Intraoral device for creating a sensation of contact, method for applying an intraoral device, and method for determining the thickness of an intraoral device

Abstract

This invention presents an intraoral device for generation of contact perception between teeth, the device being configured for application to the upper or lower dental arch of a user and comprising a contact means (20, 20′) configured to be associated with at least a portion of one to four posterior teeth (D1) of the upper or lower dental arch, the device (10) being configured to generate a perception of contact to the user upon the contact between the contact means (20, 20′) and at least a portion of the opposing arch to at least a portion of one to four posterior teeth (D1), offering the option of an accessible intraoral device for practical use to the user, and that does not impair the mouth functions of the user during its use in the waking period. This invention further comprises a method of applying the device which allows the user to apply the device without assistance of a skilled professional, and a method for determining the thickness of the aforesaid device.

Claims

1. A device configured to be applied as a splint to an upper or lower dental arch of a user, covering at least a portion of one to four posterior teeth, the device having a thickness less than a distance between the user's upper and lower dental arches when a jaw of the user is in a resting state, and wherein the thickness is at least of a width to cause contact against the upper and lower dental arches perceptible to the user upon tightening of the user's jaw.

2. The device of claim 1, configured to assume a surface shape of at least a portion of one to four opposing teeth with which it is associated.

3. The device of claim 1, comprising a portion having a state of malleability and a portion having a state of rigidity.

4. The device of claim 3, characterized in that the malleability state is achieved when the device is subjected to a softening temperature range.

5. The device of claim 4, characterized in that at least a portion of the device comprising a contact means, when in the malleability state, assumes a surface shape of at least a portion of one to four opposing teeth upon its deformation by pressing the contact means against at least a portion of the one to four opposing teeth to with which it is associated.

6. The device of claim 1, comprising a thickness between 0.5 and 10.0 millimeters.

7. The device of claim 1, comprising a thickness between 1.0 and 8.0 millimeters.

8. The device of claim 1, comprising a thickness between 2.0 and 7.0 millimeters.

9. The device of claim 1, comprising a thickness between 2.0 and 4.5 millimeters.

10. The device of claim 1, comprising at least partially a metallic filament.

11. The device of claim 1, comprising a rigid surface and a moldable surface, the moldable surface comprising a state of rigidity and a state of malleability.

12. The device of claim 11, characterized in that the rigid surface is removable.

13. The device of claim 11, comprising between the rigid surface and the moldable surface, a pressure sensor, wherein the pressure sensor is configured to send a signal to an application of a mobile device upon a contact of the upper and lower arches, and wherein the application is configured to record upper and lower arch contacts.

14. The device of claim 1, further comprising a pair of magnets disposed on an outer face of a pair of proximal teeth such that the magnets are brought together upon tightening of the user's jaw, the magnets being configured to send a signal to a receiving/transmitting unit upon approximation between the magnets.

15. The device of claim 13, characterized in that the receiving/transmitting unit is configured to send information relating to a time and frequency of reception of the signal to an application of a mobile device.

16. A method to determine a thickness to make a device applied as a splint to an upper or lower dental arch, the method comprising steps of: continuously monitoring a load acting on masticatory muscles of the user; gradually moving the user's jaw towards opening and/or closing; identifying a minimum load acting on the masticatory muscles of the user; measuring a distance between the user's upper and lower arches corresponding to the minimum load acting on the user's masticatory muscles; and determining the thickness to make the device according to the distance measured between the upper and the lower arches of the user corresponding to the minimum load acting on the user's masticatory muscles.

17. The method of claim 16, further comprising steps of: continuously monitoring the distance between the user's upper and lower arches; and identifying the distance between the user's upper and lower arches corresponding to the minimum load acting on the user's masticatory muscles.

18. The method of claim 16, further comprising emitting a sound and/or luminous signal whose frequency and/or intensity is determined by the load acting on the masticatory muscles of the user.

