Means and Methods for Preventing or Treating Dental Implant Associated Inflammation

20170181930 ยท 2017-06-29

    Inventors

    Cpc classification

    International classification

    Abstract

    The present invention relates to a dental implant (118) or an element thereof comprising a trans-mucosal portion (122), wherein at least a part of said trans-mucosal portion (122) comprises a biocide (132) and/or a pH regulator. Moreover, the present invention relates to methods for preventing biofilm formation on a trans-mucosal portion (122) of a dental implant (118) and for preventing or treating dental implant associated inflammation, comprising providing and implanting a dental implant (118) or an element thereof according to the present invention. The present invention further relates to the use of a biocide for manufacturing a dental implant (118) or element thereof, and to a biocide (132) released from a dental implant (118) or an element thereof according to the present invention for use in preventing and/or treating dental implant associated inflammation. Further the present invention relates to the use of a biocide for manufacturing denture teeth and/or denture resin.

    Claims

    1. A dental implant (118) or an element thereof comprising a trans-mucosal portion (122), wherein at least a part of said trans-mucosal portion (122) comprises a biocide (132) and/or a pH regulator.

    2. The dental implant (118) or element thereof of claim 1, wherein said biocide (132) (i) is comprised as an integral constituent within said trans-mucosal portion (122); (ii) is permanently fixed to the dental implant (118) or element thereof as a ring (142), as one or more pins (144), or is comprised in a cavity (134) of said dental implant (118) or element thereof, wherein said cavity (134) is connected to the environment via at least one aperture (136) comprised in said trans-mucosal portion (122); or (iii) is comprised in a removable means mountable onto said trans-mucosal portion (122).

    3. The dental implant (118) or element thereof of claim 1, wherein said biocide (132) is comprised in a removable means, wherein said removable means is a ring (142) or one or more pins (144) mountable onto said trans-mucosal portion (122).

    4. The dental implant (118) or element thereof of claim 1, wherein said pH-regulator is comprised in a cavity (134) of said dental implant (118) or element thereof and wherein said cavity (134) is connected to the environment via at least one aperture (136) comprised in said trans-mucosal portion (122).

    5. The dental implant (118) or element thereof of claim 1, wherein said biocide (132) is an anti-inflammatory compound, preferably an antibacterial, antimycotic, antiviral, antiseptic, and/or immunosuppressive compound.

    6. The dental implant (118) or element thereof of claim 5, wherein said antibacterial compound is a bactericidal compound, a bacteriostatic compound, or a compound inhibiting bacterial adhesion to a dental implant.

    7. The dental implant (118) or element thereof of claim 6, wherein said bactericidal compound is a metal, preferably at least one of silver (Ag), mercury (Hg) and gold (Au), or an antibiotic, preferably amoxicillin, amoxicillin in combination with clavulanic acid, metronidazole, clindamycin, azithromycin, ciprofloxacin, a tetracycline, or any arbitrary combination thereof.

    8. The dental implant (118) or element thereof of claim 5, wherein said immunosuppressive compound is a glucocorticoid, an alkylating agent, an antimetabolite, an immunophilin interacting agent, or a mycophenolate.

    9. A biocide (132) and/or a pH regulator for use in preventing and/or treating dental implant associated inflammation, wherein said biocide (132) and/or pH regulator are/is released from a dental implant (118) according to claim 1.

    10. The biocide (132) and/or pH regulator for use according to claim 9, wherein said dental implant associated inflammation is dental peri-implant mucositis and/or dental peri-implantitis.

    11. The biocide (132) and/or pH regulator for use according to claim 9, wherein said use is treating dental implant associated inflammation and wherein said treating comprises administering at least two different biocides, preferably successively administering at least two different biocides.

    12. The biocide (132) and/or pH regulator for use according to e claim 9, wherein said use is treating dental implant associated inflammation and wherein said treating comprises administering an antimicrobial compound followed by administration of an immunosuppressant.

    13. A method for producing a dental implant (118) or an element thereof, comprising including a biocide and/or pH regulator in at least an element of a transmucosal portion (122) of said dental implant (118) or element thereof.

