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混合牙弓夹板与 Erich 牙弓夹板在下颌骨骨折治疗中的疗效与安全性比较:一项随机临床试验

Comparison of Efficacy and Safety of Hybrid Arch Bar with Erich Arch Bar in the Management of Mandibular Fractures: A Randomized Clinical Trial.

作者信息

Sankar Hariram, Rai Sachin, Jolly Satnam S, Rattan Vidya

机构信息

Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Craniomaxillofac Trauma Reconstr. 2023 Jun;16(2):94-101. doi: 10.1177/19433875221080019. Epub 2022 Mar 29.

Abstract

STUDY DESIGN

A clinical randomized control trial.

OBJECTIVE

To compare the efficacy and safety of Hybrid arch bar (HAB) with Erich arch bar (EAB) in fracture management of the mandible.

METHODS

In this randomized clinical trial, 44 patients were divided into 2 groups:- Group 1, N = 23 (EAB group) and Group 2, N = 21 (HAB group). The primary outcome was time taken for the application of arch bar, while the inner and outer glove puncture, operator prick, oral hygiene, arch bar stability, complications of HAB, and cost comparison were secondary outcomes.

RESULTS

The time taken for the application of arch bar in group 2 was significantly shorter than group 1 (55.66 ± 17.869 min vs 82.04 ± 12.197 min) and the frequency of outer glove puncture was also significantly lesser for group 2 (0 punctures vs 9 punctures). Better oral hygiene was found in group 2. EAB was cost-effective than HAB (Rs 700 ± 239.79 vs Rs 1742.50 ± 257.14). The stability of the arch bar was comparable in both groups. Group 2 had associated complications of root injury in 2 out of 252 screws placed and the screw head got covered by soft tissue in 137 out of 252 screws placed.

CONCLUSIONS

Thus, HAB was better than EAB with a shorter time of application, less risk of prick injury, and improved oral hygiene.Clinical trial registry name- clinical trials registry- India, URL-http://ctri.nic.in, registration number- CTRI/2020/06/025966.

摘要

研究设计

一项临床随机对照试验。

目的

比较混合牙弓夹板(HAB)与埃里希牙弓夹板(EAB)在下颌骨骨折治疗中的疗效和安全性。

方法

在这项随机临床试验中,44例患者被分为两组:第1组,N = 23(EAB组);第2组,N = 21(HAB组)。主要结局指标是应用牙弓夹板所需的时间,而内、外手套穿刺、术者刺伤、口腔卫生、牙弓夹板稳定性、HAB的并发症以及成本比较为次要结局指标。

结果

第2组应用牙弓夹板所需的时间明显短于第1组(55.66 ± 17.869分钟对82.04 ± 12.197分钟),第2组外手套穿刺的频率也明显更低(0次穿刺对9次穿刺)。第2组的口腔卫生状况更好。EAB比HAB更具成本效益(700 ± 239.79卢比对1742.50 ± 257.14卢比)。两组牙弓夹板的稳定性相当。第2组在植入的252颗螺钉中有2颗出现牙根损伤相关并发症,在植入的252颗螺钉中有137颗螺钉的螺钉头被软组织覆盖。

结论

因此,HAB在应用时间更短、刺伤风险更低以及口腔卫生改善方面优于EAB。临床试验注册名称 - 印度临床试验注册中心,网址 - http://ctri.nic.in,注册号 - CTRI/2020/06/025966。

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