Questions of the use of treatment protocols in the provision of medical care to patients with mandibular fractures

Currently, a widespread form of organization of the treatment process in modern world medical practice is clinical guidelines or treatment protocols. The purpose of their development and applying is, firstly, to provide the patient with a modern level of medical care, regardless of where it is provided — in a large specialized center or a district hospital. Secondly, in connection with the transition to insurance medicine, clinical guidelines make it possible to detail the amount of payable medical care, depending on the specific nosological form of the disease and the ways of its clinical course.

Another reason is related to the increase of the number of lawsuits for the inadequate provision of medical services. A considerable part of them is generated by such a phenomenon of recent years as consumer extremism, i.e. the desire to make money in a medical institution. Clinical guidelines, in this case, allow the doctor to be protected, releasing him from unnecessary red tape, material and moral costs.

In 2018, the Ministry of Health of the Russian Federation developed order No. 53n “On approval of the procedure for developing standards of medical care”. According to paragraph 8 of this order, projects of medical standards should be developed on the basis of clinical guidelines (treatment protocols) drawn up by the relevant professional medical associations. This position is completely justified, since no one, even a large, team, especially one leader, is capable of developing such a draft standard that would summarize all the advanced clinical experience and the real conditions for organizing the treatment process throughout the country. The competence of the working group includes the preparation of the project, which should be discussed, approved, and then regularly revised in the framework of conferences and congresses of professional associations.

Only one type of Clinical Guidelines is presented so far on the website of the Dental Association of Russia in the field of “Maxillofacial Surgery”. They are about fractures of the lower jaw and approved by Resolution No. 13 of the Council of the Association of Public Associations “Dental Association of Russia” dated April 19, 2016.

As is known, these injuries are the most common type of injuries to the bones of the facial skeleton, accounting for more than 70% of their total number [1—5], etc., and being a serious public health problem worldwide [6, 7]. According to some reports, the proportion of patients with this type of injury can reach 75—95% among the total number of patients with maxillofacial profile [8]. Accordingly, the issues of providing them with medical care are not only medical, but also of important socio-economic importance

At the end of the 20th century, surgical methods of treatment for patients with this type of injury prevailed restrained attitude, due to the high risk of developing complications, primarily of an inflammatory nature. According to RP Winstanley (1995): “Jaw fractures are a case in which minimal medical intervention is indicated” [9]. A similar opinion was expressed by V.A. Kozlov: “The use of surgical methods of treatment is justified only when the advantages of osteosynthesis exceed its biological disadvantages” [9]. Nevertheless, the incidence of traumatic osteomyelitis alone was 10—12% [9], and the total number of inflammatory complications of mandibular fractures, according to some data, could reach 41% [10]. Subsequently, new surgical technologies based on the use of various types of bone fixators entered clinical practice [11, 12], which significantly reduced the length of time required to build an organotypic regenerate in the injury zone [12, 13]. Their introduction forced a significant revision of views on the prospects of surgical treatment. However, to date, there are still no clearly defined indications for its implementation nor rules governing its implementation.

Thus, the development of a unified concept of a therapeutic and diagnostic approach for these patients is an urgent task. The purpose of this work is to analyze the clinical guidelines StAR “Mandibular fractures” for compliance with this task.

By form, they complies the requirements of the Methodological recommendations for the development and updating of Clinical Recommendations developed by the Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. The strongest side of these recommendations is the inclusion of provisions on the need to evaluate the general condition of the patient in order to identify general somatic pathology, combined trauma, which is essential for the determination of treatment tactics.

However, issues related to the direct provision of medical care to patients with fractures of the mandible are not fully covered. When listing the indications for hospitalization (section of the organization of medical care), situations are not mentioned when there is a displacement of bone fragments that cannot be eliminated during primary reduction. Meanwhile, there are cases when the patient is not offered surgical treatment, despite the continued dislocation of the fragments.

In the patient model “Closed mandible fracture” (paragraph 7.1), fractures in the area of the mandible body are excluded, which in a significant percentage of cases remain closed in elderly and edentulous patients, and in children with “green branch” fractures. The situation is similar with the open fracture patient model (paragraph 7.2). Here, fractures in the area of the mandible branch are completely excluded, although they can be combined with soft tissue injuries. Most often this occurs when a fracture is localized in the area of the condylar process with a displacement, combined with a bone fracture of the external auditory canal. None of the models mentioned fractures S02.65 — in the area of the symphysis and S02.67 — multiple fractures.

According to the point 4 of Order No. 53n of the Health Ministry, the main part of the standard should include averaged indicators of the frequency of provision and frequency of use of drugs, indicating the average doses. The tables contained in clauses 7.1.7 and 7.2.7 of the protocol does not comply with this requirement and will have to be revised. Moreover, the point of the use of tetanus toxoid demanded is in direct conflict with the current order of the Ministry of Health No. 174 of 05/17/1999 [12]. According to him, in all cases of injuries accompanied by rupture of the skin and mucous membranes, immunization against tetanus should be carried out. Thus, the inclusion of tetanus toxoid in the list of medical help for closed fractures is meaningless, and when open, its use, on the contrary, should be mandatory, except the cases provided by this order. He also regulates the conduct of passive immunization, for which horse tetanus serum and human anti-tetanus immunoglobulin are used. However, these drugs are not included in the current clinical guidelines.

