Single dental implant retained mandibular complete dentures - influence of the loading protocol

在德国，65岁至74岁年龄组中有30.5%的人上颌骨和/或下颌无牙。无牙颌患者经常抱怨巨大的功能缺陷，特别是下颌全口义齿，导致生活质量下降和咀嚼功能下降。当植入牙种植体以保留下颌全口义齿时，两者都可以得到极大的改善。研究表明，在患者满意度和生活质量方面，使用单个正中种植体的结果与使用两个植入物的结果相当，但在第二次手术后三个月加载植入物时，可以降低成本和治疗时间。然而，在种植后立即加载种植体将使第二次手术变得可有可无，并将改善义齿固位力，并立即为患者提供所有好处。关于直接加载的单个下颌种植体在无牙下颌骨中的存活率的长期数据仍然缺乏。这项要求延期的前瞻性多中心随机临床试验的目的是表明，当一个正中种植体在无牙下颌中用于保持全口义齿时，种植成功不会因即刻加载而受到影响。此外，这项试验的目的是证明生活质量、患者对义齿的满意度和咀嚼功能将导致类似的临床长期结果。158名年龄在60岁到89岁之间、没有种植禁忌症和现有全口义齿的无牙列患者被纳入研究。患者在下颌接受了一个正中种植体，保留了现有的带有球状附着体的全口义齿。种植体植入后直接加载(实验组)，或在二期手术后三个月埋藏愈合后加载(对照组)。

In Germany, 30.5% in the age group of 65 to 74 years are edentulous in the maxilla and/or mandible. Edentulous people often complain about great functional deficits especially with the mandibular complete denture resulting in a reduce quality of life and a reduced masticatory function. Both can be greatly improved when dental implants are inserted to retain mandibular complete dentures. Using a single median implant has been shown to result in comparable outcomes as using two implants especially regarding patients’ satisfaction and quality of life, but to reduce costs and treatment time when implants are loaded three months after a second surgery. However, loading the implant immediately after implant placement would make a second surgery dispensable and would improve denture retention and provide all benefits for the patient immediately. Long-term data on the survival rate of directly loaded single mandibular implants in the edentulous mandible are still missing. It is the aim of the present prospective multicenter randomized clinical trial, which is requested for a prolongation, to show, that implant success is not compromised by immediate loading when one median implant in the edentulous mandible is used to retain a complete denture. In addition the trial aims to show that quality of life, patients’ denture satisfaction and chewing function will result in comparable clinical long-term outcomes. Edentulous patients between 60 and 89 years without contraindication for implant placement and an existing complete denture were included in the study (n=158). Patients received one median implant in the mandible, which retains the existing complete denture with a ball attachment. The implant was either loaded directly after implant placement (experimental group) or after three months of submerged healing at second stage surgery (control group).