Digital composite biteplate and manufacturing method thereof

Abstract

The invention belongs to the technical field of crossing of oral medical instruments and digital manufacturing, and particularly discloses a digital composite biteplate and a manufacturing method thereof. According to the composite biteplate, the replaceable biteplate parts are arranged and can be replaced in different stages according to different clinical conditions; the shell and the meshing part can be made of soft elastic and hard materials. When the occlusal part is made of a hard material, the occlusal part is the same as a traditional hard occlusal plate, and then the occlusal part is in uniform contact with a jaw dentition through clinical adjustment; when the biteplate is made of a soft elastic material, the biteplate does not need to be blended clinically, can be directly worn, is suitable for remote manufacturing, and is used in an environment without a blending technology and condition; furthermore, the occlusion part of the occlusion plate can also be designed into a left part and a right part which are respectively made of hard and soft materials, so that the occlusion plate is suitable for being used under the condition of clinical abnormal occlusion of rear teeth on two sides; the occlusion part of the occlusion plate can be designed into a stable type or a protraction repositioning type respectively, and is suitable for different clinical conditions respectively.

Description

Technical Field

[0001] This invention belongs to the interdisciplinary field of oral medical devices and digital manufacturing, specifically relating to a digital composite occlusal plate and its manufacturing method. Background Technology

[0002] Occlusal pads can be classified as maxillary or mandibular occlusal pads depending on whether they are worn in the maxillary or mandibular dentition. Their structure mainly consists of two parts: first, a shell covering the dentition, primarily serving as a retainer and support; this shell can completely or partially cover all or part of the posterior dentition, with the latter connected to the anterior teeth via a curved section similar in shape to the anterior dental arch; second, an occlusal surface forming part on the shell corresponding to the occlusal surface of the opposing dentition, which is the main functional part of the occlusal pad. This part can be either a general-purpose or personalized occlusal type. This part can be a pre-prepared flat plate structure, a uniformly thickened occlusal surface of the dentition covered by the shell, or a personalized occlusal surface adapted to the occlusal function of the opposing dentition. The latter can be further divided into occlusal surfaces adapted to static occlusion, such as fixation or positioning guides often used in head and neck surgery, or occlusal surfaces adapted to dynamic occlusion, such as stable occlusal plates often used to treat temporomandibular joint disorders.

[0003] There are several methods for manufacturing occlusal pads, mainly divided into general-purpose and personalized types. The former are mostly standard-sized parts made from the same material and processed into shape, either integrally molded or assembled later. This method can be mass-produced quickly and at a low cost. Occlusal pads made from these pads are mostly used by patients with bruxism. However, because their shape does not conform to the soft and hard tissues in the patient's mouth, they usually have poor retention and comfort. They are not suitable for patients with severe malocclusion, temporomandibular joint disorders, or orofacial pain. Inappropriate occlusal contact can also lead to temporomandibular joint disorders and / or orofacial pain.

[0004] Personalized manufacturing methods can be divided into traditional handmade methods and digital manufacturing methods. The former involves taking an impression inside the mouth, making a plaster model, shaping the bite plate shell on the plaster model, and then shaping the bite surface on the frame or directly inside the mouth, followed by mixing, grinding, and polishing to complete the process. Currently, the most common materials for traditional bite pads on the market include soft resin, hard resin, and a mixture of soft and hard resin. Soft resin-based occlusal pads are mostly made of ethylene-vinyl acetate copolymer (EVA) and are manufactured using vacuum molding. They have good elasticity and are comfortable in the patient's mouth, but this also makes occlusion adjustment difficult. Hard resin-based occlusal pads are mainly made of polymethyl methacrylate (PMMA) and glycol-modified polyethylene terephthalate (PETG). They are widely used because they are relatively hard, have moderate elasticity, and are easy to adjust, making them the most widely used occlusal pad material. They can be used in areas such as temporomandibular joint disorders, orofacial pain, bruxism, and sports braces. Hybrid soft-hard materials mainly consist of an inner layer of soft thermoplastic polyurethane (TPU) resin and an outer layer of hard PETG resin. They are mostly manufactured using molding. Because the inner layer is softer, they are more comfortable and also act as a cushion and splint.

[0005] Traditional occlusal splint fabrication relies on plaster models, facebow transfer, and manual molding, a cumbersome process highly dependent on the technician's experience. Digital occlusal splint technology digitizes this process, improving accuracy, efficiency, and predictability, but also introducing new challenges. The fabrication of digital occlusal splints mainly involves the following three steps: ① Data acquisition stage: acquiring three-dimensional data of the patient's stomatognathic system; ② Computer-aided design (CAD): planning all parameters of the occlusal splint in software; ③ Digital manufacturing stage: producing the occlusal splint through 3D printing or cutting. Because personalized occlusal splints conform to the morphology of the patient's oral soft and hard tissues, they generally offer better fit and comfort, and stronger retention, making them suitable for patients with malocclusion.

[0006] Data acquisition is the first step in the fabrication of digital occlusal splints, with jaw position recording being the most crucial and challenging step. The goal of this step is to obtain an accurate, repeatable, and therapeutic positional relationship between the mandible and maxilla (e.g., relaxed position, stable disc-condylar relationship, etc.) and accurately transfer this spatial relationship to a virtual digital design environment. This position may be determined through manual manipulation, tool assistance, or experience.

