目的:评估在上颌侧切牙或下颌中切牙或侧切牙区域立即设置单冠的窄直径(3.0mm)植入物的5年安全性和有效性。
方法:开放,prospective,单组,进行了多中心研究,其中窄直径的植入物被放置在新鲜的,愈合提取物,或先天缺失的部位。所有患者都需要满足立即加载的严格标准。主要终点是从植入物放置到5年随访的边缘骨水平(MBL)和MBL变化(MBLC)。次要终点包括累积5年生存率和成功率,软组织健康,和美学参数。
结果:77例患者共植入91枚植入物。从1年开始,平均MBL保持稳定(-0.79±0.73mm,n=75)至5年(-0.74±0.87mm,n=65)随访。从1年到5年的随访观察到0.11±0.83mm的边缘骨增加。累计5年生存率为96.5%,累计5年成功率为93%。临床参数,包括修改的菌斑指数,改良沟出血指数,杰姆特的乳头指数,在整个5年的研究中,粉红色的美学评分得到了改善。
结论:该研究表明,窄直径植入物是一种安全且可预测的治疗选择,适用于立即加载且骨骼体积有限或牙间间隙有限的受试者。
结论:可以考虑使用立即预备的窄直径植入物来修复缺失或受损的牙齿,并具有可预测的功能和美学结果。该试验在ClinicalTrials.gov(NCT02184845)注册。
OBJECTIVE: Evaluate the 5-year safety and efficacy of a narrow-diameter (3.0 mm) implant that was immediately provisionalized with a single crown in the maxillary lateral incisor or mandibular central or lateral incisor area.
METHODS: An open, prospective, single-cohort, multicenter study was conducted, in which narrow-diameter implants were placed in fresh, healed extraction, or congenitally missing sites. All patients were required to meet strict criteria for immediate loading. The primary endpoints were marginal bone levels (MBL) and MBL changes (MBLC) from implant placement to 5-year follow-up. Secondary endpoints included cumulative 5-year survival and success rates, soft tissue health, and esthetic parameters.
RESULTS: A total of 91 implants were placed in 77 patients. The mean MBL remained stable from the 1-year (- 0.79 ± 0.73 mm, n = 75) to 5-year (- 0.74 ± 0.87 mm, n = 65) follow-up. A marginal bone gain of 0.11 ± 0.83 mm was observed from the 1-year to 5-year follow-up. The cumulative 5-year survival rate was 96.5%, and the cumulative 5-year success rate was 93%. The clinical parameters, including the modified plaque index, modified sulcus bleeding index, Jemt\'s papilla index, and pink esthetic score improved throughout the 5-year study.
CONCLUSIONS: The study demonstrated that narrow-diameter implants represent a safe and predictable treatment option for subjects suitable for immediate loading and with limited bone volume or limited inter-dental space.
CONCLUSIONS: Narrow-diameter implants with immediate provisionalization can be considered for use to restore missing or damaged teeth with predictable functional and esthetic outcomes. This trial was registered with ClinicalTrials.gov (NCT02184845).