Clroa 4 137
Clroa 4 137
Sci Forschen
Open HUB for Scientific Researc h ISSN 2469-6714 | Open Access
*
Corresponding author: Shail K Chaube, Cell Physiology Laboratory, Department of Zoology, Institute of Science, Banaras Hindu University,
Varanasi, Uttar Pradesh, India, Tel: 91-542-26702516; Fax: 91-542-2368174; E-mail: [email protected]
Introduction
Over the past three decades, there has been extensive
Citation: Kumar V, Gour S, Chaube RK, Chaube RK, Chaube SK, et development of techniques used in the management of cranio-
al. (2018) Comparative Efficacy and Adaptability of Bioresorbable
Plates with Titanium Miniplates in the Management of Mandibular
maxillofacial trauma. The most significant advancement
Fractures. Clin Res Open Access 4(2): dx.doi.org/10.16966/2469- related to the management of fractures of mandible is the use
6714.137 of metal plates and screws [1]. These advancements are based
Copyright: © 2018 Kumar V, et al. This is an open-access article on specific technical refinement in the rigid internal fixation
distributed under the terms of the Creative Commons Attribution methods [2]. The field of oral and maxillofacial surgery had
License, which permits unrestricted use, distribution, and undergone a sea of change from the closed reduction of facial
reproduction in any medium, provided the original author and source fractures to the non-rigid fixation using metallic wires [3], lag
are credited.
screws [4]. These changes were further replaced by rigid fixation
Abstract devices using dynamic compression (DCP) and eccentric
Majority of bioresorbable plates used today are produced from dynamic compression plates (EDCP) [5]. The evolution of
synthetic semicrystailine poly-4 and its co-polymers. Though the mini plate osteosynthesis had revolutionized the management
bioresorbable plates have been extensively used in orthognathic of facial injuries and had proved to be the right alternative to
surgery and midface trauma, the reports for their use in the
DCP and EDCP. The metallic mini plates and screws currently
mandibular fracture treatment are limited. Present study was
aimed to compare the efficacy of bioresorbable plates with titanium in use for cranio maxillofacial fracture, although provide
miniplates for the treatment of mandibular fractures. For this rigid internal bone fixation but have few drawbacks: (1) Once
purpose, 60 cases of fracture mandible were selected, out of which osteosynthesis is achieved, they are no longer needed and they
30 were treated with bioresorbable plates and other 30 with titanium may act as foreign body and create problems in future due to
miniplates. Follow up was done after 2, 4, 8, 12 weeks and then
every after 6 months. The patients were checked for pain, oedema,
stress-shielding effect [6], (2) they may cause under-lying bone
infection, occlusal derangement, suture dehiscence, paraesthesia, atrophy, [6] (3) interfere with computed tomography (CT) and
anesthesia, plate rejection, malunion, non-union and palpability of magnetic resonance imaging (MRI) [7], (4) palpability [8], (5)
plate. Data suggest that the bioresorbable plates are easily adapted sensitivity to the extremes of temperature of any oral-intake
and reduction of fracture segments was better than titanium
[8], (6) sometimes exposure of the plate requires removal and
miniplates. But it is weaker than the titanium plates and resulted in
cases of screw breakage, loosening of screw and decreased primary second surgery [6] and (7) Growth retardation and intracranial
stability of the fracture segments, thus requiring longer period of IMF. migration have also been documented with metal plates [9].
