WO2021187785A1 - Feuille multicouche pour dispositif d'alignement transparent - Google Patents

Feuille multicouche pour dispositif d'alignement transparent Download PDF

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Publication number
WO2021187785A1
WO2021187785A1 PCT/KR2021/002814 KR2021002814W WO2021187785A1 WO 2021187785 A1 WO2021187785 A1 WO 2021187785A1 KR 2021002814 W KR2021002814 W KR 2021002814W WO 2021187785 A1 WO2021187785 A1 WO 2021187785A1
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WO
WIPO (PCT)
Prior art keywords
layer
outer layer
transparent
orthodontic
present
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Application number
PCT/KR2021/002814
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English (en)
Korean (ko)
Inventor
권두연
임희정
장일석
송주동
Original Assignee
오스템임플란트 주식회사
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Publication of WO2021187785A1 publication Critical patent/WO2021187785A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C7/00—Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
    • A61C7/08—Mouthpiece-type retainers or positioners, e.g. for both the lower and upper arch
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/40—Layered products comprising a layer of synthetic resin comprising polyurethanes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/02—Physical, chemical or physicochemical properties

Definitions

  • the present invention relates to a transparent orthodontic multi-layer sheet, and more particularly, as a transparent orthodontic material required for orthodontic procedures, it is composed of multiple layers to increase orthodontic retention, reduce patient pain, and have excellent interlayer bonding and durability. It relates to a transparent orthodontic multi-layer sheet that can be configured to increase the stability of the orthodontic device and safety when worn by a patient.
  • Orthodontic treatment is a therapeutic action applied to treat irregular tooth arrangement or abnormal interlocking of upper and lower jaws.
  • treatment is performed using brackets and wires for orthodontic treatment, and metal brackets and wires are used to apply orthodontic force to teeth.
  • metal brackets and wires they are not aesthetically good, and since treatment is carried out by fixing them to the teeth, there is a disadvantage that more attention should be paid to the cleanliness of the oral cavity.
  • the transparent orthodontic device is used for treatment by molding a polymer sheet to suit the patient's oral cavity through vacuum thermoforming.
  • Most of the conventional polymer sheets are composed of polyethylene terephthalate glycol (PETG).
  • PETG polyethylene terephthalate glycol
  • Transparent orthodontic devices made of conventional polymer sheets, including PETG have a characteristic that the pain applied to the patient at the initial stage of wearing the device is great, and the orthodontic force applied to the teeth decreases over time. This causes discomfort and pain to the patient, and gives the teeth a lower orthodontic force unlike the initial one, resulting in tooth movement that does not match the predicted results.
  • a multi-layer sheet (Polyester-TPU) has been developed to improve this, but there is a disadvantage in that the interlayer bonding strength is weak due to the difference in thermal properties. Due to this, delamination occurs when applying orthodontic products, which causes performance degradation, and the peeled layer exists in the patient's mouth or enters the digestive tract, affecting patient safety. Therefore, there is a need for a material with increased long-term stability of the orthodontic device and safety when wearing the device by a patient through improved interlayer bonding.
  • the present invention is to solve the problems of the prior art described above, and an object of the present invention is to increase orthodontic retention and reduce patient pain by being composed of multiple layers as a transparent orthodontic material required for orthodontic treatment, excellent interlayer bonding strength and An object of the present invention is to provide a transparent orthodontic multi-layer sheet that is configured to have durability and can increase the stability of the orthodontic device and safety when worn by a patient.
  • one aspect of the present invention is a first outer layer made of a soft thermoplastic polymer material, a second outer layer made of a soft thermoplastic polymer material, and between the first outer layer and the second outer layer. It provides a transparent orthodontic multi-layer sheet comprising an intermediate layer made of a rigid thermoplastic polymer material.
  • At least one of the first outer layer and the second outer layer may be a transparent orthodontic multi-layer sheet made of a flexible polyurethane material.
  • the intermediate layer may be a multi-layer sheet for transparent correction, characterized in that made of a rigid polyurethane material.
  • At least one of the first outer layer and the second outer layer may be a multi-layered sheet for transparent correction, characterized in that it is configured to have a thickness of 20 ⁇ m or more and 200 ⁇ m or less.
  • the intermediate layer may be a multi-layer sheet for transparent correction, characterized in that it is configured to have a thickness of 200 ⁇ m or more and 1500 ⁇ m or less.
  • At least one of the first outer layer and the second outer layer may be a multi-layer sheet for transparent correction, characterized in that it is configured to have a hardness of 60A or more and 100A or less. .
  • the intermediate layer has a yield strength of 40 MPa or more and 60 MPa or less, and a Young's modulus of 1500 MPa or more and 2200 MPa or less. It may be a sheet.
  • the peel strength representing the interlayer bonding force between the first outer layer or the second outer layer and the intermediate layer is 0.2N/cm or more for transparent correction multilayer It may be a sheet.
  • the transparent orthodontic multi-layer sheet of the present invention has excellent orthodontic holding power due to less deformation at the tooth deformed position compared to conventional materials, and excellent interlayer bonding strength, so that durability and safety when worn by a patient can be improved. have.
  • the outer layer is made of a soft polymer material to give flexibility, it is possible to reduce the pain of the patient during the initial correction.
