Personalized retention device and manufacturing method for keratinized gingival grafting around oral implants

Abstract

The present application provides a personalized retention device and manufacturing method for keratinized gingival transplantation around oral implants, relating to the field of medical device technology. The personalized retention device includes a tissue surface, which 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 patient's alveolar crest incision. The graft area is used to accommodate and fix the transplanted keratinized gingiva. The root area is used to fix the root-oriented reduction flap. The keratinized area is also provided with a healing abutment retention hole for accommodating the healing abutment. The graft area is also provided with an observation window for observing the fixation pressure and healing status of the soft tissue. The root area is also provided with a retention hole for a retention pin for accommodating a retention pin. The personalized retention device can achieve accurate, efficient, and stable fixation of the root-oriented reduction flap and the transplanted soft tissue, reduce surgical difficulty and operation time, and improve the widening effect of the keratinized gingiva.

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 a focus of basic and clinical oral 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 believed to be associated with more plaque accumulation, tissue inflammation, gingival recession, and attachment loss. When the keratinized gingiva width is <2mm, patients are more likely to experience peri-implant gingival discomfort, soft tissue recession, plaque accumulation, mucosal inflammation, and marginal bone resorption. 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 the prevention and treatment of implant mucositis. Based on long-term clinical observations, keratinized gingiva width of not less than 2mm is an important protective factor for peri-implant disease.

[0003] A variety of factors can lead to a reduction in keratinized gingiva at the implant site, such as tooth extraction due to long-term periodontal or periapical infection, long-term tooth loss, and the prolonged use of removable dentures. Based on the 2018 clinical consensus opinion, keratinized gingival augmentation is considered necessary for implant sites with less than 2mm of keratinized gingiva. Keratinized gingival grafting achieves the goal of widening the keratinized gingiva by suturing and securing the root-oriented repositioned flap and autologous soft tissue. Keratinized gingival grafting is generally performed at the same time as the second-stage implant surgery.

[0004] The classic radicular flap combined with autologous soft tissue transplantation (free gingival grafting) procedure mainly uses sutures to firmly fix the radicular soft tissue flap and transplanted keratinized soft tissue to the thin periosteum. This procedure is a highly technically sensitive implant surgery that is highly dependent on the physician's clinical experience and surgical skills. The suture fixation effect is significantly affected by the location of the missing teeth and the surgeon's experience. During the operation, a semi-thick flap needs to be prepared and the integrity of the periosteum needs to be ensured. If the periosteum is damaged or too thin, the stable fixation of the transplanted soft tissue and the radicular flap will be significantly reduced, resulting in unsatisfactory surgical results. The visual field and operating space in the posterior area are limited by the patient's mouth opening, the size of the mouth angle, 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 therapeutic effect. Especially in the mandibular posterior area, the surgical widening effect faces 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 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 tissue on the periosteum and the surrounding wound margin 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 gingiva loss is the mandibular posterior teeth area. Therefore, reducing the difficulty of free gingival grafting surgery and improving the effectiveness 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 effectiveness 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-positioned flap and transplanted soft tissue, reduce surgical difficulty and operation time, and improve the widening effect of 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 grafting 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 based on 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 the implant in the jaw of the edentulous area;

[0010] The boundaries and tissue surfaces 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 an apical area; the keratinized area is used to fit the lingual or palatal area of ​​the patient's alveolar crest incision; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the apical area is used to fix the root-reset flap; the keratinized area includes a healing abutment retention hole, which is used to accommodate the healing abutment; the graft area includes an observation window, which is used to observe the fixation pressure and healing condition of the soft tissue; the apical area includes a retention hole for a retention pin, which is used to accommodate a retention pin;

[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 a keratinized gingival transplant around an oral implant, comprising: the personalized retention device for a keratinized gingival transplant around an oral implant is manufactured using the manufacturing method for a personalized retention device for a keratinized gingival transplant around an oral implant described in the first aspect, the personalized retention device for a keratinized gingival transplant around an oral implant comprising:

[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 the lingual or palatal area of ​​the patient's alveolar crest incision; the graft area is used to accommodate and fix the transplanted keratinized gingiva; and the root area is used to fix the root-oriented 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, which 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, which 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 patient's alveolar ridge incision. The graft area is used to accommodate and fix the transplanted keratinized gingiva. The root area is used to fix the root-oriented reduction flap. The keratinized area is also provided with a healing abutment retention hole for accommodating the healing abutment. The graft area is also provided with an observation window for observing the fixation pressure and healing status of the soft tissue. The root area is also provided with a retention hole for a retention pin for accommodating a retention pin. The personalized retention device can achieve accurate, efficient, and stable fixation of the root-oriented reduction flap and the transplanted soft tissue, reduce surgical difficulty and operation time, 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 following briefly introduces the drawings required for use in the embodiments. 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 creative work.