The bioresorbable plates exhibit negligible complications and good
handling properties. However, high cost of the material is the greatest The quest to overcome the drawbacks of metal plates,
deterrent for its wider use in treatment of mandibular fractures. researchers tried to develop the resorbable plates [10]. The
On the other hand, titanium plates have shown better stability of interest to this increased in 1980s when use of these materials
fractured fragments. in fixation of the mandibular osteotomy [11] and fracture
Keywords: Bioresorbable plates; Intermaxillary fixation; Mandibular [12] was proposed and performed using polydioxanone-PDS
fractures; screws and pins. The majority of bioresorbable plates used
today are produced from synthetic semicrystailine poly-4
(alfa-hydroxy acid) and its co-polymers [13]. Though the
bioresorbable plates have been extensively used in orthognathic (INION INC, Weston FL, USA). The plates were activated in
surgery and midface trauma, the reports for their use in the the water bath after which they remain contour able at room
mandibular fracture treatment are limited and few randomized temperature for few minutes. Plate contouring and adaptation
controlled trials are available [14-16]. The use of resorbable were carried out with digital pressure. Once the plate was
plates in mandibular fracture treatment appears very exciting adapted across the fracture line a screw hole was created by
as the subsequent hydrolysis of the plates would mean no extra using appropriate drill with constant irrigation. Then screw
hardware in the facial skeleton. The better evaluation of fracture threads were tapped manually (Figure 2). Once it reached the
healing as PLLA plates are radiolucent and would obviate the full depth and resistance was felt, tapping was stopped and
need for second surgery at a later date [10]. Therefore, present gently the tap unscrewed. The tapped holes were irrigated to
study was aimed to use the PLLA plates as well as titanium remove any bone chips and debris and plates were stabilized
plates in a randomized controlled trial setting to achieve the with minimum of two screws on either side of fracture line.
primary end point of bony union. The aim of internal fixation Routine postoperative care was followed.
of traumatic and iatrogenic skeletal fracture is to achieve Data collection was done at the immediate post-operative
undisturbed fracture healing. The need for plates and screws for period (within 72 hrs.) and at the end of 1,2,4,6 and 8 weeks.
fixation is only temporary, until the fracture has been united. These patients were checked for pain, oedema, infection,
Materials and Methods occlusal derangement, suture dehiscence, paresthesia,
anesthesia, plate rejection, malunion, non-union, palpability
A prospective randomized clinical study was conducted
of plate. Radiographically orthopantomogram (OPG) was
to compare the efficacy of resorbable fixation with titanium
done post operatively and on routine follow up, the fracture
miniplate fixation in fracture of mandible. For this purpose,
was accessed on its reduction, changes at the fracture line, sign
60 patients who sustained fracture of mandible were selected. of osteogenesis, visibility and osteolysis around the drill holes
These patients reported at the Oral and Maxillofacial Surgery in the case of bioresorbable group of patients. All percentage
Department of our Hospital during November 2013 to August data were subjected to arcsine square-root transformation
2016. The inclusion criteria were oblique fractures and straight before statistical analysis. Data are analyzed statistically using
fractures present on one or both cortex of mandible, fractures of
the symphysis, parasymphysis, body or angle region associated
or unassociated with subcondylar fractures and patients
with mandibular fracture who opted to have unrestricted
jaw movements. The exclusion criteria were refused consent,
pediatric patients, patients with associated midface fractures,
patients with major systemic diseases. The 54 patients were
male and only 6 cases of female patient were included. All
patients were informed about the study and their consent was
taken to use their information and records for this study, for
ethical guidelines fulfillment.
A detailed history of each patient was carefully recorded
and a thorough extra-oral as well as intra-oral examination of
each patient in good light and exposure was done at the time of
Figure 1: Bioresorbable screws and plates pre-sterilized and made
reporting to the department of oral and maxillofacial surgery. of polylactic acid, poly glycolic acid and poly dioxanone polymers.
Radiographic assessment was carried out in regards to the site,
direction of the fracture line and extent of displacement. Pre-
operative enrich arch bar or ivy loops were placed in maxillary
and mandibular arches and elastic traction or wires were
applied to bring fracture ends in reduced position and for inter
maxillary stabilization.
Patients were operated either under general anesthesia
or local anesthesia under strict aseptic conditions. Local
anesthesia with adrenaline was infiltrated at the site of incision
and a 1 to 1.5 cm Risdon’s incision was placed with 15 no. bard
parker (BP) blade and layer wise dissection was done to expose
the fractured segments, which was then reduced and firmly Figure 2: Resorbable plate fixations in mandibular fracture showing
maintained in proper position. The plates and screws (Figure 1) good adaptation of plates with contour of mandible and in ideal
were gamma sterilized and supplied in sterile double packing reduction position.
