A Randomized Clinical Trial Evaluating Rubber Dam Clamp Pain Reduction from a New Topical Liposomal Anesthetic Gel.

Abstract

PURPOSE: Discomfort during rubber dam clamp often occurs in pediatric dentistry. The purpose of this randomized, triple-blind, clinical trial was to evaluate the effect of pain reduction using a new topical liposomal thermo-sensitive gel (TLTG) or a placebo gel during rubber dam clamp isolation for sealants in children. METHODS: Eighty-one children (eight to 12 years old) had LTSG or the placebo gel with random assignment placed around the gingival tissue of their permanent mandibular first molars. A clamp was placed after two minutes on the teeth, and intensity of pain was registered using a Wong-Baker FACES scale and an 11-point numerical scale. The data were evaluated using McNemar's test and Wilcoxon signed rank test. RESULTS: The odds ratio for pain (OR equals 0.7; 95 percent confidence interval equals 0.3 to 1.8) was not statistically significant (P=0.52). However, there was a small difference in the pain intensity between liposomal and placebo groups for both scales (P<0.05). CONCLUSION: The liposomal thermo-sensitive anesthetic gel may reduce, to a small extent, the pain intensity in children submitted to rubber dam isolation before resin sealant placement.