Occlusion fork device with impression material pumping device

Abstract

An occlusal fork or tray device with channels for facilitating flow of impression material through a base plate when held within the oral cavity of a patient to obtain an occlusal record or impression consisting of a full or local tooth impression or a full or local gingival impression or alveolar bone or alveolar process or alveolar ridge or a combination of these. A method of using the system for the prescription, design or manufacture of an appliance by providing the necessary steps.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims priority to U.S. patent application No. 17 / 952,992, filed on September 26, 2022, the entire contents of which are incorporated herein by reference.

[0003] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0004] The work upon which this application disclosure is based was not funded by any federally sponsored research or development in the United States of America. Background Art Technical Field

[0005] The present invention relates to instruments for dental evaluation or intervention for designing and fabricating aligners, dentures and oral appliances or mouth guards for preventing snoring, sleep apnea, bruxism or similar other conditions, and more particularly to a bite fork or bite rest that can be used for bite registration to achieve bite classification, jaw classification or bite curvature measurement.

[0006] Description of Related Technology

[0007] It is well known and documented that the bite fork or bite rest is a useful instrument platform for recording the position of the maxillary teeth or upper teeth relative to the skull base. Mechanical and other jaw simulators often use the information obtained with the bite fork to design and manufacture aligners, dentures, and other oral or orthodontic appliances. The typical first step in manufacturing an orthodontic or orthopedic appliance (also known as an oral appliance) for a closed bite situation is to obtain what is commonly known as a "constructed bite" or "jaw relationship" recorded using a bite fork (and therefore also referred to as a bite fork record or bite record). Because proper alignment of a person's teeth and jaws in relation to the manufactured appliance is critical, a device for conveniently and accurately capturing the bite record is important to eliminate or minimize potential misalignments.

[0008] Some of the information obtained through bite registration with a bite fork is well known and established in the art. Broadly speaking, a bite registration helps estimate or measure a person's jaw class, bite class, or bite curvature (also known as jaw relationship). One or more of these classifications may be relevant to the design and manufacture of an appropriate oral appliance.

[0009] Bite classification or jaw relationship usually includes the so-called vertical dimension of occlusion (VDO) which represents the relationship between the upper or maxillary arch and the lower or mandibular arch of the human dentition. VDO is the vertical dimension of occlusion, while VDR is the vertical dimension of occlusion considered when the person or patient is completely relaxed. The difference between VDO and VDR is called the "resting gap" or interocclusal space. When manufacturing dental appliances we manufacture within these boundaries and the bite fork allows us to measure this range correctly, which is why our bite forks also come in different thicknesses, from 0.5mm to 10mm, suitable for verifying the person's VDO and in addition optionally verifying the resting gap that is suitable for the specific appliance that is prescribed, designed or manufactured. For example, some appliances, such as night guards do not require much "resting gap", in which case we use a thinner bite fork. For other appliances, we may need a thicker bite fork. Therefore, the choice of bite fork is also based on the appliance that is prescribed, designed or manufactured.

[0010] Generally, there are five types of bite classification: class I bite, class II bite or overbite, class II one-part, class II two-part, class III bite or crossbite, or other emerging categories. Bite classification is essential for evaluating malocclusion, which is known in the art as the incorrect relationship or misalignment between the teeth of the lower or mandibular dental arch and the teeth of the upper or maxillary dental arch as they approach each other as the person's jaw closes. Although Edward Angle's classification (Angle E. "Classification of Malocclusions," Encyclopedia of Dentistry, 1899; 41: 248-64) is the most popular, there are several subsequent and emerging classifications known in the art.

[0011] Jaw classification determines the relationship of the alveolar bone to the human dentition and includes three types of classifications, including primary, secondary, and tertiary, or other emerging classifications (Graber TM., Principles and Practice of Orthodontics, 3rd ed., Philadelphia, WB Saunders Publishers, 1972, pp. 155-6; Unger JW., Comparison of vertical morphometry in edentulous and dentate patients, Journal of Prosthodontics, August 1990, Vol. 64 (No. 2): pp. 232-4)

[0012] The occlusal curvature or jaw relationship curvature includes three types of curves, including Wilson curve, Spee curve, Monson curve or other emerging curves (Kagaya K, Minami I, Nakamura T, Sato M, Ueno T, Igarashi Y, "Three-dimensional analysis of occlusal curvature in healthy Japanese young adults", Journal of Oral Rehabilitation, 2009, Vol. 36: 257-63; Ferrario VF, Sforza C, Miani A Jr., "Statistical evaluation of the Monson sphere in healthy permanent human dentition", Archives of Oral Biology, 1997, Vol. 42: 365-9; Patil P., "Monson curve, a century later, is still relevant", International Journal of Restorative and Prosthetic Dentistry, 2022, Vol. 11 (Issue 3): 110).

[0013] Typically, a bite fork is approximately horseshoe-shaped to conform to the shape of a human dental arch, coated or loaded with a semi-solid impression material on the outside, and placed in a person's mouth between the maxillary and mandibular teeth. The patient is then asked to bite down on the bite fork, thereby forming a mold of the impression material that captures an impression of the patient's teeth.

[0014] Several bite forks have been disclosed that include features that improve ease of use, stability, the ability to scan teeth while taking a bite registration, and other such inventive steps.

[0015] Adell, in U.S. Patent No. 5,346,395, dated September 13, 1994, entitled "Dental Arch Occlusal Registration Device," describes a device comprising a multilayer structure made of ethylene vinyl acetate, one layer bonded to another layer using an injection molding method without the use of any adhesive, wherein different layers have different durometer properties.

[0016] Jacobs and Jacobs, in U.S. Pat. No. 5,562,449, dated October 8, 1996, entitled "Customized Dental Trays," describe a double dental tray assembly comprising a flexible, resilient outer dental tray using a thin inner tray of preformed thermoplastic material nested within the flexible outer tray. While Jacobs' disclosure is not directly related to the bite fork of the presently disclosed subject matter, the use of thermoplastic materials has a commonality in that both trays are heated to a temperature between 145°-160° Fahrenheit causing the inner tray to become more moldable, thereby allowing the inner tray to be accurately formed on the patient's teeth. Subsequent cooling to room temperature causes the tray to become hard and rigid, retaining the acquired shape.

[0017] Patent application DE 20105234 U1 published on July 5, 2001 and entitled "Ready-to-use bite fork for single use in dental technology" describes a bite fork with a U-shaped bite part and a holding part as well as a partial reference pad support and an anti-twist carrier.

[0018] Karapetyan, in U.S. Patent No. 7,220,123, dated May 22, 2007, entitled "Device for Dental Bite Registration," describes a two-piece device for dental bite registration, each piece being generally of semi-U-shaped configuration, coupled to each other to form a complete U-shape, with means in the handle to lock them together.

