WO2015104559A1 - Dispositif prosthodontique revêtu comprenant une polyaryléthercétone - Google Patents

Dispositif prosthodontique revêtu comprenant une polyaryléthercétone Download PDF

Info

Publication number
WO2015104559A1
WO2015104559A1 PCT/GB2015/050041 GB2015050041W WO2015104559A1 WO 2015104559 A1 WO2015104559 A1 WO 2015104559A1 GB 2015050041 W GB2015050041 W GB 2015050041W WO 2015104559 A1 WO2015104559 A1 WO 2015104559A1
Authority
WO
WIPO (PCT)
Prior art keywords
framework
coating
area
less
denture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2015/050041
Other languages
English (en)
Inventor
Nuno Sereno
Marcus Jarman-Smith
Reinhard LOBENHOFER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Juvora Ltd
Original Assignee
Juvora Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GB201400369A external-priority patent/GB201400369D0/en
Priority claimed from GB201401142A external-priority patent/GB201401142D0/en
Application filed by Juvora Ltd filed Critical Juvora Ltd
Publication of WO2015104559A1 publication Critical patent/WO2015104559A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0048—Connecting the upper structure to the implant, e.g. bridging bars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/0001—In-situ dentures; Trial or temporary dentures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/0003—Making bridge-work, inlays, implants or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/0003—Making bridge-work, inlays, implants or the like
    • A61C13/0004—Computer-assisted sizing or machining of dental prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/10—Fastening of artificial teeth to denture palates or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/225—Fastening prostheses in the mouth
    • A61C13/2255—Frames for partial dentures; Lingual bars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C13/00—Dental prostheses; Making same
    • A61C13/225—Fastening prostheses in the mouth
    • A61C13/26—Dentures without palates; Partial dentures, e.g. bridges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C2201/00—Material properties

