An oral bone regeneration postoperative isolation and retention device and a design method thereof

Abstract

The application discloses an oral bone regeneration post-isolation retention device and a design method thereof, and belongs to the technical field of oral medical instruments. The oral bone regeneration post-isolation retention device comprises a fixed layer and an isolation layer which is integrally formed with the fixed layer. The fixed layer is covered on a tooth crown part adjacent to a bone regeneration area through a profiling structure, and the isolation layer is covered on the bone regeneration area through an arc-shaped barrier structure. The lateral coverage range of the isolation layer covers 1mm-5mm of an outer edge of the bone regeneration area, the longitudinal coverage range extends to 1mm-5mm of a root side outer edge of the bone regeneration area and does not exceed 2mm below a vestibular groove, a bone regeneration space with a spacing of 1mm-3mm is arranged between the inner wall of the isolation layer and the bone regeneration area, and the inner surface contour is matched with a lip side soft tissue form. The design can fully protect the bone regeneration area, avoid the interference of direct external force and soft tissue movement, maintain the stable space of the bone regeneration area, and provide necessary space and ideal three-dimensional micro-environment for new bone growth.

Description

Technical Field

[0001] This invention belongs to the field of oral medical device technology, and in particular relates to an isolation and fixation device after oral bone regeneration surgery and its design method. Background Technology

[0002] Oral bone tissue regeneration, as a core technology for repairing alveolar bone defects, occupies a vital position in the field of oral medicine. However, in actual clinical application, the absorption of graft materials has become a major problem that plagues clinicians. This problem seriously affects the bone regeneration effect and may lead to adverse consequences such as insufficient bone regeneration and unstable bone structure, thereby affecting the recovery of patients' oral function and the improvement of their quality of life. To address this issue, scholars have proposed the classic PASS principle for bone regeneration. This principle emphasizes the crucial role of local spatial stability during bone regeneration. Studies have shown that even micro-level micro-movements during bone regeneration can lead to regeneration failure. While the movement of the lip and cheek muscles is part of normal oral function, the periodic pressure they generate can continuously disturb the bone regeneration area, disrupting the stable environment required for bone regeneration and thus affecting the quality and speed of regeneration.

[0003] To address this issue, current techniques largely rely on auxiliary devices to stabilize the bone graft environment, such as titanium mesh and tent pins. However, numerous studies have shown that the use of titanium mesh can lead to defects such as mesh exposure and significant flap trauma. To align with minimally invasive principles, many studies have also modified implant materials to avoid the use of auxiliary titanium mesh, thereby reducing postoperative complications. However, current techniques struggle to maintain material stability for up to six months post-surgery, and their strength is insufficient to completely isolate the cyclical pressure generated by postoperative lip and cheek muscle movements. Summary of the Invention

[0004] The purpose of this invention is to address the problems existing in the prior art by providing an isolation and fixation device and its design method after oral bone regeneration surgery.

[0005] To achieve the above objectives, the invention employs the following technical solution: a postoperative isolation and fixation device for oral bone regeneration, comprising a fixation layer and an isolation layer integrally formed with the fixation layer. The fixation layer covers the crown of the tooth adjacent to the bone regeneration area through a contoured structure, and the isolation layer covers the bone regeneration area through an arc-shaped barrier structure. A buffer layer is provided at the edge of the isolation layer that fits against the edge of the bone regeneration area.

[0006] By adopting the above technical solution, the fixation layer tightly covers the crown of the tooth adjacent to the bone regeneration area through a contoured structure, which can provide a stable retention base for the device, ensure the stability of the device in the oral cavity, and prevent the device from shifting due to oral movements, thereby ensuring a stable environment in the bone regeneration area. Meanwhile, the arc-shaped barrier structure of the isolation layer covers the bone regeneration area, playing an effective role in isolation and protection, preventing external factors from interfering with the bone regeneration area, and creating a relatively closed and stable microenvironment for the bone regeneration process. This helps to improve the quality and effect of bone regeneration, effectively solves the problems of unstable retention and insufficient isolation of traditional devices, and provides a reliable protective device for oral bone regeneration surgery.

