ORIGINAL ARTICLE. G. K. Vivek 1, Akshay Shetty 2, N. Vaibhav 2, Mohammad Imran 2

Transcription

1 Journal of Advanced Clinical & Research Insights (2016), 3, ORIGINAL ARTICLE A comparative study of single 3-D titanium plate versus conventional Champy s 2 miniplate fixation in the management of mandibular anterior fracture: A prospective clinical study G. K. Vivek 1, Akshay Shetty 2, N. Vaibhav 2, Mohammad Imran 2 1 Consultant Oral and Maxillofacial Surgeon, Bengaluru, Karnataka, India, 2 Department of Oral and Maxillofacial Surgery, RGCODS, Bengaluru, Karnataka, India Keywords 3-dimensional miniplates, Champy s miniplate, mandibular anterior fractures Correspondence Dr. G. K. Vivek Consultant Oral and Maxillofacial Surgery, House NO: 513, 12 th main Road, Yelahanka Newtown, Bengaluru , Karnataka, India. Phone: , vivekbhatfaciomax@gmail.com Received 20 th August 2016; Revised 28 th September 2016 doi: /ins.jcri.137 Abstract Introduction: Rigid internal fixation using Champy s miniplates is one of the commonly used treatment modalities to treat mandibular anterior fractures. The drawbacks of these methods have led to the evolution of 3-dimensional (3-D) miniplates. This study was designed to compare the efficacy of single 3-D miniplates over Champy s 2 miniplates in mandibular symphysis and parasymphysis fractures. Materials and Methods: 20 patients with anterior mandibular fractures were randomly were divided into 2 groups, wherein single 3-D plates were placed in Groups I and 2 miniplates in Group II. The efficacy of 3-D miniplates over Champy s miniplates was evaluated in terms of the following parameters: Operating duration, occlusal discrepancy, infection, mobility of fracture segment, wound dehiscence, neurological function. Results: The mean operation duration for Group I was less compared to Group II (statistically significant), wound dehiscence were present in 2 cases in Group II, neurological deficit in one case in-group II (statistically insignificant). Conclusion: The results of the study confirms that single plate fixation of mandibular anterior fractures with 3-D titanium miniplates system is a good alternative to Champy s 2 miniplates system as it provides good stability, requires less intraoperative time and carries lower rates of infection compared to the regular miniplate systems. Introduction Treatment of mandibular fractures is governed by certain principles that are essential for successful bone healing and restoration of function. These include establishment of early diagnosis and specific treatment, accurate functional anatomic reduction of bone fragments, immobilization of reduced and fixed units until healing occurs. It also includes prevention of infection, malunion or nonunion of fracture, restoration of occlusion and masticatory function. [1] The goal should be to ensure fastest recovery time with minimal morbidity and discomfort so that the patient s functional and esthetic normalcy can return in the shortest time possible. Over the decades, emphasis is being placed on greater patient comfort and early return to normal function using different methods of open reduction and direct fixation, allowing anatomical reduction of fragments. [2] The limitations of the existing rigid and semirigid fixation systems led to the evolution of a relatively new three-dimensional (3-D) miniplates system. The design and the quadrangular shape of the 3-D plates ensure a geometrically sturdy cuboidal configuration that offers greater stability. [3,4] Broader platforms that 3-D systems offer better stability against torsional forces. This mechanical property is desirable in cases of anterior mandibular fractures, which experience greater degree of torsional strain. Keeping all these aspects in mind, a study was carried out by the author to evaluate the efficacy of 3-D titanium plate over traditional Champy s miniplates in the treatment of mandibular anterior fractures. [5] Principles of 3-D fixation Increased stability offered by 3-D fixation systems can be attributed to its geometrically closed quadrangular configuration, which offers increased resistance against torqueing forces. 194 Journal of Advanced Clinical & Research Insights Vol. 3:6 Nov-Dec 2016