Description

SUMMARIZED DESCRIPTION OF DRAWINGS

(1) This invention will hereinafter be more fully described based on an example of operation shown in the drawings. The figures show:

(2) FIG. 1—it is a perspective view of the intraoral device of this invention in its preferred configuration;

(3) FIG. 2—it is a perspective view of the intraoral device of this invention in a first alternative configuration;

(4) FIG. 3A—it is a top view of the intraoral device of this invention in its preferred configuration;

(5) FIG. 3B—it is a side view of the intraoral device of this invention in its preferred configuration;

(6) FIG. 4—it is a top view of a lower arch of a user with the device of this invention applied thereto;

(7) FIG. 5A—it is a side view of the face of a user detailing the positioning of the intraoral device of this invention on the upper arch in a situation of no contact with an opposing tooth;

(8) FIG. 5B—it is a side view of the face of a user detailing the positioning of the intraoral device of this invention on the upper arch in a situation of contact with an opposing tooth;

(9) FIG. 6—it is a side view of the face of a user detailing the positioning of the intraoral device of this invention in a second preferred configuration, on the upper arch;

(10) FIG. 7—it is a side view of the face of a user detailing the positioning of the intraoral device of this invention in a third preferred configuration, on the upper arch;

(11) FIG. 8A—it is a perspective view of a molding plate to manufacture the device of this invention;

(12) FIG. 8B—it is a perspective view of a molding plate to manufacture the device of this invention in the shape of the portion of the user's arch molded on its surface;

(13) FIG. 8C—it is a perspective view of the device of this invention after having been obtained from the molding plate;

(14) FIG. 9A—it is a top view of a molding plate to manufacture the device of this invention;

(15) FIG. 9B—it is a top view of a molding plate to manufacture the device of this invention in the shape of the portion of the user's arch molded on its surface;

(16) FIG. 9C—it is a top view of the device of this invention after having been obtained from the molding plate;

(17) FIG. 10A—it is a side view of a molding plate to manufacture the device of this invention;

(18) FIG. 10B—it is a side view of a molding plate to manufacture the device of this invention in the shape of the portion of the user's arch molded on its surface;

(19) FIG. 10C—it is a side view of the device of this invention after having been obtained from the molding plate;

DETAILED DESCRIPTION OF THE FIGURES

(20) It is first clarified that intraoral device 10 is designed for awake (daytime) treatment by generating a contact perception between the device and at least one opposing tooth in real time for the user's instant understanding and immediate control of parafunctions. In other words, the tightening of the jaw is immediately perceived and interrupted by the patient with the use of this device.

(21) The intraoral device of this invention is configured to be applied to the upper or lower dental arch of a user, preferably at the rear of the arch, to be arranged in opposition to the other arch, i.e., opposite the opposing teeth. For a better understanding of this invention, the term “opposing tooth” is to be understood as any tooth on the arch opposite the arch to which the device of this invention is applied.

(22) Essentially, intraoral device 10 of this invention comprises a contact means 20, 20′ configured to be associated with at least a portion of one to four posterior teeth D1 of the user's upper or lower arch. Said device 10 is further configured to generate a perception of contact to the user upon the touch/contact of the contact means 20, 20′ to an opposing tooth of the arch to which said device 10 is associated.

(23) More specifically, the splints 20, 20′ are designed to cover the occlusal and lateral surfaces of up to four posterior prosthetic teeth or crowns D1, as more fully seen in FIGS. 5A and 5B, and can be placed on both the right and left sides of the dental arch, either in the upper or lower arch.

(24) The number of teeth covered by device 10 depends on the anatomy of each user's arch. During development studies of this invention, it has been determined that covering at most four teeth of the arch is the ideal situation for maintaining oral functionality (such as speech, salivation ability, among others) and patient aesthetics, as well as to maintain the perception of a slight but efficient contact as perceived by the user.

(25) In addition, a portion of one to four overlapping teeth allows to avoid a very large load on a single area of the arch, such as, for example, an area comprising a prosthesis which is, of course, more fragile than an actual tooth, thus preventing its breakage.

(26) In particular, to ensure a comfortable and efficient use of this invention, the contact means 20, 20′ has a thickness that is less than the distance between the upper and lower arches of the user in a situation of lower load on the jaw (more specifically, on the masticatory muscles) of the user. This situation of lower load corresponds to the resting state of the jaw, that is, its natural position when not being actively used. It is understood, therefore, that the occurrence of parafunctions depends on the closure of the jaw beyond this resting state, which requires the use of device 10 of this invention.

