Personalized retention device for oral implant peripheral keratogingival transplantation and manufacturing method

Abstract

The invention provides a personalized retention device for oral implant peripheral keratinized gingival transplantation and a manufacturing method, and relates to the technical field of medical instruments.The personalized retention device comprises a tissue surface, and the tissue surface comprises a keratinized area, a graft area and a root area; the keratinization area is used for being attached to a lingual side or palatal side area of an alveolar ridge crest incision of a patient, the graft area is used for containing and fixing transplanted keratinization gingiva, and the root area is used for fixing a root reduction valve; the keratinization area is also provided with a healing abutment retention hole, and the healing abutment retention hole is used for accommodating a healing abutment; the graft area is also provided with an observation window, and the observation window is used for observing the fixing pressure and the healing condition of the soft tissue; a fixing nail fixing hole is further formed in the root square area and used for containing a fixing nail. And accurate, efficient and stable fixation of the root-direction reset valve and the transplanted soft tissue can be realized, the operation difficulty and the operation time are reduced, and the keratinized gingival widening effect is improved.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a personalized retention device for keratinized gingival transplantation around oral implants and a manufacturing method thereof. Background Art

[0002] The long-term stability of oral implant treatment has always been the focus of oral basic research and clinical research. The prevention and control of biological complications after oral implant treatment are key factors affecting the long-term stability of implant treatment. Keratinized soft tissue around oral implants plays an important role in maintaining the long-term success rate of implants and reducing biological complications after implant treatment. Insufficient keratinized gingiva width (KGW) around implants is considered to be related to more plaque accumulation, tissue inflammation, gingival recession and attachment loss. When the keratinized gingiva width is <2mm, the patient's chance of experiencing peri-implant gingival discomfort, soft tissue recession, plaque accumulation, mucosal inflammation, and marginal bone resorption increases. Cross-sectional studies have shown that insufficient keratinized gingiva width around implants is a high-risk factor for peri-implant mucositis. Schwarz et al. believe that keratinized gingiva width plays an important role in preventing and treating implant mucositis. From the results of long-term clinical observations, keratinized gingiva of not less than 2mm is an important protective factor for peri-implant diseases.

[0003] A variety of factors can lead to a reduction in keratinized gingiva in the implant area, such as extraction of affected teeth due to long-term periodontal or periapical infection, long-term tooth loss, and long-term wearing of removable dentures. Based on the 2018 clinical consensus opinion, it is considered necessary to perform keratinized gingival widening surgery at implant sites where the keratinized gingiva is less than 2 mm. Keratinized gingival transplantation achieves the purpose of widening keratinized gingiva by suturing and fixing the root-oriented repositioning flap and autologous soft tissue. The timing of keratinized gingival transplantation surgery is generally performed at the same time as the second stage of implant surgery.

[0004] The classic root-repositioned flap combined with autologous soft tissue transplantation (free gingival transplantation) mainly uses sutures to firmly fix the root-repositioned soft tissue flap and the transplanted keratinized soft tissue on the thin periosteum. This procedure is a type of implant surgery with high technical sensitivity, which is highly dependent on the physician's clinical experience and surgical skills. The suture fixation effect is significantly affected by the edentulous site and the surgeon's experience. During the operation, it is necessary to prepare a semi-thick flap and ensure the integrity of the periosteum. If the periosteum is damaged or too thin, it will significantly reduce the stable fixation of the transplanted soft tissue and the root-repositioned flap, resulting in unsatisfactory surgical results. The visual field and operating space in the posterior teeth area are limited by the patient's mouth opening, the size of the corners of the mouth, and the tension of the cheek skin, which are not as ideal as those in the anterior teeth. Therefore, the surgeon's visual field and operation are greatly restricted, which has an adverse effect on the efficacy. Especially in the mandibular posterior teeth area, the surgical widening effect faces greater challenges. Since the natural morphology of the vestibule groove in the mandibular molar area is shallower than that in the anterior teeth area, and the buccinator muscle is attached at a higher position, when teeth are lost and accompanied by alveolar bone absorption, the probability of the vestibule groove becoming shallower or even disappearing increases significantly. In a histological clinical study on widening keratinized gingiva, it was found that the tissue characteristics after healing were affected by the supraperiosteal tissue and the surrounding wound edge tissue. If the correction of high muscle attachment is not accurate, it will significantly affect the widening effect of the keratinized gingiva. Clinically, the most common site for keratinized gingival loss is the mandibular posterior teeth area. Therefore, reducing the difficulty of free gingival transplantation surgery and improving the effect of the surgery are clinical hot issues that need to be explored urgently. Among them, effectively, quickly and easily fixing the root-repositioned soft tissue flap and the transplanted keratinized gingiva is the key link to ensure the effect of the surgery. Summary of the invention

[0005] The purpose of this application is to provide a personalized retention device and manufacturing method for keratinized gingival transplantation around oral implants, which can achieve accurate, efficient and stable fixation of the root-oriented repositioned flap and transplanted soft tissue, reduce surgical difficulty and operation time, and improve the effect of widening keratinized gingiva.

