Dental metal implantation guide plate and preparation method thereof

Abstract

The invention relates to a dental metal implantation guide plate and a preparation method thereof. The guide plate comprises a guide plate body, and the guide plate body comprises a gingiva attaching area and an implantation positioning area; wherein the gingiva attaching area is provided with a curved surface structure matched with an alveolar bone, the implant positioning area is provided with a positioning hole matched with an implant, the positioning hole penetrates through the guide plate body, a heat dissipation channel for cooling liquid to circulate is arranged on the peripheral side of the positioning hole, and the heat dissipation channel is communicated with the positioning hole; the guide plate body is made of titanium alloy powder and copper powder through the additive manufacturing technology. The implant guide plate has the advantages of being high in strength, light, thin, efficient in heat dissipation, biocompatible, recoverable and environmentally friendly, and the precision, safety and sustainability of a dental implant operation are improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of oral medical devices, in particular to a dental metal implant guide and a preparation method thereof. BACKGROUND

[0002] Dental caries and periodontal disease are common oral diseases that often lead to early tooth loss or shedding, resulting in tooth loss or even tooth loss. Among them, removable partial dentures, fixed bridges, and implant dentures are the three common repair methods for tooth loss. Compared with the weak retention of removable partial dentures and the damage to the abutment teeth of fixed bridges, implant denture repair is attracting attention due to its good retention and non-damage to the adjacent teeth in the missing area.

[0003] CBCT (Cone-Beam Computed Tomography, Cone-Beam Computed Tomography) is a medical imaging technology specifically used in the field of oral and maxillofacial surgery. With the improvement of CBCT accuracy, the development of related implant software, and the rapid development of 3D printing technology (also known as "additive manufacturing technology" or "rapid prototyping technology"), the use of 3D printing digital implant guides and dynamic navigation technology for preoperative planning and accurate implantation of implants during surgery can achieve repair-oriented and achieve the best treatment effect of implant repair.

[0004] In implant guide surgery, personalized 3D printed static implant guides mostly use stereolithography technology (SLA), among which 3D printed photosensitive resin implant guides made of light polymerization resin additive are the most widely used, with the advantages of convenient operation, high precision, etc. However, it also has the following defects: the mechanical properties of photosensitive resin static guides are insufficient, and the low resin strength leads to easy cracking during surgery, so a 2-3mm thick solution is often used to ensure strength, but it will also result in a large volume of the guide; thick design will also occupy the operating space in the posterior region or in cases with limited opening, limiting clinical operation and affecting the operator's vision and instrument implantation; due to the properties of resin, it will hinder the flow of cooling liquid, making it difficult to dissipate heat during implant socket preparation, and there is a risk of thermal damage to bone tissue when the temperature exceeds the critical value of 47℃, which will affect bone integration; resin is not degradable, which poses an environmental pollution risk of medical waste pollution. SUMMARY

[0005] To solve or partially solve the problems in the related art, the present application provides a dental metal implant guide and a preparation method thereof, which has high strength, thinness, high efficiency heat dissipation, biocompatibility, recyclability, and environmental protection characteristics, improving the accuracy, safety, and sustainability of dental implant surgery.

[0006] The first aspect of the application provides a dental metal implant guide plate, comprising a guide plate body, the guide plate body comprising a gum fitting area and an implant positioning area; wherein the gum fitting area has a curved surface structure matching the alveolar bone, the implant positioning area is provided with a positioning hole matching the implant, the positioning hole penetrates through the guide plate body, a heat dissipation channel for cooling liquid circulation is provided on the side of the positioning hole, and the heat dissipation channel is in communication with the positioning hole; the guide plate body is made of titanium alloy powder and copper powder by additive manufacturing technology.

[0007] In some embodiments, the mass ratio of the titanium alloy powder and the copper powder in the guide plate body is 1: (0.01-0.05).

[0008] In some embodiments, the mass ratio of the titanium alloy powder and the copper powder in the guide plate body is 1: (0.02-0.03).