[0019] Patent application DE202011105953U1 entitled “Bite Fork and Bite Sampling Kit” published on October 20, 2011 describes a bite fork with an impression material, which has a bite registration part with a first fastening device, and a position marking part with a second fastening device matching the first fastening device, and the position marking part is detachably connected to the bite registration part.

[0020] Patent application DE202015105356U1 entitled "Bite fork with strips" published on October 12, 2016 describes a bite fork with occlusal grooves to enable partial visualization of the tooth surface by 3D surface scanners and markings when the bite fork is placed in the patient's mouth. In a substantially similar disclosure, Brunner describes in patent publication EP2964136B1 dated March 10, 2021 entitled "Bite fork with grooves" (the earlier version also published was WO 2014 / 135160 on September 12, 2014) a bite fork comprising: a first processing device for associating a tooth surface image and bite fork position data to provide a real space coordinate image of the tooth surface, an auxiliary bite plate to be attached to the tooth with other position marking elements, a second position detection device of other position marking elements suitable for continuous position detection of the auxiliary bite plate during dentition movement, and corresponding processing means.

[0021] Kopp, in U.S. Patent No. 8,123,521, dated February 28, 2012, and entitled "Device for Recording Protruding Mandibular Position," describes a bite fork-type device, albeit for the different purpose of recording a protruding mandibular position relative to a normal position, but with a U-shaped impression plate having a finger-like recording surface.

[0022] Kerschensteiner and Christen, in U.S. Patent No. 10,299,898, dated May 28, 2019, entitled "Method for Preparing a Partial or Full Dental Prosthesis," describe a broad method for preparing a dental prosthesis, including preparing a bite plate or bite fork, and describing a review of the Angle occlusal classification (Angle classification as described in Handbook of Dental Technology, Vol. 1, ed. A. Hohmann / W. Hielscher, Quintessenzverlag, pp. 130 / 131).

[0023] Charkhandeh, in U.S. Patent No. 10,751,153, dated August 25, 2020, entitled "Device and method for recording digital dental occlusion," describes another configuration of a bite fork for obtaining a digital open bite recording, including at least one molar pad and at least one incisor pad, each pad having a respective upper and lower occlusal surface, with the alternative being a strip extending between the molar pad and the incisor pad. The application of this patent is primarily directed to the manufacture of oral appliances for patients with obstructive sleep apnea (OSA).

[0024] Ackel describes a method for molding a dental tray in U.S. Patent No. 11,096,764, dated August 24, 2021, entitled "Dental tray molding kit and dental molding method", which includes providing a universal tray, heating a thermoformable member until it is sufficiently flexible, placing the thermoformable member on the universal tray, placing a deformable spacing member on the thermoformable member, applying a bite force from a user to the thermoformable member through the deformable spacing member, cooling the thermoformable member and separating the thermoformable member, so that the thermoformable member forms a customized dental tray. Here, a bite fork is provided as a component part of the dental tray molding kit.

[0025] However, these and other similar bite forks require the impression material to be applied manually externally onto the surface of the bite fork without any more efficient and controlled method of doing the same. Manual application by a spoon, putty applicator or spoon-type device does not ensure uniform and just enough distribution of the impression material on the occlusal surface. Furthermore, most bite forks currently available do not have the flexibility to conform to the curvature of the bite. Summary of the invention

[0026] Description of the Purpose of the Invention

[0027] An object of the present invention is to improve the convenience, quality and accuracy of applying impression material to one or more surfaces of a bite fork device. Since bite forks are a very common and widely used device in the field of oral appliance design and manufacturing, its improvement has a significant and significant impact on users of the device. Bite forks are used by dental professionals, including dentists, orthodontists, prosthodontists, denture technicians, etc., for the prescription of various orthodontic appliances, such as aligners, retainers, night guards or mouth guards, sleep apnea treatment oral appliances (such as mandibular advancement devices or braces), anti-snoring devices, dentures, etc. Bite forks can also be used by the user or patient at home or in a clinical setting, possibly following written, oral or other instructions from the professional. As an example, let us consider two major markets where dentists and denture technicians use bite forks: aligners and dentures.

[0028] According to SEC filings (U.S. Securities and Exchange Commission, Registration No. 333, Form S-1 filed on August 16, 2019), the major emerging market share holders for aligners are Inc.’s submission indicated that the global orthodontic market is estimated to be approximately 500 million people, with the U.S. market leading the way at approximately 124 million people. The submission also assumes that perhaps 85% of the world’s population suffers from malocclusion, with less than 1% receiving treatment only annually, leaving significant room for future expansion of this market. Since bite registration is an important step in aligner design and manufacturing, this is a significant opportunity to improve functionality and user convenience during the patient’s bite registration. As so-called clear aligners are poised to emerge as direct-to-consumer (DTC) orthodontics, e.g. With new entrants such as Inc. leading the way (Wexler et al., “Direct-to-Consumer Orthodontics: Investigating User Experience,” Journal of the American Dental Association, August 2020, Vol. 151(No. 8): 625-636, 4 pages of electronic supplementary material; doi:10.1016 / j.adaj.2020.02.025), user experience has become more important in terms of ease of use features.

[0029] According to several estimates cited in the Journal of Prosthodontics, an estimated 37.9 million Americans will need dentures in 2020 (Douglass et al., "Will the United States Still Need Complete Dentures in 2020?", Journal of Prosthodontics, January 2002, Vol. 87 (No. 1): pp. 5-8, doi: 10.1067 / mpr.2002.121203). This is almost 9% of the U.S. population. Because the Canadian population is approximately 0.11 of the U.S. population (Simon Fraser University, Comparative Populations of Canada, the United States, and Mexico: A Fact Sheet, World Population), assuming similar North American demographics, the estimated number of Canadian denture users is 4.17 million, bringing the potential applications of the improved benefits of the disclosed invention to approximately 42 million. The overall bite fork user market is much larger than this, probably about three times this number, considering that the younger population also needs devices such as aligners, mouth guards, anti-snoring, obstructive sleep apnea therapy devices and several other oral or orthodontic appliances that require a bite registration as a preliminary step as mentioned above. By providing features in bite forks that make it easier and faster to perform bite registration with them, use less impression material by applying an even and just enough amount, and achieve flexibility in capturing the curvature of the bite registration, we will provide a groundbreaking solution that is not currently available on the market.

[0030] Thus, we can conclude from this brief statement of the purpose of the present invention that it would be of great benefit to fill a much desired gap in the art by providing an improved solution for the large number of bite fork users involved in oral appliance design and manufacture.

