A system for peri-orthodontic alveolar process expansion and bone regeneration

Abstract

A system for peri-orthodontic expansion of the alveolar process and bone regeneration is disclosed, intended for use in combination with a surgical procedure for breaching the cortical layer of the alveolar process in the form of incisions or perforations. The system comprises a set of at least two means of skeletal anchorage (A) in the form of orthodontic mini-implants or bone mini-plates that are connected to the orthodontic arch (B) or the resilient element, wherein the means of skeletal anchorage (A) are provided with fastening means for connection to the orthodontic arch (B) or the resilient element. The means of skeletal anchorage (A) are attached in the interroot areas of the teeth, adjacent to the breaches of the cortical layer in the alveolar process, and the shape of the orthodontic arch (B) or resilient element is adapted to the shape of the alveolar process and pre-stressed accordingly, exerting positive pressure on the means of skeletal anchorage (A).

Description

[0001] A system for peri-orthodontic alveolar process expansion and bone regeneration

[0002] The invention belongs to the field of medical science and mechanical engineering. The subject matter of the invention is a system for peri-orthodontic expansion of the alveolar process and its regeneration, i.e. for expansion of the alveolar process bone. The invention is also a new application of selected types of mini-implants.

[0003] The invention is applicable to orthodontic and periodontal treatment - it can be used in parallel with any system of mechanical guidance of tooth crowns, e.g. fixed, lingual, segmental braces, aligners, or independently of them, as an independent corrective and regenerative system at the level of the alveolar process. The invention increases the bone envelope in which orthodontic movement can take place and minimizes the risk of complications in the form of bone fenestration and gum recession as a result of expansion of the dental arch during orthodontic treatment and allows the regeneration of bone tissue after periodontal disease.

[0004] Various types of dental implants are known, typically used to rebuild lost teeth. A dental implant is an implanted pillar into the bone of the alveolar process constituting a tooth root that does not give signs of rejection in the human body so as to replace the lost tooth root on which the artificial tooth is fixed with a connector so as to restore the function of the original tooth.

[0005] Implants vary depending on the type of pillar, and are used by drilling the implantation site using a predetermined drill, implanting the pillar into the alveolar process bone to osteointegrate the pillar with the alveolar process bone, connecting the connector to the pillar, and then covering the connector with a final prosthesis. However, dental implants are not used in orthodontics.

[0006] Known implants are made up of parts such as a pillar implanted as an artificial tooth root, a connector connected to the pillar, a connector screw fixing the connector to the pillar, and an artificial tooth connected to the connector. In addition, the pillar, which is a part implanted into the implantation hole formed in the alveolar process bone usinga drill, or the like, at the site where the implant treatment is to be performed, serves as an artificial tooth root and includes the pillar body and a screw part or corresponding to a threader formed on the outer surface of the pillar body.

[0007] The threaded portion is inserted into the alveolar process bone to allow the pillar and the alveolar process bone to be firmly connected to each other and to increase the contact area between the pillar and the alveolar process bone, thereby increasing the strength of the pillar attachment to the alveolar process bone.

[0008] A typical implant pillar includes a body portion having a bolt thread formed in the same size from its upper end to its lower end, and an entrance portion located on the lower side of the body portion and having a groove cut out formed on its outer portion. The bolt thread has a triangular cross-section, the ends of which are sharp, it can be easily inserted during rotation.

[0009] Patent document US 2013 / 260339A1 depicts a titanium threaded dental implant in which the upper side surface of said threading can be concavely curved, while the lower side surface can extend substantially perpendicular to the longitudinal axis of the implant, the thread pitch can range from 1.20 mm to about 2.50 mm, and the thread can have a radial depth ranging from about 0.40 mm to about 1.00 mm. The thread has a thickness on the spine of about 0.025 mm to about 0.30 mm, and in the area of contact between the thread and the implant body, the thread thickness is from about 0.25 mm to about 0.75 mm.

[0010] However, such an implant is typically used to rebuild lost teeth.

[0011] However, the implant is not applicable for use in orthodontics, especially for expansion of the alveolar process, reconstruction of bones after corticotomy.

[0012] From patent specification EP3332734B1, a dental implant is known, with a threader formed of titanium and formed spirally along the circumference of the outer surface of the pillar body, wherein the threader has a structure in which a plurality of thread parts are arranged in pitch intervals from 500 to 1500 pm, each thread part has the shape of a flat plate having a thin trapezoidal cross-section looking at the structure cut in the axial direction of the pillar body, wherein the thickness of each thread part is from 50 to 200 pm, and the height of each thread part is from 200 to 2000 pm, and wherein the angle of the thread part in the direction of its apex is from 0.1 to 5°. The ratio of the length between the thickness and the pitch between the parts p of the thread may befrom 1 :5 to 12. The ratio of the length between the pitch between the thread parts p and the height of the bolt thread of the thread part h may be 1 :0.3 to 1.5. In a case where the pillar body has a conical structure that becomes narrow towards the bottom side, each apex of the thread portion may have a conical structure corresponding to the pillar body. However, the implant is not applicable for use in orthodontics, especially for expansion of the alveolar process, reconstruction of bones after corticotomy.

