Objective

To report and discuss the lessons learned from the conduct of a clinical study on the associations between sleep bruxism and (peri-)implant complications, the protocol of which has been pre-published.

Materials and methods

A single-center, double-blind, prospective cohort study with a 2 year follow-up was performed in the Academic Centre for Dentistry Amsterdam (ACTA), The Netherlands. Eleven adult participants were included, where an inclusion of 98 was planned. Sleep bruxism was assessed by multiple single-channel electromyographic (EMG) recordings. Main outcomes were biological and technical complications. Results of the study are presented alongside with comments on encountered difficulties.

Results

Insufficient participant recruitment and failed EMG recordings were encountered. The small sample size did not allow answering the study’s main aim, and was mainly attributed to the study’s protocol complexity. EMG recording failures were attributed to insufficient quality of the EMG signal and detachments of the electrode.

Discussion

The lessons learned from the conduct of this study can be used to design successful future clinical studies.

Conclusions

Adequate participant recruitment, effective EMG recordings, and a careful selection of predictor variables are important ingredients for the successful conduct of a longitudinal clinical study on the association between sleep bruxism and (peri-)implant complications.

中文翻译：

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睡眠磨牙症和（周围）种植体并发症之间的关联：从临床研究中吸取的教训。

客观的

报告和讨论从一项关于睡眠磨牙症和（周围）种植体并发症之间关联的临床研究中获得的经验教训，该研究的方案已预先发布。

材料和方法

在荷兰阿姆斯特丹牙科学术中心 (ACTA) 进行了一项为期 2 年的单中心、双盲、前瞻性队列研究。包括 11 名成年参与者，其中计划包括 98 名。通过多个单通道肌电图 (EMG) 记录评估睡眠磨牙症。主要结果是生物学和技术并发症。研究结果与对遇到的困难的评论一起呈现。

结果

遇到参与者招募不足和 EMG 记录失败。小样本量无法回答研究的主要目的，主要归因于研究方案的复杂性。EMG 记录失败归因于 EMG 信号质量不足和电极脱落。

讨论

从本研究的实施中吸取的经验教训可用于设计成功的未来临床研究。

结论

充分的参与者招募、有效的 EMG 记录和仔细选择预测变量是成功开展关于睡眠磨牙症和（种植体周围）并发症之间关联的纵向临床研究的重要因素。