[0007] Optionally, the thickness of the fixation layer is 0.8mm-1.2mm, the lateral coverage of the fixation layer covers the surface of at least one crown on each side of the bone regeneration area, and the longitudinal coverage of the fixation layer extends from the lingual side to 1mm-2mm apical to the junction of the tooth and gingiva, forming a clasp-free, continuous wrapping structure.

[0008] By adopting the above technical solution, the thickness design of the fixation layer ensures sufficient strength and stability without affecting patient comfort and oral function due to excessive thickness. Its lateral coverage design can widely distribute the force, enhance the overall retention effect of the device, and make the device more firmly and reliably fixed in the oral cavity. The longitudinal coverage design breaks through the traditional clasp retention mode, avoids mechanical compression of gingival tissue, reduces the occurrence of complications such as gingivitis, improves patient comfort and user experience, better protects gingival tissue, and provides better retention conditions for postoperative recovery after bone regeneration.

[0009] Optionally, the lateral coverage of the isolation layer extends 1mm-5mm beyond the outer edge of the bone regeneration area, and the longitudinal coverage of the isolation layer extends 1mm-5mm beyond the pedicle of the bone regeneration area without exceeding 2mm below the vestibular sulcus.

[0010] By adopting the above technical solution, the design of the horizontal and vertical coverage of the isolation layer can fully protect the bone regeneration area, avoid the direct action of external forces caused by oral movements such as pronunciation and chewing on the bone regeneration area, reduce the mechanical pressure and interference on the bone regeneration area, maintain the stable space of the bone regeneration area, and provide more comprehensive protection for the bone regeneration process.

[0011] Optionally, a bone regeneration space with a spacing of 1mm-3mm is provided between the inner wall of the isolation layer and the bone regeneration area, and the inner surface contour of the isolation layer is adapted to the morphology of the labial soft tissue.

[0012] By adopting the above technical solutions, the design of the bone regeneration space provides the necessary space for the growth of new bone, avoids direct contact between the new bone and the isolation layer, and is conducive to the free growth and maturation of the new bone. At the same time, the inner surface contour design of the isolation layer enables the isolation layer to maintain a uniform height space in the oral cavity and soft tissue, avoids friction and pressure between the soft tissue and the isolation layer, improves patient comfort, reduces the risk of soft tissue injury, maintains bone regeneration space, and improves regeneration effect.

[0013] Optionally, the inner surface of the bone regeneration space is a negative curved surface, and the negative curved surface is adapted to the shape of the bone regeneration area.

[0014] By adopting the above technical solutions, negative surface design can better match the morphology of the bone regeneration zone, providing an ideal three-dimensional microenvironment for the growth of new bone.

[0015] Optionally, the width of the buffer layer is 1mm-5mm, and the height of the buffer layer is 1mm-3mm.

[0016] By adopting the above technical solution, the design of the thickness and height of the buffer layer can effectively buffer the intermittent pressure generated during chewing or vocalization, preventing these pressures from being directly transmitted to the bone regeneration area. This protects the bone regeneration area from interference and damage from external pressure. At the same time, the presence of the buffer layer also allows for a certain degree of elastic deformation to adapt to the dynamic displacement of soft tissue, further improving the adaptability and stability of the device. This ensures a stable environment for the bone regeneration area during normal oral functional activities, providing more reliable protection for the bone regeneration process and helping to improve the success rate and quality of bone regeneration.

[0017] Optionally, the fixing layer and the isolation layer are made of medical-grade polymer material using 3D printing technology, wherein the medical-grade polymer material is modified polyethylene terephthalate.

[0018] By adopting the above technical solution, it is clear that the fixation layer and the isolation layer are made of medical-grade polymer materials using 3D printing technology. The modified polyethylene terephthalate has good biocompatibility, mechanical properties and durability, which can ensure the long-term stable use of the device in the oral cavity without causing adverse reactions in the human body. At the same time, the use of 3D printing technology can achieve precise molding of the device, ensuring the structural accuracy and surface quality of the device, and improving the adaptability and comfort of the device.

