WO2002038068A2

WO2002038068A2 - Periodontal medicament delivery tray

Info

Publication number: WO2002038068A2
Application number: PCT/US2001/048363
Authority: WO
Inventors: Duane C. Keller
Original assignee: Keller Duane C
Priority date: 2000-11-13
Filing date: 2001-11-13
Publication date: 2002-05-16
Also published as: WO2002038068A3; AU2002232585A1

Abstract

A tray (10) fitted to at least some teeth (18) of a patient's upper or lower arch is provided for the application of medications to the teeth (18) and to adjacent gum tissue (20) for treatment of periodontal disease. The tray (10) is constructed from resilient material molded to conform to the teeth and gum tissue. The tray (10) includes at least one recess (40) formed to conform to the teeth. A seal (44) surrounds the recess (40) at a location corresponding to the patient's gum line (28) for applying pressure at the patient's gum line when the patient's teeth are disposed in the recess (40). The recess (40) contains a quantity of a medication. Upon installation of the tray (10) on the teeth, the medication is forced into any pockets (19) in the patient's gums (20) proximate the teeth. If desired, a propulsion agent can be disposed within the recess (40) such that upon application of the tray onto the patient's teeth, the propulsion agent generates pressure within the recess so as to positively force the medication onto the patient's teeth and into any of the pockets in the patient's gums proximate the teeth.

Description

PERIODONTAL MEDICAMENT DELIVERY TRAY Technical Field

This invention relates to treatment of periodontal disease, and in particular to a dental tray and method for delivering medicament subgingivally to treat the infected area. Background Art

Periodontal (gum) disease affects a majority of adults at some time in their lives. Warning signs often are unnoticed until advanced stages of the disease. Treatment methods depend upon the type of disease and how far the condition has progressed. When deep pockets (3 mm or greater) exist between teeth and gums, it is difficult for the dentist to thoroughly remove plaque and tartar. While surgery may be necessary to reduce the depth of the pockets or to restore or reshape bone that has been destroyed, typically it is preferable to attempt to avoid such invasive procedures by treating the affected areas with antibacterial or antimicrobal agents (i.e., chemical, antibiotic, or other pharmacological agents) to restore periodontal health. Such antibacterial or antimicrobal agents have been found to control the growth of bacteria that create toxins and cause periodontal disease and encourage normal healing, thereby reducing the necessity or the invasiveness of periodontal or oral surgery.

Several methods have been developed for treating periodontal disease that enable medicament to be delivered to the infected site below the gingiva. For example, as set forth in U.S. Patent No. 5,330,357, issued July 19, 1994 to the present inventor, the disclosure of which hereby is incorporated by reference, medicament can be delivered in close proximity to the bone and supporting structure of the teeth by flossing using tufted floss, brushing using an interdental brush, injection using a syringe, or by hydrostatic or mastication pressure using a dental tray. Dental trays often are constructed from a soft plastic elastomeric material that is molded in place to a patient's teeth so as to firmly and closely fit in place on the patient's teeth, and a seal is made to hold the tray solidly against the dental tissues. Medicament is placed in recesses formed in the tray that are adapted to accommodate the patient's teeth, and then guided or forced along the teeth and into the gingiva by the sealing means to the infected site as the patient closes his jaw on the tray. A propulsion agent such as hydrogen peroxide also can be placed in the recesses to guide or force the medicament into the infected site as the hydrogen peroxide breaks down and increases the pressure within the recesses. Other examples of dental trays are set forth in U.S. Patent Nos.

4,902,227, issued February 20, 1990 to Smith; 4,428,373 issued January 31 , 1984 to Seid et al.; and 4,138,814, issued February 13, 1979 to Weitzman. While these types of dental trays do allow for application of the medicament subgingivally, none of these references discloses a dental tray that applies positive pressure to the tooth or edentulous region associated with the infected area to assist in forcing the medicament into the infected site.

U.S. Patent No. 3,874,084, issued April 1 , 1975 to Cole, discloses a molded tooth cleansing and gingival therapeutic device that includes a plurality of bristles projecting inwardly from the inner walls of the upper and lower channels of a tray. The bristles are provided to clean food particles and bacteria from the surfaces of a user's teeth and the gingival crevices. The walls of the channels are of a sufficient thickness to form ridges or ledges extending away from the gingival lines. These ridges compress the gingiva to allow for cleansing of the gingival crevice between the teeth and gum and massaging of the free marginal gingival. However, the Cole device does not form a sufficient seal around the teeth and gums to allow for application of medicaments subgingivally. Thus, it is desirable to provide a dental tray and method for treatment of periodontal disease that provides a seal around teeth associated with the infected area to guide or force medication onto the surface of the teeth and subgingivally into the infected area. Such a seal also should assist in holding the medication in a desired location corresponding to the infected site. Such a tray and method of treatment also should be easily and conveniently administered by the patient, without special training or undue skill. Summary of the Invention

Accordingly, one object of the present invention is to provide an improved periodontal medicament delivery tray and method for treating periodontal disease providing a seal around each tooth or edentulous region associated with the infected area to guide or force medication onto the surface of the teeth and subgingivally into the infected area.