Definitions

  • This invention relates to a prosthodontics device and particularly, although not exclusively, relates to a coated polyaryletherketone prosthodontics device.
  • Prosthodontics devices are arranged to address missing or deficient teeth in patients.
  • One type of prosthodontics device may be fixed within a patient's mouth, for example by screws or adhesive and is not intended to be removed under normal conditions.
  • Such a device may comprise an implant which is osseointegrated into a patient's jaw bone.
  • a framework incorporating a crown or bridge may then be substantially permanently secured to the implant via an abutment.
  • Another type of prosthodontics device may be fixed in the patient's mouth by clasps, telescopes or precision attachments and is intended to be removed by the patient under normal conditions for cleaning.
  • Such device may consist of a complete or partial denture.
  • prosthodontics devices for example in the form of a crown or bridge, suitably carry prosthetic teeth and gums which may be made from acrylic or the like, so the teeth and gums look relatively natural.
  • other parts of the framework which do not carry prosthetic teeth or gums for example clasps and attachment bars, may remain in the natural colour of the base material from which they are made.
  • This base material is often metal.
  • a darkish metallic colour may be at least partially visible in use, for example when a person talks. This is undesirable.
  • production of filled polymeric materials introduces an additional, potentially relatively expensive, step in the manufacture of prosthodontics devices and, furthermore, the mechanical (and/or other) properties of polymeric materials filled with, for example, coloured pigments may be detrimentally affected.
  • known dentures may comprise a framework which may be made from plastics or metal.
  • the framework may be overlaid with acrylic material (which is itself not strong/rigid enough to be used as a denture framework for high performance dentures) to define gums, teeth and surfaces which are arranged to contact a patient's gingiva when the denture is positioned in the patient's mouth.
  • acrylic material which is itself not strong/rigid enough to be used as a denture framework for high performance dentures
  • acrylic material which is itself not strong/rigid enough to be used as a denture framework for high performance dentures
  • the denture may be uncomfortable and/or act as an unpleasant irritant during wear by the patient.
  • a prosthodontics device comprising a framework which carries prosthetic teeth and/or gums, wherein said framework includes a coating over an area (herein referred to as the or said "exposed area") of the framework which would otherwise be exposed in use when the device is positioned in a patient's mouth, wherein said framework comprises a polymeric material which comprises a repeat unit of formula (I)
  • Said coating over said exposed area suitably faces outwardly and/or may be visible to a person interacting with the patient, for example during talking by the patient or during other normal situations wherein the patient's mouth may be opened.
  • Said polymeric material preferably consists essentially of a repeat unit of formula I.
  • said polymeric material is selected from polyetheretherketone, polyetherketone, polyetherketoneetherketoneketone and polyetherketoneketone. In a more preferred embodiment, said polymeric material is selected from polyetherketone and polyetheretherketone. In an especially preferred embodiment, said polymeric material is polyetheretherketone.
  • Said polymeric material may have a Notched Izod Impact Strength (specimen 80mm x 10mm x 4mm with a cut 0.25mm notch (Type A), tested at 23°C, in accordance with ISO180) of at least 4KJm “2 , preferably at least 5KJm "2 , more preferably at least 6KJm “2 .
  • Said Notched Izod Impact Strength measured as aforesaid, may be less than 10KJm “2 , suitably less than 8KJm "2 .
  • the Notched Izod Impact Strength, measured as aforesaid may be at least 3KJm "2 , suitably at least 4KJm “2 , preferably at least 5KJm “2 .
  • Said impact strength may be less than 50 KJm "2 , suitably less than 30KJm "2 .
  • Said polymeric material suitably has a melt viscosity (MV) of at least 0.06 kNsm “2 , preferably has a MV of at least 0.09 kNsm “2 , more preferably at least 0.12 kNsm “2 , especially at least 0.15 kNsm “2 .
  • the MV may be at least 0.35 kNsm "2 and especially at least 0.40 kNsm "2
  • An MV of 0.45 kNsm "2 has been found to be particularly advantageous in the manufacture of accurate, strong frameworks.
  • MV is suitably measured using capillary rheometry operating at 400°C at a shear rate of 1000s "1 using a tungsten carbide die, 0.5mmx3.175mm.
  • Said polymeric material may have a MV of less than 1 .00 kNsm "2 , preferably less than 0.5 kNsm "2 .
  • Said polymeric material may have a MV in the range 0.09 to 0.5 kNsm “2 , preferably in the range 0.14 to 0.5 kNsm “2 , more preferably in the range 0.4 to 0.5 kNsm “2 .
  • Said polymeric material may have a tensile strength, measured in accordance with IS0527 (specimen type 1 b) tested at 23°C at a rate of 50mm/minute of at least 20 MPa, preferably at least 60 MPa, more preferably at least 80 MPa.
  • the tensile strength is preferably in the range 80-1 10 MPa, more preferably in the range 80-100 MPa.
  • Said polymeric material may have a flexural strength, measured in accordance with IS0178 (80mm x 10mm x 4mm specimen, tested in three-point-bend at 23°C at a rate of 2mm/minute) of at least 50 MPa, preferably at least 100 MPa, more preferably at least 145 MPa.
  • the flexural strength is preferably in the range 145-180MPa, more preferably in the range 145-164 MPa.
  • Said polymeric material may have a flexural modulus, measured in accordance with IS0178 (80mm x 10mm x 4mm specimen, tested in three-point-bend at 23°C at a rate of 2mm/minute) of at least 1 GPa, suitably at least 2 GPa, preferably at least 3 GPa, more preferably at least 3.5 GPa.
  • the flexural modulus is preferably in the range 3.5-4.5 GPa, more preferably in the range 3.5-4.1 GPa.
  • Said polymeric material may be amorphous or semi-crystalline. It is preferably crystallisable. It is preferably semi-crystalline.
  • the level and extent of crystallinity in a polymer may be measured by wide angle X-ray diffraction (also referred to as Wide Angle X-ray Scattering or WAXS), for example as described by Blundell and Osborn (Polymer 24, 953, 1983).
  • WAXS Wide Angle X-ray Scattering
  • crystallinity may be assessed by Differential Scanning Calorimetry (DSC).
  • the level of crystallinity of said polymeric material (suitably measured by DSC) may be at least 1 %, suitably at least 3%, preferably at least 5% and more preferably at least 10%. In especially preferred embodiments, the crystallinity may be greater than 25%. It may be less than 50% or less than 40%.
  • the main peak of the melting endotherm (Tm) of said polymeric material may be at least 300°C.
  • Said framework may comprise (preferably consist essentially of) a composition which comprises said polymeric material.
  • Said composition suitably includes at least 90 wt%, preferably at least 95 wt%, more preferably at least 99 wt% of said polymeric material (especially polyetheretherketone).
  • the balance of the composition may include one or more fillers, for example colourants.