[0019] Optionally, the buffer layer is made of medical-grade silicone material.

[0020] By adopting the above technical solutions, medical silicone materials have good biocompatibility, flexibility and elasticity, and can be well compatible with oral soft tissues, reducing irritation and damage to soft tissues. Its flexibility and elasticity allow the buffer layer to play a better role in buffering, effectively attenuating the pressure generated during chewing or pronunciation, while allowing the natural movement of soft tissues and avoiding discomfort and complications caused by materials that are too hard or too brittle.

[0021] Optionally, a design method for an isolation and retention device after oral bone regeneration surgery includes the following steps: Within 2-3 weeks after surgery in the bone regeneration area, intraoral scanning is performed using oral digital scanning software to obtain scanning data of intraoral soft tissue and teeth; open cone-beam computed tomography images are taken to obtain three-dimensional image data of intraoral bone tissue and teeth. The acquired scan data and 3D image data are imported into the dental system software, calibrated using teeth as a reference, and the two types of data are fitted. Based on the location of the bone regeneration area, a contoured structure is designed to form a fixed layer on the surface of the crown; an isolation layer is generated based on the three-dimensional image data and the area is expanded; a bone regeneration space is generated based on the range of the isolation layer and the surface morphology of the labial soft tissue, and a negative curved surface is designed. Based on the initial model generated from the scan data, the force data of the bone regeneration space during the patient's pronunciation and chewing movements were obtained by the lip muscle strength detection device and finite element analysis was performed to generate a stress cloud map. The topology optimization and morphology optimization schemes were used to gradually remove the material in the low stress area and retain the material in the high stress area, and finally generate an isolation layer morphology with equal strength. Regenerate the stress cloud map for verification, and design a buffer layer at the edge of the isolation layer; Generate the overall model and perform 3D printing.

[0022] By adopting the above-mentioned technical solutions, this digital design method achieves precise control over the entire process from data acquisition to device manufacturing. It can provide patients with personalized and precise isolation and fixation devices after oral bone regeneration, improve the effect of bone regeneration and the postoperative quality of life of patients, and has important clinical application value.

[0023] Compared with the prior art, the beneficial effects of the present invention are: 1. The lateral coverage of the isolation layer extends 1mm-5mm beyond the outer edge of the bone regeneration zone, and the longitudinal coverage extends 1mm-5mm beyond the pedicle of the bone regeneration zone without exceeding 2mm below the vestibular sulcus. A bone regeneration space with a 1mm-3mm gap is provided between its inner wall and the bone regeneration zone, and the inner surface contour conforms to the morphology of the labial soft tissue. This design effectively protects the bone regeneration zone, avoiding direct external force and interference from soft tissue movement, maintaining a stable space for the bone regeneration zone, providing the necessary space and ideal three-dimensional microenvironment for new bone growth, while reducing friction and pressure between the soft tissue and the isolation layer, improving patient comfort, reducing the risk of soft tissue injury, and effectively solving the problem of insufficient isolation in traditional devices.

[0024] 2. The oral bone regeneration postoperative isolation and retention device of the present invention adopts an integrated molding design of the fixation layer and the isolation layer. The fixation layer covers the crown of the adjacent tooth in the bone regeneration area with a thickness of 0.8mm-1.2mm, covering at least one crown on each side laterally and extending longitudinally to 1mm-2mm below the gingival junction, forming a continuous wrapping structure without clasps. This design breaks through the traditional clasp retention mode, ensuring sufficient strength and stability while avoiding mechanical compression of the gingival tissue, reducing the occurrence of complications such as gingival inflammation, making the device more firmly and reliably fixed in the oral cavity, providing a stable retention foundation for the bone regeneration area, and effectively solving the problem of unstable retention of traditional devices.

