Abstract
ObjectiveTo 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 methodsA 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.ResultsInsufficient 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.DiscussionThe lessons learned from the conduct of this study can be used to design successful future clinical studies.ConclusionsAdequate 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.
Highlights
Bruxism, either sleep or awake, can be a significant source of overload for dental implants
Systematic reviews have shown a positive association between bruxism and implant failures.[2,3,4]
As pointed out in these reviews, the results need to be taken with great caution, since the reviewed studies suffer from poor bruxism definitions and a lack of objective methods to diagnose bruxism.[2,3,4]
Summary
Either sleep or awake, can be a significant source of overload for dental implants. Its association with (peri-) implant complications is already hypothesized for a long period of time.[1] The body of literature on this topic has been growing steadily in the past few years. Systematic reviews have shown a positive association between bruxism and implant failures.[2,3,4] as pointed out in these reviews, the results need to be taken with great caution, since the reviewed studies suffer from poor bruxism definitions and a lack of objective methods to diagnose bruxism.[2,3,4] More recently, a prospective cohort study using an objective diagnostic method for sleep bruxism, i.e., single-night portable electromyography (EMG), found no relationship between high intensity of sleep bruxism and a higher risk of complications in patients with implant-supported fixed complete dentures.[5]
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