2 Comparative study between 3-D miniplates versus Champy s miniplates in mandibular fracture treatment Vivek, et al. Therefore, these plates show better ability to prevent splaying at the lower border of the mandible due by occlusal forces as compared to a single plate. [6,7] The plates are designed in such a way that the fixation points remain close to the fracture line. The connecting arms between the screw-holes are positioned almost rectangular to the fracture line. Stability offered by 3-D plate is because of its configuration, not due to its thickness or length. The bone screws secure each arm of the plate separately without any tension to the underlying bone [Figure 1a and b]. The design also precludes the need for accurate adaptation of the plates, as it is necessary with the thicker conventional miniplates. [3,5-7] According to biomechanical studies conducted by Champy s et al. (1978) and Gerlach et al. (2002), the maximum load capacity of the mandible is normally about N. The 1.0 mm standard plate can easily withstand traction forces worth 690 N. Despite the thin connecting arms of the plate, the 3-D plates are also quite sturdy against torsional forces. This is because the forces are distributed over a wide surface area and not along a single line. [8,9] Materials and Methods A comparative clinical study was conducted over a period of 2 years (January 2013 and January 2015) in private practice of the author wherein 20 patients within the age group of 19 to 55 years with fractures of the anterior mandible were included in the study after obtaining a written informed consent. The study design and methods were consistent with protocols laid down by the Helsinki declaration of 1975, as revised in Inclusion criteria Only fracture of mandible at symphysis, parasymphysis, was indicated for open reduction with internal fixation. Fracture cases who are reported to hospital within 1 week of injuries nonsmokers, nonalcoholics. Exclusion criteria Malunited fracture, Patients with head injury, Fracture sites with signs of infection, e.g., pus discharge, Patient with immunocompromised status, e.g., diabetes and steroid therapy, Noncompliant patients. All the patients reported to the hospital for management of mandibular anterior fracture were subjected to through history taking followed by clinical examination of oral and maxillofacial region. Routine pre-operative investigations were advised and relevant radiographs were taken. After preanesthetic evaluation and fitness were taken, patients were prepared for mandible fracture reduction and internal rigid fixation under general anesthesia. Patients were placed on arch bars and given 1 g cefotaxime IV 1 h before surgery and diclofenac sodium 75 mg IM injection for analgesic. Patients were randomly divided into 2 groups. Group I - fractures to be fixed with single 3-D titanium plate Group II - fractures to be fixed with traditional Champy s 2 miniplates. Intraoperative local infiltration of lignocaine 2% with 1:80000 was infiltrated at the incision site for local hemostasis. A standard vestibular intraoral incision was placed in both the groups of patients to approach the fractures site. After fracture reduction, fixation of bone was done using 3-D 2 mm titanium 2 2 holes plates for Group I patients and standard Champy s 2 mm 2 hole or 4 hole stainless steel miniplates with gap plates for osteosynthesis in the other group. The 3-D plates wherein horizontal crossbars were right angles to the fracture line and vertical struts were along the fracture line, in oblique fracture, line plates were placed along the lower border of mandible [Figure 1a and b]. In Group II patients, one miniplate was fixed 5 mm below the apices of teeth and another inferior to it to resist torsional forces in mandibular anterior region, in parasymphysis fractures, the plates were secured with special care taken to avoid the mental foramen. These two plates would help in preventing splaying at inferior border due to action of muscles of mastication [Figure 2a and b]. In Champy s plates 2 8 mm stainless steel screws, in 3-D plating 2 8 mm titanium screws were used. Closure was achieved in both groups with 3-0 polyglycolic acid (Vicryl). Post-operative assessments included wound dehiscence, infection, segmental mobility, post-operative occlusion [Table 1] at intervals of 1,2,4,8,16 weeks period. a Figure 1: (a) Post-operative OPG of 3-dimensional single plate fixation of parasymphysis fractures, (b) Intraoperative picture of 3-dimensional plate fixation of parasymphysis fracture b Journal of Advanced Clinical & Research Insights Vol. 3:6 Nov-Dec

3 Vivek, et al. Comparative study between 3-D miniplates versus Champy s miniplates in mandibular fracture treatment a b Figure 2: (a) Intraoperative picture of Champy s 2 miniplate plate fixation of symphysis fracture, (b) post-operative OPG of Champy s 2 miniplate plate fixation Table 1: Distribution of mandibular fracture according to site Parameters Group I (n:10) Group II (n:10) P value (t test) patient parameters patient parameters Mean operating time Occlusal discrepancy 0 2 Infection At 2 weeks At 2 months 0 0 At 3 months 0 0 Segment mobility At 2 weeks 0 0 Wound dehiscence Neurological defecit Table 2: Age and sex distribution of cases Sex Age Male 19 Male 24 Female 34 Female 28 Male 32 Male 54 Male 45 Female 28 Female 35 Male 45 Male 32 Male 31 Male 23 Male 51 Male 34 Data were analyzed using student s t-test to compare clinical utility of using 3-D plates and Champy s miniplates in the treatment of mandibular anterior fractures. P < 0.05 was considered statistically significant. Results The patient s age ranged from 19 years to 55 years