[0031] Key points of the invention

[0032] Preferred embodiments of the disclosed invention provide additional features in the bite fork base plate to facilitate easy connection to a source of impression material (a means for pumping impression material through channels inside the base plate) to achieve seepage of material from holes or openings on the base plate where a bite impression is particularly desired. The pumping process can be completed after the base plate is inserted into the patient's mouth. This method achieves uniform distribution of impression material while minimizing the amount of impression material by pumping just the necessary and sufficient amount of impression material.

[0033] According to one aspect of the invention, the bite fork base plate can be equipped with a snap-on connection, threading or clamping mechanism, such as a worm clamp or a spring clamp, to facilitate connection and disconnection between the base plate and the impression material source. According to another aspect of the invention, the impression material source can be integrated with a manual pumping mechanism to pressurize the flow of material into the bite fork. In addition, or alternatively, the pumping mechanism can be driven by an integrated miniaturized electric pump. It will be appreciated by those skilled in the art that there can be several configurations of locations where the pump is integrated with the impression material source and the bite fork base plate, such as directly pressurizing the impression material or indirectly pressurizing it, such as by air or hydraulic pressure from a relatively remote location, so that the bite fork assembly is lightweight and compact when maintained in a person's mouth.

[0034] According to another aspect of the invention, the substrate has internal or external channels to facilitate the passage and flow of impression material from a source to a destination area where bite registration is achieved. Optionally, but preferably, the channel may be internal and cylindrical. Other shapes of channels may also be used, such as square or rectangular or triangular, or oval cross-sections, as they are conveniently achieved if the substrate is manufactured using additive manufacturing or 3D printing technology (which is the preferred manufacturing mode in the present invention). However, within the spirit and scope of the present invention, other manufacturing modes are also included, such as injection molding or milling and drilling or other methods that may be available in the most advanced technology, although they may have limitations, for example, if formed by drilling, the channel may only be cylindrical and made of a lightweight, flexible biocompatible material, such as nylon-12 or a stretchable biocompatible elastomer. The substrate can be manufactured by several alternative methods, such as molding, 3D printing or additive manufacturing or milling.

[0035] The bite fork base plate can be made of a lightweight, flexible, biocompatible material, such as nylon-12 or a stretchable biocompatible elastomer. Broadly speaking, the base plate can be made of a plastic material, such as biocompatible polyamides, polyolefins, polyesters, fluoropolymers, elastomers, parylene, polystyrene, biopolymers, resins, and several other combinations and reinforced hybrids. Preferably, but optionally, the bite fork base plate can be made of a biocompatible thermoplastic, such as polyoxymethylene, methacrylate, or ethylene vinyl acetate, such as manufactured by Epoxy Labs of Wilmington, Delaware, USA. Manufactured by Elvax250.

[0036] According to another aspect of the invention, alternatively, but in addition, the pumped impression material may be formed of a multi-layer hybrid construction, wherein a tougher (when cured and hardened) impression material layer forms a core to provide strength and stability in the impression area in contact with the teeth or gums, on which a softer impression material is layered, allowing a combination of strength and flexibility. The softer material, if restrained by a barrier device around the impression area, may act as a spring to ensure a tighter and more compact and thereby more accurate bite registration. The multi-layer construction may be achieved by several alternative pumping methods, such as pumping different impression materials simultaneously from different channels, and pumping different impression materials sequentially from the same channel.

[0037] According to an additional but optional aspect of the invention, one or more guide plates, valves or other devices or combinations thereof are used sequentially or simultaneously to achieve controlled distribution of the ejection of the impression material from the different openings. Optionally, the control of the ejection of the material is based on feedback from at least one or more sensors.

[0038] According to another additional but alternative method of use of the present invention, a person's occlusal or jaw relationship classification can be obtained to determine malocclusion by recording the vertical distance of the occlusal relative to the upper and lower arches of the person's dentition. Additionally, but alternatively, a person's jaw classification can be obtained to determine the relationship of the alveolar bone relative to the person's dentition. Further, additionally, but alternatively, an occlusal curvature or jaw relationship curvature can also be obtained.

[0039] In summary, the disclosed inventive bite fork device with means for pumping impression material provides significant improvements and advantages over those generally described in the prior art, in particular more convenient application with just the right impression material. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 An overall assembly block diagram view of an embodiment of the present invention is shown, with a bite fork base plate, connections to sources of one or more components of impression material through a mixer unit, various sources of impression material, and a representative amount of impression material pumped on the base plate of the bite fork.

[0041] Figure 2 A perspective view of a typical non-edge-to-edge double-bow bite fork base plate is shown.

[0042] Figure 3 Shows Figure 2 A plan view of the bottom of the body without showing the crop, or cut, and retention lines.

[0043] Figure 4 Shows Figure 3 Side view or side view -P.

[0044] Figure 5 Shown in Figure 4 The cross-sectional view at section BB shows a typical impression material flow channel configuration of a typical non-edge-to-edge double-bow bite fork substrate.

[0045] Figure 6 A slight perspective view (near top view) of a typical edge-to-edge double-bow bite fork base plate is shown.

[0046] Figure 7 Shows Figure 6 Side view or side view -Q.

[0047] Figure 8 A perspective view of a typical single-bow bite fork base plate is shown.

[0048] Fig. 9 Shows Figure 8 Flat top view.

[0049] Fig.10 Shows Fig. 9 Side view or side view-R.

[0050] Fig.11 Shown in Fig.10 The same cross-sectional view at section CC and section DD of , shows a typical impression material flow channel configuration of a typical single-arch bite fork substrate.

[0051] Fig.12 A typical edentulous gingival configuration is shown in which inserts have been implanted to receive a denture set at the maxillary and mandibular surfaces of the patient.

[0052] Fig.13 An exemplary flow chart showing the steps involved in an exemplary method for using one of the embodiments of the system of the present invention.

[0053] Fig.14A Shows Figure 2 An alternative embodiment has an integrated connection between the engaging fork and part of the mixer unit outlet.

[0054] Fig. 14B Shows Fig.14A A perspective view of an alternative embodiment of the invention with emphasis on the integrated connection.

[0055] Fig.15 Shows Figure 8 An alternative embodiment has an integrated connection between the engaging fork and part of the mixer unit outlet.

[0056] Fig.16A , Fig. 16B and Fig. 16CPhotographs showing perspective, top and bottom views, respectively, of a typical disclosed bite fork after an impression material has been pumped through a base plate and a bite registration of a patient has been obtained on the base plate.

[0057] Fig.16D yes Fig. 16C Close-up view of.

[0058] Fig.16E and Fig.16F is from Fig.16A Photo of an example stereogram as seen from the end side.

[0059] Fig.17A and Fig. 17B They are Figure 2 Photographs of the top and bottom views of the bite fork diagram shown.

[0060] Fig. 17C and Fig.17D They are respectively Figure 2 Photographs of top and bottom views of a version of a snap fork similar to that shown, but with an optional alternative construction having a cylindrical hole opening instead of a slotted opening.