  • Said composition suitably includes less than 5 wt%, preferably less than 1 wt%, more preferably 0 wt% hydroxyapatite.
  • Said composition preferably includes substantially no metal.
  • Said framework may be for a denture, for example a precision attachment denture, a telescopic denture, an over-denture, a clasp denture or an implant supported denture.
  • the framework suitably includes at least two female elements which are arranged to engage male elements (which may comprise a patient's natural teeth or implants and/or parts secured to such natural teeth or implants).
  • the female elements preferably comprise sockets which are arranged to receive the aforementioned male elements.
  • Walls which define the sockets suitably include regions of thickness less than 2mm, less than 1 .5mm or even 1 mm or less.
  • Said framework may include an area of thickness less than 2mm.
  • Said framework preferably includes an area of at least 0.5cm 2 , preferably at least 1 cm 2 which has a thickness of less than 2mm.
  • Said framework preferably includes an area of thickness less than 1 .5mm.
  • Said framework preferably includes an area of at least 0.2cm 2 , preferably at least 1 cm 2 which has a thickness of less than 1 .5mm.
  • Said framework preferably includes an area of less than 1 .0mm.
  • Said framework preferably includes an area of at least 0.5cm 2 , preferably at least 1 cm 2 which has a thickness of less than 1 .0mm.
  • the framework includes openings, for example holes which extend through the framework.
  • the holes preferably have an area of less than 10mm 2 , or less than 8 mm 2 or less than 6 mm 2 .
  • the holes may have an area of at least 1 mm 2 .
  • the framework suitably includes at least 4, preferably at least 6, more preferably at least 8 holes.
  • holes are positioned in regions of said framework which are to be covered with prosthetic teeth and/or gum-like material, suitably to facilitate keying of the prosthetic teeth and/or gum-like material on the framework.
  • Said prosthodontics device suitably includes less than 2 wt% of metal, preferably less than 1 wt% of metal, more preferably less than 0.5 wt% of metal, especially less than 0.1 wt% of metal. Said device is preferably substantially metal-free.
  • Said prosthodontics device is preferably a removable prosthodontics device, i.e. removable by a patient in normal use. It may be a removable partial prosthodontics device; or may be a removable complete prosthodontics device. Advantageously, it may be a precision attachment denture or a telescopic denture.
  • Said exposed area of said framework is suitably an area of said framework which does not carry prosthetic teeth.
  • Said exposed area of said framework is suitably an area of said framework which does not carry prosthetic gums.
  • Said exposed area of said framework preferably comprises a surface of a part of said framework which extends between two regions of the framework which carry prosthetic teeth and/or gums; or may comprise a surface of a part of said framework which part is arranged to releasably secure the framework in position.
  • said exposed area comprises a surface of a part which extends between two regions as aforesaid
  • said part may extend between two regions of the framework which carry prosthetic teeth and gums.
  • Said part may be arranged to extend across and/or contact the palate of a patient in use.
  • the entirety of said part which extends between said two regions is not coated as described; eg at least part of a surface of said part which faces and/or abuts the palate of the patient in use is not coated.
  • Such uncoated part suitably includes a surface defined by (e.g. which is the colour of) said polymeric material from which the framework is made.
  • Preferably less than 90%, or less than 75% of the surface area of said part which extends between said two regions is coated with said coating.
  • said part which extends between said two regions is coated with a pink-coloured material suitably so said part blends into the palate of the patient in use.
  • said exposed area comprises a surface of a part which extends between two regions
  • said part could comprise an attachment bar which may be arranged to extend between two teeth and behind and/or adjacent to a row of existing teeth.
  • said part may be arranged to follow the curvature of and extend behind a row of existing teeth.
  • Said exposed area may be provided with a pink or tooth-coloured coating.
  • said exposed area comprises a surface of a part of said framework which is arranged to releasably secure the framework in position
  • said part may be arranged to engage a tooth of a patient.
  • Said part may comprise a female element, for example a clasp, which is arranged to engage a patient's tooth.
  • Said exposed area of the female element may be provided with a pink or white coating.
  • one exposed area may comprise a surface of a part of said framework which is arranged to releasably secure the framework in position as described and the other may comprise a surface of a part (e.g. an attachment bar) which extends between two regions as described.
  • Said coating preferably has a different composition compared to the composition of layers used to define said prosthetic teeth and gums.
  • Said coating preferably does not comprise said polymeric material described.
  • Said coating suitably includes less than 50 wt%, preferably less than 35 wt%, more preferably less than 20 wt%, especially less than 10 wt% of ceramic filler. It may advantageously include less than 5 wt% or substantially zero wt% of ceramic filler. Low (or no) ceramic filler may facilitate the coating being relatively flexible (i.e. non-stiff) and/or having a similar elastic modulus to the polymeric material of formula I. Said coating is preferably pink or tooth-coloured.
  • Said coating may have a thickness of less than 250 ⁇ (suitably less than 200 ⁇ , preferably less than 150 ⁇ , more preferably less than 100 ⁇ ).
  • Said coating may have a surface area of 2mm 2 to 20mm 2 and said coating may have a thickness of less than 250 ⁇ (suitably less than 200 ⁇ , preferably less than 150 ⁇ , more preferably less than 100 ⁇ ) over said entire area.
  • Said coating preferably has a thickness in the range 10 to 100 ⁇ , preferably over an area of 2mm 2 to 200mm 2 .
  • Said prosthetic teeth and/or gums may be made from acrylic or other plastics material. Said prosthetic teeth and/or gums are preferably secured to a roughened area of the framework which has a Ra from 0.06 to 7.0 micrometres, where Ra is the roughness average of a surface, expressed in micrometers. This is the arithmetic mean of the absolute departures of a roughness profile from the mean line of a measurement carried out along an arbitrary line along a surface.
  • Ra is suitably measured by a mechanical contact method by means of a stylus drawn in a straight line over the surface with the height of the stylus measured at regular intervals along the surface, wherein the stylus tip has a diameter of 2 micrometres in accordance with DIN EN ISO 4288 and DIN EN ISO 3274, using a Perthometer SP6 surface profilometer. More preferably, the roughened area may have a Ra from 0.5 to 2.0 micrometres.
  • Said coating preferably comprises a resin.
  • the resin may be applied over a surface having a Ra from 0.06 to 7.0 micrometers wherein Ra is as described hereinbefore.
