Magnesium based cleaning device

Abstract

This document relates to a cleaning device for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface. The cleaning device has cleaning means that comprises or consists of magnesium and / or a magnesium alloy which is hard enough to allow for curettage. Further, when the cleaning device is used, the magnesium and / or magnesium alloy detaches from the cleaning device and deposit on the cleaned surface thereby providing a positive biological effect in addition to the cleaning action, such as e.g. increased wound and / or bone healing, and / or reduced inflammation.

Description

[0001] MAGNESIUM BASED CLEANING DEVICE

[0002] TECHNICAL FIELD

[0003] This document relates to a cleaning device having cleaning means comprising magnesium or a magnesium alloy for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface.

[0004] BACKGROUND ART

[0005] Medical implants are today frequently implanted into vertebrate animals, including humans, to replace anatomy and / or restore a function or appearance of the body.

[0006] Medical implants may be made of various materials depending on their intended use. Examples of materials include composite materials (mixed materials without chemical bond in between), metallic materials, such as are steel, titanium, zirconium, tantalum, niobium, hafnium and alloys thereof, and biodegradable materials that are absorbed by the body when they have fulfilled their tasks. Biodegradable materials are not only absorbed by the body but rather metabolized in the body and the end products completely secreted, excreted or exhaled from the body, e.g.,as in the form of water and carbon dioxide. Silicon implants may be used to replace soft tissue parts. Stainless steel is a strong material often used when a high mechanical strength is necessary, such as for repairing fractures or replacing parts of joints. Polyethylene implants may be used for parts of joint replacement implants.

[0007] Dental implants are utilized in dental restoration procedures in patients missing one or more teeth. A dental implant comprises a dental fixture, which is utilized as an artificial tooth root replacement. Thus, the dental fixture serves as a root for a new tooth. The dental fixture is typically screw-shaped, i.e. , it has the threads of a screw. The implant is surgically implanted into the jawbone, where after the bone tissue grows around the fixture, optimally with the bone in direct contact with the implant surface. The process of integration of an implant into bone is called osseointegration when the bone grows directly in contact with the surface of the implanted fixture. By means of the osseointegration, a rigid, permanent installation of the implant is obtained. Periodontal diseases are caused by bacteria and toxins in dental plaque, which is a sticky colourless film constantly forming on the surfaces of the teeth. These diseases are very common; it has been estimated that they affect as much as between 70-90% of the world population, and they are a major cause of tooth loss in people over 35 years of age. The most common forms of periodontal disease are gingivitis and periodontitis.

[0008] Periodontal disease is caused by bacterial deposits accumulating on tooth surfaces along the gingival margins and results in destruction of tooth-supporting tissues. The destruction of tooth-supporting tissues results in a deepening of the space (periodontal defect) between the root of the tooth and the gum tissue.

[0009] In patients with implants, a periodontitis-like condition may develop into a condition called peri-implantitis and is caused by the colonization of bacteria of the implants’s surface. Peri-implantitis is an inflammation accompanied by bone loss. So far, no predictable treatment strategy has been developed for healing of peri-implantitis, and no evidencebased treatment regime is currently available. The infection may be caused by bacteria introduced during surgery or post-surgically by insufficient oral hygiene. Inflammation in the tissues surrounding the implant then causes loss of bone that ultimately may lead to loss of the implant. Patients with implants are also susceptible to developing a condition called peri-implant mucositis. This condition involves the presence of inflammation in the mucosa at an implant, but with no signs of loss of supporting bone in contrast to the observed bone loss in peri-implantitis patients.

[0010] Treatment of periodontal disease usually involves removing the biofilm and hard deposits. This is commonly performed by manual scaling of the exposed root surface to remove bacterial deposits and dental calculus, including deposits in the gingival margin. However, full access for treating deeper periodontal pockets is difficult to achieve, resulting in remaining bacteria that may re-infect the tissue. Therefore, the treatment is often combined with surgical procedures to open the tooth pocket to expose the tooth. The roots are then mechanically freed from bacterial deposits and calculus but also granulation tissue and bacterial toxin removal. Alternative treatments also include debridement and rinsing of the subjacent affected tissue and local or systemic treatment with antibiotics and anti-inflammatory drugs. Gingival curettage is a procedure for removing the soft tissue lining of the periodontal pocket, typically with a device called a curet. Gingival curettage may be performed to promote new connective tissue attachment to the tooth, by the removal of pocket lining and junctional epithelium. Bacterial infections around implants are treated similarly by curettage of the exposed surfaces and are of course not only a problem in the oral cavity but also in other parts of the body where implants are placed.

[0011] Further it is often advantageous or necessary to clean surgically exposed hard tissue surfaces. For example, cleaning surgically exposed hard tissue surfaces may be advantageous or necessary to perform before regenerative treatment, i.e. , in order to prepare the hard tissue surfaces for regenerative treatment.

[0012] Total treatment outcome may also depend on the amount of contaminating material residues that is left on the treated surface by the debridement tool. Contaminating material residues may trigger a foreign body response, toxic response or inflammation disproportionate to its beneficial effect. For a positive treatment outcome it is therefore of utmost importance to not to leave remnants of the instrument on the cleaned surface.

[0013] In addition, the surface of implants and the surrounding tissue sometimes need cleaning after placement of the implant in the body. This is particularly important when an infection or contamination occurs. In these cases, the surface of the ailing implant has to be cleaned from microbes and contaminants to stop the progression of the disease and potentially make re-integration of the implant possible. To maintain a stable treatment outcome and to prevent further disease progress, the implant surface must also be regularly cleaned both by the patient himself and by a dental professional in a clinic. If the implant surface is not sufficiently cleaned and maintained, it may lead to disease progression and eventually the loss of both the implant and the surrounding tissue, such as the jawbone.

[0014] Tools commonly used today for cleaning metallic implants are mostly designed for cleaning teeth and are relatively rigid and sharp in order to provide a thorough cleaning of the tooth root surfaces. Such cleaning devices may, for example, be made of stainless steel, titanium, hard metal alloys or hard polymers. These tools may not always be suitable for cleaning medical implants that often have a delicate surface structure that may be damaged when debrided with a rigid and sharp cleaning device. Also, such cleaning devices may destroy the implant surface morphology and form surface damages in which bacteria may hide and adhere making surface decontamination difficult.

[0015] Also, the cleaning devices used for curettage today leave contaminating material residues on the treated surface. Such material residues can cause a toxic reaction or a foreign body reaction and / or or other inflammatory reactions disproportionate to their beneficial effects, that may further exaggerate the peri-implant disease and thus potentially induce further loss of implant attachment.

[0016] Accordingly, there is still a need for medical cleaning devices that provide a better treatment outcome, that do not cause harm to treated surfaces and / or that do not leave toxic or harmful remnants in the body after use.

[0017] The object of the present invention is to overcome or at least mitigate some of the problems associated with the prior art.