  • the intermediate layer is made of a hard polymer material and has high elastic recovery force, interlayer bonding strength and durability with the outer layer may be improved.
  • FIG. 1 is a perspective view showing a transparent orthodontic device made of a multi-layer sheet for transparent correction according to an embodiment of the present invention.
  • FIG. 2 is a perspective view showing a multi-layer sheet for transparent correction according to an embodiment of the present invention.
  • FIG. 4 is a graph comparing peel strength between a multi-layer sheet for transparent correction according to an embodiment of the present invention and a conventional material.
  • FIG. 5 is a photograph comparing the recovery rate after deformation between the multi-layer sheet for transparent correction according to an embodiment of the present invention and a conventional material.
  • FIG. 6 is a graph comparing the retention of orthodontic force between the transparent orthodontic multi-layer sheet according to an embodiment of the present invention and a conventional material.
  • FIG. 1 is a perspective view showing a transparent orthodontic device made of a multi-layer sheet for transparent correction according to an embodiment of the present invention
  • FIG. 2 is a perspective view showing a multi-layer sheet for transparent correction according to an embodiment of the present invention.
  • the transparent orthodontic device 10 is an intraoral structure that is molded and used to suit the patient's upper or lower teeth 20. used for treatment for
  • the tooth groove 11 into which the teeth are fitted is engraved.
  • the transparent orthodontic device 10 is formed in a structure that covers the portion that engages the relative teeth of the teeth, that is, the end surface of the crown (insulation of the anterior teeth, the occlusal surface of the posterior teeth).
  • the transparent orthodontic device 10 may be made of a transparent orthodontic multi-layer sheet 1000 made of a thermoplastic transparent polymer material.
  • the transparent orthodontic device 10 made of a polymer material instead of a conventional metal material is transparent and aesthetically excellent, as well as being detachable to the teeth, so it is easy to manage oral hygiene.
  • the transparent orthodontic multi-layer sheet 1000 may have a triple-layer structure including a first outer layer 100 , a second outer layer 200 and an intermediate layer 300 . have.
  • the transparent orthodontic multi-layer sheet 1000 of the present invention is different from the conventional single-layer material sheet, the orthodontic force applied to the teeth over time by configuring the material of the outer layer in contact with the soft tissue in the oral cavity and the inner layer providing rigidity differently. It is possible to reduce discomfort and pain inflicted to the patient while maintaining it.
  • the first outer layer 100 and the second outer layer 200 constitute the outer layer of the transparent orthodontic multi-layer sheet 1000 and are in contact with the soft tissue in the oral cavity, and may be made of a soft thermoplastic transparent polymer material. That is, the first outer layer 100 and the second outer layer 200 are made of a soft polymer material to give flexibility to the transparent orthodontic multi-layer sheet 1000, and when a deformation force is applied, complex stress acts to provide high correction It can provide holding force and elastic recovery force.
  • the intermediate layer 300 constitutes the inner layer of the transparent orthodontic multi-layer sheet 1000 and provides orthodontic force for tooth movement, and may be made of a rigid thermoplastic transparent polymer material. That is, the intermediate layer 300 is made of a hard polymer material to impart strength to the transparent orthodontic multilayer sheet 1000, and can provide an orthodontic force for applying a force in a direction in which the teeth want to move.
  • the first outer layer 100 and the second outer layer 200 may be made of a flexible thermoplastic polyurethane (TPU).
  • TPU thermoplastic polyurethane
  • Polyurethane has the characteristics of both rubber and plastic, and is a non-toxic material without harmful substances such as environmental hormones and TVOC. In addition, it is an elastic material that does not require a separate plasticizer and has the highest abrasion resistance among thermoplastic elastomers that can be plastically processed by heat.
  • the first outer layer 100 and the second outer layer 200 of the present invention may be made of a flexible polyurethane having a high strain recovery rate to give flexibility to the transparent orthodontic multi-layer sheet 1000, thus It is possible to alleviate the pain inflicted on the patient in the early stages of orthodontic treatment.
  • the first outer layer 100 and the second outer layer 200 of the present invention may be configured to have a thickness of 20 ⁇ m or more and 200 ⁇ m or less.
  • the thickness of the first outer layer 100 and the second outer layer 200 is less than 20 ⁇ m, the flexibility of the multi-layer sheet 1000 for transparent correction may be lowered because it cannot sufficiently receive elastic deformation, and the If the thickness of the first outer layer 100 and the second outer layer 200 exceeds 200 ⁇ m, the thickness of the transparent orthodontic multi-layer sheet 1000 may become too thick, and thus the patient's wearing comfort may be reduced.
  • the first outer layer 100 and the second outer layer 200 are preferably configured to have a hardness of 60A or more and 100A or less. If the hardness of the first outer layer 100 and the second outer layer 200 is less than 60A, there is a fear that sufficient strength for maintaining orthodontic force may not be provided when in contact with the teeth, and if it exceeds 100A, the strength of the outer layer is excessively increased Therefore, it may not provide sufficient elasticity, and the pain relief of the patient may be reduced.
  • the intermediate layer 300 may be made of rigid thermoplastic polyurethane (TPU).
  • transparent polymer materials such as PET, PE, and PC were used as materials for securing corrective power, that is, strength as materials for interlayer materials.
  • PET PET
  • PE PE
  • PC PC