(27) Thus, device 10 is configured so that the thickness of the contact means 20, 20′ is less than the distance of the arch at rest, so that the user has the perception of contact only in case a parafunction occurs.

(28) In a preferred configuration, and as can be seen in FIG. 1, said intraoral device 10 comprises a splint 20. Such splint 20 may be integrally or partially composed by a number of different materials, such as acrylic resin, thermoplastic material, metal, silicone or any other biocompatible material.

(29) Particularly, to ensure a better fit and to make the use of device 10 comfortable to the user, the contact means 20, 20′ comprises a shape that covers the surface of at least a portion of the teeth D1 to which device 10 is associated. This feature of a shape that covers the portion of the teeth D1 allows an accurate fit of device 10 on the user's arch, ensuring a comfortable use thereof. FIG. 4 shows a top view of the arch of a user with device 10 associated with a portion of teeth D1.

(30) To obtain such a shape, the contact means 20, 20′ of device 10 may, in particular, be molded into the shape of the user's arch surface in a variety of ways. It is possible, for example, to mold the contact means 20, 20′ by using a replica of the user's arch in the laboratory. It is also possible to have a dental professional mold the contact means 20, 20′ directly in the patient's mouth.

(31) Notwithstanding the foregoing, a material of particular relevance for the construction of splint 20 in this preferred configuration of device 10 is thermoplastic material, which comprises a state of rigidity and a state of malleability, wherein the malleability state is configured when the material is subjected to a softening temperature range.

(32) Thermoplastic materials are widely known by the state of the art, and it is also known that the softening temperature range changes drastically between one material and another. Therefore, further details of this material will not be explored in this application, it being understood only that a thermoplastic material whose softening temperature is bearable to the user upon insertion of device 10 inside their mouth within said gap is applicable.

(33) In this sense, device 10 may have its contact means 20, 20′ made of thermoplastic material, which can be easily handled and shaped by the manipulation of its temperature. Although a dental practitioner may assist the user in this molding, this invention allows the user to perform the molding of the splint for it to fit in their arch, by using the construction and the arrangement of device 10 and the material in its constitution.

(34) More specifically, the molding of the contact means 20, 20′ into the shape of the user's arch surface can be particularly accomplished by pressing the contact means 20, 20′ against the portion of the rear teeth D1 chosen. Thus, the contact means 20, 20′ takes the shape of the surface of the desired portion of the arch, configuring an efficient fit.

(35) This molding method can be used for materials with a malleable state and a rigid state, such as acrylic resin and thermoplastic materials. For thermoplastic materials, and in accordance with what this invention proposes, the user him or herself can perform the molding and application in an intuitive and practical manner.

(36) In this sense, the user can purchase a P splint of thermoplastic material (easily distributed material that can be supplied in suitable establishments such as pharmacies), whose temperature range is intended for this use. A representation of this splint is illustrated in FIGS. 8A, 9A and 10A, noting that such representation is merely intended to exemplify the construction and use of the splint, such representation not being a mandatory way for achieving the objects of this invention.

(37) The heating of the material can be done in any available way, such as dipping in hot water. After reaching the softening temperature range of the thermoplastic material, splint P can then be inserted into the mouth by the user, and the molding is accomplished by pressing splint P against the portion of one to four teeth D1 by the user him or herself. FIGS. 8B, 9B and 10B illustrate the state of splint P after it has been pressed against said portion.

(38) The pressing can be carried out by manually pushing splint P against the teeth D1, or if the user bites the splint after it has been positioned adjacent to the teeth, or by any other suitable means. Thus, splint P takes the shape of the surface of the arch. Finally, splint P is hardened, usually by cooling the thermoplastic material, and the edges of splint P are adjusted by cutting and sanding, for greater user comfort, thus obtaining the final shape of device 10. FIGS. 8C, 9C and 10C illustrate device 10 obtained after the adjustment stage.