Citation: Kumar V, Gour S, Chaube RK, Chaube RK, Chaube SK, et al. (2018) Comparative Efficacy and Adaptability of Bioresorbable Plates with
Titanium Miniplates in the Management of Mandibular Fractures. Clin Res Open Access 4(2): dx.doi.org/10.16966/2469-6714.137 2
Sci Forschen
Open HUB for Scientific Researc h
Clinical Research: Open Access
Open Access Journal
SPSS version 16.0 software (SPSS Inc., Chi-cago, IL, USA). Table 1: Preoperative demographic data.
Differences between groups were examined and the significance Characteristic
Bioresorbable
Titanium plates P value
plates
value was set at p<0.05 level.
Sex
Results Male 28 (93.33%) 26 (86.67%) 0.389
Female 2 (6.67%) 4 (13.33%)
In the present study, maximum patients were males 90% Mechanism of injury
(54 patients), while 6 patients were female 10% (6 patients). RTA 25 (83.33%) 26 (86.67%) 0.717
The plates and screws (Figure 1) used were gamma sterilized Altercation 5 (16.67%) 4 (13.33%)
by the manufacturer and supplier in sterile double packing. In Concomitant fracture pattern
bioresorbable plate group, a good adaptation of the plate by Parasymphysis 15 (50%) 13 (43.33%)
Angle 11 (36.67%) 9 (30%) 0.435
digital pressure (Figure 2) was seen in all 30 patients (100%).
Subcondylar 4 (13.33%) 8 (26.67%)
However, titanium plate group was good only in 24 patients
(80%) and fair in 4 patients (13%). The different anatomical
locations of fractures revealed that parasymphysis is the most Table 2: Comparison of outcomes in bioresorbable group with titanium
group.
common site of fracture (28 patients, 46.6%), followed by angle
Bioresorbable Titanium
(20 patients, 33.33%) and subcondylar (12 patients, 20%) (Table Variability
plates plates
P value
1). Good reduction of fracture was achieved in all the 30 patients Good adaptation of plate 30 (100%) 24 (80%) 0.0098
of bioresorbable group (100%). However, in titanium group, a Good reduction of fracture
30 (100%) 24 (80%) 0.0098
good reduction was achieved in 24 patients (80%) and fair in 6 achieved
patients (20%). In bioresorbable plate group, a good primary Primary stability of fracture
25 (83%) 30 (100%) 0.010
achieved
stability was achieved in 25 patients (83%) intra operatively and
Screw breakage 15 (50%) 0 0.000
fair in 5 patients (17%). In titanium plate group, a good stability
Loosening of screw 6 (20%) 0 0.009
was achieved in all 30 patients (100%). Screw breakage intra
operatively was seen in 15 patients (50%) of bioresorbable group
due to its innate property and weakness as compare to titanium Table 3: Comparison of post-operative criterias in bioresorbable group
and titanium group.
screws. Loosening of screw intra operatively was noticed in 6
patients (20%) of bioresorbable group, while no loosening of Bioresorbable Titanium
Variability P value
plates plates
screw was encountered in the titanium group (Table 2). 1 13 (43.33%) 13 (43.33%)
Pain present in
Post-operative pain and oedema were present in both the 2 17 (56.67%) 11 (36.67%) 0.0262
Days
groups. In 6 patients of titanium group, post-operative pain 7 0 (0%) 6 (20%)
1 13 (43.33%) 13 (43.33%)
and oedema persisted for almost 1 week with signs of infection. Oedema
2 17 (56.67%) 11 (36.67%) 0.0262
In bioresorbable group, inter maxillary fixation (IMF) was kept present in days
5 0 (0%) 6 (20%)
for 4 weeks due its less ability to counter muscle and occlusal 2 0 (0%) 24 (80%)
Duration of IMF
forces except in 8 patients where it was kept for 5 weeks because 4 22 (73.33%) 06 (20%) 0
in weeks
a proper reduction and stability of fracture segments was not 5 8 (26.67%) 0 (0%)
achieved intra operatively. In titanium group, IMF was kept for Rejection of No 30 (100%) 24 (80%)
0.009
plate Yes 0 (0%) 6 (20%)
2 weeks except in 6 patients where it was kept for 4 weeks. Due
Palpability of No 30 (100%) 24 (80%)
to the presence of infection and plate rejection, the plate was plate Yes 0 (0%) 6 (20%)
0.009
removed from this patient. Rejection and palpability of plates
was observed only in 6 patients in titanium group (Table 3). Table 4: Visibility of fracture line on OPG in bioresorbable and titanium
In radiographic observations (OPG) was carried out study groups.