[0061] Fig.18 The bite fork is shown slightly curved after the occlusal curvature or jaw relationship curvature has been recorded.

[0062] Fig.19 An example of a partial construction of a bite fork or bite rest is shown.

[0063] Fig. 20 An example of a bite rest is shown, providing a thin mesh at the middle portion to facilitate close approximation of the maxillary and mandibular arches during occlusion. DETAILED DESCRIPTION

[0064] Figure 1An overall assembly block diagram view of an embodiment of the present invention is shown, for use with a complete set of mandibular dentures 20 and maxillary dentures 30, with a bite fork base plate 60 inserted therebetween, a connection 70 to a source of one or more components of the impression material through a mixer unit 75, sources of impression material 80 and 81, a piston rod 90, a pressure applying platen 91, a representative amount of impression material 85 pumped on the base plate of the bite fork. The bite fork base plate may be equipped with a snap-on connection, threads or a clamping mechanism, such as a worm clamp or a spring clamp, to facilitate connection and disconnection between the base plate and the source of impression material, thereby facilitating modularity and multiple uses. The snap-on connection may have different configurations and shapes, such as cylindrical, conical, spherical or other geometries that may make the connection rigid or flexible as required. Optionally, it has been found that an integrated version has better reliability when the impression material flow is pressurized through the system because it cannot be disconnected unexpectedly. The impression material source may be integrated with a manual pumping mechanism to pressurize the material flow into the bite fork. Additionally, and optionally, the pumping mechanism may be driven by an integrated miniaturized electric pump. It will be appreciated by those skilled in the art that there may be several configurations of locations where the pump is integrated with the impression material source and the bite fork base plate, such as directly pressurizing the impression material or indirectly pressurizing it, such as by air or hydraulic pressure from a relatively remote location, so that the bite fork assembly is lightweight and compact when held within a person's oral cavity. Alternatively, and additionally, the integrated pumping device with the impression material may be a single use and disposable alternative embodiment.

[0065] The figure shows the construction of mandibular and maxillary dentures in relation to the user's mandible and maxilla, respectively, indicating the location of different anatomical sites of interest relative to the disclosed inventive aspects of a bite fork for bite registration. The user's jaws are shown in an open position so that the interior portion of the user's mouth can be seen, as well as a view of the bite fork base plate inserted and retained therebetween. The mandible has a lower gingival (also known as gum) portion 10 placed on a bone structure 11 in the mandible. The bone structure extends to the back as a temporomandibular joint (TMJ) 15, including portions of the condyle 12, fossa 13 and articular disc 14 as are well known in the art. The mandibular denture 20 is placed on the lower gum 10 with a reasonably tight but comfortable fit and remains fixed during the user's daily activities (e.g., speaking, chewing, etc.). In a standard denture that does not use any implants to secure the denture to the mandible, the shape and fit between the mandible and the mandibular denture serves as retention.

[0066] The user can often choose to increase the level of retention, for example, by inserting or coating a biocompatible, human-safe adhesive material between the denture 20 and the gums 10 that has several properties: for example, zinc-free, impermeable, providing a soft cushion, a seal to prevent the ingress of food particles, exudate control, using natural ingredients such as gum wax, beneficial herbs and vitamins. There are several adhesive products available, such as, Denture adhesive paste (manufacturer: Prestige Consumer Healthcare, Irvington, New York; source: Amazon, U.S.), Ultra-strong and durable denture adhesive (Procter & Cincinnati, Ohio, USA Sensitive adhesive (CuttingEdge International, LLC, Los Angeles, California, USA), Instant Smile TM Secure Fit Adhesive (Billy Bob Products Inc., Hardin, IL, USA), Super Denture and partial denture adhesive paste (Glaxo Smith Kline, Philadelphia, Pennsylvania, USA), Denture adhesive paste (Glaxo SmithKline, Bulgaria; source: Amazon, USA), Y-Kelin denture adhesive paste (Anhui Kelin Healthcare Technology Co., Ltd., Bengbu, Anhui Province, China), Lower Denture Relining Kit (OTC Dental Inc., Vancouver, WA, USA), and many other manufacturers or sources.

[0067] According to reported studies, good average retention forces can be obtained using adhesives between dentures and gums, for example, ranging from 16.66 ± 7.32 lbs for milled denture bases to 12.19 ± 6.15 lbs for conventional heat-polymerized denture bases (AlHelal, Abdulaziz Abdullah, "Comparison of Retention of Milled Denture Bases and Conventional Denture Bases: A Clinical Study" (2016), Loma Linda University Electronic Theses, Dissertations and Projects, 323). Our experimental tests showed that 3D printed dentures provide better retention, or at least comparable retention to milled denture bases. We found this retention force to be sufficient to withstand mandibular advancement forces reported in the art, which are approximately 1 to 1.2 Newtons per millimeter of mandibular advancement (e.g., 1.18 Newtons per millimeter according to J Cohen-Levy, B Pételle, J Pinguet, E Limerat, B Fleury, Sleep Breathing, May 2013; Vol. 17(No. 2): pp. 781-9, doi: 10.1007 / s11325-012-0765-4. Published online: Sep 11, 2012).

[0068] The mandibular denture 20 includes an outer wall or flange 21, an outer ridge or border 22, and an inner ridge or border 23. A cavity, referred to in the art as a trough, is formed between the outer wall and the inner wall, which is fitted on the lower gum 10. The tooth group 25 replacing the natural teeth, termed in the art as (starting from the rear or temporomandibular joint side, tooth group, one on the left and one on the right) second molars, first molars, second premolars, first premolars, canines or cuspids, lateral incisors, and central incisors (the most anterior tooth group), are symmetrically embedded in the mandibular denture in a U-shaped configuration. This is in view of the mainstream trend that there is no third molar or wisdom tooth at the rearmost position, like the natural teeth that the dental profession recommends to be extracted, so there are a total of 14 teeth in the mandibular denture.

[0069] Similar to the mandibular denture 20, the maxillary denture 30 includes an outer wall or flange 31, an outer ridge or border 32, and an inner ridge or border 33. A cavity, known in the art as a groove, is formed between the outer wall and the inner wall, which fits on the upper gum 16. Typically, an impression of the upper palate of the user's mouth is obtained to provide a bridge between the inner walls on the left and right sides of the inner wall in the maxillary denture. This bridging portion, known as the palate 34, is typically in close contact with the user's upper palate, helping to improve the retention of the maxillary denture. The maxillary denture 30 is placed on the upper gum 16 with a relatively tight but comfortable fit and remains fixed during the user's daily activities (such as speaking, chewing, etc.). In a standard denture that does not use any implants to fix the denture to the maxillary bone, the shape and fit between the maxilla and the maxillary denture and the palate contact play a role in retention. The user can often choose to increase the level of retention, for example, by inserting or coating a biocompatible, human-safe adhesive material between the denture 30 and the gums 16, which has several of the properties mentioned above in the context of the mandibular denture. The tooth set 35 replacing the natural teeth, termed in the art as (starting from the posterior or temporomandibular joint side, the tooth set, one on the left and one on the right) the second molars, first molars, second premolars, first premolars, canines or canines, lateral incisors, and central incisors (the most anterior tooth set), are symmetrically embedded in the maxillary denture in a U-shaped configuration. This is in view of the prevailing trend of not having third molars or wisdom teeth in the rearmost position, like the natural teeth that the dental profession recommends to be extracted, so there are a total of 14 teeth in the maxillary denture.