Another object of this invention is to provide such a periodontal medicament delivery tray and method of treatment that reduces the invasiveness of and the need for periodontal surgery.

Still another object of this invention is to provide such a periodontal medicament delivery tray and method of treatment that can be conveniently and easily implemented by the patient, without requiring special training or undue skill. Yet another object of this invention is to provide such a periodontal medicament delivery tray and method of treatment that impedes deterioration of the bone and gums, and promotes regeneration of supporting structures around the patient's teeth.

Another object of this invention is to provide such a periodontal medicament delivery tray that applies pressure from chewing or mastication to help to deliver or force the medicament to the source of the periodontal infection.

Another object of this invention is to provide such a periodontal medicament delivery tray that applies positive pressure around each tooth or edentulous region where periodontal disease is present to forcefully deliver medicament to the infected site below the gingiva. Still another object of this invention is to provide such a periodontal medicament delivery tray that can be used as a protective mouthpiece during athletic activities.

Another object of this invention is to provide a dental tray that can be used as an anti-bruxing or anti-clenching appliance.

Yet another object of this invention is to provide a dental tray that can be used as a mouthpiece to properly relate the lower jaw to the upper jaw, and relax muscles and decrease pressure on the jaw joints. These and other objects will become apparent to those skilled in the art in light of the following disclosure and accompanying drawings.

In accordance with the invention, generally stated, a tray fitted to at least some teeth of a patient's upper or lower arch is provided for the application of medications to the teeth and to adjacent gum tissue for treatment of periodontal disease. The tray is constructed from resilient material molded to conform to the teeth and gum tissue. The tray includes at least one recess formed to conform to the teeth. A seal surrounds the recess at a location corresponding to the patient's gum line for applying pressure at the patient's gum line when the patient's teeth are disposed in the recess. The recess contains a quantity of a medication. Upon installation of the tray on the patient's teeth, the medication is forced onto the surface of the teeth and subgingivally by the seal into any pockets in the patient's gums proximate the teeth. If desired, a propulsion agent can be disposed within the recess such that upon application of the tray onto the patient's teeth, the propulsion agent generates pressure within the recess so as to positively force the medication onto the patient's teeth and into any of the pockets in the patient's gums proximate the teeth.

Another aspect of the present invention is of a dental tray for delivering medicament subgingivally including a molded body that conforms to at least a portion of a patient's dentition and adjacent gingival tissue. The body has at least one recess formed therein that is adapted to snugly accommodate the crown portion of at least certain of the patient's teeth. A seal projects outwardly from the body and surrounds the recess at locations corresponding to the patient's gum line. The recess contains a quantity of medicament, whereby medicament is forced subgingivally by the seal and onto the patient's teeth when the patient's teeth are positioned in the recess.

A third aspect of the present invention is that of a method for applying medication to at least certain of a patient's teeth and to gums proximate said teeth. This method includes the steps of: making a female impression of the patient's teeth and adjacent gums supporting the teeth from a suitable hardenable material; making a male model of the patient's teeth and surrounding gums from the female impression, the male model being formed of a suitable hardenable material; at the intersection of the gums and at least certain of the teeth of the male model, removing a bead (i.e., a desired amount or quantity) of the hardenable material from the male model proximate the juncture of each of the teeth and the gum surrounding the teeth and/or between the teeth thereby to form at least one trough; forming a tray of moldable resilient material molded over the male model having at least one recess representative of the teeth with a quantity of said resilient material formed in the groove forming a seal; applying a mediation into the recess of the tray; and fitting the tray with the medication in the recess onto the patient's teeth thereby to force the medication into contact with the patient's teeth and into pockets in the gum proximate the juncture with the teeth.

Other objects and features will be apparent and in part pointed out hereinafter. Brief Description of Drawings

The objects of the invention are achieved as set forth in the illustrative embodiments shown in the drawings which form a part of the specification. In the drawings, FIG. 1 is a perspective new of the dental tray and mold of the present invention;

FIG. 2 is a bottom plan view of the dental tray;

FIG. 3 is a sectional view of a patient's tooth and adjacent soft tissue aid support structure;

FIG. 4 is a sectional side view of the dental tray showing the patient's tooth and gingiva disposed therein; and

FIG. 5 is a perspective view of an alternative embodiment of the dental tray and mold.; Corresponding reference characters indicate corresponding parts throughout the several views of the drawings. Best Mode for Carrying Out the Invention

The following detailed description illustrates the invention by way of example and not by way of limitation. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what I presently believe is the best mode of carrying out the invention.