(39) Again, these procedures for applying device 10 of this invention may be performed by the user without the help of a dental practitioner or any other person, although the intervention of the practitioner per se is not an impediment to the application of the procedure.

(40) It is further emphasized that the contact means 20, 20′ (particularly a splint 20, 20′) may have only a portion of its structure consisting of thermoplastic material. Such a construction is desirable mainly in cases where the molding is performed through a user bite, so that the opposing arch does not interfere with the modeling of the chosen arch, i.e. so that the contact means 20, 20′ is not pressed by the opposing arch and takes the shape thereof.

(41) An alternative configuration of device 10 of this invention, shown in FIG. 2, and in more detail in FIGS. 6 and 7, comprises only a portion of the contact means 20′ made of thermoplastic material. More specifically, the contact means 20′ comprises a rigid surface 21′ and a moldable surface 22′ opposite each other.

(42) The rigid surface may be a rigid material or a material that has a state of permanent stiffness after molding, such as acrylic resin. The moldable surface comprises a state of stiffness and a state of malleability, the state of malleability being particularly configured through a softening temperature, for example using thermoplastic material.

(43) As in the case of the above-mentioned preferred configuration, the contact means 20′ in its first alternative configuration is associated with a portion of one to four rear teeth D1 of the user's upper or lower arch, taking the shape of the surface of this portion. However, in this first alternative configuration, the molding of the contact means 20′ is done by pressing the moldable surface 22′ against the portion of the teeth D1.

(44) The presence of the rigid portion 21′ on the surface opposite the arch to which device 10 is applied prevents the user's bite (or any other means used to press the contact means 20′) from altering the shape of this surface, thereby allowing the obtainment of a contact means 20′ whose surface that will touch the opposing tooth is not impaired by the opposing arch, allowing a more practical application and a better contact perception of the final product.

(45) It should also be noted that the rigid surface 22′ may be removable or permanent, i.e. it may serve only as a tool to prevent the deformation of the surface of device 10 or also as an integral part of the contact portion with the opposing tooth. In the case of a permanent rigid surface 22′, it may be pre-molded into a suitable contact shape, such as a uniform surface or the surface shape of the portion of one to four teeth D1 chosen for the application of device 10.

(46) FIG. 6 shows a second alternative configuration of the device of this invention. In this configuration, device 10 comprises a contact means 20′ made up of a rigid surface 21′ and a moldable surface 22′, like the first alternative configuration shown in FIG. 2.

(47) In addition, this second alternative configuration receives, between the rigid surface 21′ and the moldable surface 22′, a pressure sensor S1 connected to an application AP installed on mobile devices DM, the mobile device being either a smartphone, a tablet or another device. Pressure sensor S1 is configured to detect the generation of contact perception to the user upon the touching of device 10 on any opposing tooth and sends information to the application AP via a wireless signal Sn. In this way, each time the opposing tooth touches the plate 20′, the sensor S1 will emit a signal Sn which will be captured by the application AP.

(48) In this second preferred configuration, the application AP has the function of mapping all the daily contacts that can cause the aforementioned disorders and helping a dental professional as well as the patient him or herself to reduce those habits.

(49) This application AP also allows the patient to manually enter, through the data collected by the sensor, the time, intensity, frequency, pattern and location of the discomfort or pain, thus enabling, through this monitoring, a more accurate diagnosis and treatment of these dysfunctions.

(50) FIG. 7 shows a third alternative configuration of the device of this invention. The device comprises a contact means 20, 20′ (splint) placed on the user's arch as seen in the other configurations. Additionally, device 10 comprises a pair of magnets 41, 42 each installed on the outer surface of a pair of proximal teeth D2, D3, i.e., close to the region where device 10 will be applied.

(51) Said magnets 41, 42, when brought together by the tightening between the upper and lower arches, create a magnetic field which emits a signal Sn1 to a receiving/transmitting unit 50 which may be positioned in a location external to the mouth, for example, behind the ear.

(52) Thus, when the patient contracts their muscles, the Sn1 signals are picked up by the unit 50 which transmits this information to the application AP, installed on mobile devices DM and mapping all the daily contacts and at what time and frequency they occur.