[0018] SUMMARY

[0019] The present document is directed to a cleaning device for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface, wherein said cleaning device comprises an elongated base member and cleaning means in a cleaning section at a first end of said base member; characterized in that said cleaning means comprises or consists of Mg and / or one or more Mg alloy(s). The Mg alloy(s) may be one or more of a Mg alloy selected from the group consisting of Mg-Zn alloy, Mg-Ca alloy, Mg-Sr alloy, Mg-Zr alloy, Mg-Si alloy, Mg-Li alloy, Mg-Y alloy, Mg-Ca-Zn alloy, and Mg-rare earth metal alloy.

[0020] The cleaning means have a stiffness and / or sharpness sufficient to remove biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from a surface. Typically, the cleaning means have a Vickers hardness of from about 60 VHN to about 150 VHN, such as from about 75 VHN to about 125 VHN, such as from about 80 to about 120 VHN such as from about 85 VHN to about 115 VHN, such as from about 90 VHN to about 105 VHN.

[0021] The cleaning means may be extended over the length of the cleaning section, so as to form a cylindrical, spherical, hourglass or tapered shape of the cleaning section. Preferably, the cleaning means have a tapered shape. The cleaning means may be in the form of bristles. The bristles may have a length of from about 0.5 mm to about 50 mm, such as from about 0.5 to about 10 mm, from about 0.5 mm to about 5 mm, from about 0.5 mm to about 3 mm, or from about 1 mm to about 3 mm. Alternatively, the cleaning device may not comprise bristles. The base member may be formed of two or more wires, such as metallic wires, being twisted with each other (or one wire folded back upon itself) and wherein said cleaning means is in the form of bristles inserted in between the twisted wires.

[0022] The cleaning means may be in the form of plates, an ultrasonic tip, discs and / or blades.

[0023] The cleaning means may have a sharp tip.

[0024] The base member may comprise or consist of a biodegradable material, steel, a plastic material, Mg and / or a Mg alloy.

[0025] The cleaning device may comprise an insert for a rotating, oscillating or ultrasonic handpiece, such as a dental handpiece, at a second end of the tool. The cleaning device may be connected to a motor-driven unit, such as a contra-angle hand piece.

[0026] The cleaning device may be a molded tool.

[0027] The diameter of the cleaning section may be from about 0.5 mm to about 8 mm, such as from about 0.5 mm to about 4 mm or from about 3 to about 8 mm. The length of the cleaning section may be from about 5 mm to about 12 mm. The length of the cleaning device, including both the base member and the cleaning section, may be from about 10 mm to about 40 mm, such as from about 15 to about 30 mm.

[0028] The base member may be solid or hollow.

[0029] The cleaning section may be positioned in the immediate vicinity of the first end of the base member.

[0030] Parts of the cleaning means may detach during use of the cleaning device, such as by breaking off or by abrasion.

[0031] At least part or all of the base member between an insert or a handle and the cleaning section comprising the cleaning means may be covered by a protective coating.

[0032] The cleaning means may be provided with a microbe growth inhibiting and / or microbe killing substance, such as an antibiotic or chlorhexidine. The present document also discloses a method for preparing a cleaning device as defined herein, said method comprising the steps of: a) melting Mg and / or a Mg alloy; b) pouring the melted Mg and / or Mg alloy of step a) into a mold; c) cooling to room temperature and removing the cleaning device from the molding cast.

[0033] Alternatively, a method for preparing a cleaning device as defined herein may involve 3D printing said cleaning device or said cleaning means.

[0034] The present document also discloses the in vivo or ex vivo use of the cleaning device of the present document for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface. The present document also discloses the use of the cleaning device of the present document, for preparing an implant surface, tooth root surface, and / or bone surface for regenerative treatment. The present document also discloses the use of the cleaning device of the present document for the prevention and / or treatment of a condition selected from the group consisting of periimplantitis, periodontitis, and / or apical periodontitis. Such uses may in some cases not involve surgery and / or may be performed in vitro (ex vivo).

[0035] The present document also discloses the cleaning device of the present document for ex vivo or in vivo use in the prevention and / or treatment of a condition selected from the group consisting of periimplantitis, periodontitis, and / or apical periodontitis.

[0036] The present document also discloses an ex vivo or in vivo method for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of placing the cleaning device of the present document against the surface to be treated and moving said cleaning device thereover. Such a method may be for the prevention and / or treatment of a condition selected from the group consisting of periimplantitis, periodontitis lesions, and / or apical periodontitis.

[0037] The present document also discloses an in vivo procedure for curettage of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of: a) surgically exposing the surface to be treated; b) removing biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from said surface using the cleaning device of the present document; c) replacing soft tissue; and d) suturing for good primary closure and wound stability.

[0038] The present document also discloses a non-surgical in vivo procedure for curettage of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of: a) removing biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from said surface using the cleaning device of the present document; b) optionally applying regenerative treatment as needed.

[0039] The present document also discloses an in vivo or ex vivo method for delivering Mg and / or a Mg alloy to a surface, such as an implant, bone or tooth root surface, said method comprising moving the cleaning means of a cleaning device of the present document over said surface so that at least part of the Mg and / or Mg alloy of the cleaning means detaches from the cleaning means and is deposited onto said surface.

[0040] DEFINITIONS

[0041] By “medical implant”, “implant”, medical prosthetic device” etc. is in the context of this document intended any structure used to support or restore a function of the body. Examples of such structures include, but are not limited to, dental implants, orthopaedic implants and vascular implants. In particular, these terms refer to structures having a supportive role in the body, thus being constructed of harder materials, such as metals or metal alloys.

[0042] By “debridement” is in the context of the present document intended removal of damaged, dead and / or infected tissue in order to improve healing of remaining tissue. The term “debridement” means cleaning of a hard tissue surface or an implant surface in order to remove, for example, biofilm, concretions, microbes, unwanted tissue, cells and cell residues, scar tissue, and / or necrotic tissue. Debridement may, for example, be performed in order to control local infections, inflammations, foreign body reactions, pathological conditions, degenerative processes (e.g. periodontitis, periimplantitis) and / or for preparing hard tissue surfaces for regenerative treatment. By “curettage” is in the context of the present document intended the scraping of a surface to remove unwanted material therefrom, such as biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium. The treated surface is typically a bone, implant and / or tooth root surface.

[0043] By “biocompatible” and the like is in the context of the present document intended the quality of not having toxic or injurious effects on biological systems (see e.g. Dorland's medical dictionary).

[0044] “Mg” or “magnesium” is in the context of the present document used to denote metallic magnesium. “Mg alloy”, “magnesium alloy” and the like refers to an alloy comprising magnesium as the base metal and an alloying component. Typically, in such an Mg alloy, Mg constitutes 50 wt% or more of the components of the alloy, such as at least 50 wt%, at least 55 wt%, at least 60 wt%, at least 65 wt%, at least 70 wt%, at least 75 wt%, at least 80 wt%, at least 85 wt%, at least 87 wt%, at least 90 wt%, at least 91 wt%,at least 92 wt%, at least 93 wt%, at least 94 wt%, at least 95 wt%, at least 96 wt%, at least 97 wt%, at least 98 wt%, or at least 99 wt% of the alloy.

