Magdalini Thymi1, Corine M Visscher2, Daniel Wismeijer3, Frank Lobbezoo2. 1. Department of Orofacial Pain & Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. m.thymi@acta.nl. 2. Department of Orofacial Pain & Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. 3. Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Abstract
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.
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.