[0009] In some embodiments, the titanium alloy powder is Ti-6Al-4V.

[0010] In some embodiments, the heat dissipation channel has multiple heat dissipation channels, and each heat dissipation channel is radially distributed on the side of the positioning hole, and the total flow area of the heat dissipation channels is ≥5mm 2 .

[0011] In some embodiments, the thickness of the guide plate body is 1.0-1.55mm.

[0012] In some embodiments, the side of the positioning hole is further provided with an observation window.

[0013] In some embodiments, the guide plate body further comprises an operation auxiliary area, and the operation auxiliary area is distributed on the side of the implant positioning area; the operation auxiliary area and the upper surface of the positioning hole form a height difference to form an instrument operation space on the side of the positioning hole.

[0014] The second aspect of the application provides a preparation method of a dental metal implant guide plate, comprising the following steps: 1) obtaining three-dimensional image data of the patient's alveolar bone by CBCT scanning for implant positioning planning to obtain an implant guide plate model; 2) using SLM technology to perform additive manufacturing processing based on the implant guide plate model to obtain a pretreated implant guide plate; the material is titanium alloy powder and copper powder; 3) performing surface sand blasting and vacuum annealing treatment on the pretreated implant guide plate to obtain an implant guide plate.

[0015] In some embodiments, the vacuum annealing treatment condition is to heat at 700-1000℃ for 1-1.5h and then cool to room temperature in the furnace.

[0016] The technical scheme provided by the present application can include the following beneficial results: high-strength titanium alloy is used as the core material of the implant guide plate, combined with precise structure design and advanced 3D printing process, so that the prepared implant guide plate has the characteristics of high strength, lightness, high efficiency of heat dissipation, biocompatibility, recyclability and environmental protection. By using titanium alloy + Cu as the material of the implant guide plate, the resin material is replaced, the mechanical property defects are solved, the antibacterial performance of the product is improved, and the environmental protection goal is also achieved; the problems of operation space and poor heat dissipation are solved through material properties and structure optimization, and the accuracy, safety and sustainability of the implant surgery are improved as a whole.

[0017] It should be understood that the foregoing general description and the following detailed description are only exemplary and explanatory, and are not limiting to the present application. BRIEF DESCRIPTION OF DRAWINGS

[0018] The above and other objects, features and advantages of the present application will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings in which like reference characters refer to like parts throughout the several views, and in which:

[0019] Figure 1 is a structural schematic diagram of a dental metal implant guide plate shown in an embodiment of the present application.

[0020] Figure 2 is a structural schematic diagram of a dental metal implant guide plate shown in an embodiment of the present application.

[0021] Figure 3 is a sectional view of a positioning hole in a dental metal implant guide plate shown in an embodiment of the present application.

[0022] Figure 4 is a sectional view of a positioning hole in a dental metal implant guide plate shown in an embodiment of the present application.

[0023] Reference signs: 1, guide plate body; 2, gum fitting area; 3, implant positioning area; 31, positioning hole; 32, heat dissipation channel; 33, notch; 4, operation auxiliary area; 5, observation window. DETAILED DESCRIPTION

[0024] The embodiments of the present application will be described in more detail below. It should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0025] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Unless otherwise defined, all terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present application, the preferred methods and materials are now described.

[0026] It should be understood that, although the terms "first," "second," "third," etc. can be used herein to describe various information, the information should not be limited by these terms. These terms are used only to distinguish one from another information. A feature described as "first," "second," etc. can implicitly or explicitly include one or more of the features described with respect to that feature. The use of the terms "first," "second," "third," etc. herein to describe various information is only used to differentiate one from another information. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0027] Where a range of values is provided, it is understood that each intervening value, to the upper and lower limit of the range is encompassed. The upper and lower limits of these smaller ranges can independently be included in the smaller ranges and are also encompassed, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included. In the description of the application, the term "plurality" means two or more, unless expressly specified otherwise.