[0045] BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 shows a cleaning device 1 with a cleaning means 3 made of magnesium applied on virgin implant surface. Figure 1a shows a photograph while figure 1b is an illustrative drawing of figure 1a.

[0047] Figure 2 shows a cleaning device 1 having a cleaning means 3 in the form of a conical tip.

[0048] Figure 3 shows a cleaning device 1 having cleaning means 3 in the form of discs and including an insert 6 for connection to a motor-driven unit (top) and the same cleaning device inserted into a motor-driven unit (bottom), a) photograph, b) illustrative drawing.

[0049] Figure 4 a)-f) show alternative designs of a cleaning device 1 having cleaning means 3 in the form of discs with a straight design of the base member 2 and with different angulation of the discs, a) no angle illustrated by photograph, b) no angle illustrated by drawing, c) negative angle illustrated by photograph, d) negative angle illustrated by drawing , e) positive angle illustrated by photograph, f) positive angle illustrated by drawing. Figure 5 shows a cleaning device 1 having cleaning means 3 in the form of discs with a straight design of the base member 2 and with discs with a positive angle mounted in a motor-driven unit.

[0050] Figure 6 show different designs of a cleaning device 1 having cleaning means 3 in the form of discs that in a) has no angle, in b) has a negative angle, and in c) has positive angle and where cleaning section has a conical shape.

[0051] Fig. 7 shows a cleaning device 1 with cleaning means 3 in the form of discs wherein the cleaning device 1 is arranged in an ultrasonic handpiece and how the cleaning device 1 can be applied to a surface to be cleaned, a) cleaning device 1 with cleaning means 3 in the form of discs with no angle mounted in an ultrasonic handpiece, b) cleaning device 1 with cleaning means 3 in the form of discs with a positive angle mounted in an ultrasonic handpiece, c) cleaning device 1 with cleaning means 3 in the form of discs with a positive angle mounted in an ultrasonic handpiece wherein the cleaning means 3 are applied to a surface of an implant (left in photograph), d) cleaning device 1 with cleaning means 3 in the form of discs with no angle mounted in an ultrasonic handpiece wherein the cleaning means 3 are applied to the surface of an implant (left in photograph),

[0052] DETAILED DESCRIPTION

[0053] Magnesium is an essential mineral that has a vital role in many physiological processes, including bone formation and maintenance. For example, magnesium is a key component of hydroxyapatite, which is the main mineral component of bone. Also, magnesium is essential for the activation of vitamin D, which in turn is necessary for the absorption of calcium, another essential mineral for bone health. Magnesium has also been shown to promote bone healing and fracture repair and magnesium supplementation has been shown to improve bone density and reduce the risk of fractures. Magnesium has antiinflammatory and antioxidant properties and positively influence bone healing by its effects on inflammation and oxidative stress. In addition, studies have shown that magnesium can stimulate the proliferation and differentiation of osteoblasts, which are cells responsible for bone formation, leading to increased bone formation and accelerated bone healing. Furthermore, studies have shown that magnesium supplementation can accelerate wound healing by promoting the proliferation of cells involved in tissue repair and reducing oxidative stress. Magnesium is a material that dissolves in a biological tissue therefore not leaving remnant particles.

[0054] Magnesium (Mg) alloys have attracted attention in biomedical applications due to their unique combination of properties such as low density, high biocompatibility, and biodegradability and have been proposed as a promising alternative to traditional metallic biomaterials such as stainless steel and titanium alloys. Magnesium has been used in dentistry in the development of biocompatible dental implants. Such magnesium-based dental implants have been proposed as a promising alternative to traditional titanium implants due to their biodegradability and ability to promote bone growth. Studies have shown that magnesium implants can promote osseointegration or the fusion of the implant with the surrounding bone tissue, leading to improved implant stability and better success rates.

[0055] Magnesium alloys are biodegradable and are gradually absorbed and metabolized by the body without causing any harm. Because of this, magnesium alloys have been used in temporary implantable medical devices such as stents, orthopedic implants, and screws.

[0056] In numerous situations today there is a need for cleaning biological tissue surfaces and / or medical implant surfaces. However, currently available methods do not always result in a satisfactory result and / or have problems with damaging of tissues or delicate surfaces of medical implants. Further, the use of brush-like devices for cleaning involves the risk that bristles and the like or other parts of a cleaning device come loose and are left in the body. This may lead to negative body reactions such as allergic reactions and an impaired healing.

[0057] This document discloses a cleaning device for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface. Such curettage may in the present document be denoted “treating”, ’’treat”, “cleaning”, ’’clean” and the like. Such curettage may be performed in situ, i.e. on and around a structure, such as a bone implant and / or tooth root surface, when such a structure is place in the body of a subject, (i.e. in vivo) or ex situ, i.e. when the structure is removed from the body, such as for curettage before placing or replacing a structure in a body (i.e. ex vivo). In particular, the present document is directed to a cleaning device for use for the treatment and maintenance of hard tissue surfaces (such as teeth or bone) or implants, such as dental implants. The cleaning device may be specially adapted for use in the oral cavity by adapting its dimensions for oral use. In the cleaning device of the present document at least the part of the cleaning device that is responsible for the curettage comprises or consists of magnesium (Mg) and / or one or more magnesium alloy(s).

[0058] As Mg and the Mg alloys used in the cleaning device of present document are softer than e.g. type IV titanium, which previously have been used in dental cleaning tools, the cleaning device is able to remove biofilm and dental calculus from hard tissue and medical implant surfaces (such as titanium implant surfaces) without damaging the surface (see Example 1). In contrast, due to the hardness of type IV titanium, titanium tools can cause damage on the surface cleaned, in particular when this surface is a titanium implant surface.

[0059] Further, when the cleaning device is used for curettage, Mg and / or Mg alloy(s) detach from the cleaning device due to the abrasion when the cleaning device is moved over the surface to be treated. Mg and / or Mg alloy(s) are therefore deposited on the surface that is treated with the cleaning device.

[0060] The deposited Mg and / or Mg alloy(s) may provide several positive effects to the treated surface. First, due to magnesium’s stimulatory effects on osteoblasts, the deposited Mg and / or Mg alloy(s) may stimulate bone healing, such as in case of a bone defect and / or after positioning of an implant, such as a dental implant, in bone. Further, the Mg and / or Mg alloys may reduce inflammation and / or oxidative stress after treatment with the cleaning device and / or may improve wound healing. These effects may therefore lead to shorter curing times and / or better outcomes of different medical procedures that involve curettage.

[0061] Further, in addition to its different beneficial effects on biological processes, as Mg and Mg alloys are biodegradable, the deposited Mg and / or Mg alloy(s) will leave no harmful contaminants on the treated surface. Thus, Mg and / or Mg alloy particles released from the cleaning device are broken down by natural processes in a body and do not remain in the body. Thereby, the risk for negative body reactions is decreased or diminished. This decreases the risk for allergic reactions, impaired wound healing, discomfort caused by a loose part compared to when more traditional cleaning devices are used. In contrast, currently used tools for curettage are often made of plastics. When pieces of such plastic cleaning devices break off the cleaning device, these will not be broken down and may thus remain in the body, causing negative body reactions such as inflammation and / or allergic reactions. Also, cleaning tools comprising titanium or titanium alloys may lead to titanium micro-particles being left in the surrounding tissues after cleaning, which may lead to further inflammation.