[0006] To achieve the above objectives, this application provides the following solutions:

[0007] In a first aspect, the present application provides a method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant, comprising:

[0008] Acquiring target data, wherein the target data includes three-dimensional information of the dentition and soft tissue in the edentulous area and three-dimensional information of the jaw;

[0009] Obtaining a three-dimensional model according to the target data, wherein the three-dimensional model includes a three-dimensional model of the dentition and soft tissue, a three-dimensional model of the jaw, and a three-dimensional model of an implant in the jaw of an edentulous area;

[0010] The boundary and tissue surface of the personalized retention device model are designed according to the three-dimensional model, wherein the tissue surface is used to contact the oral soft tissue; the tissue surface is divided into a keratinized area, a graft area and a root area; the keratinized area is used to fit with the lingual or palatal area of ​​the alveolar crest incision of the patient; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the root area is used to fix the root repositioning flap; the keratinized area includes a healing abutment retention hole, and the healing abutment retention hole is used to accommodate the healing abutment; the graft area includes an observation window, and the observation window is used to observe the fixing pressure and healing condition of the soft tissue; the root area includes a retention hole for a retention nail, and the retention hole for a retention nail is used to accommodate a fixing nail;

[0011] A personalized retention device is manufactured according to the personalized retention device model.

[0012] In a second aspect, the present application provides a personalized retention device for keratinized gingival transplantation around an oral implant, comprising: the personalized retention device for keratinized gingival transplantation around an oral implant is manufactured using the manufacturing method of the personalized retention device for keratinized gingival transplantation around an oral implant described in the first aspect, and the personalized retention device for keratinized gingival transplantation around an oral implant comprises:

[0013] Organizational aspect;

[0014] The tissue surface is used for contacting with oral soft tissue;

[0015] The tissue surface includes a keratinized area, a graft area and a root area; the keratinized area is used to fit with the lingual or palatal area of ​​the alveolar crest incision of the patient; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the root area is used to fix the root repositioning flap;

[0016] The keratinized area is provided with a healing abutment retention hole, and the healing abutment retention hole is used to accommodate the healing abutment;

[0017] The graft area is provided with an observation window, and the observation window is used to observe the fixation pressure and healing condition of the soft tissue;

[0018] The root area is provided with a retaining nail retaining hole, and the retaining nail retaining hole is used to accommodate the fixing nail.

[0019] According to the specific embodiments provided in this application, this application has the following technical effects:

[0020] The present application provides a personalized retention device and manufacturing method for keratinized gingival transplantation around oral implants, the personalized retention device includes a tissue surface, the tissue surface includes a keratinized area, a graft area and a root area, the keratinized area is used to fit with the lingual or palatal area of ​​the alveolar crest incision of the patient, the graft area is used to accommodate and fix the transplanted keratinized gingiva, the root area is used to fix the root-oriented repositioning flap; the keratinized area is also provided with a healing base retention hole, the healing base retention hole is used to accommodate the healing base; the graft area is also provided with an observation window, the observation window is used to observe the fixing pressure and healing condition of the soft tissue; the root area is also provided with a retention nail retention hole, the retention nail retention hole is used to accommodate the fixing nail. It can achieve accurate, efficient and stable fixation of the root-oriented repositioning flap and transplanted soft tissue, reduce the difficulty and operation time of the operation, and improve the widening effect of the keratinized gingiva. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 This is a schematic diagram of fixing the root-oriented repositioned flap and transplanted keratinized gingiva by suturing in Example 1 of the present application;

[0023] Figure 2 A schematic diagram of a digital model of the dentition and soft tissue in the edentulous area in Example 1 of the present application;

[0024] Figure 3 A schematic diagram of a three-dimensional imaging image of the jaw in Example 1 of the present application;

[0025] Figure 4 Schematic diagram of the intraosseous implant model in the edentulous area in Example 1 of the present application;

[0026] Figure 5 This is a schematic diagram of adjusting two models to be registered to the same orientation in Example 1 of the present application;

[0027] Figure 6 A schematic diagram of three points selected for two models to be registered in Example 1 of the present application;

[0028] Figure 7 A schematic diagram of the preliminary registration of two models to be registered by selecting three points in Example 1 of the present application;

[0029] Figure 8 This is a schematic diagram of the registration of two models to be registered after optimal fitting in Example 1 of the present application;

[0030] Fig. 9 A front view schematic diagram of the finally registered three-dimensional model of the dentition and soft tissue of the edentulous area and the three-dimensional model of the jaw in Example 1 of the present application;

[0031] Fig.10 A schematic side view of the finally registered three-dimensional model of the dentition and soft tissue in the edentulous area and the three-dimensional model of the jaw in Example 1 of the present application;

[0032] Fig.11 This is a schematic diagram of the three-dimensional model of the jaw in the surgical area in Example 1 of the present application;

[0033] Fig.12 This is a schematic diagram of the combined view of the personalized retention device model in Example 1 of the present application;

[0034] Fig.13 This is a schematic diagram of the occlusal view of the personalized retention device model in Example 1 of the present application;

[0035] Fig.14 This is a schematic diagram of the buccal side of the personalized retention device model in Example 1 of the present application;

[0036] FIG. 15( a ) is a schematic diagram of a first example of a personalized retention device in Embodiment 1 of the present application;

[0037] FIG. 15( b ) is a schematic diagram of a second example of the personalized retention device in Example 1 of the present application;

[0038] FIG. 16( a ) is a buccal image of the left lower posterior tooth area of ​​the patient before surgery in Example 1 of the present application;

[0039] FIG16( b ) is an occlusal image of the left lower posterior teeth area of ​​the patient before surgery in Example 1 of the present application;

[0040] Fig.17 This is a schematic diagram of cutting a suitable size of keratinized soft tissue from the maxillary palate of a patient according to the transplantation range indicated by the personalized retention device in Example 1 of the present application;