with mean age of the being 33.9 years. There were 20 patients included in the study, out of which 17 were male and 3 were female, 18 of them had isolated parasymphysis fractures. The other 2 cases had both symphysis and parasymphysis fractures. Two patients had multiple fragments of parasymphysis fracture but uninfected, hence included in the study [Table 2]. Mean operating time as was recorded and was 8.3 min for Group I and 14 min in Group II patients. Postoperatively in Group I, all 10 patients had good post-operative occlusion, and in Group II, 2 patients had mild occlusal open bite, which was managed successfully by giving guiding elastics for 10 days [Table 3]. During follow-up the patients were evaluated for signs of infection at 2,4,8, and 16 weeks, after 2 weeks infection was seen Male 32 Male 28 Male 26 Male 29 Male 30 Table 3: Comparison of operating time Group N Mean±SD P Result Group I (3 D plates ±1.33 P<0.05 (Significant) P<0.05 Group II (Champy s plate) 10 14±0.8 P>0.05 (Not significant) P>0.05 in one patient of Group I and two of patients of Group II which was managed conservatively by local irrigation, debridement, and antibiotics but after 4 weeks there was no signs of infection noticed in both the group. Fracture segment preoperatively was mobile in all the patients in both Group I and II but postoperatively it was absent in both the groups after 6 weeks. Two patients developed wound dehiscence in both the groups, respectively, it was because of loss 196 Journal of Advanced Clinical & Research Insights Vol. 3:6 Nov-Dec 2016

4 Comparative study between 3-D miniplates versus Champy s miniplates in mandibular fracture treatment Vivek, et al. of buccal soft tissues and comminuted type of mandible fracture in the region [Table 4]. Mild nerve dysfunction like paresthesia was present in one of 10 patients in Champy s plate group and none in 3-D plate group, but postoperatively the patient showed complete neurological signs of recovery in 3 months [Table 1]. Discussion The goals of fracture management in mandible are to restore anatomic form and function and to achieve functional occlusion. Although closed reduction techniques also can achieve some of these objectives in most cases but a prolonged period of immobilization of the fractured mandible it requires is associated with many complications and disadvantages, e.g., a patient is always on liquid diet, has to be hospitalized for a longer period of time, speech and oral hygiene is affected. With prolonged MMF fibrous ankylosis might develop in patients with trauma to temporomandibular joint. Maxillomandibular immobilization also offers restriction in the treatment of mentally deficient, epileptic or uncooperative patients. During the last decade, there has been tremendous advancement in surgical techniques, instrumentation and materials in the field of oral maxillofacial surgery wherein open reduction and rigid internal fixation has almost become standard of care in maxillofacial surgical practice. Keeping the limitations of closed reduction in mind, open reduction has been advocated which has the advantage of superior strength and obviates the need for immobilization of the mandible which further permits the early return of patient to normal diet and function. Lambotte, in 1913, used extraoral approach for mandible fracture management. He used a geometrically quadrangular plate that required fixation with bone screws at the lower border of the mandible. He reported that this type of plate ensured adequate stability without the need for prolonged Table 4: Comparison of parameters between Groups I and II Parameters Group I (n:10) Group II (n:10) P value (t test) patient parameters patient parameters Occlusal discrepancy 0 2 Infection At 2 weeks At 2 months 0 0 At 3 months 0 0 Segment mobility At 2 weeks 0 0 Wound dehiscence Neurological defecit immobilization, provided that the fracture fragments were adequately reduced. However, this method though reasonably effective did not gain widespread acceptance because of the material used, which was not as biocompatible as some of the others. Besides, closed reduction techniques were traditionally better accepted and preferred at that time. [3,4,7] The AO group in 1950 conducted an organized research, which highlighted the advantages and improved patient comfort/compliance of open method of osteosynthesis. In this open osteosynthesis technique, there has been shift in technique from rigid fixation in earlier years to semirigid fixation later. Michelet et al., in the year 1973, conducted various studies with monocortical noncompression miniplates using a cantilever beam model. Champy et al., in the year 1978, demonstrated in their studies that the superior border of the mandible is subjected to tension forces, and the inferior border was subjected to compression. Champy s referred to this transition zone as neutral zone running along the inferior alveolar nerve. His experiments