[0062] Further, the cleaning device may e.g. be provided with a microbe growth inhibiting and / or microbe killing substance, such as an antibiotic or an antiseptic substance, e.g. silver, iodine or chlorhexidine.

[0063] The Mg alloys suitable for the cleaning device of the present document are biodegradable. Examples of Mg alloys suitable for the present cleaning device include, but are not limited to, Mg-Zn alloy, Mg-Ca alloy, Mg-Sr alloy, Mg-Zr alloy, Mg-Si alloy, Mg-Li alloy, Mg-Y alloy, Mg-Ca-Zn alloy, and Mg-rare earth metal alloy. The Mg alloys may be used alone or in combination with two or more alloys. Also, it is possible to combine Mg with one or more Mg alloy(s) in the cleaning device. The term "alloy" is herein intended to mean a metallic material containing a base metal and at least one alloying component. The term "base metal" is herein intended to mean the metal being the primary constituent of the alloy and the term "alloying component" is intended to mean a component added to the base metal in order to form the alloy. In the context of the present document, Mg is the base metal in the Mg alloys. Thus, the term "Mg alloy" is intended to mean an alloy comprising Mg as base metal and at least one alloying component.

[0064] The Mg and Mg alloys used according to the present document are biocompatible.

[0065] Design of the cleaning device

[0066] The cleaning device 1 of the present document comprises an elongated base member 2 with a cleaning means 3 in a cleaning section 4 at a first end 5 of the base member 2. In the cleaning device of the present document, at least the cleaning means 3 comprises or consists of Mg and / or Mg alloy(s). Typically, the cleaning means 3 consists of Mg and / or Mg alloy(s). However, the cleaning means 2 may alternatively comprise an inner core made of a different material than Mg and / or Mg alloy(s) and be covered by an outer layer (coating) comprising or consisting of Mg and / or Mg alloy(s).

[0067] A cleaning device may have any design allowing it to effectively perform curettage of a hard tissue or medical implant surface. Examples of designs suitable for the cleaning device and cleaning means 3 can e.g. be found in WO2013072308. The cleaning device may be manufactured consisting only of the base member 2 and the cleaning means 3 in a cleaning section 4.

[0068] The cleaning means 3 are positioned in a cleaning section 4 of the base member 2. The cleaning means 3 are preferably extended over the length of the cleaning section, so as to form a cylindrical, spherical, hour-glass shaped or tapered (conical) shape of the cleaning section. These shapes are e.g. advantageous as they allow one to efficiently reach the surfaces that are to be treated with the cleaning device. The cleaning device may be constructed as a straight tool or it may adopt a bent structure.

[0069] Typically, a cleaning device, in addition to a base member 2 and a cleaning section 4 comprising the cleaning means 3, comprises a handle suitable for manual use or an insert 6 for connection to a motor-driven unit, such as a rotating, oscillating (horizontally and / or vertically) or ultrasonic handpiece, such as a dental handpiece, at a second end of the cleaning device. Such a handle / insert 6 is positioned at the second end 7 of the cleaning device opposite to the cleaning section 4 comprising the cleaning means 3. The insert 6 may also be denoted a “connector”, a “mandrel” or a “coupling”. The use of a motor- driven unit allows for the efficient treatment of a surface due to the high frequency of rotation or oscillation and the ability to apply the necessary forces as compared to using a handheld device. The use of a contra-angle handpiece also allows for more easy access to dental implants positioned in the back of the mouth where manual instrumentation is difficult or even impossible. This document is also directed to a cleaning device connected to such a motor-driven unit, such as a contra-angle handpiece.

[0070] When the cleaning device also comprises a handle, the handle may be a separate entity from the cleaning device or be an integral part of it. E.g. when the cleaning device is manufactured by molding the base member 2 and the cleaning section 4 comprising the cleaning means 3 in one piece, the handle may be molded with the base member 2 and cleaning section 4 comprising the cleaning means 3 at the same time, so that the resulting cleaning device comprises the base member 2 and the cleaning section 4 comprising the cleaning means 3 and the handle in one piece.

[0071] The cleaning device may adopt a brush-like construction, which may be either molded or as a twisted in wire brush. Therefore, the cleaning device may comprise a base member 2 formed of two or more wires (or a single wire being folded back on itself), such as metallic wires, being twisted with each other and cleaning means 3 in the form of bristles inserted in between the twisted wires. Alternatively, the cleaning means 3 may not be in the form of bristles but in the form of e.g. plates, an ultrasonic tip, discs and / or blades etc. Non-limiting illustrative designs for the cleaning device having different designs of the means for cleaning are shown in Figures 1-7. Preferably, the cleaning means 3 are in the form of discs as illustrated in e.g. Fig. 4. The number of discs are typically from 4 to 6, such as 5. The base member 2 in a cleaning device 1 with cleaning means 3 in the form of discs is preferably a solid or hollow rod.

[0072] A cylindrical brush shaped cleaning device, optionally with a tapered (conical) shape and / or cleaning means 3 in the form of discs, may be preferred for treating modern dental implants as well at undercuts and necks of abutments and prosthesis parts. Because of the sometimes-complicated configuration of dental prosthesis fixed to the jaw with dental implants it is also necessary to have specialized cleaning devices that have shapes that can reach into crevices and occulted areas to remove concretions, biofilm etc. without having to expose the area through surgical intervention or disassembly of the prosthetic construct, which is not feasible for regular implant maintenance treatment.

[0073] The cleaning section 4 may have the same or a varying diameter over, i.e. , along, the longitudinal direction of the base member 2. For example, may a tapered (conical) design of the cleaning section 4 be advantageous for the treatment of deep and wide V-shaped pathological bone pockets. Such a tapered (conical) shape of the cleaning section 4 is also suited for treating an exposed hard tissue surface, such as in treatment of, for example, wide bone defects, such as marginal periodontal defects and dehiscent defects. A varying diameter of the cleaning section 4 may be achieved by varying the width of the cleaning means 3 and / or varying the diameter of the base member 2.

[0074] The cleaning means 3 may preferably be in the form of a sharp tip. Such a shape of the cleaning means 3 is particularly suitable for curettage in the oral cavity. Further, such a sharp tip may preferably be used with an ultrasonic device.

[0075] The cleaning section 4 may alternatively adopt a diamond shaped or spherical shape. A diamond shape may be particularly suitable for the treatment of narrow V-shaped pathological bone pockets while a spherical shape may be advantageous for the treatment of an exposed hard tissue surface, such as in the treatment of, for example, granulomas and apical periodontal defects. In such a sphere-shaped cleaning section, the diameter of the cleaning section 4 is typically from about 3 to about 8 mm. When the cleaning means 3 is in the form of discs, these discs may have different angles as is illustrated in Fig. 4, 5, 6, and 7 i.e. no angle, a positive angle or negative angle in relation to the base member. The positive angle may be from about 15° to about 25°, such as about 20°. The negative angle may be from about 15° to about 25°, such as about 20°. The discs may be arranged so that the diameter of the cleaning section 4 increases when going from the first end 5 of the cleaning device 1 , e.g. by varying the width of the discs and / or the diameter of the base member 2 in the cleaning section 4 (as is illustrated in Fig. 6). This conical angle may be from about 2° to about 4°, such as 3°.