[0028] With the improvement of CBCT accuracy, the development of related implant software and the rapid development of 3D printing technology, the use of 3D printing digital implant guide and dynamic navigation technology for preoperative planning and accurate implantation of implants can achieve repair-oriented and achieve the best treatment effect of implant repair. Among them, 3D printing technology is to design data through computer-aided technology, and to manufacture by layer-by-layer accumulation of raw materials. Compared with subtractive technology, 3D printing technology has more flexibility in the use of materials and geometric construction. 3D printing technology has been widely used in various fields of oral medicine. 3D printing static implant surgery guide plate technology has the characteristics of convenient operation, easy clinical promotion and high precision, and has many advantages: ①It can significantly reduce the risk of surgery. Through digital software modeling and visual design, the implant site and depth can be accurately avoided from important anatomical structures such as blood vessels, nerves and sinus cavities, thereby reducing the risk of surgery. ②It can greatly shorten the operation time. Under the guidance of the implant surgery guide plate, the position, direction and depth of the implant are more scientific and accurate, reducing blind operation during surgery. Preoperative preparation and comprehensive design planning can greatly reduce the adjustment and operation time during surgery. ③It can effectively relieve postoperative discomfort. Because the application of implant guide plate can improve the accuracy of implantation and shorten the operation time, the trauma after implantation is smaller, and the discomfort symptoms such as swelling, pain and numbness can be effectively controlled. The application of 3D printing implant guide plate is suitable for various indications, including single tooth loss, multiple tooth loss and complete dentition loss. Through accurate positioning and personalized program design, successful implantation can be achieved to meet the needs of different patients and improve the precision and comfort of implant repair treatment.

[0029] In implant guided surgery, personalized 3D printing static implant guide plate is mostly made by stereolithography apparatus (SLA). The 3D printing photosensitive resin implant guide plate made by additive manufacturing of photosensitive resin is the most widely used. However, due to the low strength of the resin, there are occasional fractures during the operation, which greatly affects the success rate of implant surgery. Therefore, the photosensitive resin guide plate needs to have enough thickness to ensure sufficient strength to prevent fracture during the operation. This often makes the photosensitive resin guide plate usually larger and thicker, which will affect the doctor's implant operation in the posterior region or in some cases with limited opening. At the same time, the thicker resin layer will also affect the inflow of the cooling liquid, which is not conducive to heat dissipation during the implant preparation process, and is easy to cause bone damage and affect the bone integration and stability of the implant. Traditional photosensitive resin materials do not have degradation properties and have a serious impact on the environment and even human health.

[0030] To solve the above problems, the embodiment of the present application provides a dental metal implant guide plate and a preparation method thereof. The implant guide plate material adopts titanium alloy + Cu, which has better stability, heat conduction and dissipation, biocompatibility, high strength, small volume, recyclability and other characteristics compared with resin guide plate. As an important material for auxiliary implant technology, it can improve the operation convenience, visual field opening and implant accuracy, and has good clinical application value.

[0031] As shown in Figure 1 and Figure 2 The dental metal implant guide plate provided by the embodiment of the present application comprises a guide plate body 1. The guide plate body 1 comprises a gum fitting area 2 and an implant positioning area 3. The gum fitting area 2 has a curved surface structure matching the alveolar bone, and the fitting precision error is ≤0.1mm. The personalized curved surface design can ensure the close fitting of the implant guide plate and the alveolar bone of the patient, and ensure the stability of the intraoperative precision. The gum fitting area 2 can be designed as a hollow structure, which not only saves materials, but also can be used as a cooling liquid flow channel to improve the heat dissipation effect and reduce the risk of patient burns during the operation.

[0032] When the gum fitting area 2 is designed as a hollow structure, the hollow holes on the edge thereof can be designed as 2-4 retention holes with a diameter of 1-1.5mm for penetrating elastic ligation wires to fix the guide plate, so as to avoid the displacement of the implant guide plate during the operation and further ensure the stability of the surgical precision. The area of the gum fitting area 2 that fits the gums can be the part of the gum fitting area 2 close to the implant positioning area 3, and the distance between the retention hole and the gum fitting area 2 that fits the gums is set to be ≥3mm to avoid pressing the soft tissue.