Referring now to the drawings, and in particular to FIG. 1 , a periodontal medicament delivery tray is shown, designated generally by reference numeral 10, for delivering medicament subgingivally to an infected area or areas. FIG. 3 shows a sectional view of a patient's tooth 18 and adjacent gingiva 20. Pockets or gingival crevices 19 exist between the patient's gingiva 21 and the teeth 18. Bacteria enter into the epithelial attachment, periodontal ligaments 23, and supporting jaw or cortical bone 25 through the gingival crevice 19. Pocket depths for gingival crevices 19 in a healthy mouth typically range from 0.05 to 3 mm. The tray 10 of the present invention is adapted for use on patient's having periodontal disease with pocket depths greater than 3 mm. To create the dental tray 10 of the present invention, a dentist takes an exact female impression (not shown) of the dentition, edentulous regions 26 (if any) and adjacent periodontal tissues 20 for a particular prospective user of the tray 10. To create the impression, the dentist can use any conventional impression-taking technique. For example, the patient can bite into a container filled with a suitable hardenable material such as, for example, an alginate material. When the alginate hardens, an accurate copy of the teeth 18 and adjacent periodontal tissue is produced. A suitable hardenable material such as, for example, plaster or dental stone is poured into the impression to create a male model or mold 16 that includes teeth 22 and gums 24 which are representative of the patient's teeth 18 and adjacent soft tissue 20. The mold 16 can be made for some or all of the upper and/or lower teeth, at locations corresponding to the infected sites into which the medicament will be delivered. The mold 16 also can be made for edentulous regions , if present, to allow for application of medicament to the bone (see FIG. 5).

After the mold has fully cured, the dentist or technician uses a hand-held tool (e.g., a round dental bar of desired dimension in a dental handpiece or laboratory engine) to remove the desired amount of the stone or plaster material at locations corresponding to desired level at the patient's gingival or gum line. In other words, the dentist removes portions of the hardenable material from the model 30 at the intersections of at least certain of the teeth 22 and gum 24 on the mold 30. This creates one or more trough-like recesses or grooves 30 formed around the front and rear surfaces of affected teeth 22 at a gum line 28 of the mold 16 (FIG 5). In the model 16 shown in FIG. 1 , the trough 30 is formed at the front and rear gum line for each tooth, and extends around the exposed surfaces of the upper second molars of the mold 16 and is make to extend between the teeth interproximally. One trough 30 is made around each tooth 22 or group of teeth 22 or edentulous region 26 (FIG.5) where a seal 44 (discussed below) will be needed in the dental tray to force medicament subgingivally into the infected site or the bone. The troughs 30 preferably are formed around exposed surfaces of teeth 22 at the gum line 28, and do not extend into interproximal spaces 34 between adjacent teeth. Multiple grooves 30 can be formed at gum lines 28 of only certain teeth 22 or edentulous regions 26 corresponding to those that are affected by periodontal disease. Furthermore, the grooves 30 can be formed along only the front gum line or the rear gum line, if desired.

FIG. 5 shows an alternative embodiment of the present invention that includes model or mold 16' and tray 10'. Mold 16' is for a patient's upper arch having two edentulous regions 26a, 26b (referred to collectively as edentulous regions 26 at locations corresponding to the upper right second bicuspid and first molar and the upper left first and second molars, respectively. Troughs 30 are formed at the gum line 28 for the central, left lateral, left cuspid, and left first and second bicuspid teeth 18a, 18b, 18c, 18d, 18e and 18f, respectively. Trough 30 also is formed around edentulous region 26b. A partial upper dental tray 10' also is shown, with a seal 44 (discussed below) formed in the tray 10 for teeth 18a-18f and region 26b.