[0025] 3. The buffer layer designed at the edge of the isolation layer can effectively buffer the intermittent pressure generated during chewing or vocalization, preventing these pressures from being directly transmitted to the bone regeneration area. At the same time, it allows a certain degree of elastic deformation to adapt to the dynamic displacement of soft tissue, further improving the adaptability and stability of the device. This ensures a stable environment for the bone regeneration area during normal oral function activities, provides more reliable protection for the bone regeneration process, and helps to improve the success rate and quality of bone regeneration.

[0026] 4. This invention employs a digital design method, which enables precise control of the entire process from data acquisition to device manufacturing. This allows for personalized and precise isolation and fixation devices for patients after oral bone regeneration, meeting the oral anatomy and bone regeneration needs of different patients, improving the effectiveness of bone regeneration and the postoperative quality of life of patients, and has significant clinical application value. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the main structure of the isolation and retention device of the present invention; Figure 2 This is a schematic diagram of the test structure of the isolation and retention device of the present invention; Figure 3 This is a schematic diagram of the cross-sectional connection structure between the isolation layer and the buffer layer of the present invention.

[0028] In the diagram: 1. Fixation layer; 2. Isolation layer; 3. Buffer layer; 4. Bone regeneration space. Detailed Implementation

[0029] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] In the description of this invention, it should be noted that the terms "middle", "upper", "lower", "left", "right", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0031] like Figure 1 As shown in Figure 3, the specific solution of Embodiment 1 is as follows: A postoperative isolation and fixation device for oral bone regeneration includes a fixation layer 1 and an isolation layer 2 integrally formed with the fixation layer 1. The fixation layer 1 covers the crown of the tooth adjacent to the bone regeneration area through a contoured structure. The contoured design is customized according to the actual shape of the patient's adjacent crown, which enables the fixation layer 1 to fit closely to the crown surface, just like the braces on the market. Its function is to provide a stable fixation base for the entire device and prevent the device from shifting in the complex movement environment of the oral cavity (the complex movement environment of the oral cavity includes chewing, speaking, swallowing, etc.). When facing various dynamic changes in oral tissues, if the device is not stable, it is easy to deviate from its original position and cannot effectively protect the bone regeneration area. The thickness of the fixation layer 1 is 0.8mm-1.2mm. The thickness design of the fixation layer 1 ensures that it has sufficient strength and stability, can withstand a certain degree of external force in the oral cavity without deformation or damage, and will not affect the patient's comfort and oral function due to excessive thickness. If the fixation layer 1 is too thick, it may occupy too much space in the oral cavity, causing the patient to feel a strong foreign body sensation in the oral cavity, affecting normal chewing, pronunciation and other functions, and may even compress surrounding tissues, causing discomfort or damage. If the fixation layer 1 is too thin, it will be easily damaged, reducing the service life of the fixation layer 1, and requiring frequent replacement, which increases the inconvenience of using the device.

[0032] The lateral coverage of the fixation layer 1 extends to the surface of at least one crown on each side of the bone regeneration area. This lateral coverage design broadly distributes force, ensuring that when external forces are applied to the oral cavity, the force is evenly distributed across multiple crowns, enhancing the overall retention of the device and making it more secure and reliable within the oral cavity. For example, when chewing hard foods, the force is transmitted to multiple crowns through the fixation layer 1, preventing the device from loosening due to excessive localized force. The longitudinal coverage of the fixation layer 1 extends from the lingual side to 1-2 mm apical distance at the junction of the tooth and gingiva, forming a clasp-free, continuous wrapping structure. This longitudinal coverage design breaks through the traditional clasp retention mode, avoiding the mechanical pressure on the gingival tissue caused by traditional clasps. Traditional clasps, when used for fixation, may tightly constrict the gingiva, potentially leading to complications such as gingivitis, swelling, and pain with prolonged use, thus affecting the health of the gingival tissue. The clasp-free, continuous wrapping structure reduces irritation and damage to the gingiva, lowering the incidence of complications such as gingivitis, while improving patient comfort and user experience, better protecting the gingival tissue, and providing superior retention conditions for post-bone regeneration surgery recovery.