  • the surface having said Ra may include Si0 2 and/or Al 2 0 3 , for example embedded as particles in the surface.
  • a method of making a prosthodontics device comprising: (i) selecting a framework which carries or is to carry prosthetic teeth and/or gums, wherein said framework comprises a polymeric material which comprises a repeat unit of formula (I)
  • t1 and w1 independently represent 0 or 1 and v1 represents 0, 1 or 2;
  • the prosthodontics device may have any feature of the prosthodontics device of the first aspect.
  • Said method of making said prosthodontics device may include the steps of:
  • t1 and w1 independently represent 0 or 1 and v1 represents 0, 1 or 2;
  • step (ii) digital technology is used to collate data on the region onto which the framework is to fit.
  • Step (ii) preferably includes scanning a region into which the framework is to fit (e.g. scanning a patient's mouth) or scanning of a model of a region into which the framework is to fit.
  • data is collated from a model, for example a cast, obtained of a patient's mouth and/or dentition.
  • Step (ii) may comprise use of Computer-aided design (CAD) technology.
  • CAD Computer-aided design
  • the method may include a step prior to step (ii) of taking an impression of a patient's mouth.
  • the impression may be used to collate said data.
  • the method preferably involves a CAD/CAM technique whereby data is collated as aforesaid and computer-aided manufacture (CAM) is undertaken in step (iii).
  • CAM computer-aided manufacture
  • a computer suitably controls the machining of the blank.
  • the selected blank is positioned in a CAD/CAM machine and the machine is arranged to machine the blank in dependence upon the data.
  • machining of said blank is undertaken using at least 5-axis machining, suitably under computer control. In some cases, higher axis (e.g. 7-axis) machining may be undertaken. Machining in step (iii) suitably comprises milling. The work piece is suitably cooled during machining so as to control crystallinity of the machined blank.
  • the method preferably includes the step of adjusting the Ra of a surface to be coated with said coating.
  • This may comprise a grit blasting process.
  • Such a process suitably utilises particulate material which becomes embedded in the framework.
  • Such particulate material may comprise Si0 2 and/or Al 2 0 3
  • coating of said exposed area preferably comprises painting said coating on said area.
  • Said coating preferably has a viscosity such that it can be applied to the area and spread across the area.
  • Said coating is preferably applied to said area using a brush.
  • Said coating may comprise a liquid in which a powder is dispersed, wherein suitably the powder is coloured to define a pink or tooth colour.
  • Said liquid suitably includes less than 30 wt%, preferably less than 20 wt%, more preferably less than 10 wt%, especially 0 wt% of ceramic solids.
  • the method preferably comprises selecting a resin or a resin precursor (suitably in liquid form) which is to define said coating and applying, suitably using a brush, said resin or precursor to predetermined areas of the framework.
  • the resin or precursor may be treated with radiation, suitably to effect polymerisation and/or curing. Said radiation may have a wavelength in the range 350 to 500nm.
  • the coating may be applied so it has a thickness, after curing, of less than 250 ⁇ , for example 10 to 100 ⁇ .
  • the second object described herein may be addressed by providing a prosthodontics device, for example a denture, having a surface arranged to contact a patient's gingiva in use, wherein said surface is defined by a lining which is secured to a framework of the device, wherein said lining comprises a polymeric material which comprises a repeat unit of formula (I)
  • Said lining suitably has a thickness of less than 500 ⁇ , preferably less than 250 ⁇ , more preferably less than 100 ⁇ .
  • the thickness may be at least 5 ⁇ .
  • said thickness is in the range 5 to 500 ⁇ , preferably 30 to 100 ⁇ .
  • Said lining may have a thickness as aforementioned across at least 50% (preferably at least 80%, especially about 100%) of its surface area.
  • Said lining preferably has a substantially constant thickness across substantially its entire extent.
  • Said lining is preferably defined by a film.
  • Said device preferably includes a first exposed surface which is arranged to face and/or at least partially contact a patient's gingiva in use and a second exposed surface which may be arranged not to face and/or not to contact a patient's gingiva in use.
  • Said second exposed surface of said device is preferably not defined by a lining comprising said polymeric material.
  • Said lining preferably defines less than 50%, less than 40%, less than 30% or even less than 20% of the total surface area of the framework of the device.
  • Said lining preferably defines less than 50%, less than 40%, less than 30% or even less than 20% of the total surface area of the device.
  • said lining may define one or more strips or bands which is/are positioned substantially only in regions of the device which may contact a patient's gingiva in use.
  • substantially the entirety of a side of the device which faces a patient's gingiva in use may be defined by said lining.
  • Said device preferably includes prosthetic teeth and gums which are suitably arranged so the device defines a complete denture.
  • the acrylic teeth and gums may be defined by a resin, for example an acrylic resin.
  • the resin may overlie a part of the lining, for example an edge thereof, for example, to facilitate provision of a smooth transition between the lining and prosthetic teeth and/or gums.
  • Said resin suitably does not overlie any part of the lining which is arranged to contact the gingiva in use.
  • Said framework of the device may comprise (e.g. at least 60wt%, 75wt%, or 95wt% the framework may comprise) one of a metal or a polymeric material.
  • the metal may be selected from titanium, CoCr, stainless steel, precious metals/gold alloys.
  • the polymeric material may be selected from a polyaryletherketone, acrylic (e.g. PMMA), nylon, acetal and polysulphone.
  • said framework may comprise (e.g. at least 90wt%, at least 95wt% or about 100 wt% of the framework may comprise) a second polymeric material which comprises a repeat unit of formula (I)
  • t1 and w1 independently represent 0 or 1 and v1 represents 0, 1 or 2.
  • Said second polymeric material may have any feature of the first polymeric material described herein. It preferably consists essentially of repeat unit of formula I and, more preferably, is polyetheretherketone.
  • Said lining may be secured to the framework by way of an adhesive; or, alternatively, it may be secured by welding (e.g. where both the framework and lining are defined by a thermoplastic, for example by a said first polymeric material).
  • Said first polymeric material may be as described for said polymeric material which comprises a repeat unit of formula (I) according to the first aspect.
  • said first polymeric material is po ly eth e reth e rketo n e .
  • Said lining may comprise (preferably consist essentially of) a first material which comprises said first polymeric material.
  • Said first material suitably includes at least 90 wt%, preferably at least 95 wt%, more preferably at least 99 wt% of said first polymeric material (especially polyetheretherketone).
