Bracket-free invisible appliance combining personalized armature and magnetic accessory

Abstract

The invention relates to the field of orthodontics, and particularly discloses a bracket-free invisible orthodontic appliance combining a personalized armature and a magnetic accessory, which comprises a bracket-free invisible orthodontic appliance, a first magnet fixed on the inner side of the bracket-free invisible orthodontic appliance and a personalized armature capable of being adhered to the tooth surface of a target tooth, and the armature comprises a second magnet or a magnetisable material. Wherein the position of the first magnet and the bonding position and form of the personalized armature are individually designed based on a three-dimensional digital model of the dentition of a patient, so that when the appliance is worn, magnetic force is generated between the two magnets, and a target tooth is driven to move in a non-contact manner; according to the invention, through organic combination of digital design and magnetic non-contact driving, precise and controllable correction of severely dislocated teeth and embedded teeth is realized. According to the method, the advantages of attractiveness and comfort of invisible correction are reserved, meanwhile, the problems that traditional invisible correction is insufficient in wrapping of teeth and difficult in force application are effectively solved, and a new solution is provided for treatment of complex malocclusion.

Description

Technical Field

[0001] This invention belongs to the field of orthodontics, specifically a bracketless invisible aligner that combines personalized armatures and magnetic attachments. Background Technology

[0002] Clear aligner technology, due to its aesthetic appeal, comfort, and ease of oral hygiene maintenance, has become an important development direction in current orthodontic treatment. The application of corrective force primarily relies on the complete coverage and elastic deformation of the aligner membrane on the tooth surface. However, in clinical practice, complex cases such as severely misaligned teeth (e.g., labial / lingual tilt, rotation, low or high eruption) and impacted teeth are frequently encountered. For these teeth, due to their abnormal initial position, the clear aligner often struggles to achieve effective coverage, resulting in insufficient or incorrectly oriented corrective force, thus severely impacting treatment efficacy and even being considered a relative contraindication for traditional clear aligner treatment.

[0003] Meanwhile, magnetism, as a continuous, stable force that can be applied across media, has long been explored for applications in orthodontics. Researchers have attempted to use the attractive or repulsive forces between magnets to directly move teeth or perform jawbone reshaping. However, applying magnetism in orthodontic clinical practice faces significant challenges: on the one hand, the retention of magnets in the mouth often requires additional adhesives or mechanical structures, increasing the complexity of the device and patient discomfort; on the other hand, the direction of magnetic force is difficult to precisely guide and control, and without careful design, it can easily lead to unintended tooth movement. Therefore, despite the unique biomechanical advantages of magnetism, its limitations in practical applications, such as difficulty in retention and insufficient control precision, restrict its widespread use in precision orthodontic treatment.

[0004] In summary, existing technologies, including clear aligners and magnetic aligners, have their own limitations and have not yet been effectively combined to solve the problems of incomplete coverage and force control faced by severely misaligned teeth and impacted teeth in the early stages of orthodontic treatment. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a bracketless clear aligner that combines personalized armatures and magnetic attachments, thereby solving the problem that existing clear aligners cannot effectively apply controllable corrective force to severely misaligned teeth.

[0006] This invention provides a bracketless invisible aligner combining personalized armatures and magnetic attachments for moving teeth during orthodontic treatment, comprising:

[0007] One or more clear aligners, said aligners being made of a transparent membrane material;

[0008] At least one first magnet is fixed to the inner surface of the bracketless clear aligner;

[0009] At least one personalized armature configured to be bonded to the tooth surface of a target moving tooth, the personalized armature comprising at least one second magnet or made of a magnetizable material;

[0010] The fixed position of the first magnet on the aligner and the bonding position and shape of the personalized armature on the target moving tooth are both designed based on the three-dimensional digital model of the patient's dentition. This allows the first magnet and the personalized armature to generate magnetic force when the clear aligner is worn, thereby driving the target moving tooth in a non-contact manner.

[0011] Preferably, the first magnet and the personalized armature are spaced apart in their initial relative positions when the clear aligner is worn in the dentition, with a spacing of 0.5 mm to 3 mm.

[0012] Preferably, the personalized armature is used to bond to the tooth surface with a surface morphology that matches the corresponding tooth surface morphology of the target moving tooth.