[0007] For occlusal plates commonly used in the treatment of temporomandibular joint disorders, due to their certain thickness, the thickness at the lowest point usually varies from 1.0-3.0 mm, gradually increasing from back to front. The vertical occlusal relationship needs to be determined after the plate is raised. Currently, there are several clinically common methods, including: 1. Direct preparation method: This involves placing a wax sheet or occlusal recording silicone rubber material directly on the patient's teeth, guiding the patient to slowly bite down, and stopping the biting once a certain height is reached. The recording material is then removed after it has hardened. The biggest drawback of this method is that it cannot quantitatively raise the occlusion. Patients need repeated training to stabilize the occlusion at a certain height, requiring a high level of clinical skill from the dentist. Furthermore, wax, as a recording material, is easily damaged during transportation, and high temperatures and pressure can deform it, leading to changes in the occlusal record; 2. Using occlusal elevation tools: Currently, commonly used tools on the market include George-Gauge, ProGauge, and Protrusion. Gauge and similar tools typically place occlusal recording material on the horseshoe-shaped end of the tool, guiding the mandible forward through the toothed indentation at the handle to record the occlusal relationship of the upper and lower jaws after mandibular protrusion. These tools are mainly used to obtain occlusal relationships when making anti-snoring devices; their function is relatively limited and they are not suitable for making stable occlusal plates. 3. Virtual articulator elevation: This method directly elevates the occlusion using the built-in digital articulator in CAD software. Because it uses average parameters, it does not perfectly match the patient's actual situation, and the resulting occlusal plates are usually not very accurate, requiring extensive clinical adjustments. 4. Digital facebow: This method is currently considered the most accurate way to obtain occlusion, but the process is extremely cumbersome and time-consuming, and it is not feasible for some patients, limiting its clinical application. 5. Digital twin: This method imports the patient's CT scans, digital models, and other data into specialized software to create a digital virtual human. The physician then adjusts the patient's jaw position and elevates the occlusion directly in the software based on clinical experience. This method is highly sensitive to clinical techniques, and the obtained occlusal relationship often does not match the patient's actual situation, requiring extensive clinical adjustments.

[0008] CAD design is the second step in digital occlusal splint fabrication. It's the core creative process, typically conducted in specialized dental design software (such as 3Shape, Exocad, DentalCAD, etc.) after all data acquisition is complete. The goal of this stage is to translate the treatment concept into a precise, manufacturable, and functionally sound 3D digital model. The design process includes: importing scanned data, setting the placement path, filling undercuts, drawing edge lines, setting occlusal splint parameters, designing the occlusal surface morphology, polishing, and optimizing details. Currently, digital occlusal splints designed in CAD software, whether stabilizing occlusal splints or protrusion repositioning splints, are generally designed as a single unit. When the occlusal surface morphology of the splint changes or its shape needs to be altered for treatment purposes, a redesign and fabrication are often required.

[0009] Digital manufacturing is the third step in the production of digital occlusal plates, mainly divided into additive manufacturing (3D printing) and subtractive manufacturing (CNC machining). 3D printing primarily uses medical-grade transparent PMMA rigid resin, offering high material utilization, rapid mass production, and low cost, but the post-processing is complex, and there is still room for improvement in material toughness. Currently, 3D-printed transparent soft elastic materials based on photocured methacrylate (UDA / UDMA) have also emerged, with performance comparable to TPU or PETG materials used in traditional clear aligners, exhibiting excellent toughness and resilience. CNC machining primarily uses medical-grade transparent or tooth-colored PMMA and polyetheretherketone (PEEK) materials. These materials offer very high and uniform wear resistance, mechanical strength, hardness, and stability, high processing precision, and excellent surface finish, requiring minimal post-processing. However, it suffers from significant material waste, low production efficiency, and high production costs. Both of these processing methods currently can only process the same material simultaneously, and cannot process or are not yet available for multi-layered occlusal plate materials.

[0010] Chinese invention patent (patent number: CN107028670A, publication date: 2017.08.11) discloses a digital occlusal pad made using a self-made jaw balancer. This occlusal pad covers a large portion of the posterior teeth, and both the inner and outer surfaces cover part of the gingival area, resulting in poor comfort. The curved section of the occlusal pad covers the incisal edge of the anterior teeth, which is aesthetically unappealing and can artificially cause the mandible to be in a retracted position, which is not conducive to restoring a normal maxillary-maxillary occlusal relationship. The occlusal pad requires an additional jaw balancer to establish the maxillary-maxillary occlusal relationship during its manufacture, making the clinical procedure more complex. The occlusal pad is ultimately manufactured using a dental carving machine, a process that involves subtractive manufacturing and is relatively wasteful of materials.

[0011] Chinese invention patent (patent number: CN102123678A, publication date: 2011.07.13) discloses a composite occlusal pad made by pressing multiple different materials together. Its manufacturing process is complicated. After the traditional pressing method is completed, the film needs to be cut and the edges of the occlusal pad need to be polished. The composite method has the risk of delamination. When the occlusal pad is heavily worn, it is difficult to repair. In addition, the occlusal pad covers more of the posterior teeth and the inner and outer surfaces cover part of the gingival area, which is not very comfortable.

[0012] Therefore, there is an urgent need for a new type of digital composite interlocking plate and its manufacturing method to solve the problems existing in the above-mentioned technologies. Summary of the Invention

[0013] The purpose of this invention is to overcome the shortcomings of the prior art and provide a digital composite interlocking plate and its manufacturing method.

[0014] The objective of this invention is achieved through the following technical solution: In a first aspect, the present invention provides a digital composite occlusal plate, comprising a shell covering all rows of teeth in a single jaw, and an occlusal portion disposed on the occlusal surface of the shell; The shell and the interlocking part are separate structures designed and manufactured independently using computer-aided design, and can be detachably or permanently combined into one unit through a connecting structure.

[0015] Furthermore, the connection structure includes at least two connecting pins disposed on the mating surface of the housing, and connecting holes disposed on the mating portion corresponding to the positions of the connecting pins. The housing and the mating portion are connected by the mutual engagement of the connecting pins and the connecting holes; or, the housing and the mating portion are connected by the mutual engagement of the connecting pins and the connecting holes, and are fixed by medical adhesive.

