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

单颗牙种植体保留下颌全口义齿 - 加载方案的影响

• 批准号: 198806387
• 负责人: Professor Dr. Matthias Kern
• 金额: --
• 依托单位: Poliklinik für Zahnärztliche Prothetik
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2012
• 资助国家: 德国
• 起止时间: 2011-12-31 至 2021-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/198806387?language=en
• 关键词: Single; dental; implant; retained; mandibular

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).

在德国，65 至 74 岁年龄组中有 30.5% 的上颌和/或下颌无牙颌无牙颌患者经常抱怨功能缺陷，尤其是下颌全口义齿，导致生活质量下降和咀嚼功能下降。当插入牙种植体以保留下颌全口义齿时，这两种情况都可以得到极大的改善。事实证明，使用单个正中种植体可以达到与使用两个种植体相当的效果。特别是关于患者的满意度和生活质量，但为了减少第二次手术后三个月装载种植体的费用和治疗时间，但是，在种植体植入后立即装载种植体将使第二次手术变得可有可无，并且可以改善义齿固位并提供良好的效果。目前仍缺乏关于无牙颌下颌直接加载单下颌种植体存活率的长期数据，目前的前瞻性多中心随机临床试验的目的是延长该试验。表明，当无牙颌下颌中使用一颗正中种植体来保留全口义齿时，立即负重不会影响种植体的成功。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产生可比较的效果。该研究纳入了 60 至 89 岁无种植体植入禁忌且现有全口义齿的无牙颌患者 (n=158)。保留了现有的带球附着体的全口义齿，种植体在种植体植入后直接加载（实验组），或在第二阶段手术三个月的埋入式愈合后加载（对照组）。

项目成果

The single mandibular implant study - Short-term effects of the loading protocol on Oral Health-related Quality of Life.

单个下颌种植体研究 - 装载方案对口腔健康相关生活质量的短期影响

• DOI: 10.1016/j.jpor.2017.12.003
• 发表时间: 2018
• 期刊: Journal of prosthodontic research
• 影响因子: 3.6
• 作者: Schwindling;Raedel;Passia;Freitag-Wolf;Wolfart;Reissmann;Ismail;von Königsmark
• 通讯作者: von Königsmark

Pain and discomfort following immediate and delayed loading by overdentures in the single mandibular implant study (SMIS)

• DOI: 10.1007/s00784-016-1930-0
• 发表时间: 2017-03-01
• 期刊: CLINICAL ORAL INVESTIGATIONS
• 影响因子: 3.4
• 作者: Mundt, T.;Passia, N.;Kern, M.
• 通讯作者: Kern, M.

Single mandibular implant study - chewing efficiency - 5-year results from a randomized clinical trial using two different implant loading protocols.

单个下颌种植体研究 - 咀嚼效率 - 使用两种不同种植体装载方案的随机临床试验的 5 年结果

• DOI: 10.2186/jpr.jpr_d_21_00216
• 发表时间: 2022
• 期刊: Journal of prosthodontic research
• 影响因子: 3.6
• 作者: Passia;Behrendt;Fritzer;Luthardt;Maltzahn;Rädel;Reissmann;Schwindling;Wolfart
• 通讯作者: Wolfart