The dental tray 10 is a precise form fitted flexible tray, preferably constructed from a moldable resilient material, such as a suitable soft plastic elastomeric material. One such elastomeric material that works well for this purpose is a about 2 - 3 mm. thick layer of mouthguard material. The tray 10 is formed placing the heated tray material on the model 16, and then applying positive air pressure to the tray material on the mold, or using a suction or other suitable methods to cure the tray material. The resulting dental tray 10 is molded as a replica of the original impression of the patient's teeth and periodontal tissue. As discussed below, the tray 10 also includes one or more seals 44 formed at locations corresponding to the troughs 30 that are added to the mold 16 by the dentist. As shown in FIGS. 1 and 2, the dental tray 10 includes a molded body 42 having a substantially U-shaped configuration that conforms to the shape of the patient's dentition and adjacent soft tissue structures. The body 42 has form fitted recesses 40 therein that is adapted to snugly accommodate the crown portion of the patient's teeth 18. The tray 10 further includes a positive pressure seal of tray material formed in the trough of the model, with each positive pressure seal 44 that preferably surrounding at least a desired portion of one or more of the recessed areas 40. Thus, the seal 40 is formed at locations corresponding to the 30 in the mold 16. As shown in FIG. 2, the seal 44 projects outwardly from body 42 of the tray 10 at locations corresponding to the juncture of the patient's teeth and gums (gum line ). As discussed below, the seal 44 applies pressure at the patient's gum line when the patient's teeth 18 are disposed in the recess 40 to force medicament 45 disposed in, the tray subgingivally into any pockets in the patient's gums 20 proximate the teeth 18. The tray 10 is shown in FIGS. 1 and 2 to be a full upper arch tray 10, but those skilled in the art will appreciate that a lower arch tray 10, dual arch tray 10 or partial arch tray 10 can be used, if desired. Prior to applying a desired antimicrobal agent or other medicament or dental substance to the tray 10, the patient preferably inserts a small amount of a propulsion agent such as a gel-based antiseptic cleanser including hydrogen peroxide or other medicament preferably into the recess 40 of the tray 10. Then, an antimicrobal agent (e.g., a tetracycline solution) is placed in the tray 10 on top of the first medicament or propulsion agent. Alternatively, the antimicrobal agent can be included in a medicament that has a potential to provide pressure to force the medicament subgingival. Those skilled in the art will understand that a wide range of medicaments and propulsion agents can be used. For example, propulsion agents could include, but not be limited to, any one of the following peroxide compounds: peroxyl, gly- oxide, carbamide peroxide, peroxide containing materials, or any other agent that will undergo status altering processes providing a change in ambient or localized pressure gradients. Such peroxide based propulsion agents are preferably, but not necessarily in a gel-like state to allow for ease of application to the tray and to the teeth and gum surfaces. Examples of antimicrobial agents that may be used with this invention include any one or more of the following anti-infective agents: penicillin, cephalosporings, carbapenem, monobactams, chloramphenicol, quinolones, floroquinolones, teteracyclines, macrolides, spectinomycin, vancomycin, lincosamides, aminoglycosides, colistimethates, ploymyxin, bactracin, vovobiocin, metronidazole, sulfnonnamides, nitrofurans, methenamines, and folate antagonists. In addition, well known antiobiotic combinations may be used as well as antiviral, antiretrovirai, immunologic agents, anti-infective agents, astringeents, topical ointments or liniments, or other antibiotics. The medicament and antimicrobal agent are collectively referred to medication 45, and schematically illustrated in FIG. 4.

The patient then fits the tray 10 onto the patient's appropriate arch, depending upon whether the tray 10 is designed for the patient's upper or lower arch or both. The hydraulic action of inserting the teeth 18 snugly into the tray 10 within the recess 40 tends to move the medicament 45 toward the gingiva 20 of the patient's mouth. As the hydrogen peroxide or other medicament breaks down and generates pressure within the recess 40, the seal 44 directs the medication 45 to the region of the infection and helps hold the medication in the desired location. When the patient chews or bites the tray 10, mastication forces forcibly squeeze the medicament 45 along the teeth 18 and into the gingiva 20 into the infected site or to the bone. That is, as the seal 44 of the tray 10 applies pressure to the patient's gingiva 20 when the patient compresses his or her jaw on the tray 10, medicament 45 is forced onto the teeth 18 and gingiva 20 and into the gingival crevices. Gingival tissues 21 are compressed by the seal 44 as the patient closes his or her jaw against the tray 10 to expose at least a portion of the gingival crevices 19 and allow for application of the medicament 45 subgingivally into the pockets (see FIG. 4). At least a portion of the pockets is exposed when the gingiva 21 is compressed by the seal 44. Compression and release of the gingiva 21 by the seal 44 because of mastication pressure also stimulates and massages the patient's gingiva 20.

Thus, the dental tray 10 allows for application of medicament 45 subgingivally by the patient several times each day. The patient can adjust the dosage or frequency of medicament delivery, as directed by the dentist or health care professional. While this method for treating periodontal disease is closely monitored by the dentist, use of the dental tray eliminates the need for the patient to make time consuming visits to the dentist for application of medicament to the infected site. Using the tray 10 to apply antibacterial or antimicrobal medicament to the site of infection subgingivally impedes deterioration of the bone and gum, and promotes healing and regeneration of the supporting bone structures around the patient's teeth. In view of the above, it will be seen that the several objects and advantages of the present invention have been achieved and other advantageous results have been obtained.

