The present invention is in the area of medical technology and relates to an applicator for medicinal substances mounted in a dental implant socket.

Dental implants are implanted into the mandible. They make use of the phenomenon of osteointegration or permanent connection between bone tissue and the implant surface. Dental implants consist of an element imitating tooth roots, on which a subsequent reconstruction is made constituting one or many teeth or which constitutes a support for a different solution, such as prostheses, with the task of rehabilitation of the stomatognathic system, or other fixtures.

Intraosseous implants utilize the phenomenon of osteointegration, which is a permanent connection to the surface of the bone implant. The secondary stabilization of the implant based on this phenomenon. In the normal process of rehabilitation of the stomatognathic system surrounding bone implants is maintained at a constant level by means of implants.

Clinical observations suggest that bone loss occurs during certain pathologies observed in the vicinity of the implant, exposing the implant due to the gradual loss of bone, as well as the most common condition resulting from the microbial infection of the tissues surrounding the implant: an inflammatory state called periimplantitis. The treatment of periimplantitis involves the mechanical removal of plaque deposits and microorganisms from the implant and the surrounding region. In addition, drug therapy is typically used, usually in the form of mouthwashes and inserts in the pocket between gum and implant, in order to eliminate proinflammatory microorganisms. In order to achieve easy introduction and initial implant stabilization, conventional titanium dental implants have threading on the outer surface. Most dental implants have a specially prepared surface, resulting in a developed surface area of the titanium or other material from which the dental implant is made. The use of a helical thread with a roughened surface increases retention space for bacterial deposition during the subsequent bone loss, impedes cleaning with a consequent increase in the inflammation around the implant and a progressive loss of bone in its surroundings.

Present invention concerns an applicator of biologically active agents, attached to the socket of a dental implant, using a screw-type connection or Morse taper connection or another permanent fastening to the socket of the implant. The subject of the present invention is an applicator for biologically active agents, attached to the mounting socket of a dental implant, characterized in that it comprises a body (5) in the form of a spatial body with substantially parallel base surfaces, having an internal chamber (2), open towards the lower base (B) of the body (5), wherein from the internal chamber (2) towards the bottom of the base (B) of the body (5) protrudes a shank (1 ) for fixing the implant in the socket, the upper base (A) of the body (5) has a recess (3) for a wrench and on the side surface of the body (5) there are apertures (4) connecting the inner chamber (2) with the external environment.

Preferably, the body (5) takes the form of a cylinder, cone, hexagon or octagon.

Preferably, the recess (3) on the upper base of the body (5) takes the form of a hexagonal socket, a slot, Phillips or Torx socket.

Preferably, the cross-section of the inner chamber (2) takes the form of a circular annulus or a section of a circular annulus.

Preferably, the shank (1 ) for attachment to the implant socket takes the form of a screw, bolt or Morse taper.

Preferably, the apertures (4) connecting the inner chamber (2) with the external environment take the form of holes or slots.

Preferably, the density of the channel (4) connecting the inner chamber (2) with the external environment is in the range of 1 to 1 000 000 per mm2.

Preferably, the diameter and/or width of the apertures (4) is in the range of from 0.01 pm to 5 mm.

Preferably, it is made of titanium, a titanium alloy, surgical steel alloys, plastic or a ceramic material.

An exemplary embodiment of the present invention is shown in the drawings, in which:

Fig. 1 shows the applicator in a vertical projection with a screw-type connection, Fig. 2 shows the applicator in a vertical projection with a cone-type connection, Fig. 3 shows the applicator in a horizontal projection as viewed from the top of the base A,

Fig. 4 shows the applicator in a horizontal projection as viewed from the bottom of the base B,

Fig. 5 shows a section through an applicator inserted into an implant socket.

The applicator shown in the Figures has: 1 ) A connecting shank for connecting with the implant,

2) An applicator chamber,

3) A recess for a mounting screwdriver,

4) Apertures connecting the chamber lumen to the external environment,

5) The applicator body.

