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

Abstract

Study Design A clinical randomized control trial. Objectives 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. Conclusion 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.