[0076] Fig. 7 shows a cleaning device 1 with cleaning means 3 in the form of discs (no angle and positive angle, respectively) wherein the cleaning device 1 is arranged in an ultrasonic handpiece and how the cleaning device 1 can be applied to a surface to be cleaned, in Fig. 7 an implant surface.

[0077] When the cleaning means are in the form of discs, the discs may have cutting edges. Such cutting edges may have a height of from about 0.8 mm to about 0.9 mm, such as about 0.85 mm.

[0078] An hour-glass shape of the cleaning section 4 of the cleaning device 1 may be advantageous when one is to treat surfaces in between two cylindrical or round dental implants placed close together or in narrow bony defects with the implant in close proximity to bony wall. The hour-glass shape will then allow for a better and more efficient cleaning of both the adjacent surfaces simultaneously, covering a larger area of each implant in the process.

[0079] The above examples of shapes of the cleaning section 4 are only exemplary and not to be seen as limiting.

[0080] The first end 5 can, e.g., be tapered, blunt or straight. The choice of the shape of the first end 5 will, e.g., be decided based on the surface to be treated, as different shapes will provide different abilities to reach different types of surfaces. A tapered end, such as a sharp tip, is advantageous for curettage of the narrowing space of the apical part of a periimplant tissue pocket. A blunt end is advantageous for curettage of a surface that is exposed in a cup-shaped (blunt ended) defect or where the dental implant is substantially exposed into the oral cavity leaving the surface to be treated longer than the cleaning section 4 of the cleaning device. A wide ended shape of the cleaning section 4 is advantageous for cleaning occulted areas under undercuts and under prosthetic supraconstructions etc.

[0081] As is evident from the above, the size and shape of the cleaning device may be adapted to a defect anatomy, i.e. the size and shape of the cleaning device may be adapted such that it is suited for curettage of a particular type of surface.

[0082] The cleaning section 4 may be positioned in the immediate vicinity of the first end 5 of the base member 2, i.e., with no part of the base member 2 between the first end 5 and the cleaning section. Such a design may be advantageous when there is a short distance between the holder (hand piece) and the surface to be cleaned as this will lead to less wobbling or bending of the cleaning device, thereby providing better control of the working part of the device. Alternatively, there may be a part of the base member 2 between the first end 5 and the cleaning section. Further, a longer part (such as 0.5-15 cm, 0.5-10 cm, 0.5-5 cm, or 1-5 cm, e.g. 0.5, 0.8, 1.0, 1.2, 1.5, 1.7, 2.0, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 , 8, 8.5, 10, 12, or 15 cm) of the base member 2 towards the second end of the device after the cleaning section, i.e. a longer “stem”, may be needed to gain access to the areas to be treated.

[0083] The diameter of the cleaning section 4 may be from about 0.5 mm to about 8 mm, such as from about 0.5 mm to about 6 mm. When the cleaning device is in the form of a brush or discs, the diameter of the cleaning section 4 typically is from about 0.5 mm to about 4 mm. When the cleaning section 4 is in the form of a sphere, the diameter of the cleaning section 4 is typically from about 3 to about 8 mm. The length of the cleaning section 4 is typically from about 5 mm to about 12 mm but can be longer or shorter depending on the intended use for the cleaning device. The length of the cleaning device, including both the base member 2 and the cleaning section 4 may typically be from about 10 mm to about 40 mm, such as from about 10 to about 30 mm, such as from about 15 to about 30 mm.

[0084] For example, the diameter of the base member 2 may be from about 0.8 mm to about 1 .0 mm, such as about 0.9 mm. The diameter of the cleaning section 4 (including the cleaning means 3) may be from about 2.5 mm to about 2.7 mm, such as about 2.6 mm. The total length of the base member 2, including the cleaning section 4 may be from about 20 mm to about 25 mm, such as about 22 mm. The cleaning section 4 may be from about 6 to about 10 mm, such as about 8 mm. When the cleaning means 3 are in the form of bristles, the bristles may typically have a length of from about 0.5 mm to about 50 mm, such as from about 0.5 to about 10 mm, from about 0.5 mm to about 5 mm, from about 0.5 mm to about 3 mm, or from about 1 mm to about 3 mm. The diameter of the bristles is typically 0.05-1 mm, such as about 0.05-0.5 mm, such as, e.g., 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or 1 mm.

[0085] Although the dimensions exemplified in this document are those which will most often be suitable for the intended use, the exact size of the cleaning device will depend on its intended use. For dental uses, the size of the cleaning device is determined by the small space in the oral cavity in which the cleaning device is to be used.

[0086] The cleaning device may or may not have an internal irrigation system i.e. , the base member 2 may or may not be hollow and with irrigation canals at for example at the first end 5 of the base member 2. The cleaning device may thus also be made hollow, i.e., the base member 2 may be made hollow in order to allow the distribution of a fluid through the device. If the cleaning device is to be made hollow, the cleaning section 4 may comprise one or more, such as a plurality, of apertures through which fluid may be distributed.

[0087] The base member 2 or part of it may be covered by a protective coating that protects supra-constructions from abrasion and / or discolouration from contact with the base member 2 during use. This protective coating is placed on the base member 2 between the insert 6 or handle and the cleaning section 4 comprising the cleaning means 3. Such a protective coating is typically in the form of a tube, e.g., in the form of a plastic cap. It is important to note that the protective coating should not cover the cleaning means 3 in the cleaning section. Such a protective coating protects the surfaces that are cleaned and / or debrided and / or surrounding surfaces from discoloration and / or damage if they come in contact with the base member 2. Also, this protective coating smoothens the action of a cleaning device so that there is much less wobbling / vibration. This makes the cleaning device easier to handle and the procedure more comfortable for the patient.

[0088] A preferred cleaning device of the present document has cleaning means 3 in the form of threads / discs and / or an ultrasonic tip. The threads / discs and the ultrasonic tip preferably consists of Mg or Mg and a Mg alloy.

[0089] A preferred cleaning device 1 according to the present document comprises or consists of a base member 2 and cleaning means 3 in the form of discs in the cleaning section 4 (preferably 4-6 discs in the cleaning section 4, such as 5 discs), wherein the cleaning means 3 and preferably also the base member 2 are made of Mg, Mg-Zr alloy, Mg-Zn alloy, and / or Mg-rare earth metal. In such a preferred cleaning device 1 the diameter of the base member 2 may be from about 0.8 mm to about 1.0 mm, such as about 0.9 mm, the diameter of the cleaning section 4 (including the cleaning means 3) may be from about 2.5 mm to about 2.7 mm, such as about 2.6 mm, the total length of the base member 2, including the cleaning section 4, may be from about 20 mm to about 25 mm, such as about 22 mm, and the cleaning section 4 may be from about 6 to about 10 mm, such as about 8 mm. Preferably the cleaning means 3 (and preferably also the base member) in such a preferred cleaning device 1 are made of an Mg-Zr-rare earth metal alloy, such as an alloy consisting of about 95 wt% Mg, about 4.4 wt% rare earth metals and about 0.6 wt% Zr.