(53) Device 10 of this invention further comprises a fourth alternate configuration, wherein the contact means 20, 20′ comprises a structure, at least partially, preferably consisting of metal filaments. As for the splints in the other configurations of the device, the structure is disposed on at least a portion of up to four rear teeth D1 of the upper or lower dental arch and is configured to be fitted on the enamel of tooth D1 and to adopt the anatomical shape of the portion of the teeth D1. Such a structure can be used to promote a better fitting of the contact means 20, 20′ to the portion of the teeth D1 by means of metal projections configured to fit on the sides of the teeth.

(54) In any of the above configurations, preferably, and as best identified in FIGS. 1 to 3B, the contact means 20, 20′ are sized with a thickness “s” between 0.5 and 10.0 mm; a width “x” between 6 and 10 mm; a height “t” between 3 and 5 mm; and a length “y” between 10 and 40 mm.

(55) In particular, the thickness “s” of the contact means comprises specific intervals covering different thicknesses of device 10 for application in or by different users, as each gap considers a range of specific distances between the user's upper and lower arches. These ranges will be explored in detail further on.

(56) More specifically, a user understands a jaw positioning state in which there is a minimum load on their masticatory muscles. This state, hereafter referred to as the “resting state of the jaw”, represents the positioning of the jaw (and hence the upper and lower arches) when it is not actively being used, which accounts for most of the state of the jaw during the waking period. Of course, any unconscious movement of the jaw during its resting state reflects a parafunction that must be corrected.

(57) For the detection of parafunctions by device 10 of the present invention to be as efficient as possible, the thickness of the contact means 20, 20′ should be determined according to the distance between the upper and lower arches during the resting state of the jaw. Briefly, the thickness of the contact means 20, 20′ should be slightly less than said distance, so that it does not produce the contact perception during this resting state but can produce such perception upon the slightest indication of occurrence of parafunction.

(58) In this way, the device of this invention comprises several thickness ranges for various possible distances between the arches of a user.

(59) It is emphasized that in any of the aforesaid configurations, device 10 allows the perception of contact between device 10 and at least a portion of the opposing arch to the arch to which device 10 is applied, allowing the user to identify the unconscious approach of the arches and, consequently, the occurrence of a parafunction. Having the knowledge of the approximation of the teeth, the user moves them to a position such as that of FIG. 5A, where there is no perception of contact, and is continuously made aware to avoid the occurrence of bruxism-related parafunctions.

(60) It should also be noted that the device of this invention does not impair the normal oral functionalities of the user, and does not influence the aesthetics of their mouth, thanks to its small size and arrangement.

(61) Considering the foregoing, it becomes clear that the device of this invention promotes the perception of contact between said device and the opposing teeth of the opposing arch, assisting the user in detecting and correcting the parafunctions leading to the various temporomandibular disorders.

(62) At the same time, the device of this invention allows this correction of the parafunctions in a manner that does not impair the user's mouth functions, and it also maintains the aesthetic of the mouth intact. The reduced size and the specific arrangement of the device also allow practicality in its use, as well as ease of manufacture and reduced cost of the device.

(63) It should be noted that, during the use of the device, dental contact that occurs during swallowing of the patient's saliva should be considered functional, and that during this act, if the individual has the device in position, the contact on the splint is considered normal. In this sense, any other contact can be considered parafunctional, and these are the contacts that must be controlled and reversed.

(64) Studies performed by the application of device 10 of this invention on users have given some feedback about applications that exceed expectations related only to bruxism and correlates. These are: The use of the intraoral device of this invention allows the reduction of TMJ inflammation and orofacial and cervical myalgias caused by constant muscle contraction which, consequently, lead to fatigue in musculature and joint disorders as well as inflammation in the soft tissues adjacent to TMJ, local swelling and compression of the internal ear artery. The decrease in this inflammation can control the presence of possible ringing in the ears. In fact, local swelling caused by inflammation of the TMJ, such as capsulitis, for example, could press noble structures of the inner ear, such as the artery and nerve endings of this organ and lead to a secondary auditory disorder, such as tinnitus.