[0016] Furthermore, the shell and the engagement part are made of medical-grade rigid resin material or medical-grade soft elastic resin material; The medical rigid resin material includes polymethyl methacrylate (PMMA) or polyether ether ketone (PEEK); the medical soft elastic resin material includes thermoplastic polyurethane (TPU), glycol-modified polyethylene terephthalate (PETG), or a photocurable resin based on photocurable methacrylate (UDA / UDMA).

[0017] Furthermore, the occlusal portion covers three or more consecutive posterior teeth on both sides of the dentition; or, the occlusal portion covers all dentition.

[0018] Secondly, the present invention also provides a method for manufacturing the aforementioned digital composite interlocking plate, comprising the following steps: Step 1: Obtain digital impression data of the patient's dentition and related soft and hard tissues; Step 2: Obtain the patient's digital occlusal relationship data; Step 3: Based on the digital impression data and digital occlusal relationship data, design the three-dimensional models of the shell and the occlusal part respectively in computer-aided design software; Step 4: Based on the three-dimensional model, using subtractive manufacturing and / or additive manufacturing techniques, and selecting resin materials that meet national medical standards, the shell, the interlocking part, and the corresponding connecting joints are processed and manufactured respectively. Step 5: Assemble the completed shell and occlusive parts using a connecting structure to form the digital composite occlusive plate.

[0019] Specifically, in step 1, the methods for obtaining the digital impression data include: Use an intraoral 3D scanner to directly scan the dentition and soft and hard tissues; or... Use an extraoral 3D scanner to scan clinically prepared impressions; or... Plaster models are created by scanning an impression using an intraoral or extraoral 3D scanner.

[0020] Specifically, in step 2, the methods for obtaining the occlusal relationship data include: After using tools such as quantitative occlusal elevation tools, modified anterior occlusal elevation tools, occlusal clamping tools, or spacers to assist in elevating the occlusion, data on the occlusal relationship after elevation can be obtained; alternatively, data can be obtained in CAD software using virtual articulators with average parameters or personalized parameters generated by electronic face bows; or it can be obtained by adjusting digital twin software; or, occlusal wax, occlusal recording silicone rubber, soft elastic sheets, or thermoplastic composite materials can be used to directly elevate the occlusion intraorally and data on the occlusal relationship after elevation can be obtained.

[0021] Preferably, the three-dimensional configuration data of the bite plate designed on computer-aided design (CAD) software can be an integrated design or a combined design divided into a shell and a bite part. The dividing surface has four or more connecting pins and connecting holes with a diameter of 1-3 mm, a height of 1-5 mm, and a spacing of 10-20 mm. Preferably, the three-dimensional configuration data of the occlusal plate designed on the computer-aided design (CAD) software can be designed only for the maxilla or mandible, or it can be designed for both the maxilla and mandible. Preferably, the material used to make the occlusal plate can be a medical rigid material such as PMMA or PEEK, or a medical soft elastic material such as TPU, PETG, or UDA / UDMA.

[0022] Specifically, the bite measurement elevation tool includes a Y-shaped body with an upper part that matches the width of the dental arch. The upper part of the Y-shaped body is detachably connected to a set of bite blocks that facilitate posterior tooth occlusion. The lower part of the Y-shaped body has a first groove for the mandibular guide slider and / or maxillary guide slider. The mandibular guide slider and / or maxillary guide slider are each provided with a locking screw that allows them to be fixed with the first groove.

[0023] Specifically, the improved anterior occlusal elevation tool includes an anterior lingual clamp, which includes a guide ramp and a base plate segment, with an obtuse angle between the guide ramp and the base plate segment; the end edge of the guide ramp is connected to the anterior labial clamp; the guide ramp and the anterior labial clamp are connected by a spring plate.

[0024] Specifically, the bite clamping tool includes a set of symmetrically arranged bite clamps and a handle for easy pressing and holding of the bite clamps. The bite clamps include a clamping part for clamping medical materials and a locking part for providing clamping force. The clamping part is an arc-shaped structure that is easy to adapt to the dental arch. The locking part is hinged to the handle to adjust the opening between the bite clamps.

[0025] The thermoplastic occlusion recording composite material is a multilayer composite material, including an elastic intermediate layer. A first plastic outer layer and a second plastic outer layer are respectively provided on both sides of the elastic intermediate layer. Multiple double frustum through holes are provided on the elastic intermediate layer. Multiple frustum protrusions are provided on the first plastic outer layer and the second plastic outer layer. The frustum protrusions are nested into the double frustum through holes. A micro-locking structure is provided in the double frustum through holes.

[0026] Compared with the prior art, the present invention has the following beneficial effects: The composite occlusal plate of the present invention, by setting a replaceable occlusal part, can be replaced according to different clinical conditions and stages, and its structure and form are very flexible; and the shell and occlusal part can be made of soft elastic or hard materials, such as medical hard materials such as PMMA and PEEK, or medical soft elastic materials such as TPU, PETG or UDA / UDMA as the main body. When the occlusal portion is made of a rigid material, it functions similarly to a traditional rigid occlusal splint, and is subsequently adjusted clinically to ensure even contact with the opposing dentition. When the occlusal splint is made of a soft, flexible material, it typically requires no adjustment and can be worn directly, making it suitable for remote fabrication and use in environments lacking the necessary adjustment techniques and conditions. Furthermore, the occlusal portion of the occlusal splint can be designed with two parts on each side, made of rigid and soft materials respectively, suitable for cases of bilateral posterior occlusal abnormalities. The occlusal portion of the occlusal splint can also be designed as either a stable type or an anterior repositioning type, suitable for different clinical situations. The occlusal splint can also be initially designed with a soft material and then replaced with a rigid material based on the patient's wear level or after the patient has become accustomed to wearing it. In addition, if the occlusal portion of the occlusal splint is severely worn, due to its removability, it is not necessary to remake the entire occlusal splint; only the worn occlusal portion needs to be processed and replaced, which is convenient, quick, and allows patients to adapt quickly. This also reduces patient costs, the number of patient visits, and the doctor's chairside work time, improving the patient experience.