[0013] An orthodontic anchorage is known comprising a body portion, an elongated bolt portion extending downward from the body portion, a head portion extending upward from the body portion spaced apart from said bolt portion, an upper member attached to said head portion spaced apart from the body portion, a pair of U-shaped grooves formed in the upper member. The grooves are formed by a pair of spaced vertical sidewalls, respectively, said sidewalls of each groove being parallel, said sidewalls having upper and lower edges, said lower edges of each groove being connected by a horizontal bottom, said grooves being open between said upper edges, and the bottoms being displaced vertically with respect to each other, said bottoms extending perpendicularly to the longitudinal axis of said orthodontic anchor. This solution is used in orthodontic treatment to obtain a suitable vector of orthodontic force anchored skeletally but not in peri-orthodontic expansion of the alveolar process and bone regeneration after corticotomy.

[0014] From the patent specification WO2019161467A1, the construction of a mini-implant for orthodontic anchorage is known, consisting of a bolt-shaped body formed from below by an external threaded section, and above this section of the head shape, characterized in that said head is composed from above of curved protrusions such as fishing hooks with rounded ends, and said fishing hooks are arranged at equal intervals. This solution is applicable to an orthodontic anchorage for fixing various types of elements generating appropriate strength and transferring the counter-reaction force to the alveolar process bone or jawbone, but not in the peri -orthodontic expansion of the alveolar process and bone regeneration after corticotomy.

[0015] Mini-implants used for skeletal anchorage purposes are known. Dental mini-implants are used in a wide range of applications in orthodontic treatment. Mini-implants are screwed into the alveolar process when closing the gap after the tooth has been removed in order to maintain the correct alignment of the remaining teeth. They are also usedwhen correcting irregularities in the midline position, as well as when the patient is struggling with large dental deficiencies. Mini-implants are very similar in appearance to ordinary implants in which the pillar and the ending of the so-called head - cap can also be distinguished, but they are set apart by a much smaller size and are usually one-piece. For most orthodontic mini-implants, it is not necessary to drill the bone in advance, which depends on the cortical layer. Many mini-implants are known, divided mainly due to the structure and shape of the end - thus the tip - of the head - of the cap from the side of connection with other orthodontic devices. Most mini-implants are made of titanium alloy or stainless steel. There are many structures of the pillar end referred to as the tip of mini-implants, i.e. the end part - the head of mini-implants with various holes, grooves and tunnels for attaching many orthodontic devices - wires, ligatures, flexible threads, flexible chains and nickel -titanium coils. Mini-implants come in different lengths as well as different diameters. Mini-implants are predominantly self-threading or self-drilling / self-threading.

[0016] As a rule, the size of mini-implants does not exceed a diameter of up to 3 millimeters. Due to the fact that mini-implants are made of surgical steel or titanium, they are characterized by biocompatibility, which means that they are indifferent to the human body but do not undergo osteointegration. Mini-implants are made of one part where a pillar with a thread on the stem can be distinguished - that is, a bolt ended with a tip -of different shape of heads connecting to the pillar. Mini -implants are therefore made of a pillar where the thread and ends of various shapes are made. For example, miniimplants with an oval or square head-shaped end having a diameter of 1.5 mm are known, e.g. 1.8 mm and 2.1 mm. Known mini-implants may also have a distinguished neck of various shapes.

[0017] The structure and type of the orthodontic mini-implant material prevents its integration with the alveolar process bone, so that it is easy to remove after use - unlike in the case of prosthetic implants, where integration with the bone is an advantage.

[0018] In orthodontics, mini-implants are screwed into the jawbone. Anchorage is screwed into the bone with the upper part protruding from the gum to anchor various orthodontic appliances in order to move the teeth in the desired direction. These types of anchors are independent of the teeth and allow the use of many orthodontic devices that can be attached to one anchorage - the head.Known mini-implants thus have application in skeletal anchorage in the biomechanics of orthodontic movement.

[0019] Orthodontic treatment, especially peri-orthodontic treatment, is associated with the displacement of teeth within the alveolar process. Both the discharge of crowding and the compensation or decompensation of skeletal or dental defects can lead to bone fenestration and gum recession as a result of crossing the so-called bone envelope. For years, attempts have been made to use additional more or less invasive procedures to minimize the above risk. In the light of publications from recent years that accurately describe the biomechanics of orthodontic tooth movement (OTM), during which the resorption of bone tissue occurs as a result of the applied force on the side of pressure and the accumulation of this tissue on the opposite side, it can be assumed that such movement takes place through the bone, and not as it was once thought with the bone. The first reaction of the tooth to the applied orthodontic force is the displacement within the periodontal ligaments causing deformation and stress in the periodontal ligament (PDL). There is a negative voltage on the pressure side and a positive voltage on the pull side. There is a relationship between this voltage and the amount of applied force, which is tested on finite element models. Tension on the pressure side reduces or, when using too much force, completely closes the blood flow in the capillaries causing tissue hyalinization. In addition, on the pressure side, fluid from the periodontal ligament is injected into the bone, while on the relaxation side it flows into the PDL gap. Also, nerve endings and fibroblasts in the periodontal ligament react to the applied force, triggering the activation of various signaling pathways. Bone remodeling is related to the activity of osteoblasts and osteoclasts. On the pressure side, there is a three-day osteoblast apoptosis, osteocyte activation and resorption activation through the increase of prostaglandins, TNF-alpha and RANKL. However, on the stretching side, osteocytes and the signaling pathway resulting in the production of type 1 collagen, osteocalcins and osteopontins are activated, the amount of TNF-beta increases and the concentration of RANKL decreases causing the formation of new bone tissue and PDL reconstruction. This makes PDL and the surrounding bone a certain functional whole. Procedures such as corticotomy are designed to reduce bone density and negative stress on the side of pressure, and thus limit bone resorption during orthodontic movement or the addition of bone replacement material so that the tooth does not exceed the buccal cortical lamina. Their use and effectiveness are limited.Therefore, the object of the invention was to develop an effective bone thickening device before or during orthodontic treatment or as a result of periodontal disease using the body's natural mechanisms. The aim was to develop a method and system that will be applicable in combination with corticotomy to expand the alveolar process bone. Surprisingly, it turned out that selected types of mini-implants and combining them with the arch bring results and thus find a new use.