(65) The decrease in muscle contraction obtained by the biofeedback treatment of real-time immediate perception of involuntary contractions by use of the device of this invention allows for facial relaxation and consequent reduction of expression lines, commonly known as the nose to mouth wrinkles (nasolabial folds); The dental application of the device in question reeducates and controls the movements of involuntary contractions, allowing the substantial reduction of functional and aesthetic problems such as reduction of crown and prosthesis breakdown, pathological tooth movement, dental wear, cervical lesions (loss of enamel in the cervical region), periodontal problems associated with mechanical stress; The device of this invention promotes aid in the treatment of periodontal problems by reducing the mechanical load between the dental arches though the use of the innovative intraoral device, reducing tooth loss; The use of the intraoral device of this invention promotes the obligatory spacing between the dental arches, helping the patient to maintain their Free Functional Space, preventing onychophagia, that is, nail biting, since for this it is necessary to have pressure between the arches; when the user is using the device, this is therefore prevented; and The use of the intraoral device of this invention decreases the patient's state of permanent and chronic pain in the regions and organs mentioned above, it also acts in the Central Nervous System decreasing its sensitization, thus attenuating the perception of other existing pains.

(66) In order to prove the effectiveness of this invention, the results of clinical trials performed with users of this device, each presenting different symptoms related to temporomandibular disorders, are presented below, with a return to evaluate the improvement scheduled for 7, 30 and 90 days after the beginning of the treatment:

(67) TABLE-US-00001 User 1 Symptoms Headaches for more than 10 years Beginning of the Aug. 13, 2016 Treatment Level of pain before Level 8 the treatment (0 to 10) 1.sup.st Return (7 days) Level of improvement of the main complaint: 8 (from 0 to 10). The user informed that they felt more tightening between 11am and 2pm. 2.sup.nd Return (30 days) Level of use of the device of this invention: almost every day. Patient assessment: They did not have any more headaches. Level of improvement of the main complaint (from 0 to 10): 10 (ten). 3.sup.rd Return (90 days) Level of use of the device of this invention: almost every day. Patient assessment: They did not have any more headaches. Level of improvement of the main complaint (from 0 to 10): 10 (ten).

(68) TABLE-US-00002 User 2 Symptoms Ringing in the ear and severe headaches for more than 5 years. Beginning of the Aug. 13, 2016 Treatment Level of pain before Level 7 the treatment (0 to 10) 1.sup.st Return (7 days) Evaluation of supposed improvement. 2.sup.nd Return (30 days) Level of use of the device of this invention: every day. Patient assessment: There were no more ringing in the ear or headaches. Level of improvement of the main complaint (from 0 to 10): 9 (nine). 3.sup.rd Return (90 days) Level of use: almost every day. Patient assessment: Did not have any ringing in the ear or headaches. Level of improvement of the main complaint (from 0 to 10): 10 (ten).

(69) TABLE-US-00003 User 3 Symptoms Bruxism, muscle tension and headaches. Beginning of the Aug. 20, 2016 Treatment Level of pain before Level 9 the treatment (0 to 10) 1.sup.st Return (7 days) Evaluation of improvement: there was greater perception of the tightening. The user recognizes a “retraining of the brain” to “move away the teeth”. 2.sup.nd Return (30 days) Level of use in 30 days: 20 days. Patient assessment: There were no more ringing in the ear or headaches. Level of improvement after treatment (from 0 to 10): 10 (ten). 3.sup.rd Return (90 days) Level of use: almost every day. Patient assessment: Did not have any ringing in the ear or headaches. Level of improvement after treatment (from 0 to 10): 10 (ten).

(70) The results above show that this invention is effective in treating different temporomandibular disorders, and FIG. 8 shows a graph summarizing the statistical results of the tests performed.

(71) Additionally, this invention comprises a method for applying an intraoral device 10 as described above, which comprises essentially the following steps: molding the contact means 20, 20′ into a shape that covers the surface of at least a portion of one to four posterior teeth D1 of the user's upper or lower arch; and attaching the contact means to at least a portion of one to four posterior teeth D1 of the user's upper or lower arch.