[0027] Furthermore, this invention employs various tools and materials, such as quantitative occlusal elevation aids, modified anterior tooth occlusal elevation devices, occlusal clamping tools, and thermoplastic composite materials, in the digital occlusal relationship acquisition step. By changing the types and thicknesses of accessories, it is applicable to the acquisition of occlusal relationships in all currently clinically oriented cases requiring vertical elevation of the dentition, and can quantitatively increase the elevation. The horizontal relationship can be in the muscular position, stable position, or protruding position. It is also suitable for acquisition using traditional wax sheets, occlusal recording silicone rubber materials, and direct acquisition using a digital optical scanner. The operation process is significantly simplified, the operational threshold is low, and efficient occlusal relationship acquisition can be achieved. Attached Figure Description

[0028] The accompanying drawings are incorporated in and form part of this specification, and together with the description serve to explain the principles of the invention.

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 Top view of the mandibular stabilizing occlusal plate shell; Figure 2 Perspective view of the mandibular stabilizing occlusal plate shell and occlusal plate assembly; Figure 3 Top view of the occlusal plate shell for maxillary protrusion repositioning; Figure 4 Perspective view of the occlusal portion of the maxillary protrusion repositioning occlusal plate; Figure 5 Perspective view of the occlusal plate shell and occlusal plate assembly for maxillary protrusion repositioning; Figure 6 A three-dimensional schematic diagram of a bite measurement elevation tool; Figure 7 Diagram of occlusal state for occlusal elevation tool; Figure 8 Schematic diagram of an explosion of a modified anterior occlusal elevation tool; Figure 9 A three-dimensional schematic diagram of a modified anterior occlusal elevation tool; Figure 10 Diagram showing the occlusal state of the modified anterior occlusal elevation tool; Figure 11 A three-dimensional schematic diagram of the clamping tool; Figure 12 This is a diagram showing the clamping state of the bite-grip tool; Figure 13 Schematic diagram of horseshoe-shaped thermoplastic composite material; Figure 14 This is a three-dimensional schematic diagram of the internal structure of a horseshoe-shaped thermoplastic composite material.

[0031] Wherein: 1 is the shell; 11 is the connecting pin; 2 is the occlusal part; 21 is the connecting hole; 3 is the occlusal quantitative elevation tool; 31 is the Y-shaped body; 32 is the occlusal block; 33 is the mandibular guide slider; 34 is the maxillary guide slider; 35 is the first groove; 36 is the upper tooth recess; 37 is the lower tooth recess; 38 is the second groove; 4 is the modified anterior tooth occlusal elevation tool; 41 is the anterior tooth labial clamp; 42 is the anterior tooth lingual clamp; 43 is the spring plate; 44 is the detachable adjustable base; 5 is the occlusal clamping tool; 51 is the occlusal clamp; 52 is the clamp piece; 53 is the third through hole; 6 is the thermoplastic occlusal recording composite material; 61-1 is the first malleable outer layer; 61-2 is the second malleable outer layer; 62 is the elastic intermediate layer; 63 is the double frustum through hole. Detailed Implementation

[0032] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatuses consistent with some aspects of the invention as detailed in the appended claims.

[0033] To enable those skilled in the art to better understand the technical solutions of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0034] Please see Figure 1-5 The present invention provides a digital composite occlusal plate, comprising a shell 1 covering all dentitions of a single jaw, and an occlusal portion 2 disposed on the occlusal surface of the shell 1; The shell 1 and the engagement part 2 are separate structures designed and manufactured independently using computer-aided design, and can be detachably or permanently combined into one unit through a connecting structure.

[0035] Furthermore, the connection structure includes at least two connecting pins 11 disposed on the occlusal surface of the housing 1, and connecting holes 21 disposed on the occlusal portion 2 corresponding to the positions of the connecting pins 11. The housing 1 and the occlusal portion 2 are connected by the mutual engagement of the connecting pins 11 and the connecting holes 21; or, the housing 1 and the occlusal portion 2 are connected by the mutual engagement of the connecting pins 11 and the connecting holes 21, and are fixed by medical adhesive.

[0036] Furthermore, the housing 1 is made of medical-grade rigid resin material; the occlusal part 2 is made of medical-grade rigid resin material or medical-grade soft elastic resin material; The medical rigid resin material includes polymethyl methacrylate (PMMA) or polyether ether ketone (PEEK); the medical soft elastic resin material includes thermoplastic polyurethane (TPU), glycol-modified polyethylene terephthalate (PETG), or a photocurable resin based on photocurable methacrylate (UDA / UDMA).

[0037] Furthermore, the occlusal portion 2 covers three or more consecutive posterior teeth on both sides of the dentition; or, the occlusal portion 2 covers all dentition.

[0038] Secondly, the present invention also provides a method for manufacturing the aforementioned digital composite interlocking plate, comprising the following steps: Step 1: Obtain digital impression data of the patient's dentition and related soft and hard tissues; Step 2: Obtain the patient's digital occlusal relationship data; Step 3: Based on the digital impression data and digital occlusal relationship data, design three-dimensional models of the housing 1 and the occlusal part 2 respectively in computer-aided design software; Step 4: Based on the three-dimensional model, using subtractive manufacturing and / or additive manufacturing techniques, and selecting resin materials that meet national medical standards, the shell 1, the interlocking part 2, and the corresponding connecting joints are respectively processed and manufactured. Step 5: Assemble the completed shell 1 and occlusive part 2 through the connecting structure to form the digital composite occlusive plate.