immediate post operatively and routine follow up and apart Bioresorbable Titanium
Variability P value
plates plates
from fracture reduction the fracture line was evaluated on
Visibility of fracture line Good 30 (100%) 0 (0%) 0
various parameters such as deviation, disastasis, no change,
sign of osteogenesis etc. The level of lower border of mandible
was accessed. In the bioresorbable group, osteolysis around the for the fracture fixation should be rigid and biocompatible.
drilled holes was checked in follow up OPG’s. Most importantly It should have mechanical properties similar to that of bone
visibility of fracture line was evaluated in both the groups, and permit osseous union through primary bone healing.
showing good visibility in the bioresorbable group as compare Although the metallic plates satisfy most of the criteria, there
to the titanium where it was fair (Table 4). are a plethora of problems associated with their use. One of
the common problems encountered with retaining metallic
Discussion plates in craniofacial region is interference with the imaging
Rigid plate and screw fixation is the mainstay of treatment techniques such as CT and MRI scans causing artifacts [17].
for complex fractures of the facial skeleton. The ideal implant Apart from these complications like corrosion, electrolysis,
Citation: Kumar V, Gour S, Chaube RK, Chaube RK, Chaube SK, et al. (2018) Comparative Efficacy and Adaptability of Bioresorbable Plates with
Titanium Miniplates in the Management of Mandibular Fractures. Clin Res Open Access 4(2): dx.doi.org/10.16966/2469-6714.137 3
Sci Forschen
Open HUB for Scientific Researc h
Clinical Research: Open Access
Open Access Journal
hypersensitive and even carcinogenic potential have been metal plate and screw after bone healing. If not removed, the
reported. In an attempt to overcome these problems, there metal implants may be painful and irritating. Post operatively
was a spur of interest in the development of bioresorbable and on routine follow up at 2, 4, 8, 12 weeks and then every after
osteofixation materials [18]. 6 months, patients were checked for pain, oedema, infection,
Kulkarni and his group (1966) applied bioresorbable plates occlusal derangement, suture dehiscenece, paraesthesia,
for the first time to treat the maxillofacial fractures [19]. anesthesia, plate rejection, malunion, non-union, palpability
Enislidis G et al. successfully fixed zygomatic fractures with of plate. Infection was seen in 6 patients of the titanium plate,
bioresorbable plate osteosynthesis found them simple and safe pain and infection persisted for almost 1 week with suture
[20]. Landes et al. used these bioresorbable plates in sagittal dehiscence, plate rejection and palpability, the plate was
split osteotomies and stated that they function as titanium removed and IMF was placed for 2 weeks, except for 6 patients
in fixation for orthognathic surgery and do not impose an where it was 4 weeks as described above. The mechanical
increase in clinical morbidity [16]. The biodegradable material properties of the bioresorbable plates and screw applied for
is softer and weaker than titanium and requires tapping to place mandibular fracture fixation are comparable with those of
the screws. Unlike titanium, in which firm pressure and tight metal fixation systems. The treatment goals of immobilizations,
screw placement is favorable, biodegradable screws need only fixation and stabilization were found to be fulfilled. The skeletal
be finger tight and care must be taken when placing them into stability was comparable with actual standards and sufficient
thin bone, if excessive torque is applied, the screw head breaks for the time needed for mandibular bone healing on the basis
off [21]. of results of the study. Indeed, the biodegradable implants
In the present study, we compared the clinical efficacy of have the potential for successful use in the fixation of human
bioresorbable plates and titanium miniplates in management of mandibular fractures.
