WO2025063862A1 - Dental physiotherapy device - Google Patents

Abstract

The utility model relates to dentistry. A dental physiotherapy device comprises a bite splint prepared according to a model of the patient's jaw, said bite splint being U-shaped in plan and conformal with the teeth and adjacent soft tissue for placement over the teeth of the jaw, as well as two electrodes that are arranged opposite one another on the inner surface of a depression in the bite splint and that are coupled to wires for connection to a source of direct current. Fastened to the surface of the depression, which runs the length of the bite splint and mirrors the shape of the tooth row, is an insert of a hydrophilic material with a spongy structure which is used to apply a therapeutic agent. The electrodes are situated beneath said insert, and the bite splint has an open cut-out in the region in which the electrodes are situated.

Description

Dental device for physiotherapy

The utility model relates to medicine, dentistry and can be used for complex prevention and treatment of inflammatory processes in periodontal tissues and enamel demineralization phenomena, including those associated with the use of non-removable orthodontic equipment. In particular, this individual device is intended for independent electrophoresis/galvanization procedures that accelerate the process of tooth movement during orthodontic treatment, as well as for the treatment and prevention of periodontal inflammation.

Physiotherapeutic procedures are of great importance among the treatment and preventive measures for periodontal diseases. They are indicated for almost all forms and stages of the disease and are widely used to influence individual pathogenetic links in the process and for symptomatic treatment. Some physical factors directly affect cells and tissues. In addition, all of them, irritating the rich receptor field of the oral mucosa, have a reflex effect, favorably influencing the nervous system, its vegetative part, hemodynamics, as a result of which blood and lymph circulation, trophism and metabolism in the periodontium improve, the growth of pathological granulations is suppressed, inflammatory and congestive phenomena are reduced, the activity of connective tissue elements increases, and the regeneration process is accelerated.

Well-known devices for introducing medicinal substances into body tissues using direct electric current during electrophoresis (Danilevsky N.D., Magid E.A., Mukhin N.A., Milikevich V.Yu. “Periodontium diseases”, Moscow, 1993, pp. 213-216). Electrophoresis is an electrokinetic phenomenon of movement of particles of a dispersed phase (colloidal or protein solutions) in a liquid or gaseous medium under the influence of an external electric field. One of the well-known devices treatment with direct electric current is the use of a mouth guard containing a medicinal preparation. A mouth guard for administering preparations using gum electrophoresis allows the preparations to be introduced directly to the site of inflammation, in a strictly dosed manner and for a certain time. With this method, the depth of penetration of the medicinal substance through the oral mucosa increases by 4-5 times.

Treatment of periodontal diseases using a mouth guard for administering medications using gum electrophoresis allows: to effectively influence the main pathogenetic mechanisms of periodontitis development in a short time, and to obtain a lasting therapeutic effect.

Thus, RU 2705621, A61C7/00, published 11.11.2019, describes a device for administering a drug through the gum, which includes two electrodes, each of which is made with an individual shape of adhesion to a specific area of the gum, and wires connected to an electrophoresis device.

After manufacturing, the electrodes are fitted in the patient's mouth so that they do not injure the patient's mucous membrane when applied or removed. Before the procedure, medicinal pads are placed on the electrodes and they are generously moistened with a 17% solution of Trilon B (disodium salt of ethylenediaminetetraacetic acid), then they are placed in the oral cavity according to the zone for which they were manufactured, and there is no danger of their incorrect installation, since they can only be installed in one correct position, since they are manufactured according to the jaw model and cannot be displaced. After installation, the electrode wires are connected to the connectors of the galvanization or electrophoresis device, and the active electrode is changed daily, either from the outer or inner side of the jaw. Then the device is turned on and the current is smoothly increased with the regulator until a slight tingling sensation appears, after which the current is slightly reduced until these sensations disappear. The disadvantage of this device is the complexity of manufacturing the electrodes and the complexity of fixing them to the gums and the fact that during the treatment session the patient's mouth must be open due to the need to lay wires through the dental arches of the jaws. For example, to make the electrodes, an impression of the patient's jaw is taken with an alginate impression material, and then electrodes are made for electrophoresis of the patient based on an X-ray examination of the patient and a model of the patient's jaw. In this case, electrodes are made from lead plates 1-2 mm thick, to which conductive conductors made of insulated copper wire up to 30-40 cm long are soldered in the middle. After this, an arched base is made into which the electrodes are fused. The finished device is put on top of the jaw teeth at the point where the drug is supplied. Such a device does not allow the jaws to close.