[0039] Specifically, in step 1, the methods for obtaining the digital impression data include: Use an intraoral 3D scanner to directly scan the dentition and soft and hard tissues; or... Use an extraoral 3D scanner to scan clinically prepared impressions; or... Plaster models are created by scanning an impression using an intraoral or extraoral 3D scanner.

[0040] Specifically, in step 2, the methods for obtaining the occlusal relationship data include: After using tools such as a quantitative occlusal elevation tool 3, a modified anterior occlusal elevation tool 4, an occlusal clamping tool 5, or a spacer to assist in elevating the occlusion, the occlusal relationship data after elevation is obtained; alternatively, it can be obtained in CAD software using average parameters or personalized parameters generated by an electronic facebow through a virtual jawbone; or it can be obtained by adjusting it using digital twin software; or, after directly elevating the occlusion in the mouth using occlusal wax, occlusal recording silicone rubber, soft elastic sheet, or thermoplastic composite material, the occlusal relationship data after elevation is obtained.

[0041] Preferably, the three-dimensional configuration data of the bite plate designed on computer-aided design (CAD) software can be an integrated design or a combined design divided into a shell 1 and a bite part 2. The dividing surface has four or more connecting pins 11 and connecting holes 21 with a diameter of 1-3 mm, a height of 1-5 mm, and a spacing of 10-20 mm. Preferably, the three-dimensional configuration data of the occlusal plate designed on the computer-aided design (CAD) software can be designed only for the maxilla or mandible, or it can be designed for both the maxilla and mandible. Preferably, the material used to make the occlusal plate can be a medical rigid material such as PMMA or PEEK, or a medical soft elastic material such as TPU, PETG, or UDA / UDMA.

[0042] Specifically, the bite measurement elevation tool 3 includes a Y-shaped body 31 with an upper part matching the width of the dental arch. The upper part of the Y-shaped body 31 is detachably connected to a set of bite blocks 32 to facilitate posterior tooth occlusion. The lower part of the Y-shaped body has a first groove 35 to facilitate the sliding of the mandibular guide slider 33 and / or the maxillary guide slider 34. The mandibular guide slider 33 and / or the maxillary guide slider 34 are each provided with a locking screw to fix them to the first groove 35.

[0043] Specifically, the modified anterior occlusal elevation tool 4 includes an anterior lingual clamp 42, which includes a guide ramp and a base plate segment, with an obtuse angle between the guide ramp and the base plate segment; the end edge of the guide ramp is connected to the anterior labial clamp 41; the guide ramp and the anterior labial clamp 41 are connected by a spring plate 43.

[0044] Specifically, the bite clamping tool 5 includes a set of symmetrically arranged bite clamps 51 and a handle for pressing and holding the bite clamps 51. The bite clamps 51 include a clamping part for clamping medical materials and a locking part for providing clamping force. The clamping part is an arc-shaped structure that is easy to adapt to the dental arch. The locking part is hinged to the handle to adjust the opening between the bite clamps 51.

[0045] The thermoplastic occlusion recording composite material 6 is a multilayer composite material, including an elastic intermediate layer 62. A first plastic outer layer 61-1 and a second plastic outer layer 61-2 are respectively provided on both sides of the elastic intermediate layer 62. A plurality of double frustum through holes 63 are provided on the elastic intermediate layer 62. A plurality of frustum protrusions are provided on the first plastic outer layer 61-1 and the second plastic outer layer 61-2. The frustum protrusions are nested into the double frustum through holes 63. A micro-locking structure is provided in the double frustum through holes 63.

[0046] To demonstrate the effectiveness of the present invention, the following embodiments are provided for verification.

[0047] Example 1 A digital intraoral optical scanner was used to scan and acquire the patient's maxillary and mandibular dentition and related soft and hard tissues. Then, a quantitative occlusal augmentation tool 3 was used, with a posterior occlusal block 32 of 2mm thickness. Occlusal recording silicone rubber material was injected onto both sides of the occlusal block 32. The end of the occlusal block 32 was placed on the occlusal surface of the last molar, and the patient was instructed to bite in a stable position. At this point, the posterior teeth were raised by approximately 2mm. After the intraoral silicone rubber hardened, the tool was removed, and the occlusal record was taken off. After appropriate adjustments, it was repositioned in the corresponding position intraorally, and the patient was instructed to bite again in the corresponding position of the silicone rubber occlusal record. The digital occlusal relationship of the maxilla and mandible was then acquired using a scanner. The acquired 2mm quantitative occlusal augmentation data was imported into CAD software to design an integrated stable occlusal plate for the mandible. Finally, it was fabricated using appropriate medical-grade PMMA resin material through a dental CNC machining center.

[0048] See Figure 6 , Figure 7 As shown, the bite measurement elevation tool 3 includes a Y-shaped body 31 whose upper part matches the width of the dental arch. The upper part of the Y-shaped body 31 is detachably connected to a set of bite blocks 32 to facilitate posterior tooth occlusion. The lower part of the Y-shaped body has a first groove 35 to facilitate the sliding of the mandibular guide slider 33 and the maxillary guide slider 34. Both the mandibular guide slider 33 and the maxillary guide slider 34 are provided with locking screws to fix them to the first groove 35. The mandibular guide slider 33 has a lower tooth recess 37 adapted to the lower teeth, and the maxillary guide slider 34 has an upper tooth recess 36 adapted to the upper teeth.

[0049] The locking screws include a first locking screw 10 and a second locking screw 11. The mandibular guide slider 33 slides or is fixed in the first slide groove 35 by the first locking screw 10. The maxillary guide slider 34 can slide in the first slide groove 35 and the second slide groove 38 by the second locking screw 11, or be fixed in the first slide groove 35.