[0070] While the above-described case of complete dentures using a bite fork for bite registration is helpful in checking the suitability of existing or old dentures and in designing and manufacturing better fitting, updated or new denture sets, the bite fork invented by the present invention has wider application for people with a full mouth of natural teeth. In these cases, we can consider Figure 1 The denture related features are not included, such as 30-34 in the maxilla and 20-23 in the mandible. The maxillary tooth set 35 and the mandibular tooth set 25 will be natural teeth well known in the art, termed in the art as (starting from the posterior or temporomandibular joint side, tooth set, one on the left and one on the right) second molars, first molars, second premolars, first premolars, canines or canines, lateral incisors, and central incisors (the most anterior tooth set), symmetrically embedded in the maxillary and mandibular, respectively, in a U-shaped configuration.

[0071] Figure 1 The configuration can also be used in edentulous cases, where the patient has no natural teeth in the upper or lower jaw and the person currently does not have any functional dentures. In this case, during biting down on the bite fork base plate to achieve bite registration, the bite fork will directly contact the lower gum 10, or the upper gum 16, or generally the lower and upper gums.

[0072] The disclosed bite fork or bite tray can be more conveniently used by dental professionals, including dentists, orthodontists, prosthodontists, denture technicians, etc., for prescription of various orthodontic appliances, such as aligners, retainers, night guards or mouth guards, sleep apnea treatment oral appliances (such as mandibular advancement devices or brackets), anti-snoring devices, dentures, etc. The disclosed bite fork or bite tray can also be used in conjunction with an analog or digital face bow. The bite fork can also be used by the user or patient at home or in a clinical setting, possibly following guidance from a professional. It can be issued to the patient as a stand-alone kit or as part of an impression tray kit.

[0073] Broadly speaking, preferred embodiments of the disclosed system facilitate obtaining a bite registration within a person's oral cavity, the bite registration consisting of a full or partial dental impression or a full or partial gingival impression or the alveolar bone or the alveolar process or the alveolar ridge or a combination of these. The edentulous maxillary and mandibular portion (EJS) consists of the alveolar bone and the basal bone. The EJS is classified as non-aesthetic and aesthetic maxillary or mandibular regions because the so-called non-aesthetic zones differ significantly from the aesthetic zones in terms of requirements and risks for achieving aesthetic results. The alveolar bone or the alveolar process or the alveolar ridge is a term used to describe the relationship of the captured associated soft tissue or exposed surface layer relative to the dentition of a person or patient.

[0074] In an additional optional embodiment, the disclosed system can also be used as a dental impression holder. In this optional embodiment, an additional sealing device is used to limit the flow of the impression material around the teeth or gums to control and strengthen the contact pressure between the teeth or gums or alveolar bones or alveolar processes or alveolar ridges and the impression material to obtain a relatively more accurate and representative impression.

[0075] The bite record obtained and / or the dental arch impression obtained is for a bite or jaw relationship classification, or a jaw classification, or a bite and jaw classification, which classification helps in prescribing or designing or manufacturing a denture set such as a removable partial denture or a removable complete denture, or helps in manufacturing an oral appliance to be worn on natural teeth or prosthetic teeth, or on a combination of natural teeth and prosthetic teeth in the case of an anti-snoring device, a mandibular advancement device, an aligner, or a mouth protector or a variety of oral appliances.

[0076] Three different bite fork types and uses are disclosed; namely, edge-to-edge double arch, non-edge-to-edge double arch, and single arch. The edge-to-edge double arch type can be used in situations where the upper and lower arch incisors meet in parallel paths or are aligned with each other. The non-edge-to-edge double arch type bite fork can be used in situations where it is desired that the patient be able to bite in any position including fully retruded, natural to fully protruded, or maximally advanced. The double arch bite fork is typically used to obtain a bite registration or impression, or to obtain a treatment position for a double arch appliance, such as mandibular advancement devices (MADs) or a night guard or mouth guard that covers the upper and lower arches. The appropriate treatment position for the oral appliance is defined as a position of the mandible that achieves an improvement in symptoms, signs, or objective indicators of sleep and breathing related disorders (such as obstructive sleep apnea).

[0077] The single arch bite fork is typically used to obtain a bite registration or impression, or to obtain a treatment position for a single arch appliance such as a mouth guard or night guard for only one of the maxillary or mandibular arches. It can be employed in situations where the patient is able to bite in any position including fully retracted, natural to fully protruded or maximally advanced. However, in additional optional embodiments, it can also be used for registration of both arches (maxillary and mandibular portions).

[0078] Figure 2 A perspective view of a typical non-side-to-side double arch bite fork base plate 200 is shown, wherein a horseshoe shape corresponding to a typical mandibular arch or maxillary arch is represented by its portion 210, and a handle portion 215 is connected to a bite registration impression material or other source of impression material for a purpose. The handle portion 215 represents Figure 1 The connection device 70 shown in FIG. 1 and can be connected by a joint, or with a mixer 75 ( Fig.14A , Fig. 14B ) is integrated as a part of the occlusal fork. The opening 211 in the occlusal fork indicates that when the impression material passes through the sectional view ( Figure 5 ) is the exit location of the impression material when it is pumped from the source. These openings can have different shapes, such as Figure 2 The slots shown are in the form of slots, but may take several other shapes, for example, a circular opening with a cylindrical tubular passage shown in another alternative configuration (photo Fig. 17C and 17D). The base plate provided is a single base plate which can be expanded according to the size of the mandibular arch or maxillary arch of a person and further optionally shortened by separating, cutting or truncating one or more ends of the base plate at a truncation groove line or cutting groove line 212 as shown in the figure. In addition, grooves, such as 213, provided on the surface of the base plate help retain the impression material as it flows out of the opening and are therefore called retention lines. The gap is formed by a protrusion 214 on only one side of the base plate in a non-edge-to-edge bite fork, because only one of the maxillary teeth group or the mandibular teeth group is expected to bite into the gap, while the other group is free and bites into the flat surface on the other side of the bite fork.