  • the balance of the first material may include one or more fillers.
  • Said first material suitably includes less than 5 wt%, preferably less than 1 wt%, more preferably 0 wt% hydroxyapatite.
  • Said first material preferably includes substantially no metal.
  • Said framework may include two or more female elements arranged to engaged projection (e.g. tooth stubs) in a patient's mouth for facilitating releasable securement of the device in the mouth in use.
  • engaged projection e.g. tooth stubs
  • Said device is preferably a removable denture.
  • a fourth aspect of the invention there is provided a method of making prosthodontics device, for example according to the third aspect, the method comprising:
  • the film may comprise a first polymeric material or first material as described according to the third aspect.
  • Said film suitably defines a lining as described according to the third aspect.
  • the lining may have any feature of the lining of the third aspect.
  • a prosthodontics device for example a denture, as described according to the third aspect is suitably defined.
  • the film may be secured in step (ii) using an adhesive means; or, in some cases, it may be treated to heat it (e.g. as in ultrasonic welding) to secure it in position.
  • Said film is preferably substantially permanently secured in position in the method.
  • the film (and/or said lining) selected in step (i) may include a wall having a thickness of less than 500 ⁇ , for example in the range 5 to 100 ⁇ .
  • a surface of the film which is to be secured to the framework may have a Ra from 0.06 to 7.0 micrometres, where Ra is the roughness average of a surface, expressed in micrometers. This is the arithmetic mean of the absolute departures of a roughness profile from the mean line of a measurement carried out along an arbitrary line along a surface.
  • Ra is suitably measured by a mechanical contact method by means of a stylus drawn in a straight line over the surface with the height of the stylus measured at regular intervals along the surface, wherein the stylus tip has a diameter of 2 micrometres in accordance with DIN EN ISO 4288 and DIN EN ISO 3274, using a Perthometer SP6 surface profilometer. More preferably, the roughened area may have a Ra from 0.5 to 2.0 micrometres.
  • the method may comprise selecting a film in step (i) and adjusting the Ra of a surface of the film which is to be secured to the framework before step (ii).
  • the framework may have a Ra from 0.06 to 7.0 ⁇ for example 0.5 to 20 ⁇ in regions thereof to which the film is secured in step (ii).
  • the method may include, prior to step (ii), treating the framework in regions thereof which are to be contacted with film in step (ii) to increase the Ra of the regions of the framework.
  • step (ii) excess film may be removed to define the lining.
  • prosthetic teeth and gums may be formed on the framework. They may be formed using a resin, for example an acrylic resin.
  • Figure 1 is an underside view of a polyetheretherketone (PEEK) framework for a removable telescope denture;
  • PEEK polyetheretherketone
  • Figure 2 is an underside view of the framework of Figure 1 provided with prosthetic teeth and gums;
  • Figure 3 is a front view from one side of a lower removable denture.
  • Figure 4 is a view of a first side of a denture framework, wherein said first side is arranged to face and contact a patient's gingiva when positioned in the patient's mouth;
  • Figure 5 is a view of a second side of the denture framework which faces in an opposite direction to said first side;
  • Figure 6 is a view from the second side of the framework, with the framework being provided with acrylic teeth and gums.
  • Figure 7 is a view corresponding to that of Figure 4, wherein the framework includes a partial covering with a polyetheretherketone (PEEK) film;
  • PEEK polyetheretherketone
  • Figure 8 is a view corresponding to that of Figure 4, wherein the first side of the framework is substantially completely covered with a PEEK film.
  • the Rocatec system from 3M ESPE - 3M ESPE Rocatec Plus is a tribochemical method for silicatising surfaces. Tribochemistry involves creating chemical bonds by applying mechanical energy. This supply of energy may take the form of rubbing, grinding or sandblasting. There is no application of heat or light which would normally be the case with chemical reactions. For this reason the Rocatec system may also be referred to as cold silicatisation because the mechanical energy is transferred to the substrate in the form of kinetic energy and thesilicatisation takes place macroscopically without any change in temperature.
  • the Rocatec system consists of a coating unit (Rocatector delta or Rocatec junior), microblasting sand Rocatec Pre (cleaning and activating the surface), coating sand Rocatec Plus or Rocatec Soft and a silane solution (3M ESPE Sil resin primer).
  • Rocatec Pre - refers to a High-purity aluminium oxide (1 10 ⁇ ).
  • Rocatec Plus - refers to High-purity aluminium oxide (1 10 ⁇ ), modified with silica
  • 3M Rocatec ESPE Sil Silane in ethanol.
  • the silane used in 3M ESPE Sil is characterised by two molecule ends of different polarity. Alkoxy groups of a silanol unit make a chemical bond with the silicatised surface.
  • 3M ESPE Sinfony Light-Curing composite refers to a high strength, light-cured, ultra- fine particle composite.
  • the main component of the filler mix in SinfonyTM is a special, ultra- fine strontium aluminium borosilicate glass in the sub-micron range. In addition it contains pyrogenic silica, also known as micro-dispersed silicon dioxide. Additionally, it includes a glass ionomer (5% by wt.).
  • the composite includes a mixture of aliphatic and cycloaliphatic monomers.
  • Dreve - refers to a material available in ceramic and gingiva colours to paint and characterise resin. Consists of a two part system comprising Lightpaint On Colourpowder for mixing with Lightpaint On Liquid. Its composition includes siliciumdioxide, dibenzoylperoxide, titanium dioxide and ferric oxide pigments.
  • the PEEK framework 2 shown may be made as described in WO2013/076493. It is then treated to define a prosthesis 3 comprising prosthetic gum areas 4 which are pink, together with a set of prosthetic teeth 6. Where the teeth and gums are defined, the normally beige coloured PEEK is covered and hidden from view. However, regions of the framework, such as a bridging region 8, which do not carry prosthetic teeth retain the beige PEEK colour. It may, in some circumstances, be possible for a beige area to be seen, for example, by a person talking to a wearer of the prosthesis. To address this, visible surfaces of the bridging region 8 (and any other potentially visible areas), are painted pink to make them more aesthetically acceptable. Processes for painting the PEEK are described in Examples. Additionally, referring to Figure 3, clasps 20 and attachment bars 22 of removable denture 18 may be painted as described in the Examples.
  • the surface to be coated (this suitably comprises PEEK framework in the absence of any prosthetic teeth or gums) is cleaned by blasting with 1 10 ⁇ aluminium oxide sand (high-purity aluminium oxide, Rocatec Pre) and then roughened. This activates the surface and creates a uniform pattern of surface roughness which is ideal for the ensuring microretentive anchorage of resin.
  • aluminium oxide sand high-purity aluminium oxide, Rocatec Pre