[0020] The essence of the invention is a system for expanding the alveolar process bone - for peri-orthodontic expansion of the alveolar process and bone regeneration, intended for use in combination with a surgical procedure for breaching the cortical layer of the alveolar process in the form of incisions or perforations. The system is characterized in that it comprises a set of at least two means of skeletal anchorage in the form of orthodontic mini-implants or bone mini-plates that are connected to the orthodontic arch or resilient member, wherein the means of skeletal anchorage is provided with fastening means for connection to the orthodontic arch or resilient element. In addition, the means of skeletal anchorage are attached in the interroot areas of the teeth, adjacent to the breaches of the cortical layer in the alveolar process, and the shape of the orthodontic arch or resilient element is adapted to the shape of the alveolar process and pre-stressed accordingly, exerting positive pressure on the means of skeletal anchorage. The combination of skeletal anchoring means with an orthodontic arch or other resilient element, geometrically set in relation to the anchorages, creates a defined direction of the orthodontic force. The location of the skeletal anchor center and the orthodontic arch or other resilient element, relative to the axis of the tooth, leads to a reduction in compression in the buccal cortical part of the periodontal ligament and an increase in tensile stresses on the opposite side, resulting in translational displacement of the tooth root.

[0021] It is preferred that the aforementioned surgical procedure for breaching the cortical layer of the alveolar process in the form of incisions or perforations is in particular: corticotomy, microperforations, decortication, segmental osteotomy or another procedure reducing the stiffness of the alveolar process cortical lamina and inducing the regional effect of accelerated reconstruction.

[0022] In a preferred form, orthodontic mini-implants are used as means of skeletal anchorage, having a longitudinal pillar with conical or cylindrical threading, a polygonal neck anda fixing end for the orthodontic arch (B), where the orthodontic mini-implants are attached in the alveolar process with their threaded pillars.

[0023] The fixing end of the orthodontic mini-implant is preferably formed in the form of a rounded head and in the longitudinal cross-section has a shape of a mushroom with a narrowed shaft with a rounded cross-section, wherein at least one hole fixing the orthodontic arch is formed in the neck.

[0024] It is also advantageous that the end of the orthodontic mini-implant is formed in the form of a hook formed as a C-shaped semicircle, terminated at the top and at the bottom with two hook grapples, with one of the grapples adjacent to the neck creating a place for joining with the orthodontic arch. Preferably, at least one second fixing hole can be formed in the neck.

[0025] It is also preferable that the end of the orthodontic mini-implant is formed in the form of a lock in the form of open pliers ended with jaws, and in the front, between the jaws, an incision adopting an orthodontic arch is provided over the entire width of the pliers. Then, a narrowing constituting a shaft with a rounded cross-section is preferably provided between the neck and the orthodontic arch. Preferably, at least one second fixing hole can be formed in the neck.

[0026] According to the preferred embodiments of the invention, it is therefore essential that the orthodontic mini-implant has elements such as a pillar with a conical or cylindrical thread and, on the other hand, a selected head shape and a connection place for inserting an orthodontic arch, with a shape adapted to insert - fix the arch - made in the head -end or in the neck. Such an arch is fixed using the previously described structural elements of the system, i.e. it is screwed after corticotomy with the use of a flap - a procedure with raising the gum and periosteum and exposing the bone or without in the interroot area.

[0027] In a preferred form, the orthodontic mini-implant is combined with the orthodontic arch and stabilized on it with a known means of stabilizing the fixing of the head with the arch, preferably an orthodontic ligature. It is also possible to use other stabilization means, such as, for example, resilient threads, resilient chains, nickel -titanium coils, etc. In the case of fixing the arch to the hook grapple adjacent to the cap or, in the caseof direct connection to the hole made in the mushroom-shaped head or by means of the hole in the neck, stabilization may not be required.

[0028] It is preferable that the neck has a hexagonal shape.

[0029] The size of orthodontic mini-implants - i.e. their diameter, length, threading is selected depending on the clinical situation, i.e. the distance between the roots and the quality of the bone. According to the invention, it is preferred that the orthodontic miniimplants have a length of up to 18 mm, especially 6 to 15 mm. It is also advantageous when the orthodontic mini-implants have a pillar with a length in the range of 6 to 14 mm, especially 6 to 11 mm. In addition, it is preferable that the orthodontic miniimplants have a fixing end with a transverse dimension of 1.4 to 2.5 mm. It is also preferred that the neck of the orthodontic mini-implant and the fixing end are made of titanium.