From the table contained in paragraphs 7.1.3 and 7.2.3, devoted to the requirements for diagnosis, it follows that the only mandatory method of radiological diagnosis for a fracture of the mandible should be panoramic radiography of the mandible. Its absence in the medical history can be regarded as non-compliance with the requirements of the current Clinical Guidelines. All other methods of X-ray examination are carried out only as needed. At the same time, the real choice can’t be called optimal. Firstly, it is difficult to be performed, due to the limitation of opening the mouth and the occlusion disorder, and secondly, and this is the main thing, it does not allow visualizing the areas of the branches of the lower jaw. In addition, not all clinics are provided with the appropriate equipment.

But even worse, the protocol completely removed the requirement to carry out, if a fracture is suspected, X-rays of the bone in two projections. This is all the more regrettable that at present days there is a widespread misconception according to which orthopantomography replaces the need for X-ray examination in the anteroposterior or, according to the former terminology, nasofrontal projection. In these clinical guidelines, this technique is not mentioned at all. In fact, on the orthopantomogram, the real position of the bone fragments can be masked due to the planar nature of the image, and the fracture line itself cannot always be seen. Thus, if we leave the present state of affairs unchanged, the doctor who prescribed anteroposterior radiography of the lower jaw to clarify the diagnosis, will expose himself to the risk of being prosecuted as in such cases, the courts are forced to be guided not by medical logic, but by regulatory documents.

It seems inappropriate to include bent toothed splints with hook loops made of aluminum wire to the Clinical Practice Guidelines. This requirement appears to be outdated and inadequate for medical safety. According to the current sanitary rules and regulations 2.3 / 2.4.3590—20, aluminum dishes at catering establishments are allowed only for cooking and short-term (no more than an hour) storage of food. In clinical practice, it is necessary to fix in the oral cavity a previously curved, i.e. deformed aluminum wire for a long time, which can cause intoxication of the body.

The most controversial are paragraphs 7.1.15 and 7.2.15 of these Clinical Practice Guidelines on possible treatment outcomes and their characteristics. With closed fractures of the mandible, the averaged data on the incidence of complications is 15%, of which 7% are iatrogenic, and with open already 19% and 9% are iatrogenic. Thirty years ago, according to V.A. Kozlova [9], the incidence of inflammatory complications in fractures of the mandible was 12%. The same indicators were obtained by us in a retrospective analysis of the case histories of patients with this type of injury who were treated in the 90s [14]. Over the past years, fundamentally new physiologically grounded methods of surgical treatment have entered clinical practice, however, it follows from the protocol that this indicator does not show a tendency to decrease. Naturally, a logical question arises: what is the reason for this, and does it even make sense to introduce new operational technologies if the effectiveness of treatment does not increase at the same time.

Indeed, over the past decade, reports have periodically appeared in the literature, the authors of which provided comparable data on the rate of complications in patients with mandibular fractures [3, 15—19], especially in the case of two or more fracture lines [20].

However, in our retrospective study of 88 somatically healthy patients with complications that developed after the use of modern technologies of bone osteosynthesis [9], it was shown that in most cases (62.5%) deviations from the requirements of the corresponding surgical technologies were revealed. These included arbitrary arrangement of plates, without taking into account the lines of force of osteosynthesis, inadequate choice of fixator, depending on the specific clinical situation, incorrect alignment of bone fragments, often masked by the planar nature of the X-ray image. In another 25.6% of cases, the stability of the connection of fragments, in our opinion, could be significantly increased by using an additional plate, which would have avoided the development of complications. This point of view correlates with the results of experimental studies on the distribution of deformation stress lines of the mandible by the method of finite elements [21,22]. According to the data obtained, when the load is applied to the posterior parts of the jaw, the stretching zone in the area of the angle and the posterior parts of the body affects the lower edge, while when loaded on the anterior part, it shifts to the alveolar part. Thus, the classical M. Champy technique, which assumes the imposition of only one plate with monocortical screws along the outer oblique line, cannot provide a sufficiently stable connection of fragments, which is probably the cause of complications.

The mobility of bone fragments preserved under the action of the masticatory muscles causes constant suction of the infected oral fluid containing pathogenic microflora deep into the bone wound, which underlies the development of complications, both of an inflammatory nature and associated with a disturbance of consolidation. Therefore, the prognosis of surgical treatment of patients with mandibular fractures should be assessed primarily in terms of achieving adequate stability of bone fragments, while other circumstances are rather of secondary importance.

