Randomized Clinical Trial
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. May 20, 2021; 11(3): 88-94
Published online May 20, 2021. doi: 10.5662/wjm.v11.i3.88
Comparison of lag screws and double Y-shaped miniplates in the fixation of anterior mandibular fractures
Lydia Melek
Lydia Melek, Department of Oral and Maxillofacial Surgery, Alexandria University, Alexandria 21411, Egypt
Author contributions: Melek L solely contributed to the design of the study, implementation of the clinical trial, writing and revision of the manuscript.
Institutional review board statement: This study was approved by the Institutional Review Board (IRB) of the Faculty of Dentistry, Alexandria University, Egypt, and the protocols used in the study were approved by the Research Ethics Committee. Human Subjects Review: Approval Number: IRB 00010556-IORG 0008839 Board Name: Research Ethics Committee, Alexandria Faculty of Dentistry Board Affiliation: Faculty of Dentistry, Alexandria University, Egypt Phone: (+203) 4812201.
Clinical trial registration statement: The study was registered on clinicaltrials.gov (ClinicalTrials.gov ID: NCT04396054).
Informed consent statement: A written informed consent was signed by each patient before the operation.
Conflict-of-interest statement: The author declares no conflict of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The guidelines of the CONSORT 2010 statement have been adopted.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Lydia Melek, PhD, Associate Professor, Department of Oral and Maxillofacial Surgery, Alexandria University, Champolion Street, Alexandria 21411, Egypt. lydia.nabil@dent.alex.edu.eg
Received: October 13, 2020
Peer-review started: October 13, 2020
First decision: December 21, 2020
Revised: January 2, 2021
Accepted: March 11, 2021
Article in press: March 11, 2021
Published online: May 20, 2021
Processing time: 210 Days and 14 Hours
Abstract
BACKGROUND

Mandibular fractures constitute about 80.79% of maxillofacial injuries in Alexandria University, either as isolated mandibular fractures or as a part of panfacial fractures. The combination of symphyseal and parasymphyseal fractures represent 47.09% of the total mandibular fractures.

AIM

To compare the effectiveness of lag screws vs double Y-shaped miniplates in the fixation of anterior mandibular fractures.

METHODS

This study is a prospective randomized controlled clinical trial, performed on sixteen patients with anterior mandibular fractures. Patients were divided equally into two groups, each consisting of eight patients. Group 1: Underwent open reduction and internal fixation using two lag screws. Group 2: Underwent open reduction and internal fixation using double Y-shaped plates. The following parameters were assessed: operating time in minutes, pain using a visual analog scale, edema, surgical wound healing for signs and symptoms of infection, occlusion status and stability, maximal mouth opening, and sensory nerve function. Cone beam computed tomography was performed at 3 and 6 mo to measure bone density and assess the progression of fracture healing.

RESULTS

The study included 13 males (81.3%) and 3 females (18.8%) aged 26 to 45 years (mean age was 35.69 ± 6.01 years). The cause of trauma was road traffic accidents in 10 patients (62.5%), interpersonal violence in 3 patients (18.8%) and other causes in 3 patients (18.8%). The fractures comprised 10 parasymphyseal fractures (62.5%) and 6 symphyseal fractures (37.5%). The values of all parameters were comparable in both groups with no statistically significant difference except for the mean bone density at 3 mo postoperatively which was 946.38 ± 66.29 in group 1 and 830.36 ± 95.53 in group 2 (P = 0.015).

CONCLUSION

Both lag screws and double Y-shaped miniplates provide favorable means of fixation for mandibular fractures in the anterior region. Fractures fixed with lag screws show greater mean bone density at 3 mo post-operation, indicative of higher primary stability and faster early bone healing. Further studies with larger sample sizes are required to verify these conclusions.

Keywords: Anterior mandibular fractures; Symphyseal fracture; Parasymphyseal fracture; Miniplates; Lag screws; Double Y-shaped plates

Core Tip: The aim of this study is to compare the effectiveness of lag screws vs double Y-shaped miniplates in the fixation of anterior mandibular fractures in terms of fracture stability and progression of bone healing.