mandibular fracture. In our study good stability was achieved Conclusions and Outlook
in titanium plate group (100%) than in bioresorbable plate
Our results suggest that biodegradable polymers exhibit
group (83%). These results are in accordance with observations
that the titanium plate group gives better stability as compare to negligible complications, good handling properties and less
bioresorbable plate group [21]. Screw breakage and loosening interference with craniofacial growth during the management
of screw intra operatively was seen only in the bioresorbable of mandibular fracture. However, high cost of material is
group, due to its innate property and weakness as compare to the greatest deterrent to its wider use and further research is
titanium screws. The better performance of titanium screws has required for its use in the treatment of mandibular fractures. On
already been reported for craniofacial fractures [22]. The screw the other hand, the titanium miniplates are also malleable and
breakages are due to material failure and incorrect handling. easily adaptable to the bone in comparison with bioreabsorable
In such cases, a new hole was easily drilled through the broken plates. The titanium plates have shown the better handling
screws and a new screw was inserted without problems, fitting properties and stability of fractured fragments. The titanium
perfectly into the mandibular bone. miniplates are much cheaper as compared to bioresorbable
plates; hence it is being used widely for the treatment of
The adaptation of the bioresorbable plates to the bone surface
mandibular fractures. The patients who are not able to offer
was not complicated as with titanium miniplates. A slight
bioresorbable plates, the titanium miniplates can be their
grade of over bending was necessary because of the elasticity
choice of treatment.
of the material. In contrast to others, bioresorbable fixation
systems no healing device was necessary. The plates were easily Competing Interests
bendable with forceps at room temperature and none of the
VK, SG, RKC, RKC, MT and SKC declare that they have
plates broke during bending. At the bending areas, white lines
no conflicts of interest directly relevant to the content of this
occurred in the transparent plates, but this did not influence the
article.
physical quality of the devices. This phenomenon is described
as microdelamination in the instruction of the manufacturer Author’s Contributions
[23]. In the present study, adaptation of plates was good in VK, SG, RKC, RKC and MT searched the literature and
all the 30 patients in bioresorbable group and 24 patients in drafted the manuscript under the supervision of SKC.
titanium group, only in 6 patients of the titanium group; the
adaptation of plate was fair. Reduction of fractured segment References
achieved intra operatively was good in all the 30 patients of
1. Michelet FX, Deymes J, Dessus B (1973) Osteosynthesis with
bioresorbable group. In titanium plate group, it was good in 24
miniaturized screwed plates in maxillofacial surgery. J Maxillofac
patients and fair in 6 patients. Surg 1: 79-84.
The biodegradable fracture fixation devices are more 2. Champy M, Lodde JP, Schmitt R, Jaeger JH, Muster D (1978)
attractive than metal ones because no removal operation is Mandibular osteosynthesis by miniature screwed plates via a
needed after bone healing. It is common practice to remove buccal approach. J Maxillofac Surg 6: 14-21.
Citation: Kumar V, Gour S, Chaube RK, Chaube RK, Chaube SK, et al. (2018) Comparative Efficacy and Adaptability of Bioresorbable Plates with
Titanium Miniplates in the Management of Mandibular Fractures. Clin Res Open Access 4(2): dx.doi.org/10.16966/2469-6714.137 4
Sci Forschen
Open HUB for Scientific Researc h
Clinical Research: Open Access
Open Access Journal
3. Thoma KH (1951) Transosseous wiring fixation of subcondylar 14. Bessho K, Lizuka T, Murakami KA (1997) A bioabsorbable poly-
fractures. Oral Surg Oral Med Oral Pathol 4: 290-295. L-lactide miniplate and screw system for osteosynthesis in oral
and maxillofacial surgery. J Oral Maxillofac Surg 55: 941-945.
4. Niederdellmann H, Shetty V (1987) Solitary lag screw
osteosynthesis in the treatment of fractures of the angle of 15. Kallela I, Lizuka T, Salo A, Lindqvist C (1999) Lag-screw fixation of
mandible: A retrospective study. Plast Reconstr Surg 80: 68-74. anterior mandibular fractures using biodegradable polylactide
screws: a preliminary report. J Oral Maxillofac Surg 57:113-118.