Also known is a device for treating gum diseases by electrophoresis, having electrodes and individually manufactured bioenergetic elastic mouth guards for medicinal preparations, into the outer surface of which, during manufacture, the said electrodes are introduced congruently to the gum contour, and the inner surface of the mouth guards is connected through a nipple to a vacuum pump to create negative pressure (RU 2185201, A61 N1/30, published 20.07.2002).

The preparations are introduced into the mouthguard immediately before use. Then a vacuum pump is connected to the nozzle via an elastic tube to create negative pressure. The active electrodes are connected to the galvanic apparatus. The passive electrode is fixed in the hand or on the forearm. The pad of the passive electrode is moistened with tap water or isotonic sodium chloride solution.

The disadvantage of this device is its complexity of execution and inconvenience of use due to the need to connect a vacuum pump, create a vacuum area under the mouthguard and the fact that the wires must be distributed over the patient's body. That is, such the device can be used under the supervision of a physician in an outpatient setting or day hospital and does not apply to devices for individual use. For the correct delivery of the drug, it is necessary that it is evenly distributed over the surface of the gums. But when using a vacuum pump, when the pressure in the cavity between the mouthguard and the gums/teeth decreases, the fit of the mouthguard surface is uneven, in some areas it is tight, in others it is not pressed enough. And under the influence of low pressure, the drug, as a fluid substance, obeys the laws of physics, that is, it will accumulate in areas of insufficient fit of the mouthguard to the gums/teeth.

Also known is a dental device for electrophoresis, comprising an individual mouth guard made of an insulating material and active and passive electrodes, wherein the active electrode is made in the form of one or more closed loops of metal wire, located vestibular-orally along the inner surface of the individual mouth guard (RU 65374, A61 C9/00, published 10.08.2007). This solution was adopted as a prototype.

The mouthguard is made of hard or elastic plastic by electropneumatic stamping and pneumatic vacuum molding using a plaster model, into which electrodes are pre-embedded. A medicinal product in the form of a solution on a turunda or gel is placed in the cavity of the dental device on the inner wall of the mouthguard, after which the device is inserted into the patient's oral cavity, put on top of the teeth and placed on the teeth, as on supports, connected to a source of direct current, the polarity of which depends on the charge of the ion being foreseen, an indifferent electrode is fixed in the corresponding area.

The disadvantage of this device is that after putting the device on the dentition, it requires sealing the cavity between the inner wall of the mouthguard and the gums. To do this, an insert is inserted into the mouthguard, which must have an exact repetition of the shape of the walls of the gums and the mouthguard. The issue of bringing the wires out is problematic; it is assumed that they can be brought out to the occlusal surfaces of large molars. To connect the terminal from the current source, the electrode has an output at the level of the occlusal surface of the teeth along the midline of the labial surface of the device. This leads to inconvenience in using the device, which requires precise adjustments.

In addition, during long-term treatment, in cases of changes in the shape of the jaw (for example, its expansion), it is necessary to replace the mouthguard, which also creates inconvenience of use.

A common drawback for all the listed analogues and the prototype is the unreliable and controllable retention of the mouthguard on the jaw. At the same time, the problem remains the uniformity of the distribution of the drug over the contact surface and the problem of leakage of this drug.

This utility model is aimed at achieving a technical result consisting of ensuring self-retention of the mouthguard on the jaw due to suction to the gums/teeth, during which the medicinal product is evenly distributed over the surface of the mouthguard.

The specified technical result is achieved by the fact that in a dental device for performing physiotherapy, containing a U-shaped dental mouth guard made from polyurethane plastic according to a model of the patient's jaw and corresponding to the shape of the dental arch and adjacent soft tissues for installation on top of the dental arch of the jaw, as well as two electrodes placed opposite each other on the inner surface of the recess of the dental mouth guard and connected to wires for connection to a source of direct current, on the surface of the recess running along the length of the dental mouth guard, displaying the shape of the dental arch, a pad made of a hydrophilic material of a spongy structure is fixed, used for applying a medicinal preparation, the electrodes are located under this pad, the dental mouth guard in the area of the electrodes is made with an open cutout. The length of the notch can be equal to the distance from the first premolar or second molar on one side of the dental arch to the first premolar or second molar on the other side of the dental arch, respectively.