[0022] Figure 1 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 Schematic diagram of the digital model of the dentition and soft tissue in the edentulous area in Example 1 of the present application;

[0024] Figure 3 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 the 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 the two models to be registered in Example 1 of the present application;

[0028] Figure 7 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 Schematic diagram of the registration of two models to be registered after optimal fitting in Example 1 of the present application;

[0030] Figure 9 A front 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;

[0031] Figure 10 A schematic side view of the finally registered 3D model of the dentition and edentulous area soft tissue and the 3D model of the jaw in Example 1 of the present application;

[0032] Figure 11 Schematic diagram of the three-dimensional model of the jaw in the surgical area in Example 1 of the present application;

[0033] Figure 12 Schematic diagram of the combined view of the personalized retention device model in Example 1 of the present application;

[0034] Figure 13 Schematic diagram of the occlusal view of the personalized retention device model in Example 1 of the present application;

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

[0036] FIG15( a ) is a schematic diagram of a first example of a personalized retention device in Example 1 of the present application;

[0037] FIG15( b ) is a schematic diagram of a second example of the personalized retention device in Example 1 of the present application;

[0038] FIG16( 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 tooth area of ​​the patient before surgery in Example 1 of the present application;

[0040] Figure 17 This is a schematic diagram of harvesting keratinized soft tissue of appropriate size from the patient's maxillary palate according to the transplant range indicated by the personalized retention device in Example 1 of the present application;

[0041] Figure 18 Schematic diagram of placing transplanted keratinized gingiva above the mucoperiosteal flap in the surgical area during surgery in Example 1 of the present application;

[0042] Figure 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] Figure 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] Figure 21 This is a buccal image of the healing effect of the keratinized gingiva on the buccal side of the alveolar ridge top during a follow-up examination one month after surgery in Example 1 of the present application;

[0045] Figure 22 This is an occlusal image of the healing effect of the keratinized gingiva on the buccal side of the alveolar ridge top in the patient's follow-up examination one month after surgery in Example 1 of the present application;

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

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

[0048] Figure 25 This is a three-dimensional intraoral scan image of the buccal keratinized gingiva of the patient before surgery in Example 1 of the present application;

[0049] Figure 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 retaining pins to fix the root-reset flap and transplanted soft tissue. However, the present inventors found that the fixation effect of the root-reset flap was limited by using this method of retaining pins to assist in fixation, and suturing operation could not be avoided, which did not significantly reduce technical sensitivity and shorten the operation time. For example, Figure 1 The fixation of the root-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 digital data of the patient's gums and jaws before surgery and uses reverse engineering methods 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 this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

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

[0054] Example 1

[0055] Regarding the problems existing in previous oral implant peri-keratinized gingival grafting surgeries:

[0056] 1) Suturing is difficult, time-consuming, and technically sensitive: Securely securing the root-repositioned soft tissue flap and transplanted keratinized soft tissue to the thin periosteum through suturing is a highly technical implant surgery procedure that relies heavily on the surgeon's clinical experience and surgical technique. The effectiveness of suture fixation is significantly influenced by the location of the edentulous area and the surgeon's experience. The field of view and operating space in the posterior region are limited by the patient's mouth opening, the size of the corners of the mouth, and the tension of the cheek skin, all of which are less ideal than those in the anterior region. This significantly restricts the surgeon's field of view and operating space, negatively impacting the therapeutic effect. Suturing is particularly challenging in the posterior mandible. Because the vestibule groove in the mandibular molar region is naturally shallower than in the anterior region and the buccinator muscle is attached at a higher position, the probability of the vestibule groove becoming shallower or even disappearing increases significantly with tooth loss and associated alveolar bone resorption. The characteristics of the healed tissue are influenced by the supraperiosteal tissue and surrounding wound margins. Improper correction of high muscle attachment can significantly impair the widening 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) Surgical results are limited and subject to significant variability: Studies have reported that the average 6-month widening effect of a classic root-oriented flap combined with an autologous soft tissue graft (free gingival graft) in the posterior mandible is only 2.68±1.80mm. The typical width of the grafted keratinized gingiva is 6-7mm. It is not difficult to see that the rate of width loss after healing is as high as 50%, and the widening effect varies greatly from patient to patient. The predictability of the procedure needs to be improved.