[0013] Preferably, the first magnet is embedded or bonded to a pre-set accessory structure inside the bracketless clear aligner, and the position and shape of the accessory structure are determined according to the personalized design.

[0014] Preferably, the first magnet and the second magnet are neodymium iron boron permanent magnets.

[0015] Preferably, the bracketless invisible aligner is a series of aligners worn in the order of treatment, and the fixed position of the first magnet on different aligners changes according to the treatment plan.

[0016] Preferably, the target moving tooth is a severely misaligned tooth or an impacted tooth.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] Through personalized design based on digital models, the direction and magnitude of orthodontic force can be precisely planned in advance, overcoming the difficulty of achieving simultaneous tooth movement and precise directional control in the early stages of orthodontic treatment using traditional methods.

[0019] Through the non-contact drive of magnets, a continuous and stable orthodontic force can be applied without the aid of mechanical attachments such as brackets and traction hooks, which significantly reduces the patient's foreign body sensation, discomfort and difficulty in maintaining oral hygiene;

[0020] By integrating the magnet unit into the invisible aligner sequence and dynamically adjusting its position, the treatment process is made procedural and controllable, simplifying clinical operation while ensuring efficacy.

[0021] Through the above comprehensive technical solutions, this invention effectively expands the indications for the treatment of severely misaligned teeth and impacted teeth while retaining the aesthetic and comfort advantages of bracketless invisible aligners, providing a new solution that combines high efficiency, comfort and aesthetics for such complex cases. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0023] Figure 2 This is a schematic diagram of the structure of the bracketless invisible orthodontic appliance of the present invention;

[0024] Figure 3 This is a simulation diagram of the personalized design of this invention;

[0025] Figure 4 This is a schematic diagram of the first magnet being fixed to the bracketless clear aligner of the present invention;

[0026] Figure 5 The diagram shows the structure of the orthodontic appliance and magnet. In the diagram, A is a schematic diagram of the canine clear aligner and its accessories combined with the magnet, and B is a schematic diagram of the resin crown of the lateral incisor with the embedded magnet.

[0027] Figure 6 The graph shows the protein expression analysis results. In the graph, A represents the expression levels of Runx2, BMP-2, and Actin proteins, and B represents the statistical graph of the relative gray values ​​of the target proteins.

[0028] Figure 7 The images show the comparison of HE staining of periodontal tissues. In the images, A represents periodontal tissues of the CAMA group (a: periodontal ligament, b: alveolar bone), B represents periodontal tissues of the fixed orthodontic group, and C represents periodontal tissues of the blank control group (a: periodontal ligament, b: alveolar bone).

[0029] Figure 8 This is a diagram of a beagle wearing a brace, as shown in Example 2.

[0030] Figure 9 This is a 3D model of a beagle's teeth, as shown in Example 2.

[0031] In the picture: 1. Clear aligner; 2. First magnet; 3. Personalized armature; 4. Second magnet. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the scope of protection of the invention.

[0033] Example 1: A bracketless invisible aligner combining personalized armatures and magnetic attachments and its application in the correction of severe labial canine misalignment.

[0034] 1. Patient Information and Design Phase:

[0035] The patient, a 15-year-old female, presented with severe labial low eruption of the maxillary right canine, which could not be effectively surrounded by traditional clear aligners. First, an intraoral scanner was used to obtain a three-dimensional digital model of the patient's entire dentition, which was then imported into 3Shape OrthoSystem or similar orthodontic design software.

[0036] 2. Personalized design and system development:

[0037] The "personalized design" referred to in this invention specifically refers to the process of planning the movement path of the target tooth from the starting position of the misalignment to the expected ending position in an orthodontic treatment simulation software environment based on a patient-specific three-dimensional digital model, and performing mechanical analysis and calculations accordingly, thereby accurately determining the fixed position and magnetic pole direction of the first magnet in the orthodontic system, as well as the bonding position and three-dimensional shape of the personalized armature; the core objective of this design is to ensure that when the orthodontic appliance is worn, the magnetic system can generate orthodontic force of predetermined size, direction and point of application, so as to achieve precise and controllable non-contact movement of the target tooth;

[0038] Orthodontic appliance sequence design: Software simulation gradually moves misaligned canines (target teeth to be moved) into their normal positions within the dental arch, generating multi-step (e.g., 20-step) orthodontic animations. Personalized designs are then created based on this 3D digital model, specifically as follows... Figure 3 As shown.