The electrodes can be made in the form of metal plates or each electrode can be a braided conductive part of an electrical wire, which is unbraided with the distribution of the wires that form it over the surface of the dental mouth guard.

The specified features are interconnected and are essential to form a stable set of essential features sufficient to obtain the required technical result.

This utility model is illustrated by a specific example of implementation, which, however, is not the only possible one, but clearly demonstrates the possibility of achieving the required technical result.

Fig. 1 is a general view of the claimed dental device; Fig. 2 is an example of the arrangement of the gasket; Fig. 3 is an example of the implementation of the electrode in the form of a loose braided wire sheath; Fig. 4 is an example of the implementation of the electrode in the form of a thin metal plate.

According to this utility model, the design of a dental device in the form of an individual dental-gingival electrode for electrophoresis/galvanization (organic chelating compounds - complexones, fluorine, calcium, phosphorus compounds, etc.) with a regulator/power supply unit is considered. This individual device is installed on the patient's jaw independently without the help of a specialist.

In general, a dental device for carrying out physiotherapy (Fig. 1) contains a dental mouth guard 1 made according to a model of the patient's jaw, U-shaped in plan and corresponding to the shape of the dental arch and adjacent soft tissues. The mouth guard is installed/put on from above onto the dental row of the jaw. Two electrodes 2 and 3 are mounted in the mouthguard, placed opposite each other on the inner surface of the cavity of the dental mouthguard. These electrodes are connected to wires 4 and 5, which carry contact connectors 6 on the end parts for connection to a source of direct current (not shown).

The peculiarity of the device is that on the surface of the recess 7 (Fig. 2) running along the length of the dental tray, which displays the external shape of the dental row, a pad 8 made of a hydrophilic material of a spongy structure is fixed, used for applying the medicinal preparation. And the electrodes 2 and 3 are located under this pad.

In addition, the dental mouth guard 1 in the area of the electrodes is made with an open cutout 9. This open cutout is essentially a technological element in the mouth guard, the location and size of this cutout along the length of the mouth guard may vary depending on the anatomical features of each patient. The main purpose of the cutout is to ensure the flexibility (elasticity) of the structure in cases of changes in the shape of the jaw (for example, its expansion) during treatment. This became possible as a result of the use of an elastic polymer.

The mouth guard for electrophoresis/galvanization is made according to the patient's jaw model. In general, a dental mouth guard is a three-dimensional molded body, essentially U-shaped in plan, and corresponding to the shape of the dental arch and adjacent soft tissues. The mouth guard is a reflection of the maxillary or mandibular dental arch. The mouth guard has a cutout (through hole), the location and size of which along the length can vary depending on the anatomical features of each patient. For example, the cutout can be from the first premolar to the first premolar, or from the second molar to the second molar. This area of the cutout is determined in each case individually in order to:

1) ensuring optimal fixation of the mouth guard on the jaw,

2) its uniform adhesion to the gingival area, 3) giving flexibility (elasticity) to the structure in cases of jaw shape changes (e.g., its expansion) during orthodontic treatment, which ensures the possibility of long-term use in cases of jaw shape changes (e.g., its expansion). During orthodontic treatment, thanks to electrophoresis procedures with organic chelating compounds, tooth movement occurs 4-5 times faster, which causes rapid changes in the anatomy of the jaw. The cutout of the cap allows its use throughout the entire treatment cycle, without requiring replacement. That is, it is possible to use one cap instead of several.

4) reducing the effect of the drug on individual areas.

5) to pass one of the wires 4 and 5, the electrode of which is located on the inside of the jaw.

The mouthguard is made from thermoforming plates, which are used in the manufacture of aligners and retainers. This is a plastic material made of medical multilayer polyurethane plastic. The chemical composition is polyethylene terephthalate glycol, it can also be polyethylene terephthalate glycol or Duran, or others based on vinyl acetate, any variety of modern plastics for thermoforming aligners.

The pad is a hydrophilic material, a special sponge made of cellulose fibers, protecting the mucous membrane from electrolysis products that occur during therapeutic effects. The fine spongy structure facilitates rapid uniform impregnation with the medicinal solution and its uniform release.

