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WO2024145375A1 - Compositions et méthodes de traitement d'une maladie parodontale - Google Patents

Compositions et méthodes de traitement d'une maladie parodontale Download PDF

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Publication number
WO2024145375A1
WO2024145375A1 PCT/US2023/086060 US2023086060W WO2024145375A1 WO 2024145375 A1 WO2024145375 A1 WO 2024145375A1 US 2023086060 W US2023086060 W US 2023086060W WO 2024145375 A1 WO2024145375 A1 WO 2024145375A1
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WO
WIPO (PCT)
Prior art keywords
composition
group
particles
combinations
kit
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/US2023/086060
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English (en)
Inventor
John Jason HATHAWAY
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.)
Orabio Inc
Original Assignee
Orabio Inc
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
Application filed by Orabio Inc filed Critical Orabio Inc
Publication of WO2024145375A1 publication Critical patent/WO2024145375A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/32—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses

Definitions

  • Periodontitis is a chronic inflammatory disease that occurs when the sulcus space, known as the periodontal pocket, is colonized by bacteria. This bacterial infection elicits an immune response, leading to chronic inflammation. This disease often has catastrophic consequences for the periodontal structures, destroying periodontal ligaments and eroding alveolar bone, which can cause tooth mobility and eventually tooth loss. While it is possible to temporarily resolve the infection and return the gingiva to a healthy state using mechanical debridement and antibiotics, minimally invasive methods of regenerating alveolar bone remain elusive. Currently, regeneration of periodontal structure requires periodontal surgery, which involves incising the gingiva to place tissue regeneration material.
  • Biphasic calcium phosphate is a two- phase mixture of hydroxyapatite and ⁇ -tricalcium phosphate, which combines hydroxyapatite's osteoconductivity with ⁇ -tricalcium phosphate's osteoinductivity to facilitate enhanced bone regeneration.
  • Calcium carbonate especially as a nanoparticle, also possesses significant ability ACTIVE ⁇ 1606258172.2 Attorney Docket No.145779-000702 ⁇ to promote osteogenesis.
  • calcium sulfate usually in its hemihydrate form, is useful in bone grafts in combination with other materials, such as calcium phosphate ceramics like hydroxyapatite, as it gets quickly resorbed, leaving behind a scaffold of osteoconductive material.
  • a method of using the kit comprises combining the sterilized powder and the fluid to form a composition for treating periodontal disease.
  • a method of treating periodontal disease comprises planing an interior surface of a periodontal pocket, and using a needle not larger than 18-gauge to administer to the periodontal pocket a composition for treating periodontal disease.
  • the composition comprises a plurality of particles of a bone growth material, wherein the bone growth material is selected from the group consisting of human bone particles, hydroxyapatite, bovine bone particles, ground coral, ⁇ -tricalcium phosphate, biphasic calcium phosphate, calcium carbonate, calcium sulfate, and combinations thereof.
  • the composition is free of collagen, polymers, and/or proteins.
  • DETAILED DESCRIPTION This disclosure is not limited to the particular systems, devices, media, and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the disclosure. [0010] The following terms shall have, for the purposes of this application, the respective meanings set forth below. Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. None in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention.
  • the bone growth material may be selected from the group consisting of human bone particles, hydroxyapatite, bovine bone particles, ground coral, ⁇ -tricalcium phosphate, biphasic calcium phosphate, calcium carbonate, calcium sulfate, and combinations thereof.
  • the plurality of particles are sized such that the composition may be injected into a periodontal pocket through a needle not larger than 18-gauge.
  • the composition may be configured to be administered to a periodontal pocket of a patient through a needle not larger than 18-gauge.
  • the plurality of particles have an average particle size of less than about 1 mm, less than about 0.9 mm, less than about 0.8 mm, less than about 0.7 mm, less than about 0.6 mm, less than about 0.5 mm, less than, about 0.4 mm, less than about 0.3 mm, less than about 0.2 mm, less than about 0.1 mm, less than about 90 ⁇ m, less than about 80 ⁇ m, less than about 70 ⁇ m, less than about 60 ⁇ m, less than about 50 ⁇ m, less than about 40 ⁇ m, less than about 30 ⁇ m, less than about 20 ⁇ m, less than about 10 ⁇ m, less than about 1 ⁇ m, less than about 0.1 ⁇ m, less than about 0.05 ⁇ m, less than about 0.01 ⁇ m, less than about 0.005 ⁇ m, or any range between any two of these values, including endpoints.
  • the composition is configured to be injected through a needle having a size of 27-gauge, 25-gauge, 23-gauge, 22-gauge, 21-gauge, 20-gauge, 18-gauge, or any range between any two of these values, including endpoints.
  • ACTIVE ⁇ 1606258172.2 Attorney Docket No.145779-000702 ⁇
  • the composition is substantially free of collagen.
  • the composition is collagen-free.
  • the composition is substantially free of polymers.
  • the composition is polymer-free.
  • the composition is substantially free of proteins.
  • the composition is protein-free.
  • the composition is a powder. In certain embodiments, the composition is substantially free of water. In an embodiment, the composition is anhydrous. [0022] In certain embodiments, the composition further comprises an additional agent. In an embodiment, the additional agent may be configured to improve the process of healing and regeneration. In certain embodiments, the additional agent may be adsorbed onto a calcium- containing compound. In some embodiments, the additional agent may be adsorbed onto a phosphorous-containing compound. [0023] In some embodiments, the additional agent is an antibiotic.
  • the antibiotic may comprise, for example, a tetracycline, such as minocycline, doxycycline, tetracycline, oxytetracycline, chlortetracycline, demeclocycline, lymecycline, methacycline, rolitetracycline, tigecycline, eravacycline, sarecycline, omadacycline, or a combination thereof.
  • the antibiotic may comprise, for example, a macrolide, such as azithromycin, erythromycin, clarithromycin, or a combination thereof.
  • the signaling molecule may be, for example, a growth factor selected from the group consisting of transforming growth factor ⁇ -1, bone morphogenetic proteins, insulin growth factor-1, platelet derived growth factors, and combinations thereof.
  • the signaling molecule may be, for example, a Specialized Pro-resolving Mediator (SPM) selected from the group consisting of lipoxins, resolvins, maresins, neuroprotectins, and combinations thereof.
  • SPM Specialized Pro-resolving Mediator
  • ACTIVE ⁇ 1606258172.2 Attorney Docket No.145779-000702 ⁇ [0026]
  • a composition as described herein may consist essentially of a plurality of particles of a bone growth material, and a fluid.
  • the bone growth material may be selected from the group consisting of human bone particles, hydroxyapatite, bovine bone particles, ground coral, ⁇ -tricalcium phosphate, biphasic calcium phosphate, calcium carbonate, calcium sulfate, and combinations thereof; and the fluid may be selected from the group consisting of sterile water, physiological saline, and a combination thereof.
  • the composition may be configured to be administered to a periodontal pocket through a needle not larger than 18-gauge.
  • a composition as described herein may consist essentially of a plurality of particles of a bone growth material, an additional agent, and a fluid.
  • the bone growth material may be selected from the group consisting of human bone particles, hydroxyapatite, bovine bone particles, ground coral, ⁇ -tricalcium phosphate, biphasic calcium phosphate, calcium carbonate, calcium sulfate, and combinations thereof;
  • the additional agent may be selected from the group consisting of an antibiotic, an anti-inflammatory agent, a signaling molecule, and combinations thereof;
  • the fluid may be selected from the group consisting of sterile water, physiological saline, and a combination thereof.
  • the composition may be configured to be administered to a periodontal pocket through a needle not larger than 18-gauge.
  • a composition as described herein may consist of a plurality of particles of a bone growth material, and a fluid.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Developmental Biology & Embryology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Botany (AREA)
  • Rheumatology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Dentistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des compositions et des méthodes de traitement d'une maladie parodontale. Une composition de traitement d'une maladie parodontale comprend une pluralité de particules d'un matériau de croissance osseuse, et est configurée pour être administrée à une poche parodontale par l'intermédiaire d'une aiguille dont le calibre n'est pas supérieur à 18. La composition peut être sans collagène. Un kit peut comprendre une poudre stérilisée comprenant une pluralité de particules d'un matériau de croissance osseuse, une aiguille ayant un diamètre non supérieur à un calibre de 18 et un fluide. Une méthode de traitement d'une maladie parodontale peut comprendre la planification d'une surface intérieure d'une poche parodontale et l'utilisation d'une aiguille dont le calibre n'est pas supérieur à 18 pour administrer à la poche parodontale une composition de traitement d'une maladie parodontale.
PCT/US2023/086060 2022-12-28 2023-12-27 Compositions et méthodes de traitement d'une maladie parodontale Ceased WO2024145375A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263435594P 2022-12-28 2022-12-28
US63/435,594 2022-12-28

