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

在德国，年龄在65至74岁的人群中，有30.5%的人在上颌骨和/或下颌骨无牙。无牙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。当植入种植体以保留下颌全口义齿时，两者都可以大大改善。使用单个中位种植体的结果与使用两个种植体的结果相当，特别是在患者满意度和生活质量方面，但在第二次手术后三个月加载种植体可以减少成本和治疗时间。然而，在种植体放置后立即装载种植体将使第二次手术变得不必要，并且可以改善义齿固位并立即为患者提供所有益处。无牙下颌骨直接加载单牙种植体成活率的长期数据仍然缺乏。这是本前瞻性多中心随机临床试验的目的，该试验要求延长，以表明，当在无牙下颌骨使用一个中位种植体来保留全口义齿时，种植体的成功并不会因立即加载而受到影响。此外，该试验旨在表明生活质量，患者的义齿满意度和咀嚼功能将导致可比的临床长期结果。无牙患者年龄在60 - 89岁之间，无种植禁忌症，并且使用了全口义齿（n=158）。患者接受下颌正中种植，保留现有的全口义齿球附着体。在种植体放置后直接加载种植体（实验组）或在第二期手术中浸泡愈合三个月后加载种植体（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).