[0030] According to the invention, it is preferred that the orthodontic arch is made of metal, e.g. stainless steel (e.g. class AISI304 / 316), beta - titanium (TMA), NiTi alloys (superelastic and / or thermoactive), Co-Cr alloys, etc. It is also possible and preferred to use polymers or polymer-fibrous composites as the material of the orthodontic arch. The arch is basically adapted to the shape of the alveolar process - and widened to such an extent (i.e. in the range of its angular extension; the width of the arch is selected individually on the basis of FEM calculations - using the finite element method) that it, thanks to the proposed design of connecting the arch to the mini-implant head, directly or indirectly, generates an appropriate force leading to the displacement of the buccal cortical plate of the process and the generation of tensile stress in the periodontal ligament. It is apparent to a person skilled in the art that, in the course of modeling, the person skilled in the art will suitably and properly select the size and width of the orthodontic arch used according to the present disclosure.

[0031] Therefore, the invention also relates to the medical use of the aforementioned orthodontic mini-implants for fixing the orthodontic arch to the peri-orthodontic expansion of the alveolar process and bone regeneration in orthodontic and periodontal treatment.

[0032] Description of the method of fixing the system and the application, i.e. expansion of the alveolar process and its regeneration, i.e. for expansion of the alveolar process bone:After the corticotomy procedure, mini-implants are screwed at the appropriate height relative to the bone level, interroot, alternately, i.e. root - mini-implant - root -corticotomy cut, etc., or the method of screwing mini-implants is selected depending on the clinical situation. Then, an orthodontic arch is applied to the mounted miniimplants - to the head of the selected shape according to the invention - it is attached to the above-mentioned part and preferably stabilized with a known agent, e.g. ligature. The inserted orthodontic arch or another resilient element generates orthodontic strength and removes the buccal cortical lamina of the alveolar process and generates tensile stress in the periodontal ligament of the appropriate size. Attaching the orthodontic arch or resilient element is done through a properly made head or neck, as described earlier.

[0033] Tensile stress in the periodontal ligament caused by the application of orthodontic force will cause the mechanisms described above, which will activate the known molecular mechanisms of depositing new bone tissue.

[0034] The choice of the mini-implant head depends on the clinical situation, i.e. the possibility of obtaining a uniform level of screwing in the mini-implants, the thickness and flexibility of the arch (or another resilient element), and at the same time the patient's comfort and the possibility of inserting the arch in the described method of attachment. The best results are achieved by fastening with a head in the form of a lock.

[0035] The invention allows the expansion of the dental arch to relieve crowding, compensate or decompensate for an orthodontic defect or regenerate bone tissue as a result of periodontal disease. The invention minimizes the need for tooth extraction during orthodontic treatment.

[0036] The object of the invention is presented in more detail in the embodiments in the attached drawings, in which:

[0037] Figs. 1-3 present a general view of the implant itself with a head in the shape of a mushroom, a hook, pliers - a lock,

[0038] Figs. 4-6 show the entire system in different versions of the mini-implant,

[0039] Figs. 7 and 8 present the entire system in different versions of the mini-implant - a hook and a rounded head in a variant with a stabilizing agent,

[0040] Fig. 9 shows a diagram of attaching the arch with mini-implants,Fig. 10 shows a numerical model with an incision,

[0041] Fig. 11 shows a diagram of attaching the arch with mini-implants with an incision on the 3D model,

[0042] Fig. 12 shows a diagram of attaching the arch with mini-implants on a real patient model developed on the basis of a CBCT image, and

[0043] Fig. 13 shows a photo showing the patient's CBCT before the procedure

[0044] List of references in the Drawing:

[0045] A - orthodontic mini-implant

[0046] B - orthodontic arch

[0047] C - stabilizing agent, e.g. ligature

[0048] D - corticotomy incisions

[0049] E - teeth / dental crown.

[0050] A - orthodontic mini-implant:

[0051] 1 The body with a thread, i.e. the pillar of the mini-implant

[0052] 2 polygonal neck,

[0053] 3 holes in the neck

[0054] 4 head - fixing end for the orthodontic arch

[0055] a) the end in the shape of the rounded head of Fig. 1 - mushroom with shaft 4T b) the hook-shaped head of Fig. 2 with sharp ends in the shape of two hooks - hook grapples - 4H - at the bottom and top, with one adjacent to the neck, c) the head in the shape of the lock of Fig. 3 open pliers with blades - two arched rounded jaws at the front - 4S, there is a narrowing between the neck and the head - shaft T

[0056] In Figs. 1 to 3 illustrate embodiments of orthodontic mini-implants used in accordance with the present invention. According of Fig. 1 The orthodontic mini -implant A has a longitudinal threaded pillar 1 attached in the alveolar process, a hexagonal neck 2 and a fixing end 4 for the orthodontic arch B (not shown). According to the present embodiment, the fixing end 4 is formed in the form of a rounded head and in the longitudinal cross-section has a shape of a mushroom with a narrowed shaft 4T with a rounded cross-section. A fixing hole 3 for the orthodontic arch B is made in the neck 2. A method of connecting the orthodontic mini-implant A according to the discussed embodiment to the orthodontic arch B, creating a system for peri-orthodontic expansionof the alveolar process and bone regeneration is indicated in Fig. 5 and in Fig. 8. Fig. 8 additionally shows the stabilization of the orthodontic arch B by means of the ligature C in the form of a rubber.