In an exemplary embodiment the applicator body 5 according to the present invention can be in the shape of a cylinder, cone, hexagon, octagon, or other spatial body, and preferably has the shape of a cylinder with a circular base. The surface of one (the upper) base of the cylinder (base A) is notched with a recess 3, preferably hexagonal, forming an opening for the wrench for mounting the applicator in the socket of the implant. The recess 3 can assume any form of socket enabling the use of standard tools for affixing, such as a Phillips, slotted or "Torx"-type socket. The second (bottom) base of the cylinder (the base B) is incised with an inner chamber 2, whose lumen is open to the outside environment applicator, located inside the cylinder in the direction of base A and having a cross section in the shape of a cylinder with a circular annular base, a circular semi-annulus or in the form of regular or irregular shaped spaces, preferably in the shape of a circular annulus. From the central part of the base B protrudes the connecting shank 1 , preferably constituting a screw that secures into the socket implant or a Morse taper for attaching into the implant socket or other solution for the durable and stable connection of the applicator to a dental implant. On a side surface of the applicator body 5, preferably cylindrical, may be four channels connecting the inner chamber 2 to the environment surrounding the applicator. They may take the form of holes, slits or slots. The number of holes on the surface should be from 1 to 1 ,000,000 holes per mm2 surface. The diameter of the holes or width of the slot or slots should be between 0.01 microns to 5 mm. In a preferred embodiment of an applicator according to the present invention, it meets the necessary strength requirements, particularly crush resistance against pressures greater than 1 kPa and lesser than 17000 MPa, a tensile force greater than 0.01 Ncm and lesser than 17 kNcm and torque resistance against a force greater than 0.1 Ncm and lesser than 200 Ncm.

After attaching the applicator in an implant socket, the chamber 2 is completely closed by the seat surface of the implant and possibly gum tissue surrounding the implant socket adjacent to the base B. In one possible implementation, the applicator is placed in the implant socket in such a way that a gap remains between the body of the applicator and the implant and possibly the gum tissue, allowing the release of the active substance contained in the chamber 2.

In one preferred embodiment of an applicator according to the present invention, by using the chamber 2 which can contain therapeutic agents and which is connected with the external environment via the apertures 4 taking the form of holes or slits, it is possible to maintain a constant desired concentration of the pharmaceutical agent at the site of the inflammation around the implant. Affixing the applicator to an implant socket allows the sustained release of a drug at the site between the implant and the bone, which decreases the risk of loss of the implant.

Owing to the construction of an applicator according to the project it is possible to easily and quickly deliver successive doses of a biologically active compound by filling the chamber 2 of an applicator. The use of an applicator suitable for the installation in the implant and removal from the implant reduces bacterial biofilm accumulates in the vicinity of the implant and facilitates applicator removal after the termination of the therapeutic effect of the active substance placed in the chamber 2 of the applicator. It is also possible to replace the whole applicator with a new one, cleared of the biofilm, or its easy cleaning outside of the oral cavity. After reaching the desired treatment effect , one can quickly remove the applicator and perform the final reconstruction. The permanent emplacement of a similar solution without the possibility of removal would cause the higher accumulation of plaque in any holes or slots (aperture 4) connecting the chamber 2 with the biologically active agent to the environment of the oral cavity. The possibility of using different diameters of holes or slots connecting the chamber 2 of the applicator with the environment allows for the dispersal of biological agents of various sizes.

Any biologically active agent, intended for administration by means of the applicator, can be used according to the recommendation for a particular patient or preventive regime, in particular anti-infection and/or anti-inflammatory pharmaceutical compositions. In a preferred embodiment, the anti-infective agents used in these compositions should be properly selected antimicrobial agents (such as antibiotics, enzymes, bacteriophages, or antibacterials such as Lysozyme), effective in combatting bacteria present in the oral cavity of the patient. The selection of an appropriate measure, particularly of an antibiotic, may be preceded by performing susceptibility testing.