    14. Use of a biocide and/or pH regulator for manufacturing a dental implant (118) or element thereof.

    15. The use of claim 14, wherein said dental implant (118) or element thereof is a dental implant (118) or element thereof according to claim 1.

    Description

    FIGURE LEGENDS

    [0091] FIG. 1 shows a schematic representation of a one-piece (tissue-level) dental implant 118 and a restoration (crown) 124. The enossal portion 126 is fixed in the bone 130 and comprises the trans-mucosal portion 122 spanning the mucosa 128 and comprising the biocide 132. The restoration (crown) 124 is fixed into the dental implant 118 via screw thread 138; a) side view, b) cross-sectional view of in situ situation along plane Ib-Ib.

    [0092] FIG. 2 shows a schematic representation of a two-piece (bone-level) dental implant 118 with an enossal element 118, 126 and a distal, trans-mucosal element 118, 120. Further shown is a restoration (crown) 124. The enossal portion 126 is fixed in the bone 130. The distal, trans-mucosal element (abutment) 118, 120 with transmucosal portion 122 is connected to the enossal element 118, 126 via a screw thread 138; the restoration (crown) 124 is plugged onto the distal, trans-mucosal element 118, 120; the transmucosal portion 122 spans the mucosa 128 and comprises the biocide 132; a) side view, b) cross-sectional view of in situ situation along plane IIb-IIb.

    [0093] FIG. 3 shows a schematic representation of a distal, trans-mucosal element 118, 120 comprising a trans-mucosal portion 122, a screw thread 138 for connecting the element to an enossal element, and a, preferably removable, ring 142 comprising the biocide 132 and which, preferably, fits into a corresponding groove in the transmucosal element 118, 120; a) side view b) cross-sectional view along plane IIIb-IIIb.

    [0094] FIG. 4 shows a schematic representation of a distal, trans-mucosal element 118, 120 comprising a trans-mucosal portion 122, a screw thread 138 for connecting the element to an enossal element, and an array of pins 144 comprising the biocide 132; a) side view b) cross-sectional view along plane IVb-IVb.

    [0095] FIG. 5 shows a schematic representation of a distal, trans-mucosal element 118, 120 having a screw thread 138 for connecting the element to an enossal element. The abutment further comprises a polymeric portion 146 with a trans-mucosal portion 122 comprising the biocide 132. The element can be equipped with a covering plate 140; a) side view b) cross-sectional view along plane Vb-Vb.

    [0096] FIG. 6 shows a schematic representation of a distal, trans-mucosal element 118, 120 comprising a trans-mucosal portion 122 and a screw thread 138 for connecting the element to an enossal portion. The abutment 118, 120 further comprises a cavity 134 comprising the biocide 132 and an array of apertures 136; a) side view b) cross-sectional view along plane VIb-VIb.

    [0097] FIG. 7 shows a schematic representation of an implant restoration (crown) 124 having a screw thread 138. A trans-mucosal portion 122 of the implant restoration (crown) 124 comprises the biocide 132.

    [0098] The following Examples shall merely illustrate the invention. They shall not be construed, whatsoever, to limit the scope of the invention.

    EXAMPLES

    [0099] In a preferred embodiment, a complete dental implant 118 with restoration (crown) 124 of the present invention is a device as schematically represented in FIG. 1. The device comprises a one-piece (tissue level) dental implant 118 comprising an enossal portion 126 and a trans-mucosal portion 122, which contains the biocide 132. It is understood by the skilled person that the one-piece dental implant 118 will be covered with a restoration (crown) 124 to form a complete tooth replacement. Preferably, only the portion of the one-piece implant 118 protruding into the oral cavity will be covered with a restoration (crown) 124. Preferably, the trans-mucosal portion 122 may consist of the biocide, e.g. an appropriate metal or alloy thereof. More preferably, the transmucosal portion consists of the same material as the enossal portion 126 and is coated with the biocide; in this case, also a biocide unsuited as a material for constituting a dental implant 118, e.g. an amalgam or a plastic comprising the biocide, can be used. The enossal portion 126 of the aforesaid embodiment will heal into the bone 130 of the patient; thus, this embodiment will be particularly suited as a permanent implant, wherein the biocide 132 preferably has the function to prevent bio film formation and/or dental implant associated inflammation from initiating.