5. Pogrel MA (1986) Compression osteosynthesis in mandibular
fractures. Int J Oral Maxillofac Surg 15: 521-524. 16. Landes CA, Krienser S, Menzer M, Kovàcs AF (2003) Resorbable
plate osteosynthesis of dislocated or pathological mandibular
6. Alpert B, Seligson D (1996) Removal of asymptomatic bone
fractures: a prospective clinical trial of two amorphous L-/DL-
plates used for orthognathic surgery and facial fractures. J Oral
lactide copolymer 2-mm miniplate systems. Plast Reconstr Surg
Maxillofac Surg 54: 618-621.
111: 601-610.
7. Sanerbier S, Scon R, Otten JE, Schmelzeisen R, Gutwald R (2008)
17. Rubin JP, Yaremchuk MJ (1997) Complications and toxicities
The development of plate osteosynthesis for the treatment of
of implantable biomaterials used in facial reconstructive and
fracture of the mandibular body - a literature review. J Cranio
aesthetic surgery: A comprehensive review of the literature.
Maxillofac Surg 36: 251-259.
Plast Reconstr Surg 100: 1336-1353.
8. Rosenberg A, Grätz KW, Sailer HF (1993) Should Titanium 18. Wiltfang J, Merten HA, Schultze-MS, Schrell U, Wénzel D, et
miniplates be removed after bone healing is complete? Int J Oral al. (2000) Biodegradable miniplates (Lacto Sorb): Long-term
Maxillofac Surg 22: 185-188. results in infant minipigs and clinical results. J Craniofac Surg 11:
9. Tonino AJ, Davidson CL, Klopper PJ, Linclau LA (1976) Protection 239-243.
from stress in bone and its effects. Experiments with stainless 19. Kulkarni RK, Pani KC, Neuman C, Leonard F (1966) Polylactic acid
steel and plastic plates in dogs. J Bone Joint Surg Br 58: 107-113. for surgical implants. Arch Surg 93: 839-843.
10. Suuronen R, Haers PE, Lindqvist C, Sailer HF (1999) Update on 20. Enislidis G, Yerit K, Wittwer G, Köhnke R, Schragl S, et al. (2005)
bioresorbable plates in maxillofacial surgery. Facial Plast Surg Self-reinforced biodegradable plates and screws for fixation of
15: 61-72. zygomatic fractures. J Craniomaxillofac Surg 33: 95-102.
11. Harada K, Enomoto S (1997) Stability after surgical correction 21. Whitley S, Jones H, Patel M (2007) Re: Wood GD, Inion
of mandibular prognathism using the sagittal split ramus biodegradable plates: The first century. Br J Oral Maxillofac Surg
osteotomy and fixation with poly-L-lactic acid (PLLA) screws. J 45: 173.
Oral Maxillofac Surg 55: 464-468.
22. Turvey TA, Profitt WP, Philipps C (2011) Biodegradable fixation
12. Lizuka T, Mikkonen P, Paukku P, Lindqvist C (1991) Reconstruction for craniomaxillofacial surgery: a 10 year experience involving
of orbital floor with polydioxanone plate. Int J Oral Maxillofac 761 operations and 745 patients. Int J Oral Maxillofac Surg 40:
Surg 20: 83-87. 244-249.
13. Rajanna R, Shetty JN, Balakrishna R, Patel A, Srungeri MK, et al. 23. Rahn B, Cordey J, Davos, prein J, Basel, et al. (1975) Biomechanics
(2015) Bioresorbable plates and screws in maxillomandibular of osteosynthesis in mandible. Fortschr Kiefer Gesichtschir 19:
fractures. J Int Oral Health 7: 78-85. 37-42.
Citation: Kumar V, Gour S, Chaube RK, Chaube RK, Chaube SK, et al. (2018) Comparative Efficacy and Adaptability of Bioresorbable Plates with
Titanium Miniplates in the Management of Mandibular Fractures. Clin Res Open Access 4(2): dx.doi.org/10.16966/2469-6714.137 5