(72) For devices 10 consisting at least partly of a thermoplastic material, the method of application further comprises the following step: softening at least a portion of the contact means by heating it to a softening temperature range.

(73) For devices 10 incorporating the use of material having a rigid state and a malleable state, the method of application further comprises the following step: pressing the contact means 20, 20′ against a portion of one to four posterior teeth D1 of the user's upper or lower arch.

(74) If the malleable state results from the heating of the contact means 20, 20′, the method further comprises the following step: pressing the contact means 20, 20′ against the portion of one to four posterior teeth D1 of the user's upper or lower arch when at least a portion of the contact means 20, 20′ is in the softening temperature range.

(75) And for materials with rigid and malleable states, the method of application further comprises the following step: hardening at least a softened portion of the contact means 20, 20′.

(76) Moreover, as previously described, for the detection of parafunctions by device 10 of the present invention to be as efficient as possible, the thickness of the contact means 20, 20′ should be determined according to the distance between the upper and lower arches during the resting state of the jaw.

(77) In accordance with this need, this invention further comprises a method of determining the thickness of an intraoral device such as the aforesaid, which essentially comprises the steps of: Continuously monitoring the load acting on the user's masticatory muscles;

(78) This first stage comprises obtaining information, in real time, relative to the load acting on the user's masticatory muscles, preferably by means of sensors. The monitoring of the load can be performed through procedures such as electromyography or electromyography, or any other procedure that allows for the monitoring of the loads acting on the masticatory muscles in real time.

(79) In the case of electromyography, which is the preferred procedure, the user has electrodes placed on the surface of the temporal and masseter muscles. The electrical impulses emitted by the muscles are captured by the electrodes and sent to a computer, which interprets and displays the images on a screen or similar.

(80) Next, there is the stage of: gradually moving the user's jaw towards opening and/or closing.

(81) At this stage, the user is asked to open and/or close their jaw gradually. By maintaining the monitoring of the load acting on the masticatory muscles, we will obtain information about the intensity of the load acting on each position of the user's jaw.

(82) After that, there is the next step: identifying the minimum load acting on the masticatory muscles of the user.

(83) Once the load information is obtained for each position of the user's jaw, it is identified at which point the acting load is minimum. This point corresponds to the aforementioned “resting state of the jaw,” which corresponds to the state in which the user maintains their jaw during most of the waking period.

(84) Once the minimum working load point has been identified, the following step is followed: measuring the distance between the user's upper and lower arches corresponding to the minimum load acting on the user's masticatory muscles.

(85) Once the minimum working load point is identified, the user returns to the aperture corresponding to this point, and then measures the distance between its corresponding upper and lower arches of this specific aperture. This distance will then correspond to the “resting distance” of the jaw, in which the user remains during most of their waking period. The resting distance between the upper and lower arches of a user is commonly in the range of 0.5 to 10.0 millimeters, particularly being between 1.0 and 8.0 millimeters, and even more particularly between 2.0 to 7.0 mm or even 2.0 to 4.5 mm.

(86) The measurement of the distance be performed, for example, by a millimeter compass (commonly referred to as “Sprung Divider” or by the introduction of a mass of silicone between the user's arches at the point of resting distance thereof. The silicone mass adopts a thickness of the same value of the resting distance and, after its solidification, said thickness is measured.

(87) Finally, we move on to the next step: determining the thickness of device 10 according to the distance measured between the upper and the lower arches of the user corresponding to the minimum load acting on the user's masticatory muscles.

(88) Having the resting distance of the jaw, the thickness of device 10 is determined according to this distance. In general, the thickness of device 10 will have a value slightly less than the value of the resting distance of the user's jaw, to prevent the perception of contact from occurring in the resting state of the jaw, while allowing consistent contact of device 10 to the opposing arch during the occurrence of parafunctions. However, the value of the thickness may be at most the value of the measured resting distance, so that the resting position of the user's jaw is not compromised.

(89) Having described an example of preferred configuration, it should be understood that the scope of this invention encompasses other possible variations, being limited only by the content of the appended claims, including possible equivalents thereto.