    [0100] The following embodiments include descriptions of distal elements of two- or more-piece dental implants, which can, preferably, be removed while leaving the enossal element in place. Accordingly, these embodiments are suited for the same purpose as the one-piece embodiment described before. However, the following embodiments are also particularly suited for treating prevalent dental implant associated inflammation. In the following embodiments, preferably, the distal, trans-mucosal element 118, 120 may be a mucosal former, a healing cap (healing abutment), an abutment (secondary element) for fixed restorations, or a retention element for removable restorations. In preferred embodiments, the polymeric abutment according to FIG. 5 and the container abutment comprising a cavity according to FIG. 6 are used for temporary treatment of prevalent dental implant associated inflammation, whereas the embodiments according to FIGS. 3 and 4 are preferably used in long-term prevention of bio film formation and/or inflammation, in particular peri-implantitis.

    [0101] In a preferred embodiment, the dental implant 118 of the present invention is an element as schematically represented in FIG. 2. In this embodiment, the trans-mucosal portion 122 is part of a distal element 118, 120 of a two-piece dental implant 118, which is connected to the osseous, proximal implant element 126 by a screw thread 138. It is understood by the skilled person that the distal element 118, 120 of the dental implant 118 may be covered with a crown 124 to complete the tooth replacement. Preferably, only the portion of the dental implant 118 protruding into the oral cavity will be covered with a crown 124. Preferably, the trans-mucosal portion 122 may consist of the biocide, e.g. an appropriate metal or alloy thereof. More preferably, the transmucosal portion 122 consists of the same material as the enossal element 126 and is coated with the biocide 132; in this case, also a biocide 132 unsuited as a material for constituting a dental implant 118, e.g., an amalgam or a plastic comprising the biocide 132 can be used. It is also envisaged that the distal, trans-mucosal element 118, 120 may be replaced during treatment in order to adjust the amount of biocide 132 released and/or to adjust the kind of biocide 132 released to the healing process. E.g. in the treatment of prevalent dental implant associated inflammation (preferably, dental peri-implant mucositis and/or dental peri-implantitis), a distal, trans-mucosal element 118, 120 releasing high concentrations of bactericidal and/or fungicidal compounds may be used initially, which may at a later stage be replaced, at least in part, by a distal, trans-mucosal element 118, 120 releasing, e.g., immunosuppressive compounds.

    [0102] In a preferred embodiment, the distal, trans-mucosal element 118, 120 of the present invention is an element (abutment) as schematically represented in FIG. 3. The element is a distal part 120 of a two-piece dental implant 118 and comprises a trans-mucosal portion 122 and a screw thread 138 for connecting the element to an enossal element 126. The element further comprises a, preferably removable, ring 142 comprising the biocide 132. The ring 142 may comprise or consist of the biocide 132, e.g. preferably, the ring 142 may be composed of a plastic or other polymeric material of sufficient durability comprising the biocide 132; or the ring 142 may comprise or consist of a metal of the present invention and/or an alloy or amalgam thereof. If necessary, the skilled person knows how to design the element of the dental implant on order to reduce abrasive forces, lysis or other deleterious effects onto the ring 142. In a more preferred embodiment, said ring 142 is a metal ring comprising at least one of the metals of the present invention as biocide 132, preferably in an effective concentration. In case the ring 142 shall be removable, the ring 142, preferably, consists of a flexible material to enable removal or exchange of the ring 142; or the ring 142 is a snap ring. It is also envisaged that a ring 142 may be replaced during treatment in order to adjust the amount of biocide 132 released and/or to adjust the kind of biocide 132 released to the healing process. E.g. in the treatment of prevalent dental implant associated inflammation (preferably, dental peri-implant mucositis and/or dental peri-implantitis), a ring 142 releasing high concentrations of bactericidal and/or fungicidal compounds may be used initially, which may at a later stage be replaced, at least in part, by a ring 142 releasing, e.g., immunosuppressive compounds. In a preferred embodiment, the ring 142 fits into a groove comprised in said trans-mucosal element. Also preferably, the ring 142 is molded into said groove and is therefore in a stable state and facilitates biocide release over years; the latter embodiment is particularly preferred for the preventive aspects and to decrease biofilm adherence.