[0079] Figure 3 for Figure 2 Flat top view of Figure 4 for Figure 3 Side view or side view - P. Figure 2 The notch formed by the protrusion 214 is shown in Figure 4 The 216 is more clearly visible. Figure 5 Depicted in Figure 4 The cross-sectional view at section BB shows a typical impression material flow channel configuration of a typical non-edge-to-edge double-bow bite fork substrate. Fig.17A and Fig. 17B A photograph of a top view and a bottom view of a typical embodiment is presented in FIG. Fig. 17C and Fig.17D They are respectively Figure 2 The figures shown are photographs of top and bottom views of a similar version of a snap fork, but with an optional alternative construction having a circular hole opening rather than a slot-shaped opening.

[0080] It will be understood that the channel path and design 540 are merely examples and that there may be several different modes thereof, all of which are encompassed by the spirit and scope of the present invention. The substrate may have multiple internal channels or external channels or combinations thereof for conveying bite registration material or impression material, and multiple openings for ejecting the material from the openings. Although not shown in this figure, the channels may also be external, where retention and flow of the material are achieved by gravity. In addition, at least one or more guide plates, valves or other devices or combinations thereof may optionally be used sequentially or simultaneously to achieve controlled distribution of the bite registration material or impression material ejected from different openings. In addition, optionally, the material ejection control is based on feedback from at least one or more sensors, which are used in the channel or substrate or in any other part of the flow channel (for example, in connection with a pumping device).

[0081] Figure 6A slight perspective view (near top view) of a typical edge-to-edge double arch bite fork base plate 600 is shown, wherein a horseshoe shape corresponding to a typical mandibular or maxillary arch is represented by portion 620 thereof, and a handle portion 640 is connected to a bite registration material or other source of intended impression material. The base plate provided is a single base plate that can be expanded according to the size of a person's mandibular or maxillary arch, and further optionally shortened by separating, cutting or truncating one or more ends 630 of the base plate, as shown at the chain line in the figure. Grooves 631 on the base plate facilitate providing the cut. In addition, grooves such as 632 provided in the surface of the base plate help retain the impression material as it flows out of the opening, and are therefore called retention lines. Figure 7 Shows Figure 6 A side view or side view-Q of the embodiment of the present invention is shown clearly in this figure, which shows that the typical edge-to-edge double-bow bite fork base plate of the present invention includes notches formed on both sides of the base plate, which is different from the non-edge-to-edge embodiment having a notch on only one side.

[0082] Figure 8 A perspective view of a typical single arch bite fork base plate 800 is shown, wherein a horseshoe shape corresponding to a typical mandibular or maxillary arch is represented by its portion 810, and a handle portion 815 is connected to a bite registration material or other source of impression material for the purpose. In an alternative embodiment ( Fig.15 ), a portion of the mixer outlet is integrated with the handle. The openings 811 and 812 in the bite fork represent the openings 811 and 812 in the bite fork when the impression material passes through the cross-sectional view ( Fig.11 ) shows the exit location of the impression material when channel 1140 is pumped from a source. Fig. 9 Shows Figure 8 Flat top view of Fig.10 Shows Fig. 9 Side view or side view-R.

[0083] Fig.11 Shows Fig.10FIG. 1 is a cross-sectional view of a section CC portion of FIG. 1 , showing a typical impression material flow channel configuration 1140 of a typical single-bow bite fork substrate. It will be appreciated that the channel path and design 1140 are merely exemplary and that there may be several different modes thereof, all of which are within the spirit and scope of the present disclosure. The substrate may have multiple internal channels or external channels or combinations thereof for conveying bite registration material or impression material, and multiple openings for ejecting the material from the openings. Although not shown in this figure, the channels may also be external, where the retention and flow of the material is achieved by gravity. In addition, at least one or more guide plates, valves or other devices or combinations thereof may optionally be used sequentially or simultaneously to achieve controlled distribution of the bite registration material or impression material ejected from different openings. In addition, optionally, the material ejection control is based on feedback from at least one or more sensors. In addition, it will be appreciated by those skilled in the art that the single-bow bite fork substrate may also have different optional configurations, such as non-edge-to-edge and edge-to-edge, by providing notches on only one or both sides of the substrate.

[0084] Fig.12 A typical edentulous gingival configuration is shown in which inserts 810 and 820 have been implanted to receive a denture set at the maxillary and mandibular surfaces of the patient, respectively. Figure 1 Outside of the denture configurations shown, fully implant-supported or fixed dentures are a minority of applications for bite fork registration. Other variations are possible, such as cosmetic prostheses made of porcelain or other materials.

[0085] Fig.13 An exemplary flow chart of the steps involved in an exemplary method for using one of the embodiments of the system of the present invention is shown. It will be understood that the set and order of steps shown in the flow chart are exemplary only and that several different alternative variations thereof are possible, all of which are covered by the spirit and scope of the present disclosure. For example, the substrate may be kept in warm water, or heated by other means (such as warm air) for a shorter or longer time than mentioned in the flow chart. Similarly, for cooling, the substrate may be kept in cold water, or cooled by other means (such as cold air) for a shorter or longer time than mentioned in the flow chart. The sequence of events may also be varied, for example, an initial or preliminary occlusal curvature or jaw relationship curvature may be obtained by directly placing the warmed bite fork substrate between the mandibular and maxillary arches in the oral cavity and biting without connecting a source of impression material to the substrate with a pump. After obtaining the preliminary jaw relationship curvature, the source of impression material may be connected and the other steps may be performed according to the flow chart.

[0086] FIG. 16A to FIG. 16F Several photographic views of an example of a bite registration performed using one of the invented devices and methods are shown.

[0087] It will be understood by those skilled in the art that features such as cut-off lines, retention lines, impression material source or mixer connection integrated with the substrate, and several other features are common optional features applicable to all disclosed embodiments and perceptible variations thereof, and that although they are illustrated and described in this description as examples in specific embodiments, their application to all other variations is covered by the spirit and scope of the invention.

[0088] We have experimented with several substrate materials, stamp materials, and combinations thereof, with and without a dedicated mixer assembly, and with several alternative ways of connecting the source of stamp material to the substrate.

[0089] The bite fork base plate can be made of a lightweight, flexible, biocompatible material, such as nylon-12 or a stretchable biocompatible elastomer. Broadly speaking, the base plate can be made of a plastic material, such as biocompatible polyamides (e.g., nylon-12, nylon 6, nylon 11, nylon 66, polyether block amides), polyolefins (e.g., polyethylene, polypropylene, cyclic olefin copolymers, polyvinyl chloride), polyesters (e.g., polybutylene terephthalate, polyethylene terephthalate), fluoropolymers (e.g., polytetrafluoroethylene known by the trade names Teflon, PVDF, FEP, ePTFE), elastomers (e.g., silicones, thermoplastic elastomers), polyparaxylene (parylene), polystyrenes (e.g., polyoxymethylene, polyurethane), biopolymers, and several other combinations and reinforced hybrid materials. The pumped impression material may be formed of a multi-layer hybrid construction, wherein a tougher (when cured and hardened) impression material layer forms a core to provide strength and stability in the impression area in contact with the teeth or gums, on which a softer impression material is layered, allowing a combination of strength and flexibility. The softer material, if restrained by a barrier device around the impression area, may act as a spring to ensure a tighter and more compact and thereby more accurate bite registration. The multi-layer construction may be achieved by several alternative pumping methods, such as pumping different impression materials simultaneously from different channels, and pumping different impression materials sequentially from the same channel.