[0090] Materials for the cleaning device

[0091] The cleaning means of the cleaning device of the present document comprises or consists of Mg (i.e. metallic magnesium) and / or one or more Mg alloy(s). As mentioned before, the cleaning means may fully be constituted by the Mg and / or Mg alloy(s) or the cleaning means 2 may have an outer surface (coating) of Mg and / or Mg alloy(s). Typically, at least the parts of the cleaning means that come into contact with the surface to be treated consists of Mg and / or Mg alloy(s). It is possible to use only Mg or one type of Mg alloy or a combination of Mg and one or more Mg alloys or a combination of two or more Mg alloys. Mg alloys suitable for the present cleaning device are typically biodegradable Mg alloys. The Mg and Mg alloys used in the context of the present document are typically of medical grade Mg and / or Mg alloy(s). Mg alloys suitable for use according to the present document include, but are not limited to, Mg-Zn alloy, Mg-Ca alloy, Mg-Sr alloy, Mg-Zr alloy, Mg-Si alloy, Mg-Li alloy, Mg-Y alloy, Mg-Ca-Zn alloy, and Mg-rare earth metal alloy. The alloying components are typically chosen from one or more of Zn, Ca, Sr, Zr, Si, Li, Y, and rare earth metal. Preferably, the alloying component is Zr, Zn and / or rare earth metal. The Mg alloy may also be an Mg alloy with more than one alloying component, such as, two, three or four alloying components. The Mg alloys preferably do not contain Ti. Preferably, the cleaning means comprise or consist of Mg or Mg and at least one Mg alloy.

[0092] Typically, in an Mg alloy according to the present document, Mg constitutes 50 wt% or more of the components of the alloy, such as at least 50 wt%, at least 55 wt%, at least 60 wt%, at least 65 wt%, at least 70 wt%, at least 75 wt%, at least 80 wt%, at least 85 wt%, at least 87 wt%, at least 90 wt%, at least 91 wt%,at least 92 wt%, at least 93 wt%, at least 94 wt%, at least 95 wt%, at least 96 wt%, at least 97 wt%, at least 98 wt%, or at least 99 wt% of the alloy. Typically, Mg constitutes at least 95 wt% Mg. For certain applications, such as when the cleaning device is to be used with an ultrasonic handpiece, it may be preferred to use an Mg alloy with a lower amount of Mg, such as from about 80 wt% to about 90 wt% Mg, such as about 85 wt% Mg.

[0093] One preferred Mg alloy for use in a cleaning means of the present document is constituted of about 95 wt% to about 96.9 wt% of Mg, from about 3 wt% to about 4.9 wt% rare earth metals and Zr in an amount of from about 0.1 wt% to about 0.6 wt%, preferably about 0.6 wt%. Preferably such a Mg alloy is constituted by about 95 wt% Mg, about 4.4 wt% rare earth metals and about 0.6 wt% Zr.

[0094] The base member may be constructed by the same material(s) as the cleaning means (i.e. , Mg and / or Mg alloy(s)), or a different material(s). For example, the base member may comprise or consist of a biodegradable material, steel, or an alloy thereof, a plastic material, Mg and / or a Mg alloy. The base member may be made of a non-bsiodegradable material, such as a metallic, composite or plastic (e.g. polyurethane) material. Examples of metals suitable for the base member include, but are not limited to, steel, tantalum or an alloy thereof, hafnium or an alloy thereof, niobium or an alloy thereof, or a chromiumvanadium alloy. Examples of plastic materials suitable for the base member 2 includes, but are not limited to nylon, polyethylene, vinyl, poly(methyl methacrylate) (PMA), polyvinyl chloride (PVC), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), or polyvinyl fluoride (PVF). The base member may also comprise two or more different materials. These materials may either be intermixed with each other, or different parts of the base member may be constructed by different materials (which in themselves may comprise intermixed combinations of materials). The base member may also be constructed of a material which is not biodegradable but that is coated with a biodegradable material.

[0095] The cleaning device, including the cleaning means, the base member, and any further parts, such as a handle or an insert, may be fully made of Mg and / or Mg alloy(s), being the same or different for the different parts of the cleaning device. The cleaning means and the base member may be molded in one piece. The insert or the handle may be made of the same material as the base member or be made of another material, such as metal or polyvinyl chloride (PVC). The insert or the handle and base member can e.g. be made of stainless steel or any type of polymer.

[0096] The protective coating, if such is present, is typically made of flexible nylon or PVDF (polyvinylidene fluoride) or any other similar material. The material is preferably white.

[0097] The Mg and / or Mg alloy materials in this document allow the construction of a cleaning device which has a stiffness and / or sharpness sufficient to remove biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from a surface. It is important that the cleaning means are hard enough to allow for an efficient curettage and / or removal of granulation tissue, crevicular epithelium and / or soft tissue. Also, it may in some instances be important that the base member has some degree of stiffness in order to be able to apply the pressure necessary to provide a cleaning action by the cleaning means. However, it may in some instances be advantageous that the base member is at least somewhat flexible if surfaces that are hard to reach are to be treated.

[0098] The cleaning means of the cleaning device are thus hard enough to clean both hard and delicate biological tissue and / or implant surfaces. At the same time, they do not have such hardness that they damage delicate surfaces, i.e. they do not essentially damage delicate surfaces. Consequently, the risk of negatively affecting the surface structure of the biological tissue or medical implant is reduced when the cleaning device 1 is utilized. In addition, when the damaging risk is reduced, the risk of formation of scratches constituting bacteria adherence sites is also reduced. Thus, the risk of re-infection in the tissue surrounding the implant, e.g. the gingival, is reduced too.

[0099] The Mg and / or Mg alloy in the cleaning means is chosen so that parts of it detach during use of the cleaning device, such as by breaking off or by abrasion. To enable this, the cleaning means typically have a Vickers hardness of from about 60 VHN to about 150 VHN, such as from about 75 VHN to about 125 VHN, such as from about 80 to about 120 VHN such as from about 85 VH N to about 115 VH N , such as 85 to 105 VH N , such as from about 90 VHN to about 105 VHN.

[0100] The Vickers test can be used for all metals and is based on an optical measurement system. In the test, a diamond indenter is used to make an indentation which is measured and converted to a hardness value. The Vickers hardness number (VHN) or diamond pyramid hardness (DPH), is defined as the applied load (in kg) divided by the projected area of the indentation (in mm2). The Vickers test to determine the hardness of a mineral is well-known to the skilled person.

