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 Table of Contents  
Year : 2021  |  Volume : 54  |  Issue : 2  |  Page : 61-65

A comparative study evaluating the efficacy of 2.0-mm mini locking plate and 2.0-mm three-dimensional locking miniplates in mandibular angle fractures

1 Department of Oral and Maxillofacial Surgery, Indira Gandhi Institute of Dental Sciences, Puducherry, India
2 Department of OMFS, Sri Venkateshwara Dental College, Puducherry, India

Date of Submission26-Mar-2020
Date of Decision02-Jun-2020
Date of Acceptance06-Oct-2020
Date of Web Publication20-Mar-2021

Correspondence Address:
Deepika Subramaniyan
23/26, Akila Nagar 3rd Street Mambalasalai T.V Kovil (P.O), Trichy - 620 005, Tamil Nadu
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/fjs.fjs_36_20

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Background: Three-dimensional (3D) mini locking plates not only provide stability due to their unique double-lead thread structure but also cause minimal interference with the underlying vasculature. However, there are not much data available regarding the application of 3D miniplates as a treatment modality for mandibular angle fracture. Therefore, this study was designed to gauge and compare the efficacy of 2.0-mm mini locking plates and 2.0-mm 3D locking miniplates in mandibular angle fractures.
Materials and Methods: This comparative randomized study involved 34 mandibular angle fracture patients with randomly categorization into Group 1 (managed using 2.0-mm conventional mini locking plate) and Group 2 (managed using 3D miniplates). The parameters evaluated were occlusal stability, displacement of fracture, signs of inflammation as well as any hardware failure postoperatively. Analysis done was Chi-square test.
Results: The mean duration of operation was significantly less in Group 2 (P < 0.05). Normal healing was noted to be more in Group 2 than in Group 1, with no hardware failure observed in any of the groups. Postoperative occlusal stability was observed to be more satisfactory during the 3rd week of follow-up in Group 2 patients, which was statistically insignificant (P = 0.2).
Conclusion: 3D miniplates have emerged as a feasible treatment option in cases of mandibular angle fractures. This study reveals comparable results depicting the effectiveness of 3D titanium miniplates to standard titanium miniplates. However, further interventions are needed to arrive at more conclusive outcomes.

Keywords: Bone plates, inflammation, mandible, mandibular fractures, titanium

How to cite this article:
Subramaniyan D, Sathyanarayanan R, Suresh V, Subramaniyan M, Venugopalan, Guna TP. A comparative study evaluating the efficacy of 2.0-mm mini locking plate and 2.0-mm three-dimensional locking miniplates in mandibular angle fractures. Formos J Surg 2021;54:61-5

How to cite this URL:
Subramaniyan D, Sathyanarayanan R, Suresh V, Subramaniyan M, Venugopalan, Guna TP. A comparative study evaluating the efficacy of 2.0-mm mini locking plate and 2.0-mm three-dimensional locking miniplates in mandibular angle fractures. Formos J Surg [serial online] 2021 [cited 2021 Sep 24];54:61-5. Available from: https://www.e-fjs.org/text.asp?2021/54/2/61/311614

  Introduction Top

The mandibular angle is an innate anatomic segment of the mandible and is a part of the body and the vertical ramus. Mandibular angle fracture is a frequently encountered fracture occurring as a result of assault and road traffic accidents.[1] It can be categorized as favorable and unfavorable fractures. Favorable fracture is when the masseter and medial pterygoid muscle action helps to reduce the fracture segment, whereas a fracture is unfavorable when fragments of the bone are displaced by muscle forces. Thus, the treatment options are channelized considering the biomechanics such as a change in the curvature and masticatory muscle attachment observed in the angle.[2]

Intermaxillary fixation (IMF) is an age-old procedure which is used for the treatment of fractures involving maxillomandibular complex. Conventionally, various types of tooth-mounted devices such as arch bars, dental and interdental wiring, and metallic and nonmetallic splints are used to achieve IMF. Monocortical miniplate osteosynthesis for mandibular angle fracture is an extending over technique. The general rule for treating fractures of the mandibular angle does not differ from that for fractures anywhere in the body, which works primarily on the fundamental norm of repositioning and immobilization of the bony fragments.[3] The conventional bone plates/screws have been traditionally used since ages for fixing defects and fractures of the mandible. However, they are not without significant downsides such as lower border flaring and proximal border rotation resulting in loosening of screws, loss of stability, and interference with the underlying vascularity often leading to cortical bone necrosis, difficulty in adaptation, bulky plates, scar formation due to extraoral approach, and increased chances of nerve injury.[4] To overcome these potential hazards, three-dimensional (3D) mini locking plates with a change in size, shape, and number came into existence. This IMF technique is based on the principle of monocortical, juxta-alveolar, and subapical osteosynthesis without compression. It uses miniaturized malleable plates that not only prevent loosening of the screws but also control rotation in the angle fracture to resist shearing, bending, and torsional forces on the fracture segments. It has a unique double-lead thread that facilitates the growth of the periosteum under the plates by causing minimal interference in the vascular supply to the bone, thus supporting fracture healing leading to greater stability and less alteration in an occlusal relationship. The use of an intraoral approach, small size, easy adaptability, and placement has facilitated an increased use of monocortical plates in maxillofacial surgery.[5]

However, despite the obvious advantages, there is not much literature available substantiating the efficacy of these 3D mini locking plates. Therefore, this study was designed to gauge and compare the effectiveness of 2.0-mm 3D locking miniplates and 2.0-mm mini locking plates in mandibular angle fractures.