Publications (1)

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WO2024145375A1 true WO2024145375A1 (fr) 2024-07-04

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070059281A1 (en) * 2005-09-09 2007-03-15 Wright Medical Technology, Inc. Composite bone graft substitute cement and articles produced therefrom
US20080014242A1 (en) * 2004-10-22 2008-01-17 Wright Medical Technology, Inc. Synthetic Bone Substitute Material
US20140141389A1 (en) * 2011-04-01 2014-05-22 Margaret V. Kalmeta Laser assisted periodontium and osseus regeneration protocol
US20190209735A1 (en) * 2017-12-14 2019-07-11 Geistlich Pharma Ag Dried implant composition and injectable aqueous implant formulation
US20210308087A1 (en) * 2005-11-18 2021-10-07 Forsyth Dental Infirmary For Children Treatment and prevention of bone loss using resolvins

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080014242A1 (en) * 2004-10-22 2008-01-17 Wright Medical Technology, Inc. Synthetic Bone Substitute Material
US20070059281A1 (en) * 2005-09-09 2007-03-15 Wright Medical Technology, Inc. Composite bone graft substitute cement and articles produced therefrom
US20210308087A1 (en) * 2005-11-18 2021-10-07 Forsyth Dental Infirmary For Children Treatment and prevention of bone loss using resolvins
US20140141389A1 (en) * 2011-04-01 2014-05-22 Margaret V. Kalmeta Laser assisted periodontium and osseus regeneration protocol
US20190209735A1 (en) * 2017-12-14 2019-07-11 Geistlich Pharma Ag Dried implant composition and injectable aqueous implant formulation

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