[0039] like Figure 1 and Figure 2 As shown:

[0040] Positioning of the first magnet 2 and accessory design: In the design, an accessory structure (a resin cavitation) is pre-set on the inner surface of the bracketless clear aligner 1 worn on the anchorage tooth (e.g., the first premolar). The position and shape of the accessory structure are individually designed and determined according to the expected position of each canine to ensure that the magnetic force direction always points in the direction in which the canine needs to move.

[0041] Personalized armature 3 fabrication: Based on the actual tooth surface morphology of the labial side of the canine, a personalized resin base matching its shape is designed and 3D printed. A neodymium iron boron permanent magnet (second magnet 4) with a size of 3mm×2mm×1mm is embedded in the resin base to form the personalized armature 3. The bonding surface of the armature is completely in contact with the tooth surface.

[0042] First Magnet 2 Integration: During the fabrication of the orthodontic appliance, another neodymium iron boron permanent magnet (i.e., first magnet 2) is fixed within a pre-designed accessory cavity using light-cured resin (such as 3MZ350). The specific method is as follows: Figure 4 As shown, the N / S pole orientation of the first magnet 2 is set according to the design so that it can generate an attractive force with the magnet in the personalized armature 3.

[0043] Sequential adjustment: A series (e.g., 20 sets) of clear aligners 1 are made for the entire treatment process and worn in the order of treatment. On each set of aligners, the fixed position of the first magnet 2 is changed according to the treatment plan, and is slightly moved towards the gingival or distal direction to continuously guide the canines.

[0044] 3. Clinical applications:

[0045] Bonding the armature: Clean and acid-etch the labial surface of the canine, and then firmly bond the prepared personalized armature 3 to the surface of the target moving tooth using light-cured resin.

[0046] Wearing the orthodontic appliance: The patient wears the first set of clear aligners 1. At this time, the initial relative position interval between the first magnet 2 on the appliance and the personalized armature 3 on the canine is about 1.5 mm, generating a magnetic force of about 80-120g. Due to the magnetic force, the canine is subjected to non-contact distal and gingival forces and begins to move.

[0047] Follow-up visits and replacements: Patients return for a follow-up visit every two weeks. After the doctor checks the tooth movement, the new set of orthodontic appliances will be replaced. The position of the first magnet 2 on the new appliance has been adjusted according to the design, maintaining an appropriate distance (about 1.0-2.0 mm) from the armature to maintain a gentle and continuous orthodontic force.

[0048] Treatment transition and completion: After about 3 months (wearing 6 sets of aligners), the canines have moved to a position where they can be effectively surrounded by clear aligners. At this point, the personalized armature 3 bonded to the canines and the corresponding first magnet 2 on the subsequent aligners are removed. Subsequent treatment uses only the standard clear aligner sequence to continue fine-tuning the canine position until the treatment is completed.

[0049] Example 2: Validation experiment of the effectiveness of the bracketless invisible orthodontic system (CAMA) based on the beagle animal model.

[0050] 1. Experimental objective:

[0051] This embodiment aims to verify the effectiveness of the clear aligner system (referred to as CAMA, Clear Aligner combined with Magnetic Appliance in this experiment) in achieving remote, non-contact orthodontic tooth movement through standardized animal experiments, and to compare it with traditional fixed orthodontic appliances. At the same time, it also preliminarily explores the influence of its associated magnetic field on osteogenic differentiation in alveolar bone remodeling.

[0052] 2. Experimental Materials and Methods:

[0053] (2.1) Laboratory animals and grouping:

[0054] Eight healthy male Beagles aged 12 months (License No.: SCXK(Liaoning)2019-0002) were selected and randomly divided into two groups:

[0055] CAMA group (Group A, n=4): The lateral incisors of the present invention were distalized using the bracketless invisible orthodontic system of the present invention in both maxillae.

[0056] Fixed orthodontic group (Group B, n=4): The distal incisors on one side of the maxilla were randomly selected using a traditional fixed orthodontic appliance (bracket + tension spring) to move them as the force-applied side (subgroup B1); the other side was left untreated as the blank control side (subgroup B2).