[0041] Fig.18 This is a schematic diagram of placing the transplanted keratinized gingiva above the mucoperiosteal flap in the surgical area during surgery in Example 1 of the present application;

[0042] Fig.19 This is an image of the occlusal surface after the personalized retention device is placed in the surgical area in Example 1 of the present application;

[0043] Fig. 20 This is an image of the buccal side after the personalized retention device is placed in the surgical area in Example 1 of the present application;

[0044] Fig.21 This is a buccal image of the healing effect of the keratinized gingiva on the buccal side of the alveolar ridge top when the patient was reexamined one month after surgery in Example 1 of the present application;

[0045] Fig. 22 This is an occlusal image of the healing effect of the keratinized gingiva on the buccal side of the alveolar ridge top when the patient was reexamined one month after surgery in Example 1 of the present application;

[0046] Fig.23 This is a buccal image of the healing effect of buccal keratinized gingival soft tissue in the patient's follow-up 2 months after surgery in Example 1 of the present application;

[0047] Fig.24 This is an occlusal image of the healing effect of buccal keratinized gingival soft tissue in the patient's follow-up 2 months after surgery in Example 1 of the present application;

[0048] Fig.25 The intraoral scanned three-dimensional image of the buccal keratinized gingiva of the patient before surgery in Example 1 of the present application;

[0049] Fig.26 This is a three-dimensional intraoral scan image of the buccal keratinized gingiva of the patient in Example 1 of the present application during a follow-up examination 2 months after surgery. DETAILED DESCRIPTION

[0050] Through research, it was found that some scholars explored a new method of using retention pins to fix the root-reposition flap and transplanted soft tissue, but the inventors found that the fixation effect of the root-reposition flap was limited by using this method of retention pins to assist in fixation, and suturing operation could not be avoided, and it would not significantly reduce technical sensitivity and shorten the operation time. Figure 1 The fixation of the root-oriented repositioned flap and the transplanted keratinized gingiva by suturing operation shown in the figure has the disadvantages of complex suturing operation, high technical sensitivity, limited fixation effect and long operation time.

[0051] In order to overcome the above-mentioned defects, this embodiment collects the digital data of the patient's gums and jaws before surgery and uses the reverse engineering method to design a personalized auxiliary retention device for free gingival transplantation surgery, thereby achieving accurate, efficient and stable fixation of the root-positioned flap and transplanted soft tissue, reducing the difficulty and operation time of the surgery, and improving the effect of widening the keratinized gingiva.

[0052] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0053] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, the present application is further described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0054] Example 1

[0055] Problems with previous oral implant peri-keratinized gingival transplantation procedures:

[0056] 1) Suturing is difficult, time-consuming, and technically sensitive: The root-repositioned soft tissue flap and the transplanted keratinized soft tissue are firmly fixed on the thin periosteum by suturing. This is a highly technically sensitive implant surgery operation, which is highly dependent on the physician's clinical experience and surgical skills. The suture fixation effect is significantly affected by the missing teeth and the surgeon's experience. The visual field and operating space in the posterior teeth area are limited by the patient's mouth opening, the size of the mouth angle, and the cheek skin tension, which are not as ideal as those in the anterior teeth. Therefore, the surgeon's visual field and operation are greatly limited, which has an adverse effect on the efficacy. Especially in the mandibular posterior teeth area, suture operation and effect face greater challenges. Because the natural morphology of the vestibule groove in the mandibular molar area is shallower than that in the anterior teeth area, and the buccinator muscle is attached at a higher position, when teeth are missing and accompanied by alveolar bone absorption, the probability of the vestibule groove becoming shallow or even disappearing increases significantly. The tissue characteristics after healing are affected by the tissue on the periosteum and the surrounding wound edge tissue. If the correction of the high muscle attachment is not accurate, it will significantly affect the widening effect of the keratinized gingiva. Clinically, the most common site of keratinized gingiva loss is the mandibular posterior teeth area, which is also the area where keratinized gingiva transplantation surgery is most difficult to perform and where the surgical effect is most limited.

[0057] 2) The surgical effect is limited and there is a large variability: Studies have reported that the widening effect of the classic root repositioning flap combined with autologous soft tissue transplantation (free gingival transplantation) in the mandibular posterior area is only 2.68±1.80mm on average 6 months after surgery. Usually, the width of the transplanted keratinized gingiva is 6-7mm. It is not difficult to see that the width loss rate of the keratinized gingiva after healing is as high as more than 50%, and the individual differences in the widening effect are also large. The predictability of the surgery needs to be improved.

[0058] In this regard, this embodiment provides a method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant, comprising:

[0059] S1: Acquire target data, wherein the target data includes three-dimensional information of the dentition in the surgical area and soft tissue in the edentulous area, and three-dimensional information of the jaw.

[0060] S2: Obtaining a three-dimensional model according to the target data, wherein the three-dimensional model includes a three-dimensional model of the dentition and soft tissue, a three-dimensional model of the jaw, and a three-dimensional model of implants in the jaw of the edentulous area.

[0061] S2 specifically includes:

[0062] S21: Reconstructing an initial three-dimensional model according to the target data, wherein the initial three-dimensional model includes an initial dentition and soft tissue three-dimensional model and an initial jaw three-dimensional model.

