评估儿童对SoftClamp™作为金属橡皮障夹替代品的疼痛反应：一项随机临床试验。

Evaluation of pain response in children to the SoftClamp™ as an alternative to the metal rubber dam clamp: A randomized clinical trial.

作者信息

Pottammal Namitha, Rao Ashwin, Natarajan Srikant, Karuna Y M, Nayak Anupama P, Rao Shweta

机构信息

Department of Pediatric and Preventive Dentistry Manipal College of Dental Sciences Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.

Department of Oral Pathology and Microbiology, Manipal College of Dental Sciences Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.

出版信息

Dent Res J (Isfahan). 2023 Feb 14;20:21. doi: 10.4103/1735-3327.369623. eCollection 2023.

DOI:10.4103/1735-3327.369623

PMID:36960019

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10028576/

Abstract

BACKGROUND

The use of a rubber dam is more important than ever in today's COVID-19 era to limit cross infections. In children, the placement of the metal clamp to retain the rubber dam is perceived to be painful and often requiring a local anesthetic injection. This dissuades many clinicians from placing the rubber dam. Hence, this study evaluated the pain response of children to a SoftClamp™ compared to the conventional metal clamp.

MATERIALS AND METHODS

This was a randomized controlled, equal allocation ratio, split-mouth clinical trial. Forty-two children aged between 8 and 12 years, having two permanent mandibular molars in need of sealants, were divided into Groups A and B (metal clamp and SoftClamp™, respectively). The pain response was recorded using both an objective and a subjective scale i.e., the Faces Legs Activity Cry Consolability (FLACC) scale and the Wong Baker Faces Pain Rating Scale (WBFPRS). The level of significance was set at 5% ( < 0.05). The pain response recorded from the WBFPRS and the FLACC scale for the metal and the SoftClamp™ were analyzed using the Wilcoxon signed rank test. The difference in pain response between genders and between two age groups (below and above 10 years of age) was analyzed using the Mann-Whitney -test.

RESULTS

The children reported mild discomfort to clamp placement in both the scales. The values for the FLACC and WBFPRS scores comparing the pain response to the metal and SoftClamp™ were 0.311 and 0.149, respectively.

CONCLUSION

There was no significant difference in the pain response of children to both the clamps. Good rubber dam application practices in children through the use of behavior guidance and a proper topical anesthesia technique may play a far more important role regardless of the clamp used. But the SoftClamp™, with its more child friendly appearance could be a viable alternative to the metal clamp in children.

摘要

背景

在当今新冠疫情时代，使用橡皮障对于限制交叉感染比以往任何时候都更为重要。在儿童中，放置用于固定橡皮障的金属夹被认为很疼，通常需要局部麻醉注射。这使得许多临床医生不愿放置橡皮障。因此，本研究评估了与传统金属夹相比，儿童对SoftClamp™的疼痛反应。

材料与方法

这是一项随机对照、分配比例相等的双侧临床试验。42名年龄在8至12岁之间、有两颗需要进行窝沟封闭的下颌恒磨牙的儿童被分为A组和B组（分别使用金属夹和SoftClamp™）。使用客观和主观量表记录疼痛反应，即面部、腿部、活动、哭泣、可安慰性（FLACC）量表和王-贝克面部疼痛评分量表（WBFPRS）。显著性水平设定为5%（<0.05）。使用Wilcoxon符号秩检验分析金属夹和SoftClamp™在WBFPRS和FLACC量表上记录的疼痛反应。使用Mann-Whitney检验分析性别之间以及两个年龄组（10岁及以下和以上）之间疼痛反应的差异。