[0058] In this regard, this embodiment provides a method for manufacturing a personalized retention device for keratinized gingival grafting 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, as well as 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 an implant 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 jaw of the edentulous area from the registered three-dimensional model.

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

[0066] S3: Design the boundaries and tissue surfaces of a personalized retention device model based on 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 an apical area; the keratinized area is used to fit 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 apical area is used to fix the root-oriented 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 apical area includes a retention hole for a retention pin, and the retention hole for a retention pin is used to accommodate a retention pin.

[0067] The boundary design process specifically includes:

[0068] Determining 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 away from the midline between the central incisors. The first distance is the distance between the semi-thickness flap root after repositioning and fixation and the alveolar crest;

[0069] The boundary is designed according to the position of the surgical incision, 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 the first preset distance is extended outward in the mesial direction of the surgical incision, the distal boundary is located at a position after the second preset distance is extended outward in the distal direction of the surgical incision, the root boundary is located at a position after the third preset distance is extended outward in the root direction of the surgical incision, the coronal boundary is located at the 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] Modifying the three-dimensional model of the dentition and soft tissue according to the boundary to obtain a three-dimensional model of the 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] Correcting the three-dimensional model of the jaw according to the boundary to obtain a three-dimensional model of the jaw within the boundary;

[0075] Moving the first target bone surface information in the three-dimensional model of the mandible within the boundary 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 gingiva 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] Modifying the three-dimensional model of the jaw according to the boundary to obtain a 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 a fifth preset distance in a direction away from the bone surface 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 using a fitting method based on the three-dimensional model of the implant within the boundary, wherein the diameter of the first cylinder is larger 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 using Boolean operations to obtain a healing abutment retention hole.

[0085] The design process of the retention hole for the retention 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 second cylinder 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 represent the position and implantation angle of the fixation pin;

[0088] The second cylinder in the root square area is processed using Boolean operations to obtain a retention hole for a 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-oriented repositioning flap, reduces the sensitivity of peri-implant keratinized gingiva 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 clear about 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 edentulous area and acquisition of three-dimensional information of the jaw: obtain digital models of the three-dimensional information of the dentition and soft tissues in the edentulous area by intraoral scanning or scanning the dentition plaster model, export and store the digital models of the dentition and soft tissues in the edentulous area as Standard Tessellation Language (STL) data, and the digital models of the dentition and soft tissues in the edentulous area are as follows: Figure 2 As shown in the figure, the three-dimensional imaging data of the jaw is obtained by cone beam CT scanning (after implantation / bone grafting surgery), 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 shown in the figure. Figure 3 shown.

[0095] (2) Reconstruction of the three-dimensional model of the jaw: import the three-dimensional imaging data of the jaw into the dental three-dimensional data processing software to reconstruct the three-dimensional model of the jaw and the model of the intraosseous implant in the edentulous area. Specifically: use the threshold segmentation function to reconstruct the three-dimensional model of the jaw by adjusting the threshold to the range of the dentition and bone tissue; use the threshold segmentation function to reconstruct the model of the intraosseous implant in the edentulous area by adjusting the threshold to the range of the intraosseous implant, such as 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 direction to facilitate subsequent operations, such as Figure 5 Then, through the "match grid" function, select three points with corresponding positions on the two models and perform preliminary alignment of the selected point coordinates, as shown in the following example: 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 Figure 9 and Figure 10 shown.

[0097] By editing the mesh of the mandibular 3D model and removing the non-operative area, the 3D mandibular model of the operative area is obtained. Figure 11 The edentulous area intraosseous implant model was extracted from the jawbone, and then the registered 3D model of the dentition and edentulous area soft tissue, the 3D model of the surgical area jawbone, 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 dentition and edentulous area soft tissue three-dimensional model, the surgical area jaw three-dimensional model and the edentulous area intraosseous implant model into Geomagic Control software. The design of the personalized retention device model is based on the "three-zone" design principle, and the tissue surface morphology of the personalized retention device model is divided into three areas, namely the keratinized area, the graft area and the root area. The keratinized area fits with the tongue / palatal area of ​​the alveolar ridge top incision in the surgical area; the graft area is the area for accommodating and fixing the transplanted keratinized gingiva; the root area is the area for fixing the root-reset flap, blocking the coronal migration of the root-reset 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 format-converted and registered three-dimensional model of the dentition and edentulous area soft tissue, the three-dimensional model of the surgical area jaw, and the model of the edentulous area endosseous implant), 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 of the surgical area. The incision position of the surgical area includes the mesial position, the distal position, the position of the alveolar ridge top incision, and the distance between the half-thickness flap and the alveolar ridge top after root reduction and fixation. Mesial refers to the position close to the midline between the central incisors, and distal 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 along 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 along 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 along 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 boundary of the personalized retention device model should not enter the undercut area of ​​the adjacent teeth.

