Optimal frequency of tooth brushing in mechanically ventilated adults: Study protocol for a randomized controlled trial.

The optimal frequency of tooth brushing in the critically ill has not been experimentally determined. For mechanically ventilated patients, optimal frequency of tooth brushing is an important unresolved issue as there is little evidence to judge the benefits or associated risks of tooth brushing. Given this knowledge gap, the project's overall goal is to determine the optimal frequency of tooth brushing (once, twice, or three times daily) for mechanically ventilated adults. A prospective, randomized, experimental design is used. Specifically, 345 subjects, with 207 expected to complete the study, are randomly assigned within 36 hr of intubation to one of three groups (once, twice, or three times tooth brushing daily). Tooth brushing with a soft compact-head toothbrush takes approximately 2 min. Dental plaque assessment, gingival crevicular fluid (GCF) determination for IL-1beta, and data regarding healthcare-acquired infection (HAI) and clinical status are collected at baseline and daily in-hospital. The clinical impact of daily frequency of tooth brushing in relation to extent of dental plaque and inflammation reflected by GCF analysis will be compared by the three treatment arms. In addition, evaluation of safety for HAIs will be compared based on calculation of the number needed to harm. The trial will empirically determine the optimal frequency of tooth brushing in mechanically ventilated adults, balancing benefits and risks. This contribution is significant because it will have immediate impact on bedside nursing practice, and is a final component necessary for specific evidence-based guidelines for the common nursing intervention of oral care in mechanically ventilated adults.