[0057] The experiment was approved by the Animal Ethics Committee of Nanchang University; all animals were acclimatized for one week before the experiment began.

[0058] (2.2) Design and fabrication of the CAMA system:

[0059] 3D digital model acquisition: After anesthetizing the beagle, a silicone rubber impression of the maxilla was made, an ultra-hard plaster model was poured in, and a 3D scanner was used to obtain a 3D digital model of the maxillary dentition. It can be seen that there is a natural gap of about 10mm between the maxillary canines and lateral incisors of the beagle.

[0060] Personalized design: Utilizing this gap, a treatment plan is designed to move the lateral incisor distally, using the canine as anchorage. This involves personalized design based on the three-dimensional digital model, such as... Figure 9 As shown, the treatment path is determined.

[0061] Attachment structure and first magnet: In the digital design software, a resin attachment bubble (attachment structure) is preset in the area of ​​the canine corresponding to the future orthodontic appliance; the position and shape of the bubble are determined according to the expected position of the lateral incisor at each step; the bracketless clear aligner is made using thermoforming technology; a 5mm×3mm×1mm N52 neodymium iron boron permanent magnet (as the first magnet) is fixed in the attachment bubble using light-cured resin.

[0062] Personalized armature: A resin crown is designed and fabricated for the lateral incisor, with its bonding surface morphology matching that of the lateral incisor tooth surface; another neodymium iron boron permanent magnet of the same specification (as a second magnet) is embedded in the distal surface of the resin crown, thus forming a personalized armature. Figure 5 A and Figure 5 (B in the middle).

[0063] Mechanical performance preset: The magnet was tested by a universal testing machine and found to generate an attractive force of about 100g at a spacing of 2mm. After the orthodontic appliance and resin crown were placed on the model, the initial spacing between the first magnet and the personalized armature was adjusted to be about 2mm.

[0064] (2.3) Animal model establishment and force application process:

[0065] CAMA Group: After anesthetizing the animals, the canine surfaces were etched with acid, and the orthodontic appliance was inserted to fix the first magnet in the preset position; the lateral incisor surfaces were cleaned, and a personalized armature (resin crown) was bonded to the lateral incisor using glass ionomer cement; after fitting, a magnetic force was generated between the first magnet and the personalized armature, driving the lateral incisor distally in a non-contact manner, such as... Figure 8 As shown; a new set of orthodontic appliances is replaced every 10 days. On the new appliance, the fixed position of the first magnet is adjusted about 0.5mm toward the canines according to the treatment plan to maintain effective orthodontic force.

[0066] Fixed orthodontic group (B1): On the other side of the same animal, orthodontic brackets were bonded to the canines and lateral incisors, and a 100g force was applied using a nickel-titanium tension spring to distalize the lateral incisors, with the force being increased once a month.

[0067] Blank control group (B2): No treatment was given.

[0068] (2.4) Observation and detection indicators:

[0069] The intensification period lasts for one month. The animals are euthanized on the 7th day after the intensification ends, and specimens are obtained for testing.

[0070] Tooth movement distance measurement: Before and after the experiment, plaster models were poured and impressions were taken. The distance between the cusps of the canines and lateral incisors was measured, and the movement distance (D1-D2) was calculated.

[0071] Protein expression analysis: Alveolar bone around the movable lateral incisor was collected, and the expression levels of osteogenic proteins BMP-2 and Runx2 were detected by Western blotting.

[0072] Histological observation: Alveolar bone blocks containing movable lateral incisors were taken, decalcified, embedded, sectioned, and stained with hematoxylin-eosin (HE). The periodontal tissue remodeling was observed under an optical microscope.

[0073] (2.5) Statistical analysis:

[0074] Data analysis was performed using SPSS 22.0 software, and one-way ANOVA was used for comparisons between groups.

[0075] 3. Experimental Results:

[0076] (3.1) Tooth movement effect:

[0077] One month after force application, the tooth movement distance in the CAMA group was 1.035 ± 0.076 mm, while that in the fixed orthodontic group (B1) was 0.983 ± 0.055 mm. The results indicate that the system of this invention is comparable to traditional fixed orthodontic appliances in achieving distal, non-contact tooth movement.

