Self-reported pain after buccal infiltration of articaine vs buccal and palatal infiltration of lidocaine for maxillary primary molar extractions: A noninferiority randomized clinical trial.

IF 3.5 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE
Danielle Cristina Alves Rigo, Pablo Silveira Santos, Bárbara Suelen Moccelini, Aurélio de Oliveira Rocha, Julia Maldonado Garcia, Isabela Ramos, Carla Miranda Santana, Mariane Cardoso
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引用次数: 0

Abstract

Background: Effective pain control is essential in pediatric dental procedures to ensure cooperation and minimize psychological trauma. Although lidocaine is the reference standard, articaine has been proposed as a less invasive alternative due to its superior diffusion properties.

Methods: A randomized, single-blind, noninferiority clinical trial was conducted with 76 children aged 6 through 9 years requiring extraction of maxillary primary molars. Participants were allocated into 2 groups: single buccal infiltration with 4% articaine and conventional buccal and palatal infiltration with 2% lidocaine. The primary outcome was self-reported pain using a visual analog scale (ie, a 10-cm horizontal line where 0 represented no pain and 10 represented the most pain imaginable). Noninferiority was assessed with a predefined margin of 1.5 cm. Negative binomial regression was used to explore predictors of pain.

Results: Mean (SD) pain scores were significantly higher in the articaine group (4.18 [3.41] cm) than the lidocaine group (1.68 [2.71] cm; P < .001). The upper limit of the 95% CI (3.90 cm) exceeded the noninferiority margin, precluding confirmation of noninferiority (P = .919). Results of regression analysis showed that articaine was associated with 2.15 times higher pain scores (P = .008) and increased heart rate correlated with increased pain (P = .023).

Conclusions: Our findings do not support the use of buccal infiltration with 4% articaine only as a noninferior technique to conventional lidocaine infiltration with palatal injection in pediatric maxillary molar extractions.

Practical implications: Buccal infiltration with articaine only may not be sufficient to ensure adequate anesthesia for extraction of maxillary primary molars. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT05443009.

上颌第一磨牙拔牙时口腔浸润阿替卡因与口腔和腭浸润利多卡因的自我报告疼痛:一项非劣效性随机临床试验。
背景:有效的疼痛控制在儿童牙科手术中是必不可少的,以确保合作和减少心理创伤。虽然利多卡因是参考标准,但阿替卡因由于其优越的扩散特性而被认为是一种侵入性较小的替代方案。方法:采用随机、单盲、非劣效性临床试验,对76名6 ~ 9岁需要拔除上颌第一磨牙的儿童进行研究。参与者被分为两组:4%阿替卡因单口腔浸润组和2%利多卡因常规口腔和腭浸润组。主要结果是使用视觉模拟量表(即,一条10厘米的水平线,其中0代表无疼痛,10代表可想象的最大疼痛)自我报告的疼痛。非劣效性评估的预定裕度为1.5 cm。采用负二项回归探讨疼痛的预测因素。结果:阿替卡因组平均(SD)疼痛评分(4.18 [3.41]cm)明显高于利多卡因组(1.68 [2.71]cm, P < 0.001)。95% CI的上限(3.90 cm)超过了非劣效性界限,排除了非劣效性的确认(P = 0.919)。回归分析结果显示,阿替卡因组疼痛评分升高2.15倍(P = 0.008),心率升高与疼痛加重相关(P = 0.023)。结论:我们的研究结果不支持在儿童上颌磨牙拔牙中使用4%阿替卡因口腔浸润作为传统利多卡因口腔浸润注射的非劣技术。实际意义:仅用阿替卡因进行颊部浸润可能不足以保证上颌初生磨牙拔除时的足够麻醉。该临床试验已在ClinicalTrials.gov网站注册。注册号为NCT05443009。
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来源期刊
Journal of the American Dental Association
Journal of the American Dental Association 医学-牙科与口腔外科
CiteScore
5.30
自引率
10.30%
发文量
221
审稿时长
34 days
期刊介绍: There is not a single source or solution to help dentists in their quest for lifelong learning, improving dental practice, and dental well-being. JADA+, along with The Journal of the American Dental Association, is striving to do just that, bringing together practical content covering dentistry topics and procedures to help dentists—both general dentists and specialists—provide better patient care and improve oral health and well-being. This is a work in progress; as we add more content, covering more topics of interest, it will continue to expand, becoming an ever-more essential source of oral health knowledge.
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