[0033] The isolation layer 2 covers the bone regeneration area through an arc-shaped barrier structure. The design of the arc-shaped barrier structure plays an effective role in isolation and protection. Its main function is to prevent external factors from interfering with the bone regeneration area and to create a relatively closed and stable microenvironment for the bone regeneration process. In the oral environment, there are many factors that may affect bone regeneration, such as food debris, bacteria, and pressure generated by the movement of oral soft tissues. The arc-shaped barrier structure of the isolation layer 2 can effectively block these adverse factors, protect the bone regeneration area from damage, and ensure that the bone regeneration process is not disturbed. The lateral coverage of the isolation layer 2 extends 1mm-5mm beyond the outer edge of the bone regeneration zone. The longitudinal coverage of the isolation layer 2 expands the protection range of the bone regeneration zone, preventing it from being affected by an insufficiently small protection area and providing a safe upper space for bone regeneration. The longitudinal coverage of the isolation layer 2 extends 1mm-5mm beyond the pedicle of the bone regeneration zone and does not exceed 2mm below the vestibular sulcus. The soft tissues on the labial and buccal sides move frequently during actions such as speaking, smiling, and chewing, potentially causing friction and compression on the bone regeneration zone. The wider lateral coverage of the isolation layer 2 effectively blocks the movement of the labial and buccal soft tissues from affecting the bone regeneration zone, maintaining a stable space and preventing morphological changes or damage to the bone regeneration zone due to soft tissue movement.

[0034] The inner wall of the isolation layer 2 is provided with a bone regeneration space 4 with a spacing of 1mm-3mm between it and the bone regeneration zone. The bone regeneration space 4 provides a necessary place for the growth of new bone. During the growth of new bone, a certain space is required for cell proliferation, differentiation, and the deposition and mineralization of bone matrix. If the labial tissue is in direct contact with the isolation layer 2, it may restrict the growth direction and morphology of new bone and affect the quality of bone regeneration. The bone regeneration space 4 can avoid this situation, which is conducive to the free growth and maturation of new bone and promotes the bone regeneration process to proceed according to normal physiological laws. The inner surface contour of the isolation layer 2 is adapted to the morphology of the labial soft tissue. The inner surface of the bone regeneration space 4 is a negative curved surface, and the negative curved surface is adapted to the morphology of the bone regeneration area. The design of the negative curved surface can better match the morphology of the bone regeneration area, providing an ideal three-dimensional microenvironment for the growth of new bone. The design of the inner surface contour of the isolation layer 2 can make the isolation layer 2 better match the labial soft tissue in the oral cavity, reduce the friction and pressure between the soft tissue and the isolation layer 2, improve the patient's comfort, and make the patient feel more natural when wearing the device, without the foreign body sensation or discomfort caused by the incoordination between the isolation layer 2 and the soft tissue.

[0035] The fixing layer 1 and the isolation layer 2 are made of medical-grade polymer material using 3D printing technology. The medical-grade polymer material is modified polyethylene terephthalate. In some embodiments, the medical-grade polymer material can be thermoplastic polyurethane. The fixing layer 1 and the isolation layer 2 can be manufactured using 3D printing equipment. Modified polyethylene terephthalate (PET) and thermoplastic polyurethane (TPU) both possess excellent biocompatibility, a fundamental requirement for dental medical devices. This ensures that the device will not cause adverse reactions in the human body during long-term use in the oral cavity, safeguarding the health and safety of patients. Simultaneously, both materials exhibit excellent mechanical properties and durability, capable of withstanding various external forces within the oral cavity, such as chewing forces and friction, without easily deforming or damaging, guaranteeing long-term stable use of the device. The use of 3D printing enables precise molding of the device. By precisely controlling parameters such as temperature and pressure during the 3D printing process, the structural accuracy and surface quality of the device can be guaranteed, ensuring a high degree of fit between the device and the patient's oral anatomy, improving comfort and effectiveness.

