4. 1. Department of Prosthodontics, Peking University School and Hospital of Stomatology, Beijing, China. 2. Department of Prosthodontics, The Ninth People's Hospital affiliated to Shanghai Jiaotong University, School of Medicine, Shanghai, China. 3. Department of Prosthodontics, Hospital of Stomatology, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Stomatology, Guangzhou, China. 4. National Engineering Lab for Digital and Material Technology of Stomatology, Peking University School and Hospital of Stomatology, Beijing, China.
Abstract
AIM: To evaluate the 12-months clinical and radiological outcomes with the OsseoSpeed(™) TX implant using an early loading protocol in patients with missing teeth in the posterior mandible. MATERIAL AND METHODS: Forty-five subjects, with Kennedy class I or II edentulism in the mandible, were enrolled at three centres in China. Two or three implants were placed in one edentulous region using a one-stage procedure. Patients received a screw-retained splinted fixed permanent restoration in one edentulous region 6-8 weeks after surgery. Follow-up took place at 6 and 12 months after loading. Marginal bone level alteration, implant survival and clinical findings were assessed using descriptive statistics. The data were analysed on a patient level, implying that the mean overall implants by patient was used as the statistical unit. The data from the three centres were pooled in the statistical analyses. RESULTS: A total of 107 implants were inserted in 45 patients. Twelve months after loading, the implant survival rate was 100%, with a mean (± std) marginal bone gain of 0.08 ± 0.411 mm and healthy soft tissue status. CONCLUSIONS: Early loading of splinted OsseoSpeed(™) TX implants was an effective and safe treatment for partial edentulism of the posterior mandible. CLINICAL TRIAL REGISTRATION NUMBER ON CLINICALTRIALS.GOV: NCT01346683.
AIM: To evaluate the 12-months clinical and radiological outcomes with the OsseoSpeed(™) TX implant using an early loading protocol in patients with missing teeth in the posterior mandible. MATERIAL AND METHODS: Forty-five subjects, with Kennedy class I or II edentulism in the mandible, were enrolled at three centres in China. Two or three implants were placed in one edentulous region using a one-stage procedure. Patients received a screw-retained splinted fixed permanent restoration in one edentulous region 6-8 weeks after surgery. Follow-up took place at 6 and 12 months after loading. Marginal bone level alteration, implant survival and clinical findings were assessed using descriptive statistics. The data were analysed on a patient level, implying that the mean overall implants by patient was used as the statistical unit. The data from the three centres were pooled in the statistical analyses. RESULTS: A total of 107 implants were inserted in 45 patients. Twelve months after loading, the implant survival rate was 100%, with a mean (± std) marginal bone gain of 0.08 ± 0.411 mm and healthy soft tissue status. CONCLUSIONS: Early loading of splinted OsseoSpeed(™) TX implants was an effective and safe treatment for partial edentulism of the posterior mandible. CLINICAL TRIAL REGISTRATION NUMBER ON CLINICALTRIALS.GOV: NCT01346683.