The foregoing description is set forth only for illustrative purposes only and is not meant to be limiting. As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. Numerous variations, within the scope of the appended claims will be apparent to those skilled in the art in light of the foregoing description and accompanying drawings. For example, the dental tray also can be used as a nighttime anti-bruxing or anti-clenching appliance. Furthermore, the tray can be used to properly relate the lower jaw to the upper jaw. The tray relaxes muscles and decreases pressure on the jaw joints. When two dental trays are used simultaneously for the upper and lower arches, the trays allow for control of jaw position, and can be used as an anti-snoring device. The trays also can be used as a protective mouthpiece for sporting activities.

Claims

Claims:

1. A tray fitted to at least some teeth of a patient's upper or lower arch for the application of medications to the teeth and to adjacent gum tissue for treatment of periodontal disease, said tray being of resilient material molded to substantially conform to said teeth and gum tissue, said tray having at least one recess formed to conform to said teeth, a seal surrounding said recess at a location corresponding to the patient's gum line for applying pressure at the patient's gum line when the patient's teeth are disposed in the recess, said recess containing a quantity of a medication such that upon installation of said tray on the patient's teeth the medication is forced onto the surface of the teeth and subgingivally by the seal into any pockets in the patient's gums proximate said teeth.

2. The tray as set forth in claim 1 further including a propulsion agent disposed within said recess such that upon application of said tray onto the patient's teeth, said propulsion agent generates pressure within said recess so as to positively force the medication onto the patient's teeth and into any of said pockets in the patient's gums proximate said teeth.

3. The tray as set forth in claim 2 wherein said medication comprises an antimicrobal agent.

4. The tray as set forth in claim 2 wherein said propulsion agent is hydrogen peroxide.

5. The tray as set forth in claim 1 wherein said recess is defined by walls of said tray, said seal projecting outwardly from said walls such that the seal applies pressure to the patient's gums when the patient bites the tray.

6. The tray as set forth in claim 1 wherein said tray is constructed from a mold representative of the patient's teeth and surrounding gum tissue, said mold including at least one trough formed in the mold at a location corresponding to the patient's gum line, said seal being formed at a location corresponding to the trough of the mold.

7. A dental tray for delivering medicament subgingivally comprising a molded body that substantially conforms to at least a portion of a patient's dentition and adjacent gingival tissue, said body having at least one recess formed therein that is adapted to snugly accommodate the crown portion of at least certain of the patient's teeth, a seal projecting outwardly from said body and surrounding said recess at locations corresponding to the patient's gum line, said recess containing a quantity of medicament, whereby medicament is forced subgingivally by the seal and onto the patient's teeth when the patient's teeth are positioned in the recess.

8. A method of applying medication to at least certain of a patient's teeth and to gums proximate said teeth comprising the steps of:

(a) making a female impression of the patient's teeth and adjacent gums supporting said teeth from a suitable hardenable material;

(b) making a male model of the patient's teeth and surrounding gums from said female impression, said male model being formed of a suitable hardenable material;

(c) at the intersection of the gums and at least certain of the teeth of said male model, removing an amount of said hardenable material from said male model proximate the juncture of each of said teeth and the gum surrounding said teeth thereby to form at least one trough;

(d) forming a tray of moldable resilient material molded over said male model having at least one recess representative of said teeth with a bead of said resilient material formed in said groove forming a seal;

(e) applying a mediation into said recess of said tray; and (f) fitting said tray with said medication in said recess onto the patient's teeth thereby to force said medication into contact with said teeth and into pockets in the gum proximate the juncture with said teeth.

9. The method as set forth in claim 8 further including the step of compressing the patient's gums to expose at least a portion of said pockets when said tray is fitted onto the patient's teeth.

10. The method as set forth in claim 8 wherein said medication is an antimicrobal agent.

11. The method as set forth in claim 8 further including the step of applying a propulsion agent into said recess of said tray prior to fitting the tray onto the patient's teeth, said propulsion agent generating pressure within said recess so as to force the medication onto the patient's teeth and into the pockets in the patient's gums.

12. The method as set forth in claim 11 wherein said step of applying a propulsion agent comprises applying a hydrogen peroxide compound into said recess.

13. The method as set forth in claim 11 wherein said step of applying a propulsion agent comprises applying a hydrogen peroxide gel into said recess.