[0078] (3.2) Expression of osteogenic-related proteins:

[0079] Western blot analysis showed that ( Figure 6 A and Figure 6 (B in the text)

[0080] BMP-2 expression: The expression level in the CAMA group was significantly higher than that in the fixed orthodontic treatment group (B1) and the blank control group (B2).

[0081] Runx2 expression: The expression level in the CAMA group was significantly higher than that in the fixed orthodontic treatment group (B1), and both groups were significantly higher than that in the blank control group (B2).

[0082] These results suggest that under the influence of the magnetic force (and associated magnetic field) of the system of this invention (CAMA), osteogenic differentiation activity in the alveolar bone may be more active during tooth movement.

[0083] (3.3) Histological reconstruction:

[0084] HE staining revealed ( Figure 7 A in Figure 7 B and Figure 7 (C in the middle)

[0085] In the CAMA group and the fixed orthodontic group (B1): on the tension side (mesial surface) of the distal movement of the lateral incisor, the periodontal ligament fibers were elongated, osteoblasts were active, and new bone formation was visible; on the pressure side (distal surface), the periodontal ligament was compressed, and osteoclast-induced bone resorption lacunae were visible; this indicates that the tooth underwent normal periodontal tissue remodeling under the action of magnetic or mechanical forces.

[0086] Blank control group (B2): Periodontal ligament fibers are neatly arranged, with no obvious osteogenic or osteoclast activity.

[0087] 4. Experimental conclusions:

[0088] This embodiment uses a beagle animal model to demonstrate:

[0089] Effectiveness: The clear aligner system (CAMA) protected by this invention can effectively achieve remote non-contact orthodontic tooth movement. Its movement efficiency is no different from that of classic fixed orthodontic techniques, providing a new and effective solution for correcting severely misaligned teeth (such as the remote movement in this model).

[0090] Biological effects: While achieving mechanical tooth movement, the associated magnetic environment of this system may have a positive regulatory effect on alveolar bone remodeling, manifested by the upregulation of expression of key osteogenic differentiation factors (BMP-2, Runx2).

[0091] The embodiments of the present invention are given for the purposes of illustration and description. Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Any changes, modifications, substitutions and variations made by those skilled in the art to the above embodiments within the scope of the present invention should be included within the protection scope of the present invention.

Claims

1. A bracketless invisible aligner combining personalized armatures and magnetic attachments, used for tooth movement during orthodontic treatment, characterized in that, include: One or more clear aligners, said aligners being made of a transparent membrane material; At least one first magnet is fixed to the inner surface of the bracketless clear aligner; At least one personalized armature configured to be bonded to the tooth surface of a target moving tooth, the personalized armature comprising at least one second magnet or made of a magnetizable material; The fixed position of the first magnet on the aligner and the bonding position and shape of the personalized armature on the target moving tooth are both designed based on the three-dimensional digital model of the patient's dentition. This allows the first magnet and the personalized armature to generate magnetic force when the clear aligner is worn, thereby driving the target moving tooth in a non-contact manner.

2. The bracketless invisible aligner combining personalized armatures and magnetic attachments according to claim 1, characterized in that, The first magnet and the personalized armature are spaced apart in their initial relative positions when the clear aligner is worn in the dentition, with a spacing of 0.5 mm to 3 mm.

3. The bracketless invisible aligner combining personalized armatures and magnetic attachments according to claim 1, characterized in that, The personalized armature is used to bond to the tooth surface with a surface morphology that matches the corresponding tooth surface morphology of the target moving tooth.

4. The bracketless invisible aligner combining personalized armatures and magnetic attachments according to claim 1, characterized in that, The first magnet is embedded or bonded to a pre-set attachment structure inside the bracketless clear aligner, and the position and shape of the attachment structure are determined according to the personalized design.

5. The bracketless invisible aligner combining personalized armatures and magnetic attachments according to claim 1, characterized in that, The first magnet and the second magnet are neodymium iron boron permanent magnets.

6. The bracketless invisible aligner combining personalized armatures and magnetic attachments according to claim 1, characterized in that, The bracketless invisible aligner is a series of aligners worn in the order of treatment. On different aligners, the fixed position of the first magnet changes according to the treatment plan.

7. The bracketless clear aligner combining personalized armatures and magnetic attachments according to any one of claims 1 to 6, characterized in that, The target tooth to be moved is a severely misaligned tooth or an impacted tooth.

Images