[0063] S22: Aligning the initial dentition and soft tissue three-dimensional model with the initial jaw three-dimensional model to obtain a registered three-dimensional model, wherein the registered three-dimensional model includes the dentition and soft tissue three-dimensional model and the jaw three-dimensional model.

[0064] S23: extracting the three-dimensional model of the implant in the jawbone of the edentulous area from the registered three-dimensional model.

[0065] S24: Using the three-dimensional model of the implant in the jawbone of the edentulous area and the registered three-dimensional model as the three-dimensional model.

[0066] S3: Design the boundary and tissue surface of the personalized retention device model according to the three-dimensional model, wherein the tissue surface is used to contact the oral soft tissue; the tissue surface is divided into a keratinized area, a graft area and a root area; the keratinized area is used to fit with the lingual or palatal area of ​​the patient's alveolar ridge top incision; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the root area is used to fix the root reduction flap; the keratinized area includes a healing abutment retention hole, and the healing abutment retention hole is used to accommodate the healing abutment; the graft area includes an observation window, and the observation window is used to observe the fixation pressure and healing condition of the soft tissue; the root area includes a retention hole for a retention nail, and the retention hole for a retention nail is used to accommodate a retention nail.

[0067] The boundary design process specifically includes:

[0068] Determine the surgical incision position according to the three-dimensional model, wherein the surgical incision position includes a mesial position, a distal position, an alveolar crest incision position, and a first distance, wherein the mesial position refers to a position close to the midline between the central incisors, and the distal position refers to a position far from the midline between the central incisors, and the first distance is the distance between the semi-thickness flap root and the alveolar crest after repositioning and fixation;

[0069] The boundary is designed according to the surgical incision position, wherein the boundary includes a mesial boundary, a distal boundary, a root boundary and a coronal boundary, the mesial boundary is located at a position after a first preset distance is extended outwardly in the mesial direction of the surgical incision position, the distal boundary is located at a position after a second preset distance is extended outwardly in the distal direction of the surgical incision position, the root boundary is located at a position after a third preset distance is extended outwardly in the root direction of the surgical incision position, the coronal boundary is located at a horizontal position of the gingival outlet on the lingual side of the implant, and the boundary should not enter the undercut area of ​​the adjacent tooth.

[0070] The design process of the keratinized area specifically includes:

[0071] Correct the three-dimensional model of dentition and soft tissue according to the boundary to obtain the three-dimensional model of dentition and soft tissue within the boundary;

[0072] The soft tissue information on the buccal side of the alveolar crest incision position in the three-dimensional model of the dentition and soft tissue within the boundary is deleted, and the soft tissue information retained in the three-dimensional model of the dentition and soft tissue within the boundary is used as the data of the keratinized area tissue surface.

[0073] The design process of the graft area specifically includes:

[0074] Correct the three-dimensional model of the jaw according to the boundary to obtain the three-dimensional model of the jaw within the boundary;

[0075] The first target bone surface information in the three-dimensional model of the mandible within the boundary is moved by a fourth preset distance in a direction away from the bone surface to obtain the first target bone surface information after the movement, wherein the first target bone surface information is the bone surface information at a preset depth from the buccal side of the alveolar crest incision position to the coronal side of the root reduction level, and the value of the fourth preset distance is the same as the value of the transplanted keratinized gingival thickness estimated before the operation;

[0076] The information of the first target bone surface after the movement is used as the data of the tissue surface of the transplant area.

[0077] The design process of the root square area specifically includes:

[0078] Correct the three-dimensional model of the jaw according to the boundary to obtain the three-dimensional model of the jaw within the boundary;

[0079] The second target bone surface information in the three-dimensional model of the mandible within the boundary is moved in a direction away from the bone surface by a fifth preset distance to obtain the second target bone surface information after the movement, wherein the second target bone surface information is the bone surface information at the root reduction level to the coronal preset depth;

[0080] The information of the second target bone surface after the movement is used as the data of the root area tissue surface.

[0081] The design process of the healing abutment retention hole specifically includes:

[0082] Creating a first cylinder by using a fitting method based on the three-dimensional model of the implant within the boundary, wherein the diameter of the first cylinder is greater than the diameter of the implant healing abutment;

[0083] moving the first cylinder to the keratinized area;

[0084] The first cylinder in the keratinized area is processed by Boolean operation to obtain a healing abutment retention hole.

[0085] The design process of the retaining hole for the retaining nail specifically includes:

[0086] Constructing a plurality of second cylinders, wherein the number of the second cylinders is the same as the number of missing teeth, and the diameter of each of the second cylinders is adapted to the diameter of the fixing pin;

[0087] Moving the second cylinder to the root area, wherein the placement position and placement angle of each second cylinder are used to characterize the position and implantation angle of the fixation pin;

[0088] The second cylinder in the root square area is processed by Boolean operation to obtain the retention hole for the retention nail.

[0089] The design process of the observation window of the personalized retention device specifically includes:

[0090] Observation windows are designed in the implant area, wherein the observation windows face the buccal side of the implant, and the number of the observation windows is the same as the number of missing teeth.

[0091] S4: manufacturing a personalized retention device according to the personalized retention device model.

[0092] This embodiment adopts the above steps S1-S4 to produce a personalized retention device. The innovative retention method solves the problem of difficult stable fixation of transplanted keratinized gingiva and root-repositioned flap, reduces the sensitivity of peri-implant keratinized gingival transplantation surgery, shortens the operation time, and improves the effect of widening keratinized gingiva.