[0050] Example 1 also provides a method for determining the occlusal relationship of an occlusal quantitative elevation assistive tool, comprising the following steps: Step 1: Select accessories: Select the appropriate Y-shaped main body 31, occlusal block 32, mandibular guide slider 33 and maxillary guide slider 34 according to the patient's dental arch width and actual condition; Step 2, Intraoral adjustment: Place the occlusal block 32 in the patient's posterior tooth area, and adjust the position of the mandibular guide slider 33 and the maxillary guide slider 34 according to clinical needs, so that the patient's upper and lower anterior teeth bite into the corresponding mandibular guide slider 33 and maxillary guide slider 34 in the lower tooth recess 37 and upper tooth recess 36, and fix the position by tightening the screw; Step 3: Record the engagement relationship: Based on the position of the locking screw in the previous step, record the engagement relationship for later use.

[0051] Example 2 The patient routinely takes upper and lower jaw impressions and casts them into plaster models. Then, using the bite measurement and heightening tool 3 of Example 1, the posterior tooth occlusion portion is selected as 2mm, and the anterior tooth guide portion (mandibular guide slider 33 and maxillary guide slider 34) is in the edge-to-edge state. The end of the bite block 32 is placed on the occlusal surface of the last molar. At the same time, the anterior tooth guide portion is adjusted so that the cut of the upper and lower anterior teeth is just located at the recess of the bite block 32 (lower tooth recess 37 and upper tooth recess 36). The first locking screw 10 and the second locking screw 11 are tightened. The auxiliary tool was removed, and occlusal recording silicone rubber material was injected onto both sides of the occlusal block 32 and repositioned in the corresponding position in the mouth. The patient was then instructed to bite down at the corresponding anterior edge-to-edge position (mandibular fossa 37 and maxillary fossa 36). After the occlusal recording material hardened, the tool was removed, and the silicone rubber material was taken from the occlusal block 32. After appropriate trimming, it was placed in the corresponding position on the upper and lower jaw plaster models. A chamber-type optical scanner was then used to scan the upper and lower jaw models and occlusal relationships, thereby obtaining digital models of the upper and lower jaws with the mandible protruding to the anterior edge-to-edge position. The digital model data was imported into CAD software, and an integrated maxillary protrusion repositioning occlusal plate was designed. Finally, it was fabricated using appropriate medical-grade PMMA resin material via 3D printing.

[0052] Example 3 A digital intraoral optical scanner was used to scan and acquire the patient's maxillary and mandibular dentition and related soft and hard tissues. A modified anterior occlusal elevation device 4 was then used, with the occlusal height selected at 6mm. After appropriate intraoral adjustment, the mandibular central incisors were brought into uniform contact with the occlusal portion. The mandibular occlusal relationship after the anterior occlusal elevation was then obtained using another intraoral optical scanner. The digital model data after the occlusal elevation was then imported into CAD software to design a maxillary stabilizing occlusal plate. The occlusal surface and occlusal base were separated, with corresponding pin holes designed on the separated surfaces. The pin holes were approximately 1.5mm wide, with a spacing of 10-20mm between them. The separated shell was then 3D printed using transparent medical-grade PMMA material. Simultaneously, the separated occlusal portion was CNC machined using transparent medical-grade PMMA material. Finally, a thin layer of transparent self-curing resin was evenly coated onto the separated surfaces. The separated shell and occlusal portion of the occlusal plate were aligned and fitted together using the corresponding pin holes and bonded to form a single unit. The maxilla in this design is manufactured using 3D printing, which reduces costs and allows for the fabrication of structures with slight undercuts, resulting in better retention. The occlusal surface is made of a cutting material, which enhances strength.

[0053] See Figures 8-10As shown, the improved anterior occlusal elevation tool 4 includes an anterior lingual clamp 42, which includes a guide ramp and a base plate segment, with an obtuse angle between the guide ramp and the base plate segment; the end edge of the guide ramp is connected to the anterior labial clamp 41; the guide ramp and the anterior labial clamp 41 are connected by a spring plate 43; and a detachable adjustable base 44, which has a polyhedral structure, with two adjacent surfaces of the detachable adjustable base 44 respectively fitting into the grooves formed by the bottom surface of the guide ramp and the bottom surface of the base plate segment.

[0054] This embodiment provides a method for using a modified anterior tooth occlusal elevation tool, as detailed below: Step 1: Fix the detachable adjustable base 44 with a height of 6mm to the upper anterior teeth. Depending on the height of the posterior teeth, if necessary, place the detachable adjustable base 44 in 60℃ warm water to soften it to a plastic state. Step 2: Attach the softened removable adjustable base 44 to the bottom surface of the anterior tooth lingual clamp 42 and have the patient bite down gently to position it. Step 3: Fine-tune the relationship between the upper and lower jaws according to clinical goals (e.g., advance 2-3 mm, increase the vertical occlusal distance by 1.0-3.0 mm). During this process, the patient continues to gently bite to position the jaw and waits for the material to cool and set. If necessary, it can be reheated for fine-tuning. Step 4: If the existing detachable adjustable base 44 is too low, a thicker 8mm base can be selected, or bases of different thicknesses can be heated together and combined to make an individualized stable or leading type bite plate according to the shaped appearance.