The use of a spongy pad allows the drug to be reliably retained in the pores of the material. When the mouth guard is put on the jaw, the pad is elastically compressed, which leads to the removal of the drug from the superficial pores. After putting on and removing the force from the mouth guard, under the action of elastic forces the pad straightens out and is sucked to the gum/tooth surface by its pores. Due to this, the mouthguard is held well on the jaw. In addition, when the mouthguard is placed on the jaw, the medicine is pumped through the pores and spreads over the pad, as a result of which the medicine held by the pores of the structure does not leak out from under the lower edge of the mouthguard even if this lower edge does not fit tightly. In this case, the medicine is distributed evenly over the pad, flowing from areas of increased volume to areas with insufficient pore filling. The purpose of the pad is to improve the conduction of current and protect the mucous membrane from irritants that are produced on the electrodes.

Fig. 2 shows an example of the placement of a gasket partially covering the surface of the recess. It is possible to use a gasket that completely covers the surface of the recess.

Thanks to its shape, which takes into account the morphology, the mouth guard with a lining is clearly fixed on the jaw and ensures a tight and uniform fit to the mucosal surface with the help of the installed lining and/or the gel applied to it.

The wires (current leads) are inserted from the outer surface of the mouthguard and pass through its body to the inner surface. As a possible embodiment of the electrodes, the ends of the conductive core of the wire, freed from insulation, are brought out to the inner surface of the mouthguard and act as electrodes that form an electric field. In this case, the braided conductive core brought out along the inner surface of the mouthguard is an electrode and can be unbraided (fluffed up) with the distribution of the wires 10 that form it over the surface of the mouthguard (Fig. 3). Also, a contact plate 11, or a contact petal (Fig. 4) can be soldered to the end of the wire. However, to achieve the effect, the wires of the conductive core are sufficient. In this case, the wires (their core) do not touch the places of the gum mucosa exposed from insulation due to the use of a gasket that covers them. The wires 10 or the plates 11 act as electrodes when interacting with the solution or gel, delivering the active substance to the tissue. The contact plate or contact petals can be made of tin foil, sheet lead, tin, stainless steel, carbon-graphite fabric pressed into plastic, a metal plate poured into conductive rubber, rubber (conductive latex) and graphite (disposable graphitized paper plates).

After the mouth guard is installed on the jaw, the electrode wires are connected to the power supply or connectors of the electrophoresis device. Switch on and adjust the current strength with the regulator until a slight tingling sensation appears. The procedure is performed using continuous direct electric current of low voltage (30-80 V) and low strength (up to 50 mA). Current density indicators are in the range from 0.02 to 0.3 mA/cm2. Portable devices such as Potok, Elfor, Elfor Prof or other similar devices that generate direct or various types of low-frequency pulsed currents are used, for example, standard batteries. When performing medicinal electrophoresis, the pad is moistened with a solution of the medicinal substance or moistened with water and the gel is applied.

This utility model is industrially applicable, tested and has shown good results in terms of good self-retention on the jaw. It has become possible to reduce the volume of the drug applied to the pad due to the fact that the new design allows the use of the full volume of the applied drug without it leaking.

Claims

Formula 1. A dental device for performing physiotherapy, comprising a U-shaped dental splint made from polyurethane plastic based on a model of the patient's jaw and corresponding to the shape of the dental arch and adjacent soft tissues for installation on top of the dental arch of the jaw, as well as two electrodes placed opposite each other on the inner surface of the recess of the dental splint and connected to wires for connection to a source of direct current, characterized in that a pad made of a hydrophilic material with a spongy structure is fixed to the surface of the recess running along the length of the dental splint, which displays the shape of the dental arch, used for applying a medicinal product, the electrodes are located under this pad, and the dental splint in the area of the electrodes is made with an open cutout. 2. The device according to item 1, characterized in that the length of the cutout is equal to the distance from the first premolar on one side of the dental row to the first premolar on the other side of the dental row. 3. The device according to item 1, characterized in that the length of the cutout is equal to the distance from the second molar on one side of the dental row to the second molar on the other side of the dental row. 4. The device according to item 1, characterized in that the electrodes are made in the form of metal plates. 5. The device according to item 1, characterized in that each electrode is a braided conductive part of an electrical wire, which is unbraided with the distribution of the wires forming it over the surface of the dental mouth guard.