[0057] According to another embodiment, Fig. 2 shows the orthodontic mini-implant A with a threaded pillar 1 and a hexagonal neck 2 with a hole 3, with the fixing end 4 for the orthodontic arch B (not shown) being formed in the form of a hook formed as a semicircle in the shape of the letter "C", terminated at the top and at the bottom with two hook grapples. One of the hooks is adjacent to the neck 2, creating a place for connecting to the orthodontic arch B. A method of connecting the orthodontic miniimplant A according to the discussed second embodiment to the orthodontic arch B, creating a system for peri -orthodontic expansion of the alveolar process and bone regeneration is indicated in Fig. 6 and in Fig. 7. Fig. 7 additionally shows the stabilization of the orthodontic arch B by means of the ligature C in the form of a rubber.

[0058] According to another further embodiment, Fig. 3 shows the orthodontic mini-implant A with a threaded pillar 1 and a hexagonal neck 2 with a hole 3. The fixing end 4 for the orthodontic arch B (not shown) is formed in this case in the form of a lock in the form of open pliers ended with jaws 4S. In the front, between the jaws 4S, an incision receiving the orthodontic arch B is provided over their entire width. In addition, a narrowing constituting a T shaft with a rounded cross-section is provided below the fixing end 4. A method of connecting the orthodontic mini-implant A according to the discussed third embodiment to the orthodontic arch B, creating a system for peri-orthodontic expansion of the alveolar process and bone regeneration is indicated in Fig.

[0059] 4, which shows the stabilization of the orthodontic arch B by means of the ligature C in the form of a rubber. According to the obtained clinical results, the solution of the mini implant with the use of the fixing end 4 in the form of a lock ensures the best effects of the system for peri-orthodontic expansion of the alveolar process and bone regeneration and the treatment program carried out with it.

[0060] Further figures, in particular Fig. 9 and Fig. 10 show the use of the system according to the invention in the alveolar process, above the crowns of the teeth E. Orthodontic implants (or: bone mini- plates) A are embedded in the alveolar process in the interroot areas of the teeth E, adjacent to the corticotomy incisions D in the alveolar process.The following are examples of the clinical use of the system for peri-orthodontic expansion of the alveolar process and bone regeneration, as well as the results, based on the treatment program carried out with it.

[0061] EXAMPLE 1

[0062] Description of the system used for peri -orthodontic expansion of the alveolar process and bone regeneration.

[0063] The system was made of 14 mini-implants A of titanium Ti6AI4Va, self-threading-self-drilling with a rounded head 4 in the shape of a mushroom with a shaft 4T, as shown in Fig. 1. Furthermore, as shown in Figs. 1 and 5, each mini -implant had a pillar 1 with a thread size - a fixed thread diameter of 1.4 mm, a pillar length - 6 mm, a hexagonal neck 2 with a size - diameter of 2.2 mm, a length of 1.5 mm with two holes 3 to fix the arch B. The dimensions of the head 4 are - a diameter of 1.8 mm, a total length with a shaft of 4T of 1.5 mm. The dimensions fit the anatomical structure of the patient within the above-mentioned range verified for this application. Hexagonal neck 2, like the head, is non-compatible - made of titanium.

[0064] Pillar 1 has sharp edges of the screwing surface - tapered threading.

[0065] The arch B in this case is adapted to the shape of the alveolar process of the patient, for whom a CBCT image was taken before the procedure, shown in Fig. 13, and widened so that, thanks to the described design of connecting the arch B to the head, it generates an appropriate force leading to the displacement of the buccal cortical plate of the process and the generation of tensile stress in the periodontal ligament, and in this case it had a dimension of 0.019*0.025 SS

[0066] Such a mini-implant adapted to this clinical case was selected, based on the CBCT image - Fig. 13 and the actual models were made, shown in Fig. 12 and on their basis, the model shown in Fig. 11 where the corticotomy cut described below is shown. Attachment on an arch with mini-implants on an anatomical model of this patient was also developed.

[0067] That is, in the described case, on the basis of the CBCT examination of the jaw in the upper arch, 7 mini-implants were mounted with a rounded head 4 shaped in the interroot region of the teeth 17 / 16; 15 / 14; 13 / 12; 21 / 22; 23 / 24; 25 / 26; 26 / 27 at a height of about4 mm above the edge of the bone and at a depth of about 4 mm bone depth at a very similar level enabling the insertion of an orthodontic arch. On the other hand, corticotomy cuts, with a traditional shape in interroot spaces not covered by miniimplants and above the roots of all teeth to the depth of the thickness of the compact buccal cortical lamina.

[0068] In the lower arch, 7 mini-implants were also screwed in the interroot region of the teeth 47 / 46; 45 / 44; 43 / 42; 31 / 41; 32 / 33; 34 / 35; 36 / 37 at a height of about 3-4 mm below the edge of the bone and a depth of about 4 mm at a very similar level. On the other hand, corticotomy cuts of a traditional shape in interroot spaces not covered by mini -implants and below the roots of all teeth to the depth of the thickness of the compacted buccal cortical lamina.

[0069] The application of the system is shown in Fig. 5, an arch 0.021*0.025 SS was inserted into mini-implants after appropriate expansion and fixed with metal ligatures.

[0070] Due to the proximity of the dental roots, the mini-implants were screwed with the use of dynamic navigation.

[0071] As shown in the Fig. 5, the applied steel arch B embedded in the holes in the neck 2 was bent in the shape of the upper and lower alveolar processes, respectively, with the appropriate widening and with the appropriate cross-section so that, after binding to mini-implants with a metal ligature, it generated appropriate orthodontic strength, caused the removal of the buccal cortical lamina and generated tensile stress in the periodontal ligament.