[0101] As is mentioned elsewhere herein, when the cleaning device is used for treating a surface, some of the Mg and / or Mg alloy(s) of the cleaning means will detach and be deposited on / around the treated surface. Depending on what kind of surface is to be treated it may be necessary to adapt the material of the cleaning means so that a suitable amount of Mg and / or Mg alloy is detached and deposited.

[0102] Uses of the cleaning device

[0103] The cleaning device of the present document may be used in vivo or ex vivo.

[0104] The cleaning device of the present document is particularly suitable for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface. Such curettage may in the present document alternatively be denoted as “treating”, “treat” or the like. The present document is therefore directed to the use of a cleaning device as defined herein for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface. The curettage may either be performed in vivo or ex vivo. The curettage may or may not involve surgery.

[0105] The surface to be treated with a cleaning device of the present document is typically a hard tissue surface, such as a bone or tooth surface (e.g. a tooth root surface), or an implant surface, such as an orthopedic or a dental implant surface. The treatment may, e.g., be performed to promote healing, such as of a bone or furcation defect, or to prepare the surface for regenerative treatment or to treat a medical condition (see below).

[0106] For example, the cleaning device may be used for removing biofilm, organic components and / or mineral depositions (e.g. tartar and calculus) from, e.g., implant surfaces, in particular dental implant surfaces. The tissue surface surrounding the implant may also be treated in such a procedure.

[0107] The cleaning device may be used for preparing an implant surface, tooth root surface, and / or bone surface for regenerative treatment. For example, an in vivo procedure for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface, may comprise the steps of: a) surgically exposing the surface to be treated; b) removing biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from said surface using the cleaning device; c) replacing soft tissue; and d) suturing for good primary closure and wound stability.

[0108] The present document is also directed to a non-surgical in vivo procedure for curettage of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of: a) removing biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from said surface using the cleaning device as defined herein; b) optionally applying regenerative treatment as needed.

[0109] When the cleaning device is used for treating a surface, the cleaning device is placed against the surface to be treated and moved thereover, typically in a rotating or oscillating manner. When a rotational manner is used, typically a motor-driven unit is used to effect such a movement. This document therefore also discloses an in vivo or ex vivo method for delivering Mg and / or a Mg alloy to a surface, such as an implant, bone or tooth root surface, said method comprising moving the cleaning means of a cleaning device of the present document over said surface so that at least part of the Mg and / or Mg alloy of the cleaning means detaches from the cleaning means and is deposited onto said surface, method for use of a cleaning device for any of the purposes specified herein wherein the cleaning device is placed against the surface to be treated and moved thereover. Such a method for treating a tissue or implant surface therefore comprises the steps of placing the cleaning device against the surface to be treated and moving the cleaning device thereover. When the cleaning means is moved over the surface to be treated, part of the Mg and / or Mg alloy of the cleaning means may detach from the cleaning means and may be deposited onto the treated surface.

[0110] The cleaning device of the present document may, e.g. be used for prevention and / or treatment of a condition selected from the group consisting of periimplantitis, periodontitis lesions, and / or apical periodontitis. Such prevention and / or treatment may be due to Mg and / or Mg alloys beneficial effects on healing processes as explained elsewhere herein, e.g., by increasing wound and / or bone healing, and / or by reducing inflammation. Alternatively, or in addition, the efficient removal of, e.g., biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium may contribute to such prevention and / or treatment. The present document therefore is also directed to cleaning device as defined herein for use in the prevention and / or treatment of a condition selected from the group consisting of periimplantitis, periodontitis, and / or apical periodontitis. Such use may take place in vivo or ex vivo. Further, the present document discloses a method for preventing and / or treating a condition selected from the group consisting of periimplantitis, periodontitis, and / or apical periodontitis, said method comprising treating a dental surface with a cleaning device as defined herein.

[0111] A relatively rapid debridement procedure of surfaces, which are otherwise hard to clean and / or hard to reach by hand instrumentation, may be performed by means of the cleaning device of the present document. Rapid treatment ensures a better treatment outcome. It is a well-known fact that the morbidity and frequency of adverse effects, such as, e.g. post-surgery effects, are directly related to, and often proportional to, the time used for the treatment of surgically exposed hard tissue surfaces. Thus, rapid treatment ensures a better total treatment outcome.

[0112] The cleaning device may also be used for treating implants, such as dental, orthopedic and / or vascular implants. Such treating may take place in vivo or ex vivo. The implant may thus be treated with the cleaning device when positioned in a body or when outside the body before its insertion into a body or after removal from its site in a body and before repositioning therein. The cleaning device may be used both for treating implants having relatively hard surfaces, such as e.g. medical and dental implants of steel and implants having delicate surface structure, such as e.g. implants of titanium, a titanium alloy, zirconium or a zirconium alloy.

[0113] By utilizing the cleaning device for treating a surface, the surface is efficiently cleaned from e.g. biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium. In particular such inflamed granulation tissue and inflamed crevicular epithelium are hard to remove from surfaces and many currently used tools are too soft to allow for efficient removal. The cleaning device of the present document having cleaning means comprising or consisting of Mg and / or a Mg alloy, are hard enough to allow for efficient removal of such tissue from surfaces.

[0114] The cleaning device may be utilized together with a substance having a cleaning effect, such as an etching substance, e.g. hydrogen peroxide, a substance promoting healing of tissue or integration of implants, such as enamel matrix derived proteins and / or a microbe growth inhibiting and / or microbe killing substance, such as an antibiotic or chlorhexidine. Such substance(s) may be provided in a separate container with the cleaning device in a kit of parts.

[0115] When the cleaning device is hollow and / or comprises apertures, fluids can be distributed by the cleaning device. Such fluids include, but are not limited to, water, saline, sterilized brine, hydrogen peroxide solution, antibiotic solution, weak acids (e.g., maleic acid, formic acid or another weak organic acid), diluted hydrogen fluoride (e.g. 0.005-0.1%). The fluid may, e.g., be used to irrigate for cooling, for removing debris, for dissolving concretions or mineral precipitations, for flushing the wound and the surface and for killing microbes during cleaning.

[0116] Manufacturing of the cleaning device

[0117] A cleaning device or cleaning means of the present document may be manufactured by molding, such as injection molding or pressfit molding using standard molding techniques. Factors affecting the choice of material(s), size and / or the shape of the cleaning device / cleaning section include for example the condition to be treated, the site of the body to be treated and the age and general condition of the subject. The cleaning means and the base member may be molded separately and later assembled. Alternatively, the cleaning means and the base member may be molded in one piece, optionally together with a handle or an insert. When the cleaning device is in the form of a twisted-in-wire construction, the cleaning means, e.g. in the form of bristles, may be twisted in between the wires which form the base member.

[0118] For example, a method for preparing a cleaning device may comprise the steps of: a) melting Mg and / or a Mg alloy; b) pouring the melted Mg and / or Mg alloy of step a) into a mold; c) cooling to room temperature and removing the cleaning device from the molding cast.

