Abstract：
OBJECTIVE: To assess the anesthetic efficacy of articaine with the needle-free/Comfort-in™ method compared to the conventional needle method. To assess pain during anesthesia application, onset of anesthesia and patient`s self-reported quality of life-related to oral health after the dental emergency appointment.
METHODS: This parallel, randomized clinical trial was conducted by a single operator/dentist in the state of Maranhao, northeast of Brazil. Included participants were adult dental patients with one molar (maxillary) or premolar (maxillary or mandibular) tooth diagnosed with symptomatic irreversible pulpitis. The primary outcome was the anesthetic efficacy, measured using a combination of electrical and cold pulp tests (cold + EPT) and the Numerical Rating Scale (NRS). Secondary outcomes were pain during anesthesia application, onset of anesthesia, and patient`s quality-of-life (measured with the OHIP-14).
RESULTS: 62 patients were randomized in the anesthesia needle-free group and Comfort-in group (34.26 ± 10.786 × 33.29 ± 8.399 years old, respectively). The group of patients in the Comfort-in group had 71.0% success. Patients from the Comfort-in group reported statistically lower pain during the anesthesia application than patients from the conventional group (2.13 ± 2.172 × 6.03 ± 3.146 NRS scores, respectively) as well as immediately after the anesthetic procedure. Patients self-reported negative impact in quality of life was similar between groups before (p > 0.05) and after (p > 0.05) the dental emergency.
CONCLUSIONS: Comfort-in™ had similar efficacy to the conventional needle method.
CONCLUSIONS: This trial showed that it is possible to anesthetize patients with tooth pulpits without using needles to provide comfort mainly to anxious patients.
METHODS: This parallel, randomized clinical trial was conducted by a single operator/dentist in the state of Maranhao, northeast of Brazil. Included participants were adult dental patients with one molar (maxillary) or premolar (maxillary or mandibular) tooth diagnosed with symptomatic irreversible pulpitis. The primary outcome was the anesthetic efficacy, measured using a combination of electrical and cold pulp tests (cold + EPT) and the Numerical Rating Scale (NRS). Secondary outcomes were pain during anesthesia application, onset of anesthesia, and patient`s quality-of-life (measured with the OHIP-14).
RESULTS: 62 patients were randomized in the anesthesia needle-free group and Comfort-in group (34.26 ± 10.786 × 33.29 ± 8.399 years old, respectively). The group of patients in the Comfort-in group had 71.0% success. Patients from the Comfort-in group reported statistically lower pain during the anesthesia application than patients from the conventional group (2.13 ± 2.172 × 6.03 ± 3.146 NRS scores, respectively) as well as immediately after the anesthetic procedure. Patients self-reported negative impact in quality of life was similar between groups before (p > 0.05) and after (p > 0.05) the dental emergency.
CONCLUSIONS: Comfort-in™ had similar efficacy to the conventional needle method.
CONCLUSIONS: This trial showed that it is possible to anesthetize patients with tooth pulpits without using needles to provide comfort mainly to anxious patients.
摘要：
目的：评估无针/Comfort-in™方法与常规针法相比阿替卡因的麻醉效果。为了评估麻醉应用期间的疼痛，在牙科急诊预约后，麻醉开始和患者自我报告的与口腔健康相关的生活质量。
方法：这种并行，随机临床试验由Maranhao州的一名操作人员/牙医进行，巴西东北部。包括的参与者是成年牙科患者，其中一颗磨牙（上颌）或前磨牙（上颌或下颌）牙齿被诊断为有症状的不可逆性牙髓炎。主要结果是麻醉效果，使用电和冷纸浆测试(冷+EPT)和数值评级量表(NRS)的组合进行测量。次要结果是麻醉应用期间的疼痛，麻醉开始，和患者的生活质量（用OHIP-14测量）。
结果：62例患者随机分为无针麻醉组和舒适组（34.26±10.786×33.29±8.399岁，分别)。Comfort-in组的患者组成功率为71.0%。Comfort-in组患者在麻醉应用期间的疼痛在统计学上低于常规组患者（2.13±2.172×6.03±3.146NRS评分，分别）以及麻醉程序后立即进行。患者自我报告对生活质量的负面影响在牙科急诊之前（p>0.05）和之后（p>0.05）组间相似。
结论：Comfort-in™具有与常规针法相似的疗效。
结论：该试验表明，可以在不使用针头的情况下对牙髓坑患者进行麻醉，以主要为焦虑患者提供舒适感。
方法：这种并行，随机临床试验由Maranhao州的一名操作人员/牙医进行，巴西东北部。包括的参与者是成年牙科患者，其中一颗磨牙（上颌）或前磨牙（上颌或下颌）牙齿被诊断为有症状的不可逆性牙髓炎。主要结果是麻醉效果，使用电和冷纸浆测试(冷+EPT)和数值评级量表(NRS)的组合进行测量。次要结果是麻醉应用期间的疼痛，麻醉开始，和患者的生活质量（用OHIP-14测量）。
结果：62例患者随机分为无针麻醉组和舒适组（34.26±10.786×33.29±8.399岁，分别)。Comfort-in组的患者组成功率为71.0%。Comfort-in组患者在麻醉应用期间的疼痛在统计学上低于常规组患者（2.13±2.172×6.03±3.146NRS评分，分别）以及麻醉程序后立即进行。患者自我报告对生活质量的负面影响在牙科急诊之前（p>0.05）和之后（p>0.05）组间相似。
结论：Comfort-in™具有与常规针法相似的疗效。
结论：该试验表明，可以在不使用针头的情况下对牙髓坑患者进行麻醉，以主要为焦虑患者提供舒适感。