[0090] Additionally, the bite forks may optionally be provided in several different colors to assist in categorizing the bite forks according to size ranges. The color coding helps to easily identify the range with the patient's size requirements according to the size of the patient's mandibular or maxillary arch.

[0091] Preferably, but optionally, the bite fork base plate may be made of a biocompatible thermoplastic such as polyoxymethylene, methacrylate, or ethylene vinyl acetate, such as that manufactured by Elvax 250 manufactured. The thermoplastic substrate becomes flexible after being heated for about 60 seconds (e.g. by placing it in warm water or by other alternative heating means, such as placing it in front of a hot air blower or any other heating means requiring less or more duration), is then inserted into the oral cavity of a person, is subsequently bitten by the person for the required duration to achieve a proper registration of the bite curve, is then removed from the oral cavity and optionally further cooled for the required duration if necessary (e.g. by placing it in cold water for 30 to 60 seconds, or by other alternative cooling means, such as placing it in front of a cold air blower or any other cooling means requiring less or more duration) so that the substrate acquires a relatively high rigidity for said bite curve registration. Fig.18 An example photograph showing an edge-to-edge bite fork (with notches on both sides of the base plate), after heating the bite fork, inserting the bite fork between the maxillary and mandibular arches in the patient's mouth and biting, removing the bite fork and cooling it sufficiently to make it rigid, thereby maintaining the bite curve record, so that the bite fork obtains a curved shape. Figure 7 The bite fork is shown in its original straight configuration before it acquires the curvature. Additionally, optionally, the substrate may change color when it transitions from a flexible state to a relatively less flexible state. The presence of a color or shade change when the rigidity or softness of the substrate changes from one state to another is advantageous because it makes it easier to identify the rigid state by visual inspection. Some prototypes were made by 3D printing or additive manufacturing using hard and soft resins (e.g., Keysplint-hard and Keysplint-soft from Keystone Industries of Gibbstown, New Jersey, USA), while injection molding and milling were also used.

[0092] Various bite registration impression materials can be used for bite fork registration or for capturing other impression materials on the left or right side of the patient's upper or maxillary arch and / or lower or mandibular arch. Vinyl polysiloxane (VPS), polyvinyl siloxane (PVS) and alginates are the most commonly used. Broadly speaking, impression materials are divided into rigid or inelastic and elastic. Rigid or inelastic impression materials include impression plasters, impression compounds, impression waxes and zinc oxide eugenol. Elastic impression materials include hydrophilic colloids such as reversible agar and irreversible alginates. Elastomeric impression materials include polyethers, condensed silicones, polyvinyl siloxanes and polysulfides.

[0093] Several examples used in the prototype experiments of the present invention are as follows. Alginate impression material Cavex Color Change TM(Cavex Holland BV, Haarlem, The Netherlands) has elastic and color-changing properties. It changes from purple to pink to indicate the end of the mixing time (30-60 seconds), from pink to white to indicate the end of the setting time (approximately 60 seconds), and from white to pink to indicate that the impression is fully cured (approximately 30 minutes). Products (Maxill, St. Thomas, Ontario, Canada) and Henry Several varieties of the product (Henry Schein, Melville, New York, USA) and several other brands available internationally were also tested. The bite registration material or impression material used with this system is typically a semi-solid or liquid that cures after a period of time, or a mixture of liquids or a mixture of liquid and solid materials that cures after a period of time (e.g., 30 seconds to 30 minutes).

[0094] It will also be appreciated by those skilled in the art that additional and optional configurations of the disclosed invention may enable the embodiments to be variations of additional specific functions covered by the spirit and scope of the disclosed invention. For example, in one variation ( Fig.19 ), only half of the horseshoe shape may be provided to capture an impression of only a portion of the dentition for bite registration. As another example, the bite support variant ( Fig. 20 ) can have a thin grid 2010 between the horseshoe-shaped ridges 2020, thereby achieving close contact between the mandibular arch and the maxillary arch, wherein the impression material flows from an opening on the outside of the wall 2030 of the horseshoe-shaped ridge, or the material circulates around a ring 2035 of the ridge (which can pass through the groove of, for example, an extracted wisdom tooth or other missing tooth), achieving the impression material flowing from an opening in at least a portion of the inner wall 2040.

Claims

1. A system for obtaining a bite registration or impression in a human oral cavity, the bite registration or impression consisting of a full or partial dental impression or a full or partial gingival impression or an alveolar bone or alveolar process or alveolar ridge or a combination of these, the system comprising: means for retaining impression material on at least one or more sides or surfaces of a base plate that is inserted into the oral cavity and retained between the mandibular and maxillary teeth or between the mandibular and maxillary gums; means for facilitating flow of said impression material through said substrate; means for connecting a source of impression material to said substrate; as well as A device for pumping the impression material around the gums or teeth or both to form an impression thereof.

2. The system according to claim 1, wherein the substrate is made of a plastic material, such as a biocompatible polyamide, polyolefin, polyester, fluoropolymer, elastomer, thermoplastic, parylene, polystyrene, biopolymer or several other combinations or reinforced hybrid materials, and optionally provided in several different colors.

3. A system according to claim 1, wherein the substrate becomes flexible when heated, is then inserted into the oral cavity of a person, is subsequently bitten by the person for a desired duration to achieve appropriate registration of a bite curve, is then removed from the oral cavity and optionally further cooled for a desired duration if necessary to enable the substrate to acquire a relatively high rigidity to achieve registration of the bite curve, and further optionally the substrate changes color when changing from a flexible state to a relatively less flexible state.

4. A system according to claim 3, wherein the occlusal curve record is a Wilson curve, or a Spee curve, or a Monson curve, or other curves of interest, or a plurality of such curve records.

5. A system according to claim 1, wherein the provided substrate is a set of different widths and lengths suitable for the size of a person's mandibular arch or maxillary arch and a substrate thickness ranging from 0.5 mm to 10 mm suitable for verifying a person's vertical height of occlusion (VDO), and optionally verifying a resting space, and optionally verifying a treatment oral position or a combination of these suitable for a specific oral appliance prescribed, designed or manufactured.