  • the Si02 is impregnated into the surface up to a depth of 15 ⁇ and at the same time fused to the surface in islands.
  • the high level of energy which is required is created by the acceleration of the grain to a velocity of up to 1000 km/h due to the geometry of the blast nozzle and a blast pressure of at least 2.8 bar.
  • the coated surfaces still have to be conditioned in order to be able to create a bond with a subsequently applied resin.
  • This next step is silanisation with 3M ESPE Sil (which is a primer). A chemical bond between the inorganic silicatised surface and the organic resin can be made in this way. A thin layer of the ESPE Sil primer is applied as described and dried.
  • Example 3 Painting bridging region (2 nd method)
  • Example 1 An alternative to the Example 1 process may be as follows:
  • Step 1 Grit blast the bridging region.
  • Material used to grit blast eg. Rocatec plus, 3M ESPE.
  • Step 2 Preparation of the LightPaint On System. Mixing LightPaint On Colour powder with LightPaint On Colour Liquid.
  • Step 3 Application of LightPaint On System (prepared in Step (ii).
  • Step 4 Polymerisation of the LightPaint On System.
  • Step 5 Application LightPaint On Surface. This is a finishing agent which smooths and homogenises the painted surface and increases durability of the colour.
  • Test samples of PEEK, painted as described in Example 3 and Comparative Example C1 were prepared and in-vitro tooth brushing was simulated for 6, 36 and 146 minutes. These three brush times are intended to simulate 4 weeks, 6 months and 2 years of intraoral service.
  • Example 3 materials display a lower increase in surface roughness which corresponds to a higher resistance to wear compared to the control dental veneer of Example C1 .
  • Colour stability was determined as follows: Test samples painted as described in Example 3 and Comparative Example C1 were divided into two groups: Half of them were thermo-cycled for 46/300/1200 cycles (5 55°C, 2min each). The other half was tooth-brushed for 6/36/146 minutes. The three cycle/brush times are intended to simulate 4weeks/6month/2years of intraoral service. Colour was assessed by measuring L*, a*, b* values using conventional apparatus.
  • the paint and dental veneers have different compositions resulting in different mechanical behaviour.
  • Dental veneers comprise composites with 75 to 85 wt% of ceramic fillers which make them very stiff when polymerized and, consequently, the elastic modulus of dental veneers is significantly higher than that of the paint.
  • the stiffness of PEEK is closer to the stiffness of the paint than to the stiffness of dental veneers.
  • a denture framework 102 may be made from polyetheretherketone (PEEK) in a CAD-CAM process.
  • the framework is shaped generally on its lower surface 104 to follow the shape of the gingiva of a patient for whom the framework is customized.
  • the framework includes attachment regions 106, 108, 1 10, 1 12 which define sockets which are arranged to engage tooth stubs (or crowns) in a patient's mouth to facilitate the releasable securement of the framework (in the form of a finished denture) in a patient's mouth.
  • the second side of the denture framework is shaped to define teeth precursors 1 14.
  • the framework 102 is finished using an acrylic resin which defines appropriately coloured prosthetic teeth 1 16 and gums 1 18 as shown in figure 6.
  • Acrylic resin is also provided on the underside of the arrangement shown in figure 6 to snugly contact the gingiva of the patient.
  • the denture includes an exposed acrylic resin layer which therefore contacts a patient's gingiva when the denture is positioned in a patient's mouth. This problem is addressed as described with reference to Figures 7 and 8.
  • framework 120 is generally as described with reference to Figures 4 and 5.
  • a band 122 of PEEK film is secured to the underside of the framework and extends generally around the entire perimeter of the lower surface 104. More particularly, the PEEK film is positioned so that it covers and/or lines the lower surface of the framework at all positions of the framework which may contact a patient's gingiva when a denture comprising the framework is positioned in a patient's mouth.
  • the framework incorporating the band of PEEK film, may be provided with acrylic teeth and gums to define a complete denture.
  • no surface of the denture which contacts the patient's gingiva is made of acrylic resin; the only surfaces of the denture which contact the gingiva are lined with PEEK film.
  • Such film advantageously, is relatively soft to touch, provides thermal resistance and is highly biocompatible.
  • the denture incorporating the PEEK film may be more comfortable for a patient to wear and/or may reduce the likelihood of allergic reactions due to contact of the denture with the gingiva.
  • the following steps may be taken to provide a finished denture:
  • a PEEK film of thickness in the range 5 to 500 ⁇ , preferably in the range 30 to 100 ⁇ is selected and is surface modified to facilitate its securement to the PEEK framework.
  • the film may be subjected to air abrasion to increase its surface roughness and/or plasma treatment (e.g. using argon gas, power 50W, pressure 0.4mb for 15 minutes) or laser surface treatment (e.g. 355nm, 70mJ, 20mm/mn) to enhance surface free energy.
  • the surface of the PEEK framework to which the PEEK film is to be attached may be treated by grit blasting to roughen it (e.g. using 50 ⁇ aluminium oxide particles at pressure 2 bar) and/or by plasma or laser surface treatment as described in A(i).
  • the PEEK film is then secured to the PEEK framework in selected positions.
  • the PEEK film may be used to build up the framework slightly to improve the fit of the framework in a patient's mouth.
  • the PEEK film may be secured in position by adhesive means.
  • the PEEK framework may be painted with a primer (e.g. a non-curing silicone primer SP-270, NuSil Technology) followed by an adhesive (e.g. implantable silicone adhesive MED- 151 1 , NuSil Technology).
  • the film may then be urged against the framework and cured under pressure at ambient temperature.
  • the PEEK film may be ultrasonically welded in position using a hand-held sonotrode having ultrasonic power supplied thereto (e.g. 70KHz at 100W).
  • high vibration amplitude e.g. 70 ⁇
  • a weld pressure of 5MPa
  • a weld time of about 1 second.
  • the framework is then provided with prosthetic teeth and gums made from acrylic resin. No region of the framework which is to contact the gingiva is coated with acrylic resin. As described, such regions of the framework which are to contact the gingiva are defined by PEEK film applied as previously described.
  • steps A(i) to A(iv) may generally be undertaken to secure the PEEK film to the metal framework and then acrylic resin may be secured to the framework to define prosthetic teeth and gums.
  • PEEK film 130 may be secured to substantially the entire lower surface 104 of framework 132 (which may be made from PEEK or metal).
  • framework 132 which may be made from PEEK or metal.
  • the framework may then be provided with acrylic teeth and gums whilst leaving the PEEK film exposed so that it may contact the gingiva when a denture incorporating the framework is positioned in a patient's mouth.
  • Application of the PEEK film 130 may be as described in steps A (i) to A (iv) mutatis mutandis.

