Objectives/Aims:

To describe the protocol of a prospective cohort study designed to answer the question: ‘Is sleep bruxism a risk factor for (peri-)implant complications?’.

Materials and Methods:

Our study is a single-centre, double-blind, prospective cohort study with a follow-up time of 2 years. Ninety-eight participants fulfilling inclusion criteria (planned treatment with implant-supported fixed suprastructure(s) and age 18 years or older) will be included. Sleep bruxism will be monitored at several time points as masticatory muscle activity during sleep by means of a portable single-channel electromyographic device. Our main outcomes are biological complications (i.e., related to peri-implant bleeding, probing depth, marginal bone height, quality of submucosal biofilm and loss of osseointegration) and technical complications (i.e., suprastructure, abutment, implant body or other).

Results:

The study is currently ongoing, and data are being gathered.

Discussion:

The results of this prospective cohort study will provide important information for clinicians treating bruxing patients with dental implants. Furthermore, it will contribute to the body of evidence related to the behaviour of dental implants and their complications under conditions of high mechanical loadings that result from sleep bruxism activity.

Conclusion:

The protocol of a prospective cohort study designed to investigate possible associations between sleep bruxism and (peri-) implant complications was presented.

中文翻译：

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睡眠磨牙症与（围）种植体并发症之间的关联：一项前瞻性队列研究

目标/目的：

描述一项旨在回答以下问题的前瞻性队列研究方案：“睡眠磨牙症是（种植体周围）并发症的危险因素吗？”。

材料和方法：

我们的研究是一项单中心、双盲、前瞻性队列研究，随访时间为 2 年。将包括 98 名符合纳入标准（计划使用种植体支持的固定上部结构进行治疗且年龄在 18 岁或以上）的参与者。睡眠磨牙症将通过便携式单通道肌电图设备在睡眠期间作为咀嚼肌活动的几个时间点进行监测。我们的主要结局是生物学并发症（即与种植体周围出血、探诊深度、边缘骨高度、黏膜下生物膜质量和骨结合丧失有关）和技术并发症（即上部结构、基台、种植体或其他）。

结果：

该研究目前正在进行中，正在收集数据。

讨论：

这项前瞻性队列研究的结果将为临床医生使用种植牙治疗磨牙患者提供重要信息。此外，它将有助于提供与牙种植体在睡眠磨牙症活动导致的高机械负荷条件下的行为及其并发症相关的证据。

结论：

提出了一项旨在调查睡眠磨牙症和（围）种植体并发症之间可能关联的前瞻性队列研究方案。