Abstract
Objectives: This study aimed to compare the efficacy of a needle-free system (MadaJet(®)XL) and the conventional injection technique for primary maxillary molar local anesthesia before restorative procedures in 6 to 12-year-old patients. Materials and Methods: This cross-over randomized clinical trial was conducted on 30 children requiring restoration of at least two primary maxillary molars. The two molars requiring restoration in each patient were randomized using quaternary random blocks to receive either local anesthesia with MadaJet(®)XL or the conventional injection technique. To assess the efficacy of the techniques, pain score during injection was recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, and the number of patients with failed local anesthesia after MadaJet(®)XL administration was reported. The Wilcoxon Signed Ranks test was employed for data analysis (alpha=0.05). Results: The highest score was reported with the conventional injection technique (FLACC score=9). The mean pain score was 4.1±2.6 in the conventional group and 2.3±1.3 in the MadaJet(®)XL group. The Wilcoxon Signed Ranks test showed significantly higher pain score in the conventional injection technique than the MadaJet(®)XL (P<0.001). Re-injection was performed for 19 patients (63.3%) due to their discomfort during dental procedure when MadaJet(®)XL was used. Conclusion: Despite the lower level of pain and discomfort experienced during local anesthesia administration by MadaJet(®)XL, this device is not suitable for restorative procedures of primary maxillary molars, due to failure to achieve complete anesthesia.