    [0103] In another preferred embodiment, the distal, trans-mucosal element 118, 120 of the present invention is an element as schematically represented in FIG. 4. The distal, trans-mucosal element 118, 120 is similar to the element of the previous embodiment. However, the biocide is comprised in pins 144 inserted into the trans-mucosal portion 122 of the element 118, 120. It is understood by the skilled person that the pins 144 may also be replaced by screws comprising a biocide 132. It is also envisaged by the present invention that more than one type of pin or screw 144 is inserted, each of said types of pin or screw 144 comprising a biocide different from the biocide comprised in the other type(s) of pin or screw 144. Moreover, it is also envisaged that at least one pin or screw 144 may be replaced during treatment in order to adjust the amount of biocide 132 released and/or to adjust the kind of biocide 132 released to the healing process. E.g. in the treatment of prevalent dental implant associated inflammation (preferably, dental peri-implant mucositis and/or dental peri-implantitis), pins or screws 144 releasing high concentrations of bactericidal and/or fungicidal compounds may be used initially, which may at a later stage be replaced, at least in part, by pins or screws 144 releasing, e.g., immunosuppressive compounds. In a preferred embodiment, the pins or screws 144 comprise or consist of a metal, an alloy, or amalgam of the present invention acting as biocide. Preferably, the biocide of the present invention is molded into pin-shaped apertures and, preferably, in a stable state for release over years; the latter embodiment is particularly preferred for the preventive aspects and to decrease biofilm adherence.

    [0104] In another preferred embodiment, the distal, trans-mucosal element 118, 120 of the present invention is an element as schematically represented in FIG. 5. The distal, trans-mucosal element 118, 120 is similar to the element as represented in FIG. 2. However, the biocide 132 is comprised in polymeric, preferably acrylic resin, portion 146 comprising the biocide 132. Preferably, in case the polymeric portion 146 consists of a material of low durability, preferably in use for inflammation treatment, said polymeric portion 146 is covered by covering plate 140, e.g. to withstand mechanical forces acting on said element. It will be understood by the skilled person that the covering plate 140 will preferably consist of a material of higher durability compared to the material the polymeric portion 146; e.g. preferably, the covering plate 140 consists of metal.

    [0105] In a further preferred embodiment, the distal, trans-mucosal element 118, 120 of the present invention is an element as schematically represented in FIG. 6. The distal, trans-mucosal element 118, 120 is a distal part of a two-piece dental implant 118 and comprises a trans-mucosal portion 122 and a screw thread 138 for connecting the element to an enossal portion 126. The element further comprises a cavity 134 comprising the biocide 132, preferably in admixture with an appropriate carrier, and at least one aperture 136 to allow diffusion of the biocide 132 into the cleft between the mucosa 128 and the distal, trans-mucosal element 118, 120. As will be understood by the skilled person, the covering plate 140 may be fixed or removable and, in case the covering plate is removable, the biocide 132 comprised in the cavity 134 may be changed during treatment. It is, however, also envisaged that the covering plate is contiguous with the body of the distal, trans-mucosal element 118, 120. Alternatively, the covering plate may be omitted from the distal, trans-mucosal element 118, 120 and be included in a restoration (crown). In a preferred embodiment, the container abutment with the cavity harboring the biocide is used for inflammation treatment.

    [0106] In another preferred embodiment, the element of a dental implant 118 of the present invention is a restoration (crown) 124 as schematically represented in FIG. 7, having a screw thread 138 for connecting the element to an enossal portion 126. The restoration 124, comprises the transmucosal portion 122 which comprises the biocide 132. It will be understood that this is a preferred embodiment in which the restoration 124 extends at least partially into the mucosa of the jawbone.

    LIST OF REFERENCE NUMBERS

    [0107] 118 dental implant [0108] 120 distal, trans-mucosal element [0109] 122 trans-mucosal portion [0110] 124 restoration (crown) [0111] 126 enossal portion or element [0112] 128 mucosa (gingiva) [0113] 130 bone [0114] 132 biocide or biocide comprising means [0115] 134 cavity [0116] 136 aperture [0117] 138 screw thread [0118] 140 covering plate [0119] 142 ring [0120] 144 pin or screw [0121] 146 polymeric portion