[0033] The implant positioning area 3 is provided with a positioning hole 31 matching the implant, and the positioning hole 31 penetrates through the guide plate body 1. The number of the positioning hole 31 is set according to the operation needs of the patient. A heat dissipation channel 32 for cooling liquid flow is arranged on the side of the positioning hole 31, and the heat dissipation channel 32 communicates with the positioning hole 31, so that the cooling liquid can directly reach the drill-bit-bone interface. Compared with external flushing, the cooling liquid can be continuously introduced during the operation, the heat dissipation effect is good, and the operation of the operator is not affected. The combination of the heat dissipation channels 32 in the gum fitting area 2 and the implant positioning area 3 not only helps to improve the heat dissipation effect, but also can be used as a chip removal passage, which is beneficial to improve the operation efficiency.

[0034] The positioning hole 31 is designed as a vertical cylindrical through hole with a hole diameter error of ±0.05mm and a hole wall perpendicularity deviation of ≤0.5°, forming an access path for the drill bit and the implant. A notch 33 is arranged on the upper end opening edge of the positioning hole 31 away from the gum fitting area 2. The design of the notch 33 forms a path for the cooling liquid to enter and exit and for the chip removal on the upper end opening edge of the positioning hole 31, which can be combined with the heat dissipation channel 32 and the hollow gum fitting area 2 to further improve the heat dissipation effect.

[0035] In some embodiments, the heat dissipation channel 32 in communication with the positioning hole 31 can be a first channel formed between the lower end opening edge of the positioning hole 31 and the hollow hole of the gum fit area 2. In other embodiments, as shown in Figure 3 and Figure 4 one end of the heat dissipation channel 32 can be arranged at the vertical hole wall of the positioning hole 31, and the other end can be arranged on the peripheral side wall of the positioning hole 31, that is, a second channel (microchannel) perpendicular or inclined to the central axis of the positioning hole 31 is formed, and the radial inclination angle of the second channel can be set to 10-90°, and the hole diameter is ≤0.1mm. The first channel and the second channel described above can also be integrated in the same guide plate to significantly improve the heat dissipation effect.

[0036] In some embodiments, as shown in Figure 2 the heat dissipation channel 32 can also be provided with a plurality of heat dissipation channels 32, and each heat dissipation channel 32 is radially dispersed around the positioning hole 31. That is, the cross section of the heat dissipation channel 32 is in the shape of an isosceles trapezoid, for example, it can be designed with an upper base of 0.8mm, a lower base of 0.5mm, and a height of 0.5mm. The two ends of the channel are connected to the edge of the guide plate and the inner wall of the positioning hole 31, respectively. The cooling liquid circulation path formed by the isosceles trapezoidal design is conducive to the entry of the cooling liquid into the positioning hole 31, and ensures the cooling and heat dissipation effect.

[0037] The total flow area of the heat dissipation channel 32 is ≥5mm 2 , which ensures that the cooling water flow during implant socket preparation is ≥20mL / min, and the bone tissue temperature can be controlled below 42℃.

[0038] The embodiment of the present application integrates the heat dissipation channel 32 with the positioning hole 31 in situ, without the need for external cooling liquid pipeline, avoids intraoperative interference, and the heat dissipation channel 32 and the guide plate body 1 of the personalized curved surface are synchronously formed, which depends on the additive manufacturing process, has high precision and good stability.

[0039] The guide plate body 1 can also include an operation auxiliary area 4 distributed around the implant positioning area 3, which can be designed for posterior teeth area and open limited cases, and therefore can also be called an operation avoidance area. At this time, the operation auxiliary area 4 is an instrument operation space with a diameter ≥8mm reserved around the positioning hole 31, which ensures that the implant and the bone drill have no obstruction in the access path.

