Effect of a bite wafer on pain relief after self-ligating orthodontic fixed appliance placement in adolescents: a single center randomized controlled trial.

Abstract
Introduction: The most common treatment proposed to relieve pain and discomfort stemming from the orthodontic treatment is NSAIDs. Non-pharmacological approaches, such as chewing a bite wafer (BW), have emerged to manage orthodontic pain to avoid side effects of ibuprofen or paracetamol in adolescents.
Aim: To compare efficiency between a bite wafer chewing group and a control group to relieve orthodontic pain after the placement of a self-ligating fixed appliance in adolescents.
Material and methods: The present randomized controlled trial included 33 teenagers who needed a self-ligating bimaxillary fixed orthodontic appliance. The patients were randomly allocated either to a test group encouraged to first chew on a BW to relieve the pain and then use paracetamol according to need, or to a control group authorized to consumed paracetamol only. The BW group was hypothesized to be non-inferior to the control group with a margin of 250 mg (one tablet). Data were collected at eight times over a seven-day period. For both groups, pain during four oral functions was assessed at each time point through the use of a numerical analog scale. The impact of orthodontic appliance on eating habits and functional limitations was evaluated at the end of the study period.
Results: At each time point, no statistically significant difference was observed between the two groups for the paracetamol consumption and the pain reported while the four oral functions. Total average consumption of paracetamol over seven days was lower in the test group (1000 ± 954 mg vs 1150 ± 844 mg) but non-inferiority of BW compared to paracetamol only could not be statistically demonstrated. The test group used BW on average 5.6 ± 8.9 times and 12.8 ± 12.4 minutes during the seven days.
Conclusion: No significant difference in consumption of paracetamol was seen between the bite wafer and paracetamol group.