[0102] The 3D model of the dentition and soft tissue in the edentulous area and the 3D model of the jaw in the surgical area within the boundary are retained, and the model outside the boundary is deleted.

[0103] Clinically, the design principles of the surgical area (surgical incision range) for keratinized gingival augmentation surgery are as follows: the coronal side is the boundary line between the keratinized gingiva at the top of the alveolar ridge and the non-keratinized gingiva on the buccal side; the apical side is 5-7 mm apical to the top of the buccal alveolar ridge, which varies depending on the width of the graft and whether there are important anatomical structures such as nerves on the apical 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] During keratinized gingival augmentation surgery, the boundaries of the personalized retention device must be determined based on the surgical area to ensure that the device covers the surgical field. During surgery, the personalized retention device assists the surgeon in determining the incision location and the radicular position of the semi-thickness flap. The surgical field is defined by the coronal-radial boundary and the mesiodistal boundary.

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

[0106] (4.3) Graft Area Design: The three-dimensional jaw model within the boundaries was trimmed, preserving the bone surface information from the buccal aspect of the alveolar crest incision to a depth of 2 mm coronal to the horizontal level of radicular reduction. Preoperatively, the thickness of the transplanted keratinized gingiva was estimated to be X mm (clinically, the thickness of keratinized gingiva is approximately 0.5-2 mm, which can be measured empirically, using a probe, or using a registered model of the jaw, maxillary dentition, and palate soft tissue). Using the "Offset" function under the "Polygon" menu in Geomagic Control software, this portion of the bone surface information was uniformly shifted X mm away from the bone surface. This shifted bone surface information was used as the tissue surface data for the graft area.

[0107] (4.4) Design of the apical region: The 3D mandibular model was trimmed within the boundary, retaining the bone surface information from the apical reduction level to a depth of 2 mm coronally. Considering the average thickness of the periosteum, the "Offset" function under the "Polygon" menu in Geomagic Control software was used to uniformly shift this portion of the bone surface information away from the bone surface by 0.5 mm. This shifted bone surface information was used as the data for the apical region tissue surface.

[0108] (4.5) Using the "Fill Hole" function under the "Polygon" menu in Geomagic Control software, smoothly connect the three designed models to form a single, complete model. This combined model will serve as the tissue surface of the personalized retention device. Using the "Shell" function under the "Polygon" menu in the software, uniformly thicken the combined model to 1.5 mm away from the bone surface.

[0109] (4.6) Design of the alveolar ridge retention hole (i.e., the healing abutment retention hole): In Geomagic Control software, select the edentulous intraosseous implant model. 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 so that it is 0.1-0.2 mm larger than the diameter of the implant healing abutment (taking into account the tolerance of subsequent production steps). Modify the length of the cylindrical feature so that it intersects 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 retention hole.

[0110] (4.7) Design of apical retention holes (i.e., retention screw holes): In Geomagic Control software, create a number of long cylinders with a diameter of 1.5 mm (matching the diameter of the retention screws) equal to the number of missing teeth and place them in the apical area to intersect with them. The placement and angle of the cylinders represent the position and angle of the fixation screws that secure the personalized retention device to the jawbone. Ensure that the position and angle of the designed fixation holes avoid important anatomical structures such as nerves and blood vessels within the surgical area. By performing a Boolean subtraction between the personalized retention device model and the aforementioned long cylinders, several guide retention screw placement holes are obtained.

[0111] (4.8) Observation Window Design: To assess the suitability of soft tissue fixation pressure, design an equal number of observation windows in the implant area to the number of missing teeth. These windows should face the buccal side of the implant, be approximately 3-4 mm wide in the mesiodistal direction, and 5-6 mm long in the coronal-radial direction. A minimum of 2 mm should be maintained between the alveolar crest and the apical retention holes. Use the "Clip with Plane" or "Clip with Curve" functions under the "Polygon" menu in Geomagic Control software to draw the observation windows in the implant area.

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

[0113] Generally, peri-implant keratinized gingival grafting is often performed simultaneously with the second-stage implant surgery. If a keratinized gingival grafting is performed before implant surgery, or if a second-stage implant surgery is not performed during the same period, step (4.6) can be omitted and step (4.7) can be applied to design a ridge retention hole in the alveolar crest region to achieve the retention of the personalized retention device in the ridge region.

