PMID- 32577305 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220425 IS - 2056-807X (Electronic) IS - 2056-807X (Linking) VI - 6 DP - 2020 TI - Associations between sleep bruxism and (peri-)implant complications: lessons learned from a clinical study. PG - 2 LID - 10.1038/s41405-020-0028-6 [doi] LID - 2 AB - 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. CI - (c) The Author(s) 2020. FAU - Thymi, Magdalini AU - Thymi M AUID- ORCID: 0000-0002-8544-6495 AD - Department of Orofacial Pain & Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. ISNI: 0000000084992262. GRID: grid.7177.6 FAU - Visscher, Corine M AU - Visscher CM AD - Department of Orofacial Pain & Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. ISNI: 0000000084992262. GRID: grid.7177.6 FAU - Wismeijer, Daniel AU - Wismeijer D AD - Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. ISNI: 0000 0001 0295 4797. GRID: grid.424087.d FAU - Lobbezoo, Frank AU - Lobbezoo F AD - Department of Orofacial Pain & Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. ISNI: 0000000084992262. GRID: grid.7177.6 LA - eng PT - Journal Article DEP - 20200130 PL - England TA - BDJ Open JT - BDJ open JID - 101709456 PMC - PMC7299950 OTO - NOTNLM OT - Dental equipment OT - Fixed prosthodontics OT - Peri-implantitis COIS- Competing interestsGrindCare is a trademark of Sunstar Suisse SA, which provided the EMG devices for the duration of the study. Sunstar Suisse SA is not involved in the design of this study, nor in the collection, analysis and interpretation of data, and writing of this manuscript. F.L. is a member of the Academic Advisory Board of Sunstar Suisse SA and has no financial interest in this company. Sunstar Suisse SA provided financial support for this study via a research grant to ACTA. M.T. is a PhD student at ACTA, whose salary is being provided through the abovementioned research grant. All other authors report no competing interests. EDAT- 2020/06/25 06:00 MHDA- 2020/06/25 06:01 PMCR- 2020/01/30 CRDT- 2020/06/25 06:00 PHST- 2019/08/28 00:00 [received] PHST- 2019/12/13 00:00 [revised] PHST- 2019/12/20 00:00 [accepted] PHST- 2020/06/25 06:00 [entrez] PHST- 2020/06/25 06:00 [pubmed] PHST- 2020/06/25 06:01 [medline] PHST- 2020/01/30 00:00 [pmc-release] AID - 28 [pii] AID - 10.1038/s41405-020-0028-6 [doi] PST - epublish SO - BDJ Open. 2020 Jan 30;6:2. doi: 10.1038/s41405-020-0028-6. eCollection 2020.