Landscapes

  • 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)
  • Orthopedic Medicine & Surgery (AREA)
  • Dental Preparations (AREA)

Abstract

La présente invention concerne un dispositif prosthodontique qui comprend un châssis portant des prothèses dentaires et/ou gingivales, le châssis comprenant un revêtement sur une zone du châssis qui fait face à l'extérieur et/ou qui peut être visible pour une personne interagissant avec un patient portant le dispositif prosthodontique. Le châssis comprend de manière adaptée un matériau polymère, qui est de préférence une polyétheréthercétone et de préférence ledit revêtement est rose ou de la couleur des dents.
PCT/GB2015/050041 2014-01-09 2015-01-09 Dispositif prosthodontique revêtu comprenant une polyaryléthercétone Ceased WO2015104559A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB1400369.3 2014-01-09
GB201400369A GB201400369D0 (en) 2014-01-09 2014-01-09 Coated polyaryletherketone prosthodontics device
GB201401142A GB201401142D0 (en) 2014-01-23 2014-01-23 Prosthodontics device comprising denture incorporating a layer of polyaryletherketone
GB1401142.3 2014-01-23

Publications (1)

Publication Number Publication Date
WO2015104559A1 true WO2015104559A1 (fr) 2015-07-16

Family

ID=52396718

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2015/050041 Ceased WO2015104559A1 (fr) 2014-01-09 2015-01-09 Dispositif prosthodontique revêtu comprenant une polyaryléthercétone

Country Status (2)