[0093] In order to make those skilled in the art more aware of the specific process of the method for manufacturing the personalized retention device for keratinized gingival transplantation around oral implants in this embodiment, it is explained below with reference to specific examples.

[0094] (1) Acquisition of digital models of the dentition and soft tissues in the surgical area and acquisition of three-dimensional information of the jaw: The digital models of the dentition and soft tissues in the surgical area with three-dimensional information are obtained by intraoral scanning or scanning of the dentition plaster model. The digital models of the dentition and soft tissues in the edentulous area are exported and stored as Standard Tessellation Language (STL) data. Figure 2 As shown; through cone beam CT scanning (after implantation / bone grafting surgery), the three-dimensional imaging data of the jaw is obtained, and the three-dimensional imaging data of the jaw is exported and stored as digital imaging and communications in medicine (DICOM). The three-dimensional imaging image of the jaw is as shown Figure 3 shown.

[0095] (2) Reconstruction of the three-dimensional model of the jaw: The three-dimensional imaging data of the jaw is imported into the dental three-dimensional data processing software to reconstruct the three-dimensional model of the jaw and the model of the bone implant in the edentulous area. Specifically: the threshold segmentation function is used to reconstruct the three-dimensional model of the jaw by adjusting the threshold to the range of the dentition and bone tissue; the threshold segmentation function is used to reconstruct the bone implant model in the edentulous area by adjusting the threshold to the range of the bone implant. Figure 4 shown.

[0096] (3) Registration of the 3D model of the dentition and edentulous area soft tissue (i.e., the digital model of the dentition and edentulous area soft tissue) with the 3D model of the jaw: The 3D model of the dentition and edentulous area soft tissue obtained by the corresponding intraoral scan / model scan is imported into the data software and registered with the 3D model of the jaw. First, the registration process first adjusts the two models to be registered to the same orientation to facilitate subsequent operations, such as Figure 5 Then, through the "match grid" function, select three points with corresponding positions on the two models to perform preliminary alignment of the selected point coordinates, as shown in Figure 6 and Figure 7 Finally, the “Best Fit” function in the matching is used to complete the fine alignment using the Iterative Closest Point (ICP) algorithm, as shown in Figure 8 The final registered 3D model of the dentition and soft tissue in the edentulous area and the 3D model of the jaw are shown in Fig. 9 and Fig.10 shown.

[0097] By mesh editing the jaw 3D model and removing the non-operative area, the jaw 3D model of the surgical area is obtained. Fig.11 The edentulous area intraosseous implant model was extracted from the jawbone, and then the registered dentition and edentulous area soft tissue three-dimensional model, the surgical area jawbone three-dimensional model and the edentulous area intraosseous implant model were exported and converted into digital models in STL format.

[0098] (4) Design of personalized retention device model: Import the format-converted and registered 3D model of the dentition and soft tissue in the edentulous area, the 3D model of the jaw in the surgical area, and the intraosseous implant model in the edentulous area into the Geomagic Control software. The design of the personalized retention device model follows the "three-zone" design principle, and divides the tissue surface morphology of the personalized retention device model into three areas, namely the keratinized area, the graft area, and the root area. The keratinized area fits the lingual / palatal area of ​​the alveolar ridge top incision in the surgical area; the graft area is the area that accommodates and fixes the transplanted keratinized gingiva; the root area is the area that fixes the root-reduction flap to block the coronal migration of the root-reduction muscle and non-keratinized mucosa. The personalized retention device model is as follows: Figure 12-14 shown.

[0099] (4.1) Determine the boundaries of the personalized retention device model: On the three-dimensional model (i.e., the three-dimensional model of the dentition and edentulous soft tissue after format conversion and registration, the three-dimensional model of the jawbone in the surgical area, and the model of the edentulous bone implant in the surgical area), first determine the incision position of the surgical area according to the design principles of the free gingival grafting operation range and the position of the membrane-gingival junction line in the surgical area. The incision position of the surgical area includes the mesial position, the distal position, the incision position of the alveolar ridge top, and the distance between the semi-thickness flap root and the alveolar ridge top after repositioning and fixation. The mesial position refers to the position close to the midline between the central incisors, and the distal position refers to the position away from the midline between the central incisors.

[0100] The mesial boundary of the personalized retention device model is located at a position after the first preset distance is extended outward in the mesial direction of the surgical incision position, the distal boundary of the personalized retention device model is located at a position after the second preset distance is extended outward in the distal direction of the surgical incision position, and the radicular boundary of the personalized retention device model is located at a position after the third preset distance is extended outward in the radicular direction of the surgical incision position. In this embodiment, the first preset distance, the second preset distance and the third preset distance are preferably 1 mm to ensure effective coverage of the surgical incision position; the coronal boundary of the personalized retention device model needs to be located at a horizontal position at the lingual gingival penetration position of the implant.

[0101] In addition, to ensure the seating of the personalized retention device, the border of the personalized retention device model should not enter the undercut area of ​​the adjacent teeth.

[0102] The three-dimensional model of the soft tissue of the dentition and edentulous area within the boundary and the three-dimensional model of the jaw in the surgical area are retained, and the model outside the boundary is deleted.

[0103] Clinically, the design principles of the surgical area (surgical incision range) of keratinized gingival augmentation surgery are as follows: the coronal side is the boundary between the keratinized gingiva at the top of the alveolar ridge and the non-keratinized gingiva on the buccal side; the apical side is 5-7mm from the top of the buccal alveolar ridge, and there are certain changes depending on the width of the graft and whether there are important anatomical structures such as nerves on the root side); the mesial side is the distal side of the adjacent teeth in the surgical area; the distal side is the mesial side of the adjacent teeth in the surgical area (in the case of free loss, it is the mesial side of the retromolar pad / maxillary tuberosity).

