一项评估新型局部脂质体麻醉凝胶减轻橡皮障夹疼痛效果的随机临床试验。
A Randomized Clinical Trial Evaluating Rubber Dam Clamp Pain Reduction from a New Topical Liposomal Anesthetic Gel.
作者信息
Wambier Letícia Maíra, de Geus Juliana Larocca, Boing Thaynara Faelly, Brancher João Armando, Chibinski Ana Cláudia, Wambier Denise Stadler, Farago Paulo Vitor, Loguercio Alessandro D, Reis Alessandra
机构信息
Professor, Departament of Dentistry, at the Positivo University Curitiba, Paraná, Brazil.
Professor, Department of Dentistry, Faculty Paulo Picanço, Fortaleza, Ceará, and Guairacá Faculty, Guarapuava, Paraná, Brazil.
出版信息
Pediatr Dent. 2018 May 15;40(3):190-194.
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.
目的
在儿童牙科治疗中，使用橡皮障夹时常常会出现不适。本随机、三盲临床试验的目的是评估在儿童使用橡皮障夹隔离以放置窝沟封闭剂时，新型局部脂质体热敏凝胶（TLTG）或安慰剂凝胶减轻疼痛的效果。
方法
81名8至12岁的儿童被随机分配，在下颌第一恒磨牙的牙龈组织周围涂抹LTSG或安慰剂凝胶。两分钟后在牙齿上放置夹子，并使用面部表情疼痛量表（Wong-Baker FACES scale）和11点数字量表记录疼痛强度。数据采用McNemar检验和Wilcoxon符号秩检验进行评估。
结果
疼痛的优势比（OR = 0.7；95%置信区间为0.3至1.8）无统计学意义（P = 0.52）。然而，在两种量表上，脂质体组和安慰剂组的疼痛强度存在微小差异（P < 0.05）。
结论
脂质体热敏麻醉凝胶在一定程度上可减轻儿童在树脂窝沟封闭剂放置前接受橡皮障隔离时的疼痛强度。
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