[0119] One example of an advantage associated with producing the cleaning device or the cleaning device with a handle in one piece is an easier production method as the tool is provided in one piece thus omitting the steps of having to produce all parts separately and then assemble them. Also, the resulting cleaning device is more robust and it does not comprise separately assembled parts. The production costs may therefore also be lowered. The method for preparing a cleaning device may involve 3D printing the cleaning device or one or more parts thereof, such as the cleaning section or the cleaning means.

[0120] The cleaning device may be manufactured with a hollow space in the base member.

[0121] The cleaning device may be formed by molding the base member and the cleaning means in one piece. Alternatively, the cleaning means may be typically welded onto a base member or inserted in a twist stem configuration, wherein two or more wires are twisted with each other with the cleaning means inserted in between. The cleaning section comprising the cleaning means may also be separately manufactured and then joined with a shaft corresponding to the part of the base member which is not the cleaning section.

[0122] The cleaning device may also be manufactured in a method comprising the steps of i) casting Mg and / or Mg alloy billets, e.g. with intermediary heat treatments ii) extruding to rods, e.g. with intermediary heat treatment; and iii) turning on a lathe to the final geometry

[0123] Another exemplary method for manufacturing the cleaning device comprises the steps of i) casting Mg and / or Mg alloy billets ii) extruding to rods iii) powderizing the billets or rods to fine powder (such as in the range of from about 1 to about 100 .m, preferably from about 10 to about 63 .m) such as by using atomisation techniques or ultrasonic powdering iv) applying additive manufacturing such as LPBF (e.g. with intermediary heat treatments) to build up the final geometry v) optionally mechanically post-processing by turning or milling

[0124] After the cleaning device has been manufactured it may be cleaned, sterilized and / or packed.

[0125] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims. The invention will be further described in the following examples, which do not limit the scope of the invention described in the claims.

[0126] Experimental section

[0127] Example 1 :

[0128] Treatment of titanium dioxide implant surfaces with a Mg cleaning device

[0129] Materials and Methods

[0130] Eight cleaning devices with cleaning means of Mg were manufactured from medical grade magnesium and glued into a standard dental mandrell insert and fitted into a slow speed dental bur piece. A dental Implant (Nobel Biocare AG) with grade IV titanium surface (TiC>2) was seated in a fixed holder and stabilized. The bur motor was used on 2000 RPM and the magnesium device applied on the implant surface with firm pressure for 2 minutes (Fig 1). The treated implant surfaces were studied with magnifiers.

[0131] One old implant with spurious amounts of calculus deposits were also treated and analyzed similarly.

[0132] Results

[0133] Only very minimal signs of damage (scratches or flattening) were seen on the surface of the virgin implant. Magnesium debris was seen during the debridement.

[0134] On the old implant with calculus deposits the instrument had a good effect on calculus removal but the titanium surface was intact at visual inspection with minimal scratches or other damage.

[0135] Conclusion

[0136] The cleaning device of the present document is different than the current commercial alternatives which is medical grade steel or peek or carbon fiber at least since it 1) Doesn’t cause damage to the implant surface but removes calculus deposits selectively, 2) Only leaves resorbable and biologically inert magnesium remnants as compared to titanium, PEEK or carbon fiber tips.

Claims

CLAIMS1 . A cleaning device for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface, wherein said cleaning device comprises an elongated base member and cleaning means in a cleaning section at a first end of said base member; characterized in that said cleaning means comprises or consists of metallic Mg and / or one or more Mg alloy(s).

2. The cleaning device according to claim 1 , wherein the Mg alloy(s) is / are selected from the group consisting of Mg-Zn alloy, Mg-Ca alloy, Mg-Sr alloy, Mg-Zr alloy, Mg-Si alloy, Mg-Li alloy, Mg-Y alloy, Mg-Ca-Zn alloy, and Mg-rare earth metal alloy.

3. The cleaning device according to claim 1 or 2, wherein said cleaning means have a Vickers hardness of from about 60 VHN to about 150 VHN, such as from about 75 VHN to about 125 VHN, such as from about 80 to about 120 VHN such as from about 85 VH N to about 115 VH N , such as from about 90 VH N to about 105 VH N .

4. The cleaning device according to any one of the preceding claims, wherein the cleaning means are extended over the length of the cleaning section, so as to form a cylindrical, spherical, hourglass or tapered shape of the cleaning section.

5. The cleaning device according to any one of the preceding claims, wherein the cleaning means is in the form of plates, an ultrasonic tip, discs and / or blades.

6. The cleaning device according to any one of the preceding claims, wherein said cleaning device comprises an insert for a rotating, oscillating or ultrasonic handpiece, such as a dental handpiece, at a second end of the tool.

7. The cleaning device according to any one of the preceding claims, wherein said cleaning device is a molded tool.

8. The cleaning device according to any one of the preceding claims, wherein the diameter of the cleaning section is from about 0.5 mm to about 8 mm, such as from about 0.5 mm to about 4 mm or from about 3 to about 8 mm.

9. The cleaning device according to any one of the preceding claims, wherein the length of the cleaning section is from about 5 mm to about 12 mm.

10. The cleaning device according to any one of the preceding claims wherein parts of the cleaning means detach during use of said cleaning device, such as by breaking off or by abrasion.11 . A method for preparing a cleaning device as defined in any one of the preceding claims comprising the steps of: a) melting Mg and / or a Mg alloy; b) pouring the melted Mg and / or Mg alloy of step a) into a mold;c) cooling to room temperature and removing the cleaning device from the molding cast.

12. A method for preparing a cleaning device as defined in any one of claims 1-10, said method involving 3D printing said cleaning device.

13. Ex vivo use of a cleaning device as defined in any one of claims 1-10 for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface.

14. Ex vivo or in vivo use of a cleaning device as defined in any one of claims 1-10, for preparing an implant surface, tooth root surface, and / or bone surface for regenerative treatment.

15. A cleaning device as defined in any one of claims 1-10 for ex vivo or in vivo use in the prevention and / or treatment of a condition selected from the group consisting of periimplantitis, periodontitis, and / or apical periodontitis.

16. An ex vivo or in vivo method for curettage, such as removal of biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium, of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of placing a cleaning device as defined in any one of claims 1-10 against the surface to be treated and moving said cleaning device thereover.

17. An in vivo procedure for curettage of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of: a) surgically exposing the surface to be treated; b) removing biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from said surface using the cleaning device as defined in any one of claims 1-10; c) replacing soft tissue; and d) suturing for good primary closure and wound stability.

18. A non-surgical in vivo procedure for curettage of a surface, such as a bone, implant and / or tooth root surface, said method comprising the steps of: a) removing biofilm, inflamed granulation tissue and / or inflamed crevicular epithelium from said surface using the cleaning device as defined in any one of claims 1-10; and b) optionally applying regenerative treatment as needed.

19. An in vivo or ex vivo method for delivering Mg and / or a Mg alloy to a surface, such as an implant, bone or tooth root surface, said method comprising moving the cleaning means of a cleaning device as defined in any one of claims 1-10 over said surface so that part of the Mg and / or Mg alloy of the cleaning means detaches from the cleaning means and is deposited onto said surface.

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