[0040] The operation auxiliary area 4 can also be an area with a height difference between the upper end opening edge / upper surface of the implant positioning area 3 and the positioning hole 31, so as to form an instrument operation space around the positioning hole 31. At this time, the operation auxiliary area 4 can be designed as a universal design, including a design higher than the upper end opening of the positioning hole 31 and a design lower than the upper end opening of the positioning hole 31. The design higher than the upper end opening of the positioning hole 31 can isolate the positioning hole 31 from the soft tissue of the patient or other areas of teeth, so as to avoid the influence of other soft tissue or teeth on the operation of the operator or cause the risk of injury. The design lower than the upper end opening of the positioning hole 31 can also form a work avoidance area, so as to ensure that there is no obstruction during the operation of the implant and the bone drill.

[0041] The upper end surface design of the operation auxiliary area 4 and the gum fitting area 2 can be a curved surface design matched with the shape and size of the teeth of the patient, so as to form a tooth accommodating position / teeth supporting position.

[0042] The guide plate body 1 is also provided with an observation window 5 located around the positioning hole 31 and penetrating through the guide plate, which serves as an observation window for the operator to observe the positioning accuracy and the progress of the operation. The observation window 5 can also serve as a heat dissipation channel 32 and a chip removal channel.

[0043] The thickness of the guide plate body 1 is 1.0-1.55 mm. Compared with the traditional resin guide plate, the volume is reduced by 30%-50%. In particular, the thickness of the gum fitting area 2 and the operation auxiliary area 4 of the guide plate body 1 is 1.0-1.3 mm, and the thickness of the implant positioning area 3 is 1.2-1.55 mm. In this way, the strength of the implant positioning area 3 can be ensured, and the guide plate will not be broken or cracked during the operation of the bone drill, the volume of the guide plate can be minimized, the operation space for the operation can be provided, and the heat dissipation efficiency can be significantly improved.

[0044] In the embodiment of the present application, the guide plate body 1 is made of titanium alloy powder and copper powder by additive manufacturing technology. The titanium alloy powder is preferably Ti-6Al-4V, which provides the basis for the guide plate body 1, and the copper powder after compounding can realize long-acting antibiosis, avoid postoperative infection, and has good biocompatibility. Moreover, the guide plate body 1 after additive manufacturing can also improve its thermal conductivity and wear resistance.

[0045] In some embodiments, the mass ratio of the titanium alloy powder and the copper powder in the guide plate body 1 is 1:(0.01-0.05), preferably 1:(0.02-0.03). Specifically, the mass ratio of the titanium alloy powder and the copper powder can be 1:0.01, 1:0.02, 1:0.03, 1:0.04, 1:0.05, or any value within the above range. With the increase of the copper powder material, the transverse deformation ability can be inhibited, the shear resistance can be improved without brittleness, the lateral deviation of the implant guide plate during the operation can be avoided, and the precision stability can be improved; too low copper powder addition cannot meet the antibacterial standard and cannot improve the heat dissipation effect; excessive amount is prone to produce thermal cracks during printing, and increases the risk of fragmentation during the operation.

[0046] The copper powder is added, the copper ions in which can achieve the sterilization effect by destroying the bacterial cell structure, interfering with the metabolic process, and inducing oxidative stress, so that the implant guide plate can efficiently inhibit the breeding of bacteria by virtue of the slow-release effect of copper ions, achieve long-acting antibacterial and antiskid, and has good biocompatibility, fully meets the ISO10993-1:2018 medical device biological evaluation standard, and can be recycled and reused, is a good environmental protection material, and meets the medical waste reduction requirement.

[0047] The copper powder and the titanium alloy have a solid solution strength effect, and the melting points of the two are close, the printing effect is good, the strength can be improved without significantly increasing the modulus, and the characteristics of light weight and high strength of the implant guide plate are ensured. Compared with other materials, the material is easy to obtain and has high cost performance.

