Oral appliance for delivering medicaments to orthodontic patients

Abstract

An oral appliance for delivering medicaments to teeth and gums which comprises a dental tray having a right side tray portion which abuts a left side tray portion at a central junction when worn by a subject. The tray portions include one or more recessed chambers formed in the interior of the trays which provide a space where a medicament can be retained when the appliance is worn by the subject.

Description

[0001] PATENT

[0002] Attorney Docket No.: SML-1017PCT

[0003] ORAL APPLIANCE FOR DELIVERING MEDICAMENTS TO ORTHODONTIC PATIENTS

[0004] INTRODUCTION / BACKGROUND

[0005] Periodontal disease is an infection of gum tissues of the mouth which is generally caused by bacteria. Various treatment methods are available depending on the type and seriousness of a subject’s condition, including surgery (to reduce the depth of the gingival sulcus) and systemic antibiotic treatment. However, local treatment with antibacterial or antimicrobial agents is advantageously used when more invasive or systemic treatments can be avoided or are not indicated.

[0006] Several methods have been developed for non-invasively delivering medicaments to an infected site below the gingiva in order to treat periodontal disease. One such method is the use of a dental tray for holding a medicament, such as the tray marketed under the trade name Perio Protect. Medicaments are placed in the tray, and the tray is then worn over the portion of a user’s mouth where the medicament is needed. There remains a need however for improved ways to treat gum disease and to apply substances to teeth and gums topically, in particular for subjects undergoing orthodontics.

[0007] SUMMARY

[0008] Described herein is an oral appliance for delivering a medication to teeth and gums of a subject wearing braces. The appliance comprises a generally U-shaped dental tray formed from a right side tray portion and a left side tray portion, with the right side tray portion and the left side tray portion being separate components. Each tray portion includes a receptacle on an interior surface for receiving teeth of the subject, as well as a lingual wall, a buccal wall, and a posterior wall. Each of these walls has a proximal end adjacent to the receptacle and a distal end, and each wall extends apically from the proximal end to the distal end. The buccal wall and the lingual wall are connected by the posterior wall at a posterior portion of the tray portion.

[0009] The lingual wall and the buccal wall are adapted to extend over the gums of the subject and beyond a bony height of contour of teeth adjacent to the lingual wall and the buccal wall when the appliance is worn. The distal ends of the lingual wall, the buccal wall, and the posterior wall are PATENT

[0010] Attorney Docket No.: SML-1017PCT adapted to form a seal between the tray portion and the gums of the subject. Each tray portion further includes a central edge in an anterior portion, and one or more chambers between the seal of the buccal wall and the receptacle. Each chamber includes an interior surface and an interior volume for retaining the medication. The chambers are positioned on a buccal side of the tray portion adjacent to embrasure spaces of the subject’s teeth when the appliance is worn and are sized to accommodate braces of the subject. When worn by the subject, the central edge of the right side tray portion abuts the central edge of the left side tray portion in order to facilitate retention of medication within the chambers of both tray portions. The one or more chambers of the right side tray portion or the left side tray portion may be a single chamber.

[0011] The trays further include a seal formed at the distal ends of the walls which is adapted to extend distally beyond the bony height of contour of the subject’s teeth, preferably by between 3 mm and 7 mm, and in some embodiments by about 5 mm. The receptacle is preferably adapted to intimately contact occlusal surfaces of the teeth of the subject and thereby inhibit a flow of the medication between the buccal side and the lingual side of the tray portion through the receptacle. The one or more chambers are preferably elastically deformable such that applying pressure to exterior surfaces of the chambers urges the medication into the receptacle. The medicament may be a liquid, gel, or paste, and the right side tray portion and the left side tray portion may be formed from an elastomeric material.

