US-20260124024-A1 - DENTAL AND SUBPERIOSTEAL IMPLANTS COMPRISING BIOCOMPATIBLE GRAFT

Abstract

The invention provides a dental or subperiosteal implant having a porous polymeric structure and uses thereof in the method of treatment of periodontal diseases, conditions and symptoms.

Inventors

• Gilad Litvin
• Almog Aley-Raz
• Patricia ASSOULINE

Assignees

• CORNEAT VISION LTD

Dates

Publication Date

20260507

Application Date

20231002

Claims (19)

1. 1 . A dental or subperiosteal implant comprising at least one synthetic biocompatible graft having a porous polymeric structure with pores of less than 5 microns.
2. 2 . A dental or subperiosteal implant according to claim 1 , wherein said pores are between about 0.01 microns to about 5 microns.
3. 3 . (canceled)
4. 4 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft is a biocompatible graft.
5. 5 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft is a non-degradable graft.
6. 6 . A dental or subperiosteal implant according to claim 1 , wherein said at least one synthetic biocompatible graft coats at least a part of said implant.
7. 7 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft has a thickness of between 10-100 μm.
8. 8 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft has a thickness of between 100-1000 μm.
9. 9 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft has a thickness of between 1000-2500 μm.
10. 10 . A dental or subperiosteal implant according to claim 1 , wherein said porous polymeric structure comprises at least one polymer.
11. 11 . A dental or subperiosteal implant according to claim 1 , wherein said porous polymeric structure comprises nanofibers.
12. 12 . A dental or subperiosteal implant according to claim 1 wherein said porous polymeric structure comprises at least one porous electrospun polymer.
13. 13 . A dental or subperiosteal implant according to claim 1 , wherein said porous polymeric structure comprises at least one polymer selected from polycarbonate, poly(DTE carbonate) polycaprolactone (PCL), polylactic acid (PLA), poly-L-lactic acid (PLLA), Poly(DL-lactide-co-caprolactone, Poly(ethylene-co-vinyl acetate) vinyl acetate, Poly(methyl methacrylate), Poly(propylene carbonate), Poly(vinylidene fluoride), Polyacrylonitrile, Polycaprolactone, Polycarbomethylsilane, Polylactic acid, Polystyrene, Polyvinylpyrrolidone, poly vinyl alcohol (PVA), polyethylene oxide (PEO), polyurethane, polyvinyl chloride (PVC), hyaluronic acid (HA), chitosan, alginate, polyhydroxybuyrate and its copolymers, Nylon 11, Cellulose acetate, hydroxyapatite, poly(3-hydroxybutyric acid-co-3-hydroxyvaleric acid), poly(DL-lactide), polycaprolactone, and poly(L-lactide) or any combination thereof.
14. 14 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft further comprises at least one active agent.
15. 15 . The dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft further comprises at least one active agent selected from a protein, type I collagen, fibronectin, or TGF-beta 2, heparin, growth factors, antibodies, antimetabolites, chemotherapeutic agents, anti-inflammatory agent, anti-biotic agent, and any combinations thereof.
16. 16 . A dental or subperiosteal implant according to claim 1 , wherein said synthetic biocompatible graft further comprises at least one non-porous layer.
17. 17 . A method of treating at least one of insufficient jawbone, fractured jawbone, edentulous patients with partial absorption of the jawbone, and any similar condition or symptom comprising providing at least one subperiosteal implant comprising at least one synthetic biocompatible graft having a porous polymeric structure with pores of less than 5 microns.
18. 18 . (canceled)
19. 19 . (canceled)

Description

BACKGROUND OF THE INVENTION Rehabilitation of edentulous patients either with or without atrophic jaws is a surgical challenge. Conventional endo-osseous implant-supported overdentures and immediate loading protocols still presents a clinical challenge nowadays. Many techniques have been described in the literature to overcome this problem. Reconstructive procedures, such as autologous bone grafting or guided bone regeneration, are often used. However, autogenous bone grafting requires a second surgical site, implying additional morbidity, and immediate loading is not always recommended. Guided bone regeneration, particularly vertical, is frequently limited in gain and also associated with possible complications in total atrophic jaws. Both techniques require several months for graft maturation. Following implantation, dental implants can present with peri-implnatitis, years following their implantation, necessitating surgical intervention and occasionally removal of the implant. Atrophic jaws are associated with anatomical changes, carrying an increased risk of injury to noble structures, thus increasing the needs of specific surgical skills during surgery. There is a need to provide a safe and reliable dental implant or dental subperiosteal implant that can provide a permanent solution for edentulous and atrophic jaws and related diseases and conditions without the risk of inflammation, implant exposure and extrusion, peri-implantitis, infection and eventually loss of the implant and the need for further surgeries. SUMMARY OF THE INVENTION The present invention provides an effective and stable solution for implanting dental implants and subperiosteal implants that are on the one hand versatile, making the procedure simple to perform, and on the other hand bio-stable and biocompatible, having an improved and lasting effect and providing effective integration with the jaw and dental tissue. The invention provides a dental or subperiosteal implant comprising at least one synthetic biocompatible graft having a porous polymeric structure with pores of less than 5 microns. When referring to “subperiosteal implant” it should be understood to refer to a metal implanted framework that rests directly on top of the bone, underlying the periosteum, and providing attachment posts, which extend through the gingival tissue for prosthesis anchorage. When referring to “dental implants” it should be understood to refer to a prosthesis that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture, or facial prosthesis or to act as an orthodontic anchor. Dental implants are typically formed from materials such as titanium or zirconia and form an intimate bond to the bone they are implanted in. The implant fixture is first placed so that it is likely to osseointegrate, then a dental prosthetic is added. A variable amount of healing time is required for osseointegration before either the dental prosthetic (a tooth, bridge, or denture) is attached to the implant or an abutment is placed which will hold a dental prosthetic/crown. The prerequisites for long-term success of osseointegrated dental implants are healthy bone and gingiva. Since both can atrophy after tooth extraction, pre-prosthetic procedures such as sinus lifts or gingival grafts are sometimes required to recreate ideal bone and gingiva. A typical conventional implant (shown in FIG. 1) comprises a root implanted part (103) made of metal (usually made of titanium or a titanium alloy) in the form of a screw (resembling a tooth root) with a roughened or smooth surface and a top part (101) resembling a tooth (or teeth) made for example from zirconia. Abutment (102) connects between the implanted root part and the upper visible tooth part. The majority of the root implanted part of said dental implants are made of commercially pure titanium, or titanium alloys. Most modern dental implants also have a textured surface (through etching, anodic oxidation or various-media blasting) to increase the surface area and osseointegration potential of the implant. In some embodiments of an implant of the invention shown in FIG. 2, the root implanted part is covered with said synthetic biocompatible graft (106), wherein the abutment (105) and the external tooth part (104) remain uncoated. Thus, an implant of the invention provides for an advantageous osseointegration. When referring to a “synthetic biocompatible graft” it should be understood to relate to an implantable being a synthetic polymeric material which is biocompatible with the dental tissue, such as the gingival tissue, wherein cell growth in the vicinity of the graft is capable of growing and integration at the jawbone-gingiva border within said graft. In some embodiments, said graft of the invention is in the form of a sheet. In some embodiments, said at least one synthetic biocompatible graft covers, envelopes, and/or coats substantially all of the metal framework (met