Should football players wear custom-fitted mouthguards? : Results from a group randomised controlled trial.

Objective: Head/orofacial (H/O) injuries are common in Australian rules football. Mouthguards are widely promoted to prevent these injuries, in spite of the lack of formal evidence for their effectiveness.Design: The Australian football injury prevention project was a cluster randomized controlled trial to evaluate the effectiveness of mouthguards for preventing H/O injuries in these players.Setting and subjects: Twenty three teams (301 players) were recruited from the largest community football league in Australia.Intervention: Teams were randomly allocated to either the MG: custom made mouthguard or C: control (usual mouthguard behaviours) study arm.Main outcome measures: All injuries, participation in training and games, and mouthguard use were monitored over the 2001 playing season. Injury rates were calculated as the number of injuries per 1000 person hours of playing time. Adjusted incidence rate ratios were obtained from Poisson regression models.Results: Players in both study arms wore mouthguards, though it is unlikely that many controls wore custom made ones. Wearing rates were higher during games than training. The overall rate of H/O injury was 2.7 injuries per 1000 exposure hours. The rate of H/O injury was higher during games than training. The adjusted H/O injury incidence rate ratio was 0.56 (95% CI 0.32 to 0.97) for MG versus C during games and training, combined.Conclusions: There was a significant protective effect of custom made mouthguards, relative to usual mouthguard use, during games. However, the control players still wore mouthguards throughout the majority of games and this could have diluted the effect.