[0072] In the calculations on the finite element model, as shown in Figs. 9-11, the magnitude of forces necessary to pull the buccal cortical lamina on the fragmentary section of the alveolar process was estimated. Corticotomy cuts and the mini-implant were simulated. The role of the depth of the cuts in the estimation of the necessary applied force was examined.

[0073] The results carried out on the patient confirm that the applied system will allow the expansion of the alveolar process and the regeneration of bone, among others, after periodontal disease, i.e. it increases the bone envelope in which orthodontic movement can take place and minimizes the risk of complications in the form of bone fenestrationand gum recession as a result of expansion of the dental arch during orthodontic treatment.

[0074] In a similar clinical case, another patient additionally applied stabilization of the arch attachment B using the C ligature, due to complications during the procedure, as shown in Fig. 8.

[0075] EXAMPLE 2

[0076] Description of the system used for peri -orthodontic expansion of the alveolar process and bone regeneration.

[0077] In the clinical case with a very small amount of the associated gum, in which there is a high risk of damage to the movable mucosa, orthodontic mini-implants with a hookshaped head 4, shown in Fig. 2, with a shape resembling a semicircle, terminated at the top and at the bottom with two hook grapples 4 H, with one of them adjacent to the neck 2, creating a place of connection with the arch B, will find a better use, as shown in Fig. 6. The system was made of 10 mini -implants A of titanium Ti6AI4Va, selfthreading- self-drilling. The attachment took place in the same way as in case 1, i.e. the placement of mini-implants and the applied orthodontic arches, as well as corticotomy cuts, the attachment took place directly to the head without additional stabilization, as shown in Fig. 6. A CBCT image and models were also taken, as previously described.

[0078] The system was made of 10 mini -implants A with a hook-shaped head 4, where one of them adheres to the neck, creating a place of connection with the arch, as shown in Fig.

[0079] 6. Each mini-implant had a pillar 1 with a tapered thread, sharp edges of the screwing surface with a size - a fixed thread diameter of 1.8 mm, a length of the pillar - 8 mm, a hexagonal neck 2 with a size - a diameter of 2.2 mm, and the upper hook made in the head 4 allowed a direct connection with the orthodontic arch B. The dimensions of the width at the front of the hook are 1.8 mm, the length from the side to the neck is 2 - 1.5 mm. Other dimensions, including the neck 2, were similar to Example 1.

[0080] In a similar clinical case, mini-implants with a head in the shape of a hook were also used in another patient - Figs. 2, 6, but additionally stabilization of the arch B attachment using the ligature C, due to complications during the procedure, as shown in Fig. 7.EXAMPLE 3

[0081] In the clinical case requiring peri-orthodontic expansion of the alveolar process, 7 miniimplants with a bracket-type head 4 were used, presented in Fig. 3 - with open pliers 4S, with an incision in the middle to attach the arch B, passing into the shaft T. The attachment took place in the same way as in case 1, i.e. the placement of mini-implants and the applied orthodontic arches, as well as corticotomy cuts, the arch was attached to the hole made in the pliers in the head 4 and was reinforced with the ligature C, as shown in Fig. 4. A CBCT image and models were also taken, as previously described. Each mini-implant had a pillar 1 with a tapered thread - sharp edges of the screwing surface with a size - a fixed thread diameter of 1.8 mm.

[0082] In the lower arch, 7 such mini-implants were-screwed in the interroot region of the teeth 47 / 46; 45 / 44; 43 / 42; 31 / 41; 32 / 33; 34 / 35; 36 / 37 at a height of about 3-4 mm below the edge of the bone and a depth of about 4 mm at a very similar level. On the other hand, corticotomy cuts of a traditional shape in interroot spaces not covered by mini -implants and below the roots of all teeth to the depth of the thickness of the compacted buccal cortical lamina. Mini -implants with a bracket-type head shown in Fig. 3, to which, after appropriate expansion, an arch 0.021*0.025 SS was inserted and fixed with metal ligatures. Each mini-implant had a pillar 1 with a thread size - a fixed thread diameter of 2.4 mm, a length of the pillar - 11 mm, a hexagonal cap 2 with a size - a diameter of 2.0 mm, and the jaws 4S in the head 4 had a diameter of 1.8 mm, a jaw length 4S 1.5 mm, a head shaft T a length of 1 mm and allowed attachment with the orthodontic arch B using a ligature C, as shown in Fig. 4, the remaining length, as described previously in Example 2.

[0083] In the case described in examples 1-3, in order to check the expansion of the alveolar process and the regeneration of the bone, CBCT images were taken after 4 weeks in the dental arch, where the mini-implants were attached and a bone growth of 0.2 to 1.1 mm was demonstrated, which confirms the effects.EXAMPLE 4 — BPS in the upper and lower arches, aligners.

[0084] In a patient requiring simultaneous expansion of the upper and lower arches and improvement of the buccal cortical phenotype in both jaws, buccal cortical corticotomy was performed along both alveolar processes. In the upper arch, 7 means of skeletal anchorage (A) were introduced in the following positions: 17 / 16, 15 / 14, 13 / 12, 21 / 22, 23 / 24, 25 / 26, 26 / 27. In the lower arch, 7 anchorages (A) were also introduced in the positions: 47 / 46, 45 / 44, 43 / 42, 31 / 41, 32 / 33, 34 / 35, 36 / 37. In both arches, orthodontic arches (B) were attached, bent in accordance with the course of the alveolar process. Active arches combined with anchorages generated controlled force vectors that: pulled the buccal cortical lamina in parallel, raised the share of tensile stresses, eliminated tipping, provided a translational path of root movement even at high expansion. The patient used orthodontic aligners with cutouts in the anchorage zone, which cooperated with the BPS system. The type of braces did not affect the operation of the system — the translation was entirely generated by combining the skeletal anchorages (A) and the activating arch (B).

