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To compare the effectiveness of the WIPSS mouth guard to other currently used mouth guards in the prevention of concussion injuries in athletes participating in varsity football and rugby.Multicenter, cluster-randomized, controlled trial comparing the WIPSS Brain-Pad mouth guard against the standard use mouth guard of choice. Teams were monitored by their respective athletic therapist, trainer, or sports physician for 1 playing season to diagnose and record incident concussion injuries and dental trauma. Concussion symptoms were also recorded at the time of injury.Five Ontario universities.University male football (394) and university male (129) and female (123) rugby athletes reporting to 2003 fall training camps.The primary end point was the incidence of any diagnosed concussion events during the 2003 playing season as defined by the American Academy of Neurology Concussion Guidelines. Secondary endpoints included the incidence of dental trauma events and observed concussion symptoms.There was no significant difference in the number of concussions observed between the intervention and control arms of this trial (P = 0.79; odds ratio, 1.06, in favor of controls; 95% CI, 0.51, ≪1.61). No dental trauma events occurred. The 5 most common symptoms experienced by concussed athletes were dizziness, general headache, nausea, loss of visual focus, and personality changes.In this study, concussion rates were not significantly different for varsity football and rugby players who wore the WIPSS Brain-Pad mouth guard compared with other types of mouth guards.