[0036] The edge of the isolation layer 2 is provided with a buffer layer 3 that fits into the edge of the bone regeneration area. The buffer layer 3 fits tightly into the edge of the bone regeneration area, forming a soft transition area, which plays a role in buffering and protection. Its position design allows the buffer layer 3 to directly act on the parts that may put pressure on the bone regeneration area, effectively reducing the impact of external pressure on the bone regeneration area. The buffer layer 3 has a width of 1mm-5mm and a height of 1mm-3mm. Its design effectively buffers the intermittent pressure generated during chewing or vocalization. During chewing, the labial and buccal tissues experience significant force, which is transmitted to the bone regeneration area. The buffer layer 3, with its thickness and height, absorbs and disperses this pressure, preventing direct transmission to the bone regeneration area and protecting it from external pressure interference and damage. Simultaneously, the buffer layer 3 allows for a degree of elastic deformation to accommodate the dynamic displacement of soft tissues. As oral soft tissues undergo morphological changes during movement, the elastic deformation of the buffer layer 3 follows these changes, maintaining a close fit to the edge of the bone regeneration area. This further enhances the adaptability and stability of the device, ensuring a stable environment for the bone regeneration area during normal oral function activities. This provides more reliable protection for the bone regeneration process, contributing to improved success rates and quality of bone regeneration.

[0037] The buffer layer 3 is made of medical-grade silicone material and is semi-transparent. Medical-grade silicone material has good biocompatibility, which means that it will not cause adverse reactions with human tissues and can be safely applied in the oral cavity. It is well compatible with the soft tissues of the oral cavity, reducing irritation and damage to the soft tissues. Its flexibility and elasticity allow the buffer layer 3 to better play a buffering role and effectively reduce the pressure generated during chewing or pronunciation. At the same time, the semi-transparent design makes it convenient for doctors to observe the bone regeneration area and understand the bone regeneration process and the fit of the device in a timely manner.

[0038] A method for designing an isolation and retention device after oral bone regeneration surgery, the method comprising the following steps: (1) Data acquisition: Within 2-3 weeks after the surgery in the bone regeneration area, intraoral scanning was performed using 3Shape software to obtain scanning data of intraoral soft tissue and teeth; cotton rolls were placed between the patient's upper and lower jaws and on the lips and cheeks to take open-mouth CBCT to obtain DICOM data of intraoral bone tissue and teeth; and a lip muscle strength detection device was used to simulate the force map of the bone regeneration area when the patient pronounced words and chewed. (2) Data fitting: The acquired scan data and DICOM data were imported into the Dental System software, calibrated with teeth as the reference, and the two types of data were fitted. (3) Generate fixed layer 1: Based on the location of the bone regeneration area, design a contour structure for at least one crown on each side of the regeneration area to form a fixed structure fixed to the crown surface; (4) Generate isolation layer 2: Observe CBCT images and record isolation layer 2. The horizontal coverage of isolation layer 2 extends 1mm-5mm to both sides of the bone regeneration area, and the vertical coverage of isolation layer 2 extends as far as possible to the outer edge of the root of the bone regeneration area, but must terminate at least 2mm below the buccal vestibule. (5) Generate bone regeneration space 4: Based on the determined range of the isolation layer 2 and the surface morphology of the labial soft tissue, design a bone regeneration space 4 with a spacing of 1mm-3mm between the inner wall of the isolation layer 2 and the bone regeneration area. (6) Design negative curved surface: The inner surface contour of the isolation layer 2 is adapted to the morphology of the lip soft tissue; (7) Design the overall shape of isolation layer 2: Finite element analysis was performed on the compression data of the bone regeneration space obtained by the lip muscle strength detection device. The model was divided into meshes, and the stress value in each mesh element was calculated to generate a Von Mises stress cloud map. Red indicates high stress area (risk area, which needs to be strengthened); blue indicates low stress area (material is not fully utilized and can be thinned); green indicates moderate stress level (ideal state); topology optimization and morphology optimization schemes were adopted to gradually remove the material in the low stress area and retain the material in the high stress area, and finally generate the shape of isolation layer 2 with equal strength. (8) Mechanical testing: Regenerate the Von Mises stress cloud diagram for verification to ensure that there are no stress concentration points in the entire isolation layer 2; (9) Generate buffer layer 3: Design a buffer layer 3 at the edge of the isolation layer 2 that fits into the edge of the bone regeneration area; (10) Printing: Generate the overall model and perform 3D printing.