[0114] like Figure 16(a)-Figure 26 The specific clinical example shown, where Figure 16(a)-Figure 16(b)This is a preoperative image of the patient's lower left posterior teeth. It can be seen that there is only a narrow keratinized gingiva 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 ligament is attached to the buccal alveolar ridge. Figure 16 (a) is a preoperative buccal image of the patient's lower left posterior teeth. 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 a preoperative occlusal image of the patient's lower left posterior teeth. It can be seen that there is only about 1-2mm of thin keratinized gingiva on the lingual side of the alveolar ridge. This case is fixed with traditional sutures, 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, such as Figures 17-20 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 retained with the healing abutment in the crest area, and the root area is stably fixed with titanium nails, which stabilizes 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 entire process. Figure 19 It can be seen that the personalized retention device is well retained with the implant healing abutment, and the graft is fixed to the surgical area by the personalized retention device. Figure 20 As can be seen in the figure, the radicularly implanted retention pins stabilize the personalized retention device, thereby achieving stable fixation of the graft and radicularly repositioned flap.

[0115] like Figure 21-22 As shown in the figure, the patient was examined intraorally 1 month after surgery. The keratinized gingiva on the buccal side of the alveolar ridge was healing well, and the tissue in the root area was healing. Figure 23-26 As shown in the figure, the patient was examined 2 months after the operation and 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 13-15(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. 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 the lingual or palatal area of ​​the patient's alveolar crest incision; the graft area is used to accommodate and fix the transplanted keratinized gingiva; and the root area is used to fix the root-oriented 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, which 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 utilizes a personalized retention device to assist in keratinized gingival grafting 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 lowering surgical sensitivity.

[0126] 2) No tedious 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-reset flap, avoids the coronal displacement of the root-reset 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 can be combined arbitrarily. 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 document uses specific examples to illustrate the principles and implementation methods of this application. The description of the above examples is only intended to help understand the method and core concept of this application. At the same time, for those skilled in the art, based on the concept of this application, there may 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 based on 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 the implant in the jaw of the edentulous area; The boundaries and tissue surfaces 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 an apical area; the keratinized area is used to fit the lingual or palatal area of ​​the patient's alveolar crest incision; the graft area is used to accommodate and fix the transplanted keratinized gingiva; the apical area is used to fix the root-reset flap; the keratinized area includes a healing abutment retention hole, which is used to accommodate the healing abutment; the graft area includes an observation window, which is used to observe the fixation pressure and healing condition of the soft tissue; the apical area includes a retention hole for a retention pin, which is used to accommodate a retention pin; 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: Obtaining a three-dimensional model based on the target data includes: 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; Registering 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; Extracting the three-dimensional model of the implant in the jaw of the edentulous area from the registered three-dimensional model; The three-dimensional model of the implant in the jaw 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: Determining 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 away from the midline between the central incisors. The first distance is the distance between the semi-thickness flap root after repositioning and fixation and the alveolar crest; The boundary is designed according to the position of the surgical incision, 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 the first preset distance is extended outward in the mesial direction of the surgical incision, the distal boundary is located at a position after the second preset distance is extended outward in the distal direction of the surgical incision, the root boundary is located at a position after the third preset distance is extended outward in the root direction of the surgical incision, the coronal boundary is located at the 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: Modifying the three-dimensional model of the dentition and soft tissue according to the boundary to obtain a three-dimensional model of the 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: Modifying the three-dimensional model of the jaw according to the boundary to obtain a three-dimensional model of the jaw within the boundary; Moving the first target bone surface information in the three-dimensional model of the mandible within the boundary 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 gingiva 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: Modifying the three-dimensional model of the jaw according to the boundary to obtain a 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 a fifth preset distance in a direction away from the bone surface 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 using a fitting method based on the three-dimensional model of the implant within the boundary, wherein the diameter of the first cylinder is larger 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 using Boolean operations 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 retention hole for the retention 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 second cylinder 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 represent the position and implantation angle of the fixation pin; The second cylinder in the root square area is processed using Boolean operations to obtain a retention hole for a 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 an oral implant is manufactured using the manufacturing method for the personalized retention device for keratinized gingival transplantation around an oral implant according to any one of claims 1 to 9, and the personalized retention device for keratinized gingival transplantation around an oral implant 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 the lingual or palatal area of ​​the patient's alveolar crest incision; the graft area is used to accommodate and fix the transplanted keratinized gingiva; and the root area is used to fix the root-oriented 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, which 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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