  Materials and Methods Top

Study design

This comparative randomized study was conducted in the Department of Oral and Maxillofacial Surgery from January 2015 to August 2016. Before the initiation of the study, informed consent from the study participants as well as ethical approval was attained from the Institutional Ethical Committee (IGIDSIEC2015 NDP03PGDSOMS).

The study involved 34 mandibular angle fracture patients of either gender in the age range of 18–70 years. Sample size calculation, based on the proportion of fracture stability, for locking miniplate was p1%–60% and that for 3D locking plate was p2%–90% as per Sehgal et al.[6] With the significance level (α) set at 0.05 and power at 80%, the sample size was calculated as 15 for each group. However, assuming a dropout rate of 10%, the sample size was recalculated as 17 for each group.

Patients with severely infected fractures, comminuted fractures, severely atrophied mandibles, and systemically medically compromised were omitted from the study.

A random categorization of patients was done into two groups through block randomization to avoid bias with 17 patients in each group. In Group 1, patients were treated with open reduction and internal fixation using a 2-mm, 4-hole titanium conventional miniplate (S. K. Surgicals, Pune, India) that was adapted and secured using 2 mm × 8 mm titanium screws (proposed by Spiessl). Group 2 patients were treated using a 2-mm, 6-hole 3D titanium miniplate (S. K. Surgicals, Pune, India) secured with 2 mm × 8 mm titanium screws dimensional locking (Farmand and Dupoirieux).[7]

Data collection

Demographic data including age of the participants were recorded. The clinical data collected from the patients included a detailed past medical and dental history omitting any underlying systemic conditions as well as the cause and type of injury. Patients were clinically assessed for laceration, swelling, tenderness, bony crepitus, step deformity, altered lip sensation, presence of infection, occlusal derangement, lingual and buccal sulci, and bimanual palpation of the mandible. Routine orthopantomograms to verify the presence of mandibular angle fracture and inferior border gapping were done for all patients.

Patients were posted for surgery under general anesthesia with all aseptic precautions and had been prescribed cefotaxime 2 g intravenous for 1 h as prophylactic antibiotic therapy twice a day for 5 days before the surgery.

IMF had to be done to achieve proper occlusion.[8],[9] Extraoral Risdon's submandibular incision was made, followed by identification of the fracture site and reduction. Osteosynthesis using either a 3D mini locking plate or a conventional 2.0-mm miniplate to achieve appropriate occlusion was done. Surgical wound closure was done in layers using 3-0 vicryl sutures.[10] The 3D locking plate was incorporated in a way such that the vertical bars were parallel and the horizontal bars were perpendicular to the fracture line whereas the two standard miniplates were placed according to Champy's principles of osteosynthesis. The ease of application of plates and the duration of the procedure were recorded. After the procedure, the surgical site was irrigated with 5% povidone-iodine, followed by normal saline. Patients were directed to maintain good oral hygiene and take only soft diet postoperatively for 6 weeks. A follow-up was scheduled on the 7th day, 3rd week, and 6th week [Figure 1] and [Figure 2].[11] The clinical parameters that were evaluated pre- and postoperatively were as follows:[11]
Figure 1: Intraoperative images. Group 1: (a) Risdon's submandibular incision; (b) Exposure of mandibular angle; (c) 2.0-mm noncompression locking miniplate

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Figure 2: Postoperative images: Group 1 orthopantomogram showing 2.0-mm locking miniplate mandible; Group 2 orthopantomogram showing 2.0-mm three-dimensional locking miniplate in the right angle of the mandible (white arrow)

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  1. Occlusion – Assessed with a Caliper between the upper and lower first molar and was categorized as:[12]

    1. Satisfactory – no gap
    2. Mild derangement – gap of 1–2 mm
    3. Deranged – gap of more than 2 mm.

  2. Inferior border gapping – Evaluated radiographically pre- and postoperatively as:[12]

    1. Nondisplaced
    2. Displaced <5 mm
    3. Severely displaced >5 mm.

  3. Surgical wound – Postoperatively, the wound was protected with dressing for 24–48 h and then examined for any signs of inflammation and infection.[12]
  4. Hardware failure while adapting the plate to the bone surface was also assessed.[12]

Statistical analysis

Data were analyzed using R version 3.5.1 software (R foundation, Vienna, Austria). The postoperative parameters such as occlusal stability, displacement of fracture, duration of procedure as well as potential complications were assessed using Chi-square test. P < 0.05 was considered statistically significant.