[0048] The application also provides a preparation method of the implant guide plate, which comprises the following steps: 1) obtaining three-dimensional image data of the patient's alveolar bone by CBCT scanning to plan the implant positioning, and obtaining an implant guide plate model; 2) performing additive manufacturing processing based on the implant guide plate model by using SLM technology to obtain a pretreated implant guide plate; the material is titanium alloy powder and copper powder; 3) performing surface sand blasting and vacuum annealing treatment on the pretreated implant guide plate to obtain the implant guide plate.

[0049] Firstly, data modeling is performed by step 1). The three-dimensional image data of the patient's alveolar bone is obtained by CBCT with a layer thickness of 0.1 mm. The implant positioning planning is achieved by using implant planning software, for example, 3Shape ImplantStudio, which is not particularly limited in the application. After the implant positioning planning is completed, the three-dimensional structure model of the implant guide plate is exported, for example, in STL format, and the model accuracy error is ≤0.02 mm.

[0050] Secondly, 3D printing forming is realized by step 2). The 3D printing technology adopts SLM (Selective Laser Melting) technology, which is a way of completely melting metal powder layer by layer to form parts by high-energy laser.

[0051] Step 2) specifically includes: 21) Powder laying: titanium alloy and copper powder are laid flat by means of scraper mixed powder laying, wherein the copper powder is 1wt%-5wt% of the titanium alloy powder.

[0052] 22) Laser scanning: the fiber laser (metal 3D printer equipped with 200W fiber laser, laser power 150-180W) scans according to the slicing path, the scanning speed is 800-1000mm / s, the layer thickness is 0.03-0.05mm, the scanning interval is 0.1-0.15mm, the forming cabin is ventilated with argon gas with purity≥99.99% for protection, and the oxygen content is controlled to≤0.005%. During the printing process, the powder is completely liquefied, the molten pool temperature (infrared thermometer) is monitored in real time to> 1600℃, and the temperature fluctuation range is ensured to be≤±5℃.

[0053] 23) Cycle stacking: repeat the powder laying-melting process until the guide plate forming is completed, and the pretreated implant guide plate is obtained.

[0054] Step 3) is the post-processing process of the pretreated implant guide plate. It includes removing support, surface treatment, heat treatment and precision calibration.

[0055] Step 3) specifically includes: 31) Removing support: the support structure in the printing process is removed by mechanical milling, and the residual amount of support is≤0.05mm.

[0056] 32) Surface treatment: the surface of the guide plate is treated by 800 mesh alumina sandblasting to make the surface roughness Ra reach 1.6-3.2μm, and the friction force with the gum tissue is enhanced.

[0057] 33) Heat treatment: the implant guide plate is placed in a vacuum annealing furnace, and after being kept at 700-1000℃ for 1-1.5h, it is cooled to room temperature with the furnace, which eliminates the printing internal stress and reduces the residual stress to≤50MPa.

[0058] 34) Precision calibration: the three-coordinate measuring instrument is used to detect the position, aperture and overall size of the positioning hole, and the calibration error is≤0.05mm.

[0059] Among them, the heat treatment condition of the implant guide plate in step 33) is preferably 900-1000℃ for 1-1.5h.

[0060] The following is prepared according to the above preparation method by TC4 (Ti-6Al-4V) titanium alloy, improved titanium alloy (TC4+1%Cu), improved titanium alloy (TC4+2%Cu), (TC4+5%Cu) as the material for the preparation of the guide plate, and its performance index is detected.

[0061] (I) Material physical property test Table 1

[0062] Through the material performance test, it is found that with the increase of the Cu material composition, the density increases, the Young's modulus (GPa) changes little, and the Poisson's ratio decreases. Selecting a small amount of 1-5wt% Cu material, especially 2wt% Cu is more suitable, the density of TC4+2%Cu material increases from 4.43g / cm 3 to 4.51g / cm 3 (density increases <1.2%), the change of other performance parameters (such as Young's modulus, Poisson's ratio) is less than 1%, which can maintain the balance of high strength and low density, enhance the antibacterial performance of the product, and ensure the structural stability while reducing the thickness.