6. A system according to claim 1, wherein the base plate provided is a single base plate that can be expanded according to the size of a person's mandibular arch or maxillary arch, and can also be optionally shortened by separating, cutting or truncating one or more ends of the base plate.

7. The system of claim 1, wherein the base plate has at least one internal passage for delivering the bite registration material or impression material and at least one opening for ejecting the bite registration material or impression material from the opening.

8. A system according to claim 1, wherein the substrate has a plurality of internal channels or external channels or a combination thereof for conveying the bite registration material or impression material and a plurality of openings for ejecting the material from the openings, and further at least one external channel serves as a retainer for the material to restrict its flow beyond the retaining channel or groove.

9. A system according to claim 8, wherein at least one or more guide plates, valves or other devices or a combination thereof are used sequentially or simultaneously to achieve controlled distribution of the bite registration material or impression material ejected from the different openings, optionally, the control of the material ejection is based on feedback from at least one or more sensors.

10. The system of claim 1, wherein the bite registration material or impression material used with the system is a semi-solid or liquid that solidifies after a period of time, or a mixture of multiple liquids or a mixture of liquid and solid substances that solidifies after a period of time.

11. The system of claim 1 , wherein the means for connecting a source of bite registration material or impression material to the base plate comprises a mixer for mixing components of the impression material.

12. The system according to claim 1, wherein the means for connecting the impression material source to the base plate comprises a snap-on connection or a threaded connection or a clamping connection, and further, optionally, the means can be integrated with or separated from the base plate.

13. The system of claim 1, wherein The base plate may be constructed to obtain only a portion of a bite registration or impression, such as half of an arch or other partial configuration, or The base plate may be constructed with a thin grid in the middle surrounded by ridges on one or more sides to facilitate a tighter fit, or Additional sealing devices are used to limit the flow of the impression material around the tooth or gum to control and strengthen the contact pressure between the tooth or gum or alveolar bone or alveolar process or alveolar ridge and the impression material to obtain a relatively more accurate and representative impression.

14. The system according to claim 1, wherein the bite record obtained is for bite or jaw relationship classification, or jaw classification, or bite and jaw classification, which classification helps to prescribe or design or manufacture a denture set such as a removable partial denture or a removable complete denture, or helps to manufacture oral braces such as aligners, anti-snoring devices, mandibular advancement devices, or mouth protectors or multiple braces worn on the teeth.

15. The system of claim 1, wherein at least one or more components are manufactured by 3D printing or additive manufacturing methods.

16. The system of claim 1, wherein all components are manufactured by 3D printing or additive manufacturing methods or injection molding methods.

17. A system according to claim 13, wherein the impression material mold formed by pumping impression material around the tooth or gum is made of a multi-layer hybrid construction, in which a stronger material layer is the core to provide strength to the impression, and a relatively softer and more flexible biocompatible material is subsequently pumped over the impression to facilitate compression of the enhanced contact pressure.

18. A method of using the system of claim 1 for the prescription or design or manufacture of an appliance by providing the following steps: Selecting for the appliance a base width and length suitable for the mandibular or maxillary arch size of a person and a base thickness suitable for verifying the vertical height of occlusion (VDO) or verifying the resting space or verifying the treatment oral position or a combination of these; connecting the source of bite registration material or impression material and the pump to the base plate; providing sufficient space between a person's mandibular or maxillary arches to facilitate insertion of a baseplate by requiring the arches to be opened relative to each other; inserting the base plate into a person's oral cavity and holding the base plate between mandibular teeth and maxillary teeth or mandibular and maxillary gums or alveolar bones or alveolar processes or alveolar ridges or a combination of these; pumping a necessary and sufficient amount of bite registration material or impression material through the base plate to surround the teeth or gums; The person is asked to bite down on the base plate to obtain one or more impressions of the following bite registration, Clenching in a natural position, and / or Biting in an edge-to-edge position, and / or Clenching in the position of maximum jaw advancement, and / or Bite firmly in the desired neutral and / or treatment position, Clenching at the maximum rearward position; Allow time for the impression mold to cure; requiring a person to slowly open the bite to an appropriate distance for safe removal of the impression mold formed on the substrate; removing the bite registration mold or impression mold and the base plate from the person's mouth; disconnecting the source of bite registration material or impression material and the pump from the base plate; The bite registration or impression mold and the base plate are packaged and shipped to the prescriber, designer or manufacturer of the oral appliance or denture.

19. A method of using the system of claim 3 by providing the following steps: Selecting for the appliance a base width and length suitable for the mandibular or maxillary arch size of a person and a base thickness suitable for verifying the vertical height of occlusion (VDO) or verifying the resting space or verifying the treatment oral position or a combination of these; connecting the source of bite registration material or impression material and the pump to the base plate; placing the substrate under heating conditions for about 60 seconds or until the substrate becomes flexibly deformable; providing sufficient space between a person's mandibular or maxillary arches to facilitate insertion of a baseplate by requiring the arches to be opened relative to each other; inserting the base plate into a person's oral cavity and holding the base plate between mandibular teeth and maxillary teeth or mandibular and maxillary gums or alveolar bones or alveolar processes or alveolar ridges or a combination of these; pumping a necessary and sufficient amount of impression material through the base plate to surround the tooth or gum; The person is asked to bite down on the base plate to obtain one or more impressions of the following bite registration, Clenching in a natural position, and / or Biting in an edge-to-edge position, and / or Clenching in the position of maximum jaw advancement, and / or clenching in the desired neutral and / or treatment position, and / or Clenching at the maximum rearward position; Allow time for the impression mold to cure; requiring a person to slowly open the bite an appropriate distance for safe removal of a bite registration mold or impression mold formed on the substrate; removing the bite registration mold or the impression mold and the base plate from the person's mouth; placing the substrate under cooling conditions for 30 seconds to 60 seconds or for a desired duration to allow the substrate to acquire rigidity; disconnecting the source of impression material and the pump from the base plate; packaging and shipping the impression mold and the base plate to a prescriber, designer or manufacturer of a denture or oral appliance, and additionally or alternatively, The impression mold is scanned using a multi-dimensional scanner, and the scan information is sent in a digital format to a prescriber or designer or manufacturer of the oral appliance or denture.

20. The method of claim 19, wherein one or more of the following is obtained: Occlusal or jaw relationship classification to determine malocclusion by recording the vertical height of the bite in relation to the upper and lower arches of a person's dentition, including five types of categories, including Class I occlusion, Class II occlusion or overbite, Class II one-part, Class II two-part, Class III occlusion or crossbite, or other emerging categories; Jaw classification to determine the relationship of the alveolar bone to the human dentition, including three types of categories, including primary, secondary, and tertiary, or other emerging categories; Occlusal curvature or jaw relationship curvature includes three types of curves, including Wilson curve, Spee curve, Monson curve or other emerging curves.

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