Country Link
GB (1) GB2525702A (fr)
WO (1) WO2015104559A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112386344A (zh) * 2020-10-15 2021-02-23 儒蓉(成都)医疗科技有限公司 一种弹性贴面桥及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB191214520A (en) * 1912-06-21 1913-05-22 William Dall Improvements in and relating to Porcelain Gum-blocks for Dentists' use.
GB446141A (en) * 1935-04-25 1936-04-24 Vita Zahnfabrik G M B H Improvements in and relating to dental bridges
US2096515A (en) * 1935-04-25 1937-10-19 Vita Zahnfabrik H Rauter Dental bridge
EP0917860A2 (fr) * 1997-11-24 1999-05-26 Helmut Purner Dispositif pour prothèse dentaire
GB2496981A (en) * 2011-11-25 2013-05-29 Invibio Ltd Cad/cam machining of prosthodontic devices made from polyetherketones

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040241614A1 (en) * 1998-04-13 2004-12-02 Goldberg A. Jon Prefabricated components for dental appliances
DE102011103027A1 (de) * 2010-11-08 2012-05-10 Peter NEUMEIER Verbundkrone/Verbundbrücke und Verfahren zu deren Herstellung
DE102012011371B9 (de) * 2012-06-11 2018-10-18 Kulzer Gmbh Herstellung individueller dentaler Prothesen via CAD/CAM und Rapid Manufacturing/Rapid Prototyping aus digital erhobenen Daten der Mundsituation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB191214520A (en) * 1912-06-21 1913-05-22 William Dall Improvements in and relating to Porcelain Gum-blocks for Dentists' use.
GB446141A (en) * 1935-04-25 1936-04-24 Vita Zahnfabrik G M B H Improvements in and relating to dental bridges
US2096515A (en) * 1935-04-25 1937-10-19 Vita Zahnfabrik H Rauter Dental bridge
EP0917860A2 (fr) * 1997-11-24 1999-05-26 Helmut Purner Dispositif pour prothèse dentaire
GB2496981A (en) * 2011-11-25 2013-05-29 Invibio Ltd Cad/cam machining of prosthodontic devices made from polyetherketones

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112386344A (zh) * 2020-10-15 2021-02-23 儒蓉(成都)医疗科技有限公司 一种弹性贴面桥及其制备方法
CN112386344B (zh) * 2020-10-15 2022-10-21 儒蓉(成都)医疗科技有限公司 一种弹性贴面桥及其制备方法

Also Published As

Publication number Publication date
GB201500363D0 (en) 2015-02-25
GB2525702A (en) 2015-11-04

Similar Documents

Publication Publication Date Title
Özcan et al. Clinical study on the reasons for and location of failures of metal-ceramic restorations and survival of repairs.
Mangani et al. Clinical approach to anterior adhesive restorations using resin composite veneers.
Miyazaki et al. Current status of zirconia restoration
Attia et al. Fracture strength of all-ceramic crowns luted using two bonding methods
Corbani et al. Fracture resistance of three-unit fixed dental prostheses fabricated with milled and 3D printed composite-based materials
Nakano et al. Development of biocompatible resins for 3D printing of direct aligners
Kassotakis et al. Evaluation of the Effect of Different Surface Treatments on Luting CAD/CAM Composite Resin Overlay Workpieces.
Tuğcu et al. Marginal Adaptation and Fracture Resistance of Lithium Disilicate Laminate Veneers on Teeth with Different Preparation Depths.
Filho et al. Ceramic inlays and onlays: clinical procedures for predictable results
CN101878004A (zh) Smc冠壳
Rocca et al. Bonded indirect restorations for posterior teeth: the luting appointment.
Özcan et al. Surface conditioning protocol for the adhesion of resin-based cements to base and noble alloys: How to condition and why
EP2893917A1 (fr) Prothèse dentaire comprenant un dentier téléscopique incorporant une polyaryléthercétone
Elzarug et al. An In Vitro Comparison of the Shear Bond Strengths of Two Different Gingiva‐Colored Materials Bonded to Commercially Pure Titanium and Acrylic Artificial Teeth
Sabanik et al. A Review of Current Systems, Materials, and Protocols for 3D‐Printed Splints, Crowns, and Dentures
GB2525702A (en) Coated polyaryletherketone prosthodontics device
Lee et al. Comparative study of the shear bond strength of various veneering materials on grade II commercially pure titanium
Khan et al. Comparison of the Effect of Implant Abutment Surface Modifications on the Retention of Implant-Supported Restorations.
Alshali et al. Effect of air-particle abrasion and methacryloyloxydecyl phosphate primer on fracture load of thin zirconia crowns: an in vitro study
Andriani Jr et al. Mechanical testing of indirect composite materials directly applied on implant abutments.
WO2015104558A1 (fr) Dispositif prosthodontique, comprenant une polyaryléthercétone, sous la forme d'une incrustation en profondeur ou d'une incrustation de surface
Kratunova et al. Chairside repair of preveneered primary molar stainless steel crowns: a pilot study
Pilo et al. The influence of dentin and/or metal surface treatment on the retention of cemented crowns in teeth with an increased taper
Favoreto et al. A 48-month clinical performance of hybrid ceramic fragment restorations manufactured in CAD/CAM in non-carious cervical lesions: case report
Fett et al. The effects of short bevels and silanization on marginal adaptation of computer-machined mesio-occlusodistal inlays.

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15701239

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15701239

Country of ref document: EP

Kind code of ref document: A1