with miniplates further defined the best site suited for plate fixation in this zone known as ideal line of osteosynthesis. [1,4-9] Farmand (1996) introduced the concept of 3-D miniplates. They derive their stability and mechanical properties because of their specialized quadrangular shape, which is dependent on the principle of a quadrangular shape being a geometrically more stable design. The stability and sturdiness are not dependent on plate dimensions and thickness alone, rather it is by the shape of these plates. This allows efficient usage of plates of even 1 mm thickness. [10-13] The 3-D plates are designed in different forms such as with 2 2 holes and 3 2 (or) 2 2 square or rectangular shapes. The term is a misnomer, as the plates are not 3-D, but they stabilize the fracture segments by resisting 3-D forces that act on the jaw during occlusal and functional loading. [8,13] The 3-D miniplates could be considered as 2 miniplates joined by interconnecting cross struts, allowing virtually no torsion movements at the region of fracture. The design of the plates does not allow movement at the upper and lower borders of the mandible with minimal torsional and bending forces, compared to Champy s plate applied at the upper border area which can cause movement along the axis of the plate with buccolingual opening and discontinuity at the lower border. In the 3-D system, the screws are secured in a quadrangular conformation on either side of the fracture instead of straight line. This results in a broad platform that improves the stability of the plate. [7,8,11,14,15] Various surgeons have experienced reduced operating time with usage of 3-D plates. Zix et al. (2007) and Wittenberg (1994) reported a mean operating time (from incision to closure) of min for mandibular fractures fixation with 3-D plates. They have demonstrated better biomechanical stability compared with conventional miniplates. Farmand conducted the first biomechanical study of 3-D plates and he found that the stability of 1 mm 3-D plate was comparable to the much thicker 2-0 mm miniplates (Steinhauser plate), which Journal of Advanced Clinical & Research Insights Vol. 3:6 Nov-Dec

5 Vivek, et al. Comparative study between 3-D miniplates versus Champy s miniplates in mandibular fracture treatment is designed for a single plate fixation of mandibular fractures. The limited screw-bone interface of Steinhauser s plate also compromised the final stability. [12,14-16] The 3-D plates allow for easy and safe placement via an intraoral approach. The surgical exposure and periosteal stripping needed was also comparable to the exposure required by a single standard miniplates and much lesser compared to what is needed for two miniplates. [10,15] In this study, it was found that swelling was present in all the patients at 24 h, which increased by 3 rd post-operative day and then gradually reduced after 1 st week. Eventually, no swelling was present at 1 month and 3 rd month postoperatively. The possible cause for post-operative swelling could have been post-operative edema due to surgery. Titanium plates are truly biocompatible, resist corrosion, and exhibit excellent osseointegration. The use of titanium bone plates has been described and appreciated by several authors. According to those studies [14-17] fractures treated with titanium bone plates and screws had less post-operative infection rate compared to stainless steel, similarly in our study, in Group II patients had infection at suture and wound dehiscence in 2 patients. Mandible fractures if it is a complex type, there can be a tendency for infection when there is breach in soft tissue cover, poor patient compliance in oral hygiene maintenance and also as a result of inadequate rigidity and immobilization. Guimond et al. (2005) in their study had infection rate of 5.4% (2 out of 37 patients) with the use of 3-D plates, Feledy et al. (2004) study had infection rate of 9% (2 out of 22 patients), Zix et al. (2007) had 0%. In our study, infection rate is 10% (1 out of 10 patients) with 3-D plates and 20% (2 out of 10 patients) in Champy s plate group probable source of infection being tooth in the line of fracture and poor oral hygiene but it subsided 2 weeks postoperatively. The inadequate restoration of occlusal balance can cause disturbances in the temporomandibular joint function. In our study, occlusions of the patients were checked postoperatively and during follow ups had no major occlusal discrepancies. [2,17,18] Minor occlusal disturbances if present can be corrected using guiding elastics. In two of our patients, wound dehiscence was seen due to inadequate tissue available or closure of wound under tension during suturing which resulted in tension along the suture line which required resuturing later, all the patients were kept on antibiotic therapy and regular follow-up was done. Delayed union could be because of contamination of fracture site, occlusal discrepancies