[0085] After 4 weeks, the following were observed: reconstruction of the buccal cortical lamina, widening of the alveolar process, pronounced thickening of the soft tissue phenotype, no fenestration or recession, parallel expansion of the upper and lower arches without uncontrolled tipping, correction of the cross bite without the risk of bone loss.

[0086] EXAMPLE 5 — BPS + fixed braces in a patient with a thin phenotype

[0087] A patient with a very thin gum phenotype and a thin buccal cortical lamina in the jaw, requiring expansion of the upper arch and leveling of crowding. Due to the high risk of fenestration and recession, buccal cortical corticotomy was performed along the segments requiring expansion. 7 means of skeletal anchorage (A) were introduced in the following interroot positions in the upper arch: 17 / 16, 15 / 14, 13 / 12, 21 / 22, 23 / 24, 25 / 26, 26 / 27. Then, an active orthodontic arch (B) was attached and connected to each of the anchorages (A). The arch generated a controlled force vector that: relieved the buccal cortical lamina, reduced compression stresses, increased tensile stresses in PDL on the vestibular side, induced a translational path of root movement, eliminating tipping of the crowns. At the same time, the patient wore a fixed thin-arch brace, whichwas only used to level and position the teeth — the type of brace did not affect the biomechanics of the BPS system, and the translation was generated by the anchor system (A) and the activating arch (B). After 6 weeks, the following were observed: no fenestration and no adverse periodontal changes, thickening of the buccal cortical phenotype over the roots of incisors and fangs, reconstruction of the buccal cortical lamina confirmed by CBCT, parallel widening of the arch without tilting the crowns.

[0088] The patient initially classified as "high periodontal risk" tolerated the expansion without complications thanks to the BPS system.

[0089] EXAMPLE 6 — "PERIO-ONLY" (without braces)

[0090] A patient with periodontal disease, buccal cortical lamina fenestrations and a recessive gum phenotype in the anterior section of the jaw, without indications for orthodontic treatment.

[0091] The aim of the procedure was to stabilize the periodontium and thicken the buccal cortical lamina in order to inhibit the progression of the disease and improve the tissue phenotype. After the buccal cortical corticotomy, means of skeletal anchorage (A) were introduced at the positions: 16 / 15, 14 / 13, 11 / 21, 23 / 24, 25 / 26. Then, an active orthodontic arch (B) connecting both anchorages was attached. The arch generated a controlled force vector that: relieved the buccal cortical lamina, induced stretching stresses in the periodontal ligament (PDL), stimulated bone reconstruction, did not require an orthodontic brace (perio-only variant). Thanks to the combination of reduced bone resistance after corticotomy and the operation of the arch (B), the BpS system generated conditions conducive to: thickening of the buccal cortical lamina, reorganization of periodontal fibers, bone growth in the area of the earlier defect.

[0092] After a few months, the following were observed: pronounced thickening of the buccal cortical phenotype, improvement of the gum contour without recession, reconstruction of the buccal cortical bone confirmed by CBCT, clinical stabilization of the periodontium and no further bone loss. The BPS system in the perio-only variant acted as a biomechanical regenerative system, independent of any orthodontic braces, using only the anchor means (A) and the arch (B).EXAMPLE 7 — Expansion with a high risk of fenestration

[0093] A patient with a very thin buccal cortical lamina in the incisors section of the jaw (thickness <0.5 mm) and the presence of the "bony dehiscence risk zone", which would lead to root fenestration with classic expansion. After the buccal cortical corticotomy, means of skeletal anchorage (A) were introduced at positions 17 / 16, 15 / 14, 13 / 12, 21 / 22, 23 / 24, 25 / 26, 26 / 27. In the lower arch, 7 anchorages (A) were also introduced in the positions: 47 / 46, 45 / 44, 43 / 42, 31 / 41, 32 / 33, 34 / 35, 36 / 37 and active orthodontic arches (B) were attached. The arches generated oriented force vectors that: reduced compression stresses in the buccal cortical part of the PDL, increased tensile stresses, transferred the rotation point apically, eliminated crown tipping, induced axial, translational root movement. The patient wore a fixed thin-arch brace to align the crowns, and the translational effect came only from the BPS system (A+B). After a few months, the following were noted: lack of fenestration, thickening of the buccal cortical lamina in high-risk areas, root displacement in the translational range without loss of the attachment, restoration of the physiological bone envelope.

[0094] This variant confirms the biomechanical advantage of the BPS system over classic expansion methods.

[0095] EXAMPLE 8 — SPLIT -MOUTH (top with full BPS 6-7 anchorages vs bottom without BPS)

[0096] A patient with a thin gum phenotype and different thickness of the buccal cortical lamina in the jaw and mandible was treated with split-mouth treatment. A full BPS system was used in the upper arch, while the lower arch was treated with the conventional method without BPS to compare the differences in action in the same patient.