[0055] Example 4 The patient's maxillary and mandibular dentition and related soft and hard tissues were obtained by scanning with a digital intraoral optical scanner. Then, the modified anterior occlusal elevation device 4 described in Example 3 was used. The occlusal portion was selected as a 2mm height base and heated in 70°C hot water for 1 minute to soften it. After softening, it was placed in the corresponding position in the patient's mouth to re-occlude. After the material hardened, the mandibular central incisors made uniform contact with the occlusal portion. Then, the anterior occlusal relationship of the maxilla and mandible after the anterior occlusal elevation was obtained by scanning with an intraoral optical scanner again. The digital model data after occlusal elevation is then imported into CAD software to design a mandibular stabilizing occlusal plate. The occlusal surface and occlusal base are separated, with corresponding pin holes designed on the separated surfaces. The pin holes are approximately 1.5mm wide, with a spacing of 10-20mm between them. The separated shell is then 3D printed using a medical-grade transparent soft elastic material based on UDA / UDMA. Simultaneously, the separated occlusal portion is CNC machined using transparent medical-grade PMMA material. Finally, a layer of self-curing liquid is applied to each separated surface to enhance adhesion. A thin layer of transparent self-curing resin is then evenly applied. The separated shell and occlusal portion of the occlusal plate are aligned and fitted using the corresponding pin holes, and then bonded together to form a single unit. This design, using 3D-printed medical-grade soft elastic material based on UDA / UDMA for the mandibular portion, offers optimal retention and excellent comfort, making it suitable for patients with crowded teeth and significant malocclusion. The use of machined materials on the occlusal surfaces further enhances strength.

[0056] Example 5 A digital intraoral optical scanner was used to scan and acquire the patient's maxillary and mandibular dentition and related soft and hard tissues. Then, a 2mm thick transparent, soft, elastic TPU sheet was simultaneously placed on both posterior teeth using an occlusal clamping tool 5. The patient was instructed to bite slightly, and the intraoral optical scanner was then used to scan and acquire the occlusal relationship of the maxilla and mandible with an elevation of approximately 2mm in the posterior teeth. The digital model data after the occlusal elevation was then imported into CAD software to design a stable occlusal plate with an anatomical occlusal surface for the mandible. The occlusal surface and occlusal base were separated, and corresponding pin structures were designed for the separated surfaces, with a diameter of approximately 1.5mm and a spacing of approximately 10mm between the two holes. The separated shell and occlusal portion were then machined separately using medical-grade PEEK material via CNC machining. The shell and occlusal portion of the occlusal plate were then aligned and fitted together using the corresponding pin structures to form a whole. In this design, the occlusal surface is made of PEEK material, whose physical properties are similar to tooth tissue. Once the occlusal portion shows significant wear, it can be re-machined and replaced.

[0057] See Figure 11 , Figure 12As shown, the bite clamping tool includes a set of symmetrically arranged bite clamps 51 and a handle for easy pressing and holding of the bite clamps 51. Each bite clamp 51 includes a clamping part for clamping medical materials and a locking part for providing clamping force. The clamping part is an arc-shaped structure for easy adaptation to the dental arch. The locking part is hinged to the handle to adjust the opening between the bite clamps 51. Each bite clamp 51 includes two thin metal sheets, one end of which is bent to form the clamping part, and the other end is welded to form the locking part. The handle includes two identical clamping pieces 52 disposed on the upper and lower sides of the bite clamps 51. Each locking part has a second through hole, and each clamping piece 52 has two symmetrical third through holes on the side away from the clamping part, which are adapted to the second through holes. A second pin is inserted through the third through holes 53 on the two clamping pieces 52 and the second through holes.

[0058] In this embodiment, taking a transparent soft elastic TPU sheet as an example: First, the opening of the occlusal clamp 51 is manually adjusted to suit the size of different patients' dental arches. Then, the handle is pressed to open the clamping part of the occlusal clamp 51, and the soft silicone pad is placed in the occlusal surface of the arc-shaped structure. Then, the handle is released and the occlusal clamp 51 is inserted into the patient's mouth between the upper and lower teeth. After the patient bites down on the soft silicone pad, the handle is immediately pressed to remove the occlusal clamp tool, leaving only the soft silicone pad between the posterior teeth. This can stably and quantitatively raise the posterior teeth occlusion, which is beneficial for the next step of digital occlusal relationship acquisition.

[0059] Example 6 A digital intraoral optical scanner was used to scan and acquire the patient's maxillary and mandibular dentition and related soft and hard tissues. A 2mm thick horseshoe-shaped thermoplastic overlay was then placed in 80°C hot water for 1 minute. Once the surface material (thermoplastic polycaprolactone PCL) changed color from blue to transparent, indicating the material was in a malleable state, the softened composite material was placed on the occlusal surface of the patient's mandibular dentition. The patient was instructed to bite down slightly. After the material hardened, it was removed, trimmed, and then repositioned in the corresponding position in the mouth, with the patient instructed to bite down again. An intraoral optical scanner was used to scan and acquire the maxillary and mandibular occlusal relationship with an approximately 2mm elevation of the posterior teeth. The digital model data after occlusal elevation was then imported into CAD software. Stable occlusal plates with flat and anatomical occlusal surfaces were designed for the mandible, and their occlusal surfaces were separated from the occlusal base. Corresponding pin structures (connecting pin 11 and connecting hole 21) were designed on the separated surfaces, approximately 1.5mm in diameter, with a spacing of approximately 10-20mm between the two holes. Subsequently, medical-grade PMMA material was used to CNC machine the separated shells and two different occlusal portions. A layer of self-curing liquid was applied to the edges and parts of the separated surfaces of the occlusal plate shell and the flat occlusal portion to increase adhesion. Then, a thin layer of transparent self-curing resin was evenly applied. The shell and occlusal portion were aligned and fitted using the corresponding pin structures and bonded together to form a single unit. After the patient adapted to the occlusion, the occlusal portion was removed and replaced with an occlusal portion with an anatomical occlusal surface, and the alignment, fitting, and bonding were repeated.

[0060] See Figure 13 , Figure 14 As shown, the horseshoe-shaped thermoplastic composite material is composed of thermoplastic interlocking recording composite material 6 and is a multilayer composite material, including an elastic intermediate layer 62. A first plastic outer layer 61-1 and a second plastic outer layer 61-2 are respectively provided on both sides of the elastic intermediate layer 62. A plurality of double frustum through holes 63 are provided on the elastic intermediate layer 62. A plurality of frustum protrusions are provided on the first plastic outer layer 61-1 and the second plastic outer layer 61-2. The frustum protrusions are nested into the double frustum through holes 63. A micro-locking structure is provided in the double frustum through holes 63.