  • the intermediate layer 300 of the present invention is made of rigid polyurethane to improve durability by increasing interlayer bonding strength with the first outer layer 100 and the second outer layer 200 to provide rigidity and It is possible to impart a high rate of recovery from deformation, thereby providing improved orthodontic force.
  • the intermediate layer 300 of the present invention may be configured to have a thickness of 200 ⁇ m or more and 1500 ⁇ m or less. At this time, if the thickness of the intermediate layer 300 is less than 200 ⁇ m, it may be difficult to secure sufficient strength for maintaining the corrective force, and if the thickness of the intermediate layer 300 exceeds 1500 ⁇ m, the thickness of the transparent orthodontic multi-layer sheet 1000 is too thick. This may reduce the patient's wearing comfort.
  • the intermediate layer 300 is preferably configured to have a yield strength of 40 MPa or more and 60 MPa or less, and a Young's modulus of 1500 MPa or more and 2200 MPa or less. If the yield strength of the intermediate layer 300 is less than 40 MPa and the modulus of elasticity is less than 1500 MPa, it may not be possible to provide sufficient elastic deformation, so it may be difficult to provide sufficient mechanical strength for securing corrective force, the yield strength is more than 60 MPa and the modulus of elasticity is more than 2200 MPa It can be difficult to relieve pain in patients in the early stages of orthodontic treatment.
  • the intermediate layer 300 may be configured to have a transmittance of 93% or more and 97% or less.
  • the transparent orthodontic sheet 1000 according to the present invention is composed of multiple layers of soft polyurethane and rigid polyurethane having similar thermal properties, thereby increasing orthodontic retention and reducing patient pain, and durability due to excellent interlayer bonding strength This improvement can increase safety when worn by the patient.
  • the first outer layer 100 and the second outer layer 200 of the transparent orthodontic multi-layer sheet 1000 used in the experiment were made of soft polyurethane, and the middle layer 300 was made of rigid polyurethane. .
  • the outer layer of the conventional material is made of flexible polyurethane, and the inner layer is configured to be made of hard polyester.
  • the universal testing machine is an experimental instrument that applies stress to the material to find out the most basic mechanical properties of the polymer material, and then measures the resulting strain to find out the physical properties of the material.
  • There are various types of experiments such as tensile, peeling, and bending.
  • the LOAD value is measured until the specimen deforms with respect to that force. Since the detailed experimental method is a known fact, it will be omitted.
  • the conventional material was measured to have a yield strength of about 30 MPa to 40 MPa and an elastic modulus of 1500 MPa to 1700 MPa
  • the transparent orthodontic multilayer sheet 1000 of the present invention has a yield strength of about 40 MPa to 60 MPa and an elastic modulus of 1200 MPa to 2000 MPa.
  • the transparent orthodontic multi-layer sheet 1000 of the present invention allows greater elastic deformation compared to conventional materials, thereby reducing pain applied to the patient at the initial stage of orthodontic treatment and improving safety when wearing the patient.
  • FIG. 4 is a graph comparing peel strength between a multi-layer sheet for transparent correction according to an embodiment of the present invention and a conventional material.
  • the conventional material was measured to have a peel strength of about 0.1N/cm to 0.15N/cm
  • the transparent orthodontic multilayer sheet 1000 of the present invention has a peel strength of about 0.2N/cm or more. was measured to have
  • the transparent orthodontic multilayer sheet 1000 of the present invention has a peel strength of about 2 to 3 times that of a conventional material, thereby improving interlayer bonding strength and preventing the occurrence of delamination between layers. Accordingly, it is possible to prevent performance degradation due to the peeling phenomenon and the peeling layer being present in the patient's oral cavity or flowing into the digestive tract, thereby compromising the safety of the patient.
  • FIG. 5 is a photograph comparing the recovery rate after deformation between the multi-layer sheet for transparent correction according to an embodiment of the present invention and a conventional material
  • FIG. 6 is a multi-layer sheet for transparent correction according to an embodiment of the present invention and a conventional material It is a graph comparing the maintenance rate of corrective power between the livers.
  • the multilayer sheet 1000 for transparent correction of the present invention and the conventional material were manufactured as a 1X8cm specimen and the amount of change during 24 hours after bending was measured.
  • the recovery rate after deformation is relatively low because a relatively large angle is maintained for 24 hours after bending
  • the transparent orthodontic multilayer sheet 1000 of the present invention It can be seen that the recovery rate after deformation is relatively large, as it is recovered almost like the initial state for 24 hours after bending.
  • the transparent orthodontic multilayer sheet 1000 and the conventional material of the present invention were manufactured as a specimen for measuring flexural strength, and the orthodontic force retention rate was measured through the strain recovery rate using a universal testing machine.
  • the corrective force decreases relatively quickly with time, and the corrective force decreases significantly after a certain period of time, and in the case of the transparent orthodontic multilayer sheet 1000 of the present invention It can be seen that the corrective force decreases with time relatively slowly, so that the corrective force is maintained at a certain level even after a certain period of time.
  • the transparent orthodontic multi-layer sheet 1000 according to the present invention has excellent orthodontic holding power due to less deformation at the tooth deformed position compared to conventional materials, and excellent interlayer bonding strength, so that durability and safety when worn by a patient can be improved.

