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Efficacy of a new light-cured anesthetic gel for clamp placement before rubber dam isolation in children: A triple-blinded randomized controlled clinical trial

Abstract:

Purpose: To evaluate the efficacy of a new light-cured anesthetic gel for pain control associated with the clamp placement for rubber dam isolation in children. Methods: 82 children in need of sealant placement on the first permanent mandibular molars were selected to take part in this randomized, split-mouth, triple-blinded study. Before rubber dam placement, the light-cured anesthetic gel (test) or a placebo gel (control) was applied on the gingival margins of the molars. The hemi-arches were isolated with cotton rolls and the gels were applied; the anesthetic gel was light-cured. After 30 seconds, clamp #26 was positioned on tooth 36 or 46. If there was pain, the clamp was removed and rescue anesthesia was applied. The absolute risk and intensity of pain were registered using three scales: facial expression (Wong-Baker), observational (FLACC) and numerical (NRS). Data were analyzed by McNemar's test and Wilcoxon Signed Rank (a= 5%). Results: Differences were detected for the risk of pain between groups (P= 0.0002) and for the different intensity of pain scales used (P< 0.001) with positive results for the anesthetic gel.