[0063] Further, the implant guide plate prepared from the above TC4+2%Cu material is subjected to mechanical property test, heat dissipation performance verification and biocompatibility detection.

[0064] (1) Mechanical property test: randomly select 3 guide plates for three-point bending test (span 20mm, loading speed 2mm / min), bending strength ≥800MPa, fracture deflection ≥2mm; fatigue test (load 50-300N, frequency 10Hz, cycle 10 4 times), no crack is generated.

[0065] (2) Heat dissipation performance verification: simulate the conditions of implant surgery (use φ3.5mm bone drill, rotation speed 1500rpm), measure the surface temperature of bone tissue simulation material (polymethyl methacrylate) by thermocouple, and the temperature is ≤42℃ after continuous drilling for 30 seconds.

[0066] (3) Biocompatibility detection: according to the standard of "ISO 10993-5:2009", the cell toxicity test is carried out, the relative proliferation rate of L929 cells in the guide plate leaching liquor (1.25cm² / mL, 37℃ leaching for 72h) is ≥90%, and there is no cell toxicity; according to the standard of "ISO 10993-10:2010", the skin sensitization test is carried out, and the guinea pig sensitization rate is 0.

[0067] Therefore, the implant guide plate prepared by the method described in the application can maintain the balance of high strength and low density, and has good biocompatibility, and is suitable for long-term contact with oral tissues after clinical verification.

[0068] Having described various embodiments of the application above, the descriptions are exemplary and not exhaustive, and are not limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, the practical application, or improvement over the technology in the field of art, or to enable other of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A dental metal implant guide, characterized in that: Includes a guide plate body, which includes a gingival apposition area and an implant positioning area; The gingival aligning area has a curved structure that matches the alveolar bone, the implant positioning area is provided with a positioning hole that matches the implant, the positioning hole penetrates the guide plate body, and a heat dissipation channel for coolant to flow is provided around the positioning hole, the heat dissipation channel is connected to the positioning hole; The guide plate body is made of titanium alloy powder and copper powder using additive manufacturing technology.

2. The planting guide plate according to claim 1, characterized in that: The mass ratio of titanium alloy powder to copper powder in the guide plate body is 1:(0.01~0.05).

3. The planting guide plate according to claim 2, characterized in that: The mass ratio of titanium alloy powder to copper powder in the guide plate body is 1:(0.02~0.03).

4. The planting guide plate according to claim 1, characterized in that: The titanium alloy powder is Ti-6Al-4V.

5. The planting guide plate according to claim 1, characterized in that: There are multiple heat dissipation channels, which are radially distributed around the positioning hole. The total flow area of ​​the heat dissipation channels is ≥5mm². 2 .

6. The planting guide plate according to claim 1, characterized in that: The thickness of the guide plate body is 1.0~1.55mm.

7. The planting guide plate according to claim 1, characterized in that: An observation window is also provided around the positioning hole.

8. The planting guide plate according to claim 1, characterized in that: The guide plate body also includes an operation assistance area, which is distributed around the periphery of the planting positioning area; the operation assistance area and the upper surface of the positioning hole form a height difference to form an instrument operation space around the positioning hole.

9. A method for preparing a dental metal implant guide as described in any one of claims 1 to 8, characterized in that, Includes the following steps: 1) Obtain three-dimensional image data of the patient's alveolar bone through CBCT scanning to plan the implant placement and obtain an implant guide model; 2) Using SLM technology, additive manufacturing is performed on the planting guide plate model to obtain a pre-treated planting guide plate; The materials selected include titanium alloy powder and copper powder; 3) The pretreated planting guide plate is subjected to surface sandblasting and vacuum annealing to obtain the planting guide plate.

10. The preparation method according to claim 9, characterized in that: The vacuum annealing process is performed by holding the furnace at 700-1000℃ for 1-1.5 hours and then cooling it to room temperature.

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