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  • Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

Abstract

L'invention concerne, selon un mode de réalisation, une feuille multicouche pour un dispositif d'alignement transparent, comprenant : une première couche externe formée d'un matériau polymère thermoplastique souple; une seconde couche externe formée d'un matériau polymère thermoplastique souple; et une couche intermédiaire disposée entre la première couche externe et la seconde couche externe et formée d'un matériau polymère thermoplastique rigide.
PCT/KR2021/002814 2020-03-19 2021-03-08 Feuille multicouche pour dispositif d'alignement transparent WO2021187785A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020200033663A KR20210117450A (ko) 2020-03-19 2020-03-19 투명 교정용 다중층 시트
KR10-2020-0033663 2020-03-19

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WO2021187785A1 true WO2021187785A1 (fr) 2021-09-23

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Publication number Priority date Publication date Assignee Title
WO2023096331A1 (fr) * 2021-11-23 2023-06-01 주식회사 덴티스 Feuille orthodontique à structure composite et dispositif orthodontique l'utilisant
WO2023096327A1 (fr) * 2021-11-23 2023-06-01 주식회사 덴티스 Feuille orthodontique à structure composite et dispositif orthodontique l'utilisant

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013190580A1 (fr) * 2012-06-21 2013-12-27 Balsport Solutions S.L. Procédé de fabrication de dispositifs dentaires et dispositif dentaire
US20160157962A1 (en) * 2013-08-09 2016-06-09 University-Industry Cooperation Group Of Kyung Hee University Dental appliance detachably attached to the teeth, and fabricating method therefor
CN207666718U (zh) * 2017-02-07 2018-07-31 苏州博理新材料科技有限公司 一种隐形矫治专用tpu复合膜片
US20190183611A1 (en) * 2012-05-14 2019-06-20 Align Technology, Inc. Multilayer dental appliances and related methods and systems
KR20200014371A (ko) * 2017-05-31 2020-02-10 베이 머트리얼스, 엘엘씨 이중 쉘 치과기구 및 재료 구성

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190183611A1 (en) * 2012-05-14 2019-06-20 Align Technology, Inc. Multilayer dental appliances and related methods and systems
WO2013190580A1 (fr) * 2012-06-21 2013-12-27 Balsport Solutions S.L. Procédé de fabrication de dispositifs dentaires et dispositif dentaire
US20160157962A1 (en) * 2013-08-09 2016-06-09 University-Industry Cooperation Group Of Kyung Hee University Dental appliance detachably attached to the teeth, and fabricating method therefor
CN207666718U (zh) * 2017-02-07 2018-07-31 苏州博理新材料科技有限公司 一种隐形矫治专用tpu复合膜片
KR20200014371A (ko) * 2017-05-31 2020-02-10 베이 머트리얼스, 엘엘씨 이중 쉘 치과기구 및 재료 구성

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HYO-WON AHN, KYUNG A KIM, SEONG-HUN KIM: "A new type of clear orthodontic retainer incorporating multi-layer hybrid materials", THE KOREAN JOURNAL OF ORTHODONTICS, vol. 45, no. 5, 1 January 2015 (2015-01-01), pages 268 - 272, XP055852158, ISSN: 2234-7518, DOI: 10.4041/kjod.2015.45.5.268 *

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