  Results Top

This study involved 17 patients each in Group 1 and Group 2 who had isolated mandibular angle fracture with an increased incidence of fracture noted in the 22–34 years' age range of patients. Road traffic accidents (58.8%) followed by assaults (23.5%), fall (14.7%), and other work-related causes (2.9%) were recorded as the frequent cause of injury.

Preoperative findings revealed a greater number of undisplaced fracture cases in Group 1 than in Group 2. Mildly deranged and deranged occlusal stability was observed to be more in Group 2 than in Group 1 [Table 1].
Table 1: Comparison of displacement of fracture fragments and occlusal stability (preoperative) between both groups

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Postoperative fracture stability was observed to be similar in both the groups. However, postoperative occlusal stability was observed to be more satisfactory in the 3rd week of follow-up in Group 2 patients, which was statistically insignificant [Table 2].
Table 2: Comparison of occlusal stability and fracture stability on the 7 th day, 3rd week, and 6th week (postoperatively) between both groups

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The mean duration of operation was significantly less in Group 2 (P < 0.05). No hardware failure was observed in either of the groups, with normal healing noted to be more in Group 2 than in Group 1 [Table 3].
Table 3: Comparison of other clinical parameters between Groups 1 and 2

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  Discussion Top

3D miniplates have emerged as a reliable treatment modality in situations of isolated mandibular angle fractures as they provide increased resistance to the torsional forces along the axis of the plate. Thus, the potential advantages of 3D miniplates over the conventional 2.0-mm miniplates are depicted through the results of this study.

In our study, the most noted cause of injury were the road traffic accidents, with maximum patients being in the age range of 22–34 years, which was in agreement with the study done by Sadhwani and Anchlia[13] who reported similar findings.

In this study, the preoperative findings depicted cases of displacement of fracture fragments and deranged occlusion to be more in Group 2 patients, which was in contrast to the outcomes of the study by Sehgal et al.[6] who reported 53% of the patients treated with 2.0-mm miniplates as having mildly deranged occlusion and gap between the fracture fragments. These differences in the findings could be attributed to the variation in the design and setting of the study.

In a study done by Mittal et al.,[14] one patient each (6.7%) had postoperative occlusion derangement which was noted at the 1st week of follow-up in Group A (treated with 3D miniplates) and Group B (treated with conventional locking plates). At the 2nd week of follow-up, one patient had occlusion derangement only in Group A. From the 3rd week of follow-up, all patients had intact occlusion. These findings were in slight contrast with the findings of this study that reported two patients (11.8%) in Group 1 as having mildly deranged occlusion and none in Group 2. The plausible reason for these variations could be attributed to different follow-up time periods.

Our results demonstrated that the duration of procedure was less with 3D miniplates, which was in accordance with the study done by Budhraja et al.[15] who reported that the placement of 3D locking plate required approximately 10.34 min less average operating time was required than that required for the placement of Champy's miniplate. The acceptable reason for it could be the easy acclimatization of these 3D miniplates to the bone as well as the concurrent steadiness at both the superior and inferior borders which makes the 3D locking plate a time-saving substitute to the conventional miniplates.

Malik and Singh[16] in their study had concluded that treatment of fractures of the mandibular angle with the conventional miniplates is often concomitant to impediments such as infection, mobility, and malocclusion. A similar study by Kumar et al.[17] reported an uneventful healing with the use of 3D miniplates in the fixation of the mandibular angle fracture. All these observations further substantiated the findings of this study.[18]

Thus, the 3D locking miniplate has all the advantages of standard miniplate fixation, i.e., superior fracture fragment stability and stable occlusion. With very less data available regarding the application of 3D locking miniplates in mandibular fracture management, the study observations further highlight the scope of this intervention.[19],[20],[21]

Our results demonstrated that the 3D locking miniplate has all the advantages of standard miniplate fixation, i.e., superior fracture fragment stability, stable occlusion, and earlier return to normal function, at the same time satisfying the biomechanical requirements for occlusal loading, while retaining its advantages such as short operating time and fewer complications.

This study, however, has a few potential limitations as well, which include small sample size, short follow-up time period, and no evaluation of the bite force on different fracture lines postoperatively. Another drawback of the study is the use of 2.0-mm mini locking plates as the traditional fixation method instead of a 2.4-mm locking plate which is better to provide the stability and bone union. Therefore, a large multicentric study with 2.4-mm locking plate with a longer follow-up duration and in-depth evaluation of bite forces on different fracture lines is needed to arrive at more conclusive findings.

  Conclusion Top

The quadrangle geometry of the 3D plate not only provides stability at the site of fracture but also offers good resistance against the torsional forces leading to diminished rates of infections and early restoration of mandibular functions postoperatively. Thus, for the management of mandibular angle fractures, 3D miniplates can be considered an efficient and reliable treatment modality which is also cost-effective.

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Conflicts of interest

There are no conflicts of interest.

  References Top

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  [Figure 1], [Figure 2]

  [Table 1], [Table 2], [Table 3]


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