[0104] In keratinized gingival augmentation surgery, the boundary design of the personalized retention device needs to be determined according to the scope of the surgical area to ensure that the scope of the personalized retention device can cover the surgical area. During the operation, the personalized retention device can assist the doctor in determining the position of the incision and the position of the root reduction of the semi-thickness flap. The scope of the surgical area is composed of the crown-root boundary and the mesiodistal boundary.

[0105] (4.2) Design of keratinized area: The 3D model of the soft tissue of the inner dentition and edentulous area within the boundary is trimmed, the soft tissue information on the buccal side of the alveolar crest incision is deleted, and the soft tissue information from the lingual side of the alveolar crest incision to the lingual side of the implant penetrating gingiva is retained. The retained soft tissue information is used as the data of the keratinized area tissue surface.

[0106] (4.3) Design of the graft area: The three-dimensional model of the jaw within the boundary is trimmed, and the bone surface information from the buccal side of the alveolar crest incision to the coronal side of the root reduction level with a depth of 2 mm is retained. The thickness of the transplanted keratinized gingiva is estimated to be X mm before surgery (the thickness of the keratinized gingiva is about 0.5-2 mm clinically, which can be measured by empirical judgment, probe measurement, or on the registered jaw and maxillary dentition and palate soft tissue models). The "Offset" function under the "Polygon" menu in Geomagic Control software is used to uniformly move the bone surface information of this part away from the bone surface by X mm. The moved bone surface information is used as the data of the tissue surface of the graft area.

[0107] (4.4) Design of the root area: The three-dimensional model of the jaw within the boundary was trimmed, and the bone surface information from the root reduction level to the coronal depth of 2 mm was retained. Considering the average thickness of the periosteum, the "offset" function under the "polygon" menu in the Geomagic Control software was used to uniformly move the bone surface information of this part away from the bone surface by 0.5 mm. The moved bone surface information was used as the data of the root area tissue surface.

[0108] (4.5) Use the "Fill Hole" function under the "Polygon" menu in Geomagic Control software to smoothly connect the three-zone design models and combine them into a single, complete model. This combined model is the tissue surface of the personalized retention device. Use the "Shell" function under the "Polygon" menu in the software to uniformly thicken the combined model to 1.5 mm in the direction away from the bone surface.

[0109] (4.6) Design of the alveolar ridge top retention hole (i.e., healing abutment retention hole): In Geomagic Control software, select the edentulous bone implant model, and under the "Feature" function, select the best fit method to create a cylindrical feature. Use the "Edit Tolerance Feature" to modify the diameter of the cylindrical feature to make it 0.1-0.2mm larger than the diameter of the implant healing abutment (considering the tolerance of subsequent manufacturing steps); modify the length of the cylindrical feature to make it intersect with the personalized retention device model. Then convert the cylindrical feature into a polygonal object. Use the "Boolean Operation" command under the "Polygon" menu to subtract the personalized retention device model from the created cylindrical model to achieve the design of the alveolar ridge top retention hole.

[0110] (4.7) Design of root-side retention holes (i.e., retention holes for retention pins): In Geomagic Control software, create a number of long cylinders with the same number of missing teeth and a diameter of 1.5 mm (matching the diameter of the retention pins) and place them in the root-side area to intersect with them. The placement position and placement angle represent the position and implantation angle of the personalized retention device to fix the fixed pins on the jawbone, ensuring that the position and angle of the designed fixing holes can avoid important anatomical structures such as nerves and blood vessels inside the surgical area. By performing "Boolean subtraction" between the personalized retention device model and the above-mentioned long cylinders, a number of guide retention pin implantation holes are obtained.

[0111] (4.8) Design of observation windows: In order to observe the suitability of soft tissue fixation pressure, the same number of observation windows as the number of missing teeth are designed in the graft area. The observation windows can face the buccal side of the implant, with a mesiodistal width of about 3-4mm and a crown-root length of about 5-6mm. And there should be at least 2mm of distance between the alveolar ridge top and the root side of the retention hole. Use the "Cut with plane" and "Cut with curve" functions under the "Polygon" menu in GeomagicControl software to draw the observation window in the graft area.

[0112] (5) Fabrication of a personalized retention device: The designed personalized retention device model is exported and converted into an STL file, and the personalized retention device is fabricated using a bio-isotropic material by 3D printing or 3D cutting. In this embodiment, a translucent medical resin material is used to fabricate the personalized retention device, such as Figure 15(a)-Figure 15(b) As shown, it is confirmed that the healing abutment can be stably retained in the ridge top retention hole.

[0113] Generally, peri-implant keratinized gingival grafting is often performed at the same time as the second-stage implantation surgery. If a keratinized gingival grafting is performed before the implantation surgery, or if the second-stage implantation surgery is not performed at the same time as the keratinized gingival grafting, the operation of step (4.6) can be omitted and the operation of step (4.7) can be applied to design the alveolar crest retention hole in the alveolar crest area to achieve the retention of the crest area of ​​the personalized retention device.