[0061] The micro-locking structure is a thread or annular rib provided on the side wall of the double frustum through hole 3; the inner wall of the dumbbell-shaped through hole is provided with a micro-locking structure, which is used to generate a micro-mechanical interlock between the outer layer of the PCL melts and flows into the through hole and the solidified PCL lock core.

[0062] The multi-layer composite material is shaped like a dental arch (horseshoe). When it is shaped like a dental arch, the multi-layer composite material includes an anterior occlusal area and a posterior occlusal area. The double frustum through holes 3 are distributed on both sides of the anterior occlusal area, and the double frustum through holes 3 are distributed in the posterior occlusal area to form multiple hexagonal arrays.

[0063] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention.

[0064] It should be understood that the present invention is not limited to the content already described above, and various modifications and changes can be made without departing from its scope. The scope of the present invention is limited only by the appended claims.

Claims

1. A digital composite interlocking plate, characterized in that, It includes a housing (1) covering all rows of teeth in a single jaw, and an occlusal portion (2) disposed on the occlusal surface of the housing (1); The shell (1) and the interlocking part (2) are separate structures designed and manufactured independently by computer-aided design, and can be detachably or permanently combined into one body through a connecting structure.

2. The digital composite interlocking plate according to claim 1, characterized in that, The connection structure includes at least two connecting pins (11) disposed on the occlusal surface of the housing (1) and connecting holes (21) disposed on the occlusal part (2) corresponding to the positions of the connecting pins (11). The housing (1) and the occlusal part (2) are connected by the mutual engagement of the connecting pins (11) and the connecting holes (21); or, the housing (1) and the occlusal part (2) are connected by the mutual engagement of the connecting pins (11) and the connecting holes (21) and are fixed by medical adhesive.

3. The digital composite interlocking plate according to claim 1, characterized in that, The shell (1) and the occlusal part (2) are made of medical hard resin material or medical soft elastic resin material; The medical rigid resin material includes polymethyl methacrylate or polyetheretherketone; the medical soft elastic resin material includes thermoplastic polyurethane, glycol-modified polyethylene terephthalate, or a light-cured resin based on photocurable methacrylate.

4. The digital composite interlocking plate according to claim 1, characterized in that, The occlusal portion (2) covers three or more consecutive posterior teeth on both sides of the dentition; or, the occlusal portion (2) covers all dentition.

5. A method for manufacturing a digital composite interlocking plate as described in any one of claims 1 to 4, characterized in that, Includes the following steps: Step 1: Obtain digital impression data of the patient's dentition and related soft and hard tissues; Step 2: Obtain the patient's corresponding digital occlusal relationship data; Step 3: Based on the digital impression data and digital occlusal relationship data, design the three-dimensional models of the shell (1) and the occlusal part (2) in computer-aided design software respectively; Step 4: Based on the three-dimensional model, using subtractive manufacturing and / or additive manufacturing techniques, and selecting resin materials that meet national medical standards, the shell (1) and the interlocking part (2) and the corresponding connecting structure are respectively processed and manufactured. Step 5: Assemble the completed shell (1) and occlusive part (2) through the connecting structure to form the digital composite occlusive plate.

6. The method for manufacturing the digital composite interlocking plate according to claim 5, characterized in that, In step 1, the methods for obtaining the digital impression data include: Use an intraoral 3D scanner to directly scan the dentition and soft and hard tissues; or... Use an extraoral 3D scanner to scan clinically prepared impressions; or... Plaster models are created by scanning an impression using an intraoral or extraoral 3D scanner.

7. The method for manufacturing the digital composite interlocking plate according to claim 5, characterized in that, In step 2, the methods for obtaining the occlusal relationship data include: After using a quantitative occlusal elevation tool (3), a modified anterior occlusal elevation tool (4), or an occlusal clamping tool (5) to assist in elevating the occlusion, obtain the occlusal relationship data after elevation; or, After directly elevating the bite in the mouth using bite wax, bite recording silicone rubber, soft elastic sheet or thermoplastic composite material, data on the occlusal relationship after elevation are obtained.

8. The method for manufacturing the digital composite interlocking plate according to claim 7, characterized in that, The bite measurement elevation tool (3) includes a Y-shaped body (31) with an upper part matching the width of the dental arch. The upper part of the Y-shaped body (31) is detachably connected to a set of bite parts (32) to facilitate posterior tooth bite. The lower part of the Y-shaped body is provided with a first groove (35) to facilitate the sliding of the mandibular guide slider (33) and / or the maxillary guide slider (34). The mandibular guide slider (33) and / or the maxillary guide slider (34) are provided with locking screws that enable them to be fixed with the first groove (35).

9. The method for manufacturing the digital composite interlocking plate according to claim 7, characterized in that, The modified anterior occlusal lifting tool (4) includes an anterior lingual clamp (42), which includes a guide ramp and a base plate segment. The angle between the guide ramp and the base plate segment is an obtuse angle. The end edge of the guide ramp is connected to the anterior labial clamp (41). The guide ramp and the anterior labial clamp (41) are connected by a spring plate (43).

10. The method for manufacturing the digital composite interlocking plate according to claim 7, characterized in that, The bite clamping tool (5) includes a set of symmetrically arranged bite clamps (51) and a handle for pressing and holding the bite clamps (51). The bite clamps (51) include a clamping part for clamping medical materials and a locking part for providing clamping force. The clamping part is an arc-shaped structure that is easy to adapt to the dental arch. The locking part is hinged to the handle to adjust the opening between the bite clamps (51).

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