Does Benzocaine Toothpaste Have More Pain-Relieving Effect Compared To Placebo Toothpaste In Orthodontic Patients? A Double-Blind Randomized Controlled Trial

Background: Pain management in fixed orthodontic treatment is an important challenge. None of the present methods has been successful in pain relief. The objective of this double-blind cross-over trial was to compare the effect of benzocaine-contained toothpaste and placebo toothpaste on relieving pain caused by fixed orthodontic treatment. Methods: and material: Patients undergoing fixed orthodontic treatment at Shahid Beheshti University of Medical Sciences with experience of pain in previous appointment were randomly assigned into 3 groups of 5% benzocaine-contained toothpaste, placebo toothpaste and control group. Eligibility criteria included being in leveling and alignment stage, 6-8 mm space deficiency, no acute or chronic pain or frequent consumption of analgesic drugs. Patients were instructed to use toothpastes 3 times in a day. Main outcome was pain experienced by patients according to Visual Analogue Scale at 8 different time intervals in 7 days. Randomization was done with random numbers in opaque envelopes for sequence of appointments. Blinding was applicable for patients, operator and outcome assessor. Data analysis was done with repeated measure ANOVA for assessing overall effect and Bonferroni for pairwise analysis. P value was assigned to be 0.05. Results: : From 33 patients who participated in the study, 27 patients (23 females and 4 males) completed the study. Each patient was randomly allocated to all 3 groups in cross-over design. Mean pain in benzocaine group was less than the placebo and control group (28.63± 25.43, 31.31± 22.09 and 31.20 ± 24.09, respectively). Benzocaine toothpaste group experienced statistically significantly less pain than the other two groups at 2 hours (P˂ 0.015). No adverse event was observed in patients. Conclusion: Benzocaine contained toothpaste can decrease pain perceived at first hours after orthodontic appointment. Registration and protocol: This trial was registered in Iranian Registry of Clinical Trials (IRCT2015010120523N1) at 16/04/2015.