[0039] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A postoperative isolation and fixation device for oral bone regeneration, characterized in that, The device includes a fixation layer and an isolation layer integrally formed with the fixation layer. The fixation layer covers the crown portion adjacent to the bone regeneration area through a contoured structure. The isolation layer covers the bone regeneration area through an arc-shaped barrier structure. A buffer layer is provided at the edge of the isolation layer to fit the edge of the bone regeneration area. The thickness of the fixation layer is 0.8mm-1.2mm. The lateral coverage of the fixation layer covers the surface of at least one crown portion on each side of the bone regeneration area. The longitudinal coverage of the fixation layer extends from the lingual side to 1mm-2mm apical to the junction of the tooth and gingiva, forming a continuous wrapping structure without clasps. The lateral coverage of the isolation layer covers the outer edge of the bone regeneration area by 1mm-5mm. The longitudinal coverage of the isolation layer extends 1mm-5mm apical to the outer edge of the bone regeneration area and does not exceed 2mm below the vestibular sulcus. A bone regeneration space with a spacing of 1mm-3mm is provided between the inner wall of the isolation layer and the bone regeneration area. The inner surface contour of the isolation layer is adapted to the morphology of the labial soft tissue.

2. The oral bone regeneration postoperative isolation and fixation device according to claim 1, characterized in that: The inner surface of the bone regeneration space is a negative curved surface, and the negative curved surface is adapted to the shape of the bone regeneration area.

3. The oral bone regeneration postoperative isolation and fixation device according to claim 1, characterized in that: The width of the buffer layer is 1mm-5mm, and the height of the buffer layer is 1mm-3mm.

4. The oral bone regeneration postoperative isolation and fixation device according to claim 1, characterized in that: The fixing layer and the isolation layer are made of medical-grade polymer material using 3D printing technology. The medical-grade polymer material is modified polyethylene terephthalate.

5. The oral bone regeneration postoperative isolation and fixation device according to claim 1, characterized in that: The buffer layer is made of medical-grade silicone material.

6. The design method of the oral bone regeneration postoperative isolation and fixation device according to claim 1, characterized in that, The design method includes the following steps: Within 2-3 weeks after bone regeneration surgery, intraoral scanning is performed using oral digital scanning software to obtain scanning data of intraoral soft tissues and teeth; open cone-beam computed tomography images are taken to obtain three-dimensional image data of intraoral bone tissues and teeth. The acquired scan data and 3D image data are imported into the dental system software, calibrated using teeth as a reference, and the two types of data are fitted. Based on the location of the bone regeneration area, a contoured structure is designed to form a fixed layer that is fixed to the surface of the tooth crown; An isolation layer is generated based on 3D image data and the region is expanded; a bone regeneration space is generated based on the extent of the isolation layer and the surface morphology of the labial soft tissue, and a negative curved surface is designed. Based on the initial model generated from the scan data, the force data of the bone regeneration space during the patient's pronunciation and chewing movements were obtained by the lip muscle strength detection device and finite element analysis was performed to generate a stress cloud map. The topology optimization and morphology optimization schemes were used to gradually remove the material in the low stress area and retain the material in the high stress area, and finally generate an isolation layer morphology with equal strength. Regenerate the stress cloud map for verification, and design a buffer layer at the edge of the isolation layer; Generate the overall model and perform 3D printing.

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