[0097] Used:

[0098] Upper arch — full BPS (6-7 anchorages)

[0099] After the buccal cortical corticotomy, 6 skeletal anchorages (A) were introduced at the positions: 17 / 16, 15 / 14, 13 / 12, 21 / 22, 23 / 24, 25 / 26. Then, an active orthodontic arch (B), connected to all anchorages (A), was attached. The arch (B) generated: parallelrelief of the buccal cortical lamina, reduced compression stresses, increased tensile stresses, translational path of root movement instead of tipping, shift of the rotation point apically. The patient wore orthodontic aligners, which cooperated with the system through cutouts in the anchorage area — however, it was BPS that generated the right root movement path regardless of the type of braces.

[0100] Lower arch — without BPS (control in split-mouth)

[0101] A standard leveling with fixed braces without skeletal anchorages and without corticotomy was performed in the mandible. There were: tipping of the crowns, increase in buccal cortical compression stresses, thinning of the buccal cortical lamina, local risk of recession and fenestration.

[0102] Results after a dozen or so months: for the upper arch (BPS: 6 anchorages), a thickening of the buccal cortical lamina by 0.3-1.1 mm, root translation without their tilting, no fenestration as well as a marked increase in the phenotype of buccal cortical tissues and safe expansion even in a thin biotype were observed. In the case of the upper arch (without BPS), tipping of the crowns in the buccal cortical direction, PDL compression overloads, thinning of the lamina and deterioration of the buccal cortical phenotype as well as an increased risk of recession were observed.

Claims

69098 / 25 2026-02-18 PCT / IB2026 / 050584 20Claims1. A system for peri-orthodontic expansion of the alveolar process and bone regeneration, for use in combination with a surgical procedure of breaching the cortical layer of the alveolar process in the form of incisions or perforations, characterized in that it comprises a set of at least two means of skeletal anchorage (A) in the form of orthodontic mini-implants or bone mini-plates that are connected to the orthodontic arch (B) or the resilient element, wherein the means of skeletal anchorage (A) are provided with fastening means for connection to the orthodontic arch (B) or the resilient element, and in that the means of skeletal anchorage (A) are attached to the interroot areas of the teeth, adjacent to the breaches of the cortical layer in the alveolar process, and the shape of the orthodontic arch (B) or the resilient element is adapted to the shape of the alveolar process and pre-stressed accordingly, exerting a positive pressure on the means of skeletal anchorage (A).

2. The system according to claim 1, characterized in that the surgical procedure of breaching the cortical layer of the alveolar process in the form of incisions or perforations is in particular: corticotomy, microperforations, decortication, segmental osteotomy or another procedure reducing the stiffness of the cortical lamina of the alveolar process and inducing the regional effect of accelerated reconstruction.

3. The system according to claim 1 or 2, characterized in that the orthodontic miniimplants, having a longitudinal pillar (1) with conical or cylindrical threading, a polygonal neck (2) and a fixing end (4) for the orthodontic arch (B) are used as means of skeletal anchorage (A), wherein the orthodontic mini-implants (A) are attached in the alveolar process with their threaded pillars (1).

4. The system according to claim 3, characterized in that the fixing end (4) of the orthodontic mini-implant (A) is formed in the form of a rounded head (4) and in the longitudinal cross-section has the shape of a mushroom with a narrowed shaft (4T) with a rounded cross-section, wherein at least one hole (3) fixing the orthodontic arch (B) is formed in the neck (2).

5. The system according to claim 3, characterized in that the fixing end (4) of the orthodontic mini-implant (A) is formed in the form of a hook formed as a C-shaped semicircle, terminated at the top and at the bottom with two hook grapples, with oneof the hook grapples adjacent to the neck (2) creating a place for joining with the orthodontic arch (B).

6. The system according to claim 5, characterized in that at least one second fixing hole (3) is formed in the neck (2).

7. The system according to claim 3, characterized in that the fixing end (4) of the orthodontic mini-implant (A) is formed in the form of a lock (4) in the form of open pliers ended with jaws (4S), and in the front, between the jaws (4S), an incision receiving an orthodontic arch (B) is provided along the entire width of the pliers.

8. The system according to claim 7, characterized in that a narrowing constituting a shaft (T) with a rounded cross-section is provided between the neck (2) and the orthodontic arch (B).

9. The system according to claim 7 or 8, characterized in that at least one second fixing hole (3) is formed in the neck (2).

10. The system according to any of claims 3 to 9, characterized in that the orthodontic mini-implant (A) is combined with the orthodontic arch (B) and stabilized thereon by an orthodontic ligature (C).

11. The system according to any of claims 3 to 10, characterized in that the neck (2) is hexagonal in shape.

12. The system according to any one of claims 3 to 11, characterized in that the orthodontic mini-implants (A) have a length of up to 18 mm, especially 6 to 15 mm.

13. The system according to any one of claims 3 to 12, characterized in that the orthodontic mini -implants (A) have a pillar (1) with a length in the range of 6 to 14 mm, especially 6 to 11 mm.

14. The system according to any one of claims 3 to 13, characterized in that the orthodontic mini -implants (A) have a fixing end with a transverse dimension of 1.4 to 2.5 mm.

15. An arrangement according to any one of claims 3 to 14, characterized in that the neck (2) and the fixing end (4) are made of titanium.

16. An arrangement according to any of the preceding claims, characterized in that the orthodontic arch (B) is made of metal, polymer or a polymer-fiber composite.

17. The system according to any one of the preceding claims, characterized in that it is intended for orthodontic applications, including especially together with a fixed, ligual, segmented orthodontic brace or an orthodontic aligner, and periodontic applications.

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