Accordingly, the provision contained in the recommendations that “Intact teeth are subject for observation under the control of electrodontometry” (section General approaches to the treatment of a fracture of the lower jaw).Undoubtedly, sparing tactics in relation of such teeth is justified, but the problem of preventing the development of inflammatory complications is no less urgent. Therefore, in our opinion, intact teeth can be preserved only if there are conditions optimal fixation of bone fragments. If we talk about conservative methods of jaw immobilization, then this requirement can be met if there are at least 3 stable teeth on each of the fragments. As for the 3 molars that fell into the fracture line in the area of the angle, their preservation is possible only if the surgical intervention is performed — functionally stable osteosynthesis within 1 day from the moment of injury. According to the results of the meta-analysis of the literature data, the presence of these teeth in the area of damage contributes to the development of complications [23].

Based on this, we believe that surgical interventions should be widely used in the treatment of patients with fractures of the mandible. The indications for their implementation are as follows:

• All cases of dislocation of bone fragments that cannot be eliminated using primary reduction and orthopedic fixation methods. This category of patients also includes patients with an insufficient number of teeth.
• All cases of delayed consolidation of bone fragments, i.e. preservation of their pronounced mobility after 7—10 days or stiffness for more than 4 weeks after immobilization.
• Patients with epilepsy, epileptiform seizures, mental illness, for whom orthopedic fixation methods are contraindicated.
• People for whom long-term wearing of dental fixing structures is undesirable due to the nature of their professional activities.
• If there are signs of inflammation in the fracture area, if there are less than 3 teeth on one of the fragments. In such cases, the operation should be performed after the acute inflammation has subsided.

The main task of the surgical intervention was to create a stable fixation of the fragments of the lower jaw. For this purpose, a surgical algorithm was developed, based on the analysis of clinical observations and biomechanical studies of the most common types of bone fixators. Its main provisions were stated by us earlier [14].

Over a 3-year period, in accordance with the requirements of this protocol, 442 patients with fractures of the mandible were operated [9]. In this study, patients with severe concomitant trauma were excluded, for whom surgical intervention in the maxillofacial region was postponed for a long time, due to the fact that they were undergoing treatment in intensive care units for a long time, underwent invasive neurosurgical and traumatological surgical interventions; as well as patients with diabetes millitus who constantly need high-dose insulin replacement therapy; patients with hepatitis B, C, liver cirrhosis; as well as patients with pathological fractures of the lower jaw on the background of osteonecrosis of various origins. In the same time, the study group included patients with comminuted fractures; multiple; with the presence of inflammation; high-risk patients admitted to the clinic more than 4 days after injury.

The result of the treatment was considered successful in restoring the anatomical integrity of the lower jaw, occlusal relationships, articulatory function, and the absence of signs of bone fragments mobility.

As already reported in our previous publications [14], the total number of complications was 4.1% (18 people). Of these, clinically significant, i.e. accompanied by a real lengthening of the treatment period, only 2.03% (9 people). The significance of this study, in our opinion, is due to the fact that here the effect of treatment was demonstrated not in a limited group, but in a rather significant clinical material.

Thus, the complication rate can actually be reduced compared to the values given in the StAR Clinical Guidelines. However, this requires further detailing, in terms of regulating the indications for surgery and the requirements for its implementation. This task seems all the more urgent because new designs of bone fixators are currently being proposed for clinical practice [24—28], including from biodegrading materials [29], improved tools for osteosynthesis [30], operative accesses associated with the use of endoscopic and fibreoptic assistance technologies [31—33]. At the moment, in section "General approaches to the treatment of a fracture of the lower jaw" the existing version of the Clinical Guidelines, only the types of osteosynthesis (direct, indirect) and the main types of fixing structures for their use are listed. On the other hand, due to the introduction of new surgical technologies, a new type of complications is described — pseudoaneurysm of the branches of the external carotid artery [34], which, although rare, but it is necessary to inform the medical community about it.

Rehabilitation actions (clauses 7.1.9 and 7.2.9) are insufficiently regulated and do not take into account modern methods of treatment. For example, it is recommended to wear individual bimaxillary splints for 4 weeks, while when using bone osteosynthesis technologies, these structures can be removed much earlier.

In conclusion, we can say that the Clinical recommendations of the StAR “Fractures of the mandible” do not fully meet the requirements of today. They not only do not form a unified conceptual approach to the provision of medical care to this contingent of patients, but, on the contrary, contain a number of controversial points that put the doctor in a very difficult position when choosing treatment tactics. Accordingly, they need to be revised as soon as possible.

Based on the analysis of this document, it is possible to formulate the requirements to be met by clinical guidelines as follows:

• To cover the maximum possible number of variants of the clinical course of the disease, the levels of damage.
• Fully match with the current orders, approved instructions for the use of medicines, materials intended for implantation.
• To take into account, on the one hand, modern advanced clinical experience, which makes it possible to increase the effectiveness of treatment, and on the other, the real conditions in which the country's medical and preventive institutions operate.

In order for the new version of clinical guidelines to match with these requirements, they must be widely discussed by the medical community before the approval stage. We believe that this work should be carried out, including on the pages of specialized magazines.