among several other reasons. In this study, no case of (0%) delayed and nonunion was found. [14,18-20] Conclusion Thus it can be concluded from the study that single plate fixation of mandibular symphysis and parasymphysis fractures with 3-D titanium miniplates system is a good alternative to Champy s 2 miniplates system as it provides good stability, requires less intraoperative time, and has low infection rates compared to the standard miniplate systems. The probable limitations of this system may be excessive implant material due to the extra vertical bars incorporated for counteracting the torsional forces, overall bulk of plate in cases of oblique fractures and it may require sufficient exposure of surgical site and fracturing of vertical strut, which in turn might compromise 3-D stability of plate. Since mandible is an important part of facial skeleton and has unique role in function and esthetics which requires the treating surgeon to give adequate attention whenever it is fractured and help the patient in fast recovery so 3-D plates has an important role to play in the success of this goal. Further studies with larger sample sizes in different clinical situations would be recommended by the authors to come to definite conclusion. References 1. Booth PW, Schendel SA, Hausamen JE. Maxillofacial Surgery. 2 nd ed. London: Churchill Livingston; p Gear AJ, Apasova E, Schmitz JP, Schubert W. Treatment modalities for mandibular angle fractures. J Oral Maxillofac Surg 2005;63: Champy M, Loddé JP, Schmitt R, Jaeger JH, Muster D. Mandibular osteosynthesis by miniaturized plates via a buccal approach. J Maxillofac Surg 1978;6: Michelet FX, Deymes J, Dessus B. Osteosynthesis with miniaturized screwed plates in maxillo-facial surgery. J Maxillofac Surg 1973;1: Szabó G, Kovács A, Pulay G. Champy plates in mandibular surgery. Int J Oral Surg 1984;13: Jain S, Gupta S. Titanium miniplates versus intraosseous wires as methods of fixation of mandibular fractures: A clinical study. Indian J Stomatol 2011;2: Gandi L, Kattimani VS. Three dimensional bone plating system in the management of mandibular fractures - A clinical study. Ann Essences Dent 2012;4: Farmand M. Experiences with the 3-D miniplate osteosynthesis in mandibular fractures. Fortschr Kiefer Gesichtschir 1996;41: Kumar BP, Kumar J, Mohan AP, Venkatesh V, Kumar HR. A comparative study of three dimensional stainless steel plate versus stainless steel miniplate in the management of mandibular parasymphysis fracture. J Bio Innov 2012;1: Guimond C, Johnson JV, Marchena JM. Fixation of mandibular angle fractures with a 2.0-mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg 2005;63: Zix J, Lieger O, Iizuka T. Use of straight and curved 3-dimensional titanium miniplates for fracture fixation at the mandibular angle. J Oral Maxillofac Surg 2007;65: Wittenberg JM, Smith B, Trigg, DD. Treatment of mandibular angle fractures with 3-D titanium miniplates. J Oral Maxillofac Surg 1994;52 Suppl 2: Feledy J, Caterson EJ, Steger S, Stal S, Hollier L. Treatment of mandibular angle fractures with a matrix miniplate: A preliminary report. Plast Reconstr Surg 2004;114: Deepak S, Manjula S. Comparison of titanium bone plates and screws vs. Stainless steel bone plates and screws in the management of mandibular fractures - A long-term clinical study. Int J Clin Dent Sci 2011;2: Journal of Advanced Clinical & Research Insights Vol. 3:6 Nov-Dec 2016

6 Comparative study between 3-D miniplates versus Champy s miniplates in mandibular fracture treatment Vivek, et al. 15. Acero J, Calderon J, Salmeron JI, Verdaguer JJ, Concejo C, Somacarrera ML. The behaviour of titanium as a biomaterial: Microscopy study of plates and surrounding tissues in facial osteosynthesis. J Craniomaxillofac Surg 1999;27: Arens S, Schlegel U, Printzen G, Ziegler WJ, Perren SM, Hansis M. Influence of materials for fixation implants on local infection. An experimental study of steel versus titanium DCP in rabbits. J Bone Joint Surg Br 1996;78: Wittenberg JM, Mukherjee DP, Smith BR, Kruse RN. Biomechanical evaluation of new fixation devices for mandibular angle fractures. Int J Oral Maxillofac Surg 1997;26: Mittal G, Dubbudu RR, Cariappa KM. Three dimensional titanium mini plates in oral and maxillofacial surgery: A prospective clinical trial. J Maxillofac Oral Surg 2012;11: Torgersen S, Gjerdet NR, Erichsen ES, Bang G. Metal particles and tissue changes adjacent to miniplates. A retrieval study. Acta Odontol Scand 1995;53: Sadhwani BS, Anchlia S. Conventional 2.0 mm miniplates versus 3-D plates in mandibular fractures. Ann Maxillofac Surg 2013;3: How to cite this article: Vivek GK, Shetty A, Vaibhav N, Imran M. A comparative study of single 3-D titanium plate versus conventional Champy s 2 miniplate fixation in the management of mandibular anterior fracture: A prospective clinical study. J Adv Clin Res Insights 2016;3: Journal of Advanced Clinical & Research Insights Vol. 3:6 Nov-Dec