[0114] like Figure 16(a) to Figure 26 The specific clinical example shown, where Figure 16(a)-Figure 16(b)This is an image of the patient's lower left posterior teeth before surgery. It can be seen that there is only a narrow keratinized gingival strip on the lingual ridge at the missing tooth position, and the buccal ridge to the root is completely alveolar mucosa, with no vestibule groove, and the muscle frenulum is attached to the buccal alveolar ridge. Figure 16(a) is an image of the buccal surface of the patient's lower left posterior teeth before surgery. It can be seen that the keratinized gingiva from the buccal alveolar ridge to the root is missing and is completely covered by soft alveolar mucosa; Figure 16(b) is an image of the occlusal surface of the patient's lower left posterior teeth before surgery. It can be seen that only about 1-2mm of thin keratinized gingiva is left on the lingual side of the alveolar ridge. This case uses traditional suture fixation, which is extremely difficult to operate and has limited surgical results. Keratinized gingival transplantation surgery is performed with the assistance of the personalized retention device provided in this embodiment. Figure 17-Figure 20 As shown in the figure, during the operation, the free keratinized gingival tissue is placed on the buccal side of the implant and fixed with a personalized retention device. The personalized retention device is stably fixed with the healing abutment in the ridge area, and the root area is stably fixed with titanium nails to stabilize the transplanted keratinized gingiva in the ideal position. The root-reduced soft tissue flap is effectively blocked and fixed in the root area by the personalized retention device. No suturing is required during the whole process. Fig.19 It can be seen that the personalized retention device and the implant healing abutment are well retained, and the graft is fixed to the surgical area by the personalized retention device. Fig. 20 It can be seen that the retention pins implanted in the root direction stably fix the personalized retention device, thereby achieving stable fixation of the graft and the root-reduction flap.

[0115] like Figure 21-22 As shown in the figure, the patient was examined intraorally 1 month after surgery, and the keratinized gingiva on the buccal side of the alveolar ridge healed well, and the tissue in the root area was healing. Figure 23-Figure 26 As shown, the patient was examined again 2 months after the operation. The buccal keratinized gingival soft tissue was completely healed. Compared with the width of the keratinized gingiva before the operation, the incremental effect was significant.

[0116] Example 2

[0117] like Figure 13-Figure 15(b) As shown, this embodiment provides a personalized retention device for keratinized gingival transplantation around an oral implant, the personalized retention device for keratinized gingival transplantation around an oral implant is manufactured using the manufacturing method of the personalized retention device for keratinized gingival transplantation around an oral implant described in Example 1, and the personalized retention device for keratinized gingival transplantation around an oral implant comprises:

[0118] Organizational aspect;

[0119] The tissue surface is used for contacting with oral soft tissue;

[0120] The tissue surface includes a keratinized area, a graft area and a root area; the keratinized area is used to fit with the lingual or palatal area of ​​the alveolar crest incision of the patient; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the root area is used to fix the root repositioning flap;

[0121] The keratinized area is provided with a healing abutment retention hole, and the healing abutment retention hole is used to accommodate the healing abutment;

[0122] The graft area is provided with an observation window, and the observation window is used to observe the fixation pressure and healing condition of the soft tissue;

[0123] The root area is provided with a retaining nail retaining hole, and the retaining nail retaining hole is used to accommodate the fixing nail.

[0124] This embodiment uses a personalized retention device to assist keratinized gingival transplantation surgery, which has the following advantages:

[0125] 1) The thickness and integrity of the periosteum no longer affect the fixation effect, significantly reducing the difficulty of preparing a semi-thick flap during surgery and reducing surgical sensitivity.

[0126] 2) No complicated and difficult suturing operations are required, which significantly shortens the operation time, reduces the time the graft is out of the body, and reduces surgical sensitivity.

[0127] 3) It solves the problem of stable retention of the root-replacement flap, avoids the coronal displacement of the root-replacement flap caused by the patient's lip and cheek muscle movement after surgery, and significantly reduces the absorption rate of the graft.

[0128] The technical features of the above embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0129] This article uses specific examples to illustrate the principles and implementation methods of this application. The description of the above embodiments is only used to help understand the method and core ideas of this application. At the same time, for those skilled in the art, according to the ideas of this application, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting this application.

Claims

1. A method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant, characterized in that: The method for manufacturing the personalized retention device for keratinized gingival transplantation around oral implants comprises: Acquiring target data, wherein the target data includes three-dimensional information of the dentition and soft tissue in the edentulous area and three-dimensional information of the jaw; Obtaining a three-dimensional model according to the target data, wherein the three-dimensional model includes a three-dimensional model of the dentition and soft tissue, a three-dimensional model of the jaw, and a three-dimensional model of an implant in the jaw of an edentulous area; The boundary and tissue surface of the personalized retention device model are designed according to the three-dimensional model, wherein the tissue surface is used to contact the oral soft tissue; the tissue surface is divided into a keratinized area, a graft area and a root area; the keratinized area is used to fit with the lingual or palatal area of ​​the alveolar crest incision of the patient; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the root area is used to fix the root repositioning flap; the keratinized area includes a healing abutment retention hole, and the healing abutment retention hole is used to accommodate the healing abutment; the graft area includes an observation window, and the observation window is used to observe the fixing pressure and healing condition of the soft tissue; the root area includes a retention hole for a retention nail, and the retention hole for a retention nail is used to accommodate a fixing nail; A personalized retention device is manufactured according to the personalized retention device model.

2. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 1, characterized in that: The three-dimensional model is obtained according to the target data, including: Reconstructing an initial three-dimensional model according to the target data, wherein the initial three-dimensional model includes an initial dentition and soft tissue three-dimensional model and an initial jaw three-dimensional model; The initial dentition and soft tissue three-dimensional model is registered with the initial jaw three-dimensional model to obtain a registered three-dimensional model, wherein the registered three-dimensional model includes the dentition and soft tissue three-dimensional model and the jaw three-dimensional model; Extracting the three-dimensional model of the implant in the jawbone of the edentulous area from the registered three-dimensional model; The three-dimensional model of the implant in the jawbone of the edentulous area and the registered three-dimensional model are used as the three-dimensional model.

3. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 1, characterized in that: The boundary design process specifically includes: Determine the surgical incision position according to the three-dimensional model, wherein the surgical incision position includes a mesial position, a distal position, an alveolar crest incision position, and a first distance, wherein the mesial position refers to a position close to the midline between the central incisors, and the distal position refers to a position far from the midline between the central incisors, and the first distance is the distance between the semi-thickness flap root and the alveolar crest after repositioning and fixation; The boundary is designed according to the surgical incision position, wherein the boundary includes a mesial boundary, a distal boundary, a root boundary and a coronal boundary, the mesial boundary is located at a position after a first preset distance is extended outwardly in the mesial direction of the surgical incision position, the distal boundary is located at a position after a second preset distance is extended outwardly in the distal direction of the surgical incision position, the root boundary is located at a position after a third preset distance is extended outwardly in the root direction of the surgical incision position, the coronal boundary is located at a horizontal position of the gingival outlet on the lingual side of the implant, and the boundary should not enter the undercut area of ​​the adjacent tooth.

4. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 3, characterized in that: The design process of the keratinized area specifically includes: Correct the three-dimensional model of dentition and soft tissue according to the boundary to obtain the three-dimensional model of dentition and soft tissue within the boundary; The soft tissue information on the buccal side of the alveolar crest incision position in the three-dimensional model of the dentition and soft tissue within the boundary is deleted, and the soft tissue information retained in the three-dimensional model of the dentition and soft tissue within the boundary is used as the data of the keratinized area tissue surface.

5. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 3, characterized in that: The design process of the graft area specifically includes: Correct the three-dimensional model of the jaw according to the boundary to obtain the three-dimensional model of the jaw within the boundary; The first target bone surface information in the three-dimensional model of the mandible within the boundary is moved by a fourth preset distance in a direction away from the bone surface to obtain the first target bone surface information after the movement, wherein the first target bone surface information is the bone surface information at a preset depth from the buccal side of the alveolar crest incision position to the coronal side of the root reduction level, and the value of the fourth preset distance is the same as the value of the transplanted keratinized gingival thickness estimated before the operation; The information of the first target bone surface after the movement is used as the data of the tissue surface of the transplant area.

6. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 3, characterized in that: The design process of the root square area specifically includes: Correct the three-dimensional model of the jaw according to the boundary to obtain the three-dimensional model of the jaw within the boundary; The second target bone surface information in the three-dimensional model of the mandible within the boundary is moved in a direction away from the bone surface by a fifth preset distance to obtain the second target bone surface information after the movement, wherein the second target bone surface information is the bone surface information at the root reduction level to the coronal preset depth; The information of the second target bone surface after the movement is used as the data of the root area tissue surface.

7. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 6, characterized in that: The design process of the healing abutment retention hole specifically includes: Creating a first cylinder by using a fitting method based on the three-dimensional model of the implant within the boundary, wherein the diameter of the first cylinder is greater than the diameter of the implant healing abutment; moving the first cylinder to the keratinized area; The first cylinder in the keratinized area is processed by Boolean operation to obtain a healing abutment retention hole.

8. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 1, characterized in that: The design process of the retaining hole for the retaining nail specifically includes: Constructing a plurality of second cylinders, wherein the number of the second cylinders is the same as the number of missing teeth, and the diameter of each of the second cylinders is adapted to the diameter of the fixing pin; Moving the second cylinder to the root area, wherein the placement position and placement angle of each second cylinder are used to characterize the position and implantation angle of the fixation pin; The second cylinder in the root square area is processed by Boolean operation to obtain the retention hole for the retention nail.

9. The method for manufacturing a personalized retention device for keratinized gingival transplantation around an oral implant according to claim 1, characterized in that: The design process of the observation window of the personalized retention device specifically includes: Observation windows are designed in the implant area, wherein the observation windows face the buccal side of the implant, and the number of the observation windows is the same as the number of missing teeth.

10. A personalized retention device for keratinized gingival transplantation around oral implants, characterized in that: The personalized retention device for keratinized gingival transplantation around oral implants is manufactured by the manufacturing method of the personalized retention device for keratinized gingival transplantation around oral implants according to any one of claims 1 to 9, and the personalized retention device for keratinized gingival transplantation around oral implants comprises: Organizational aspect; The tissue surface is used for contacting with oral soft tissue; The tissue surface includes a keratinized area, a graft area and a root area; the keratinized area is used to fit with the lingual or palatal area of ​​the alveolar crest incision of the patient; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the root area is used to fix the root repositioning flap; The keratinized area is provided with a healing abutment retention hole, and the healing abutment retention hole is used to accommodate the healing abutment; The graft area is provided with an observation window, and the observation window is used to observe the fixation pressure and healing condition of the soft tissue; The root area is provided with a retaining nail retaining hole, and the retaining nail retaining hole is used to accommodate the fixing nail.

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