[0012] Also included is a method of treating periodontal disease that includes using the oral appliance by placing the medication into the one or more chambers of the right side tray portion and placing the right side tray portion in the subject’s mouth, and placing the medication into the one or more chambers of the left side tray portion and placing the left side tray portion in the subject’s mouth. Placement of each tray portion can include first placing the lingual wall into the subject’s mouth and onto the subject’s teeth, applying pressure to the buccal wall to deform it elastically outwardly in order to widen the distance between the buccal wall and the lingual wall, and then urging the buccal wall over braces of the subject, thereby placing the tray portion over the subjects’ teeth and gums in order to apply the medicament. To remove the trays, pressure is applied to the buccal wall of each tray portion to deform it elastically outwardly and widen the distance between the buccal wall and the lingual wall, followed by urging the tray portion away from the subject’s teeth. Removal thereby is not prevented by the orthodontic brackets or wires (braces) worn by the subject. The appliance can be used to treat periodontal disease. PATENT

[0013] Attorney Docket No.: SML-1017PCT

[0014] BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. l is a top, left side perspective view of an embodiment of the present appliance.

[0016] FIG. 2 is a bottom plan view of the appliance of FIG. 1.

[0017] FIG. 3 is a front elevation view of another embodiment of the present appliance.

[0018] FIG. 4 is a top plan view of the appliance of FIG. 3.

[0019] FIG. 5 is an exploded, top plan view of the appliance of FIG. 3.

[0020] FIG. 6 is a cutaway view of a portion of the present appliance showing a medicament chamber.

[0021] FIG. 7 is the cutaway view of FIG. 6 showing the appliance applied to the teeth of a subj ect wearing braces.

[0022] FIG. 8 is a cutaway view of an illustration of a tooth and gums of a subject.

[0023] The reference numbers in the figures have the following meanings: PATENT

[0024] Attorney Docket No.: SML-1017PCT PATENT

[0025] Attorney Docket No.: SML-1017PCT

[0026] DETAILED DESCRIPTION

[0027] Definitions

[0028] As used herein, the following terms and variations thereof have the meanings given below, unless a different meaning is clearly intended by the context in which such term is used.

[0029] “About” and “approximately” refer to a quantity which is within 10% of a stated quantity, preferably within 5% of the stated quantity. PATENT

[0030] Attorney Docket No.: SML-1017PCT

[0031] “Abut” refers to a relative positioning of two components of the present appliance, in particular the right side tray portion and the left side tray portion, in which the components are immediately adjacent to each other and contact each other over at least a portion of the adjacent surfaces of the right side tray portion and the left side tray portion when the appliance is worn by a subject. Preferably, more than 50%, more than 70%, more than 80%, or more than 90% of the adjacent surfaces are in contact when the appliance is worn by a subject.

[0032] “Anterior” and “front” mean in the direction of or toward or adjacent the front portion (opening) of a subject's mouth. “Back” and “posterior” mean in the direction of or toward or adjacent the rear portion of a subject's mouth.

[0033] “Apical” refers to a direction toward the root of a tooth of a user of the present appliance when the appliance is worn, i.e., toward the apex of the tooth. When referring to a dental tray worn on maxillary dentition, apical will refer to an upward direction when worn by a subject in an upright position, and when referring to a dental tray worn on mandibular dentition, apical will refer to a downward direction when worn by a subject in an upright position.

[0034] “Bony height of contour” refers to the upper extent (in maxillary teeth) or lower extent (in mandibular teeth) of tooth tissue which is exposed and not covered by gum tissue.

[0035] “Braces” refer to the components of a fixed orthodontic appliance, which generally comprise brackets which are attached to a subject’s teeth with dental adhesive and are connected with a thin wire.

[0036] “Buccal” means in the direction of or toward a subject's cheek. In relation to a subject's teeth, this refers to the side of the teeth facing the cheek.

[0037] “Chamber” refers to a partially enclosed space or compartment, and specifically to the recesses formed in the present appliance.

[0038] “Cementoenamel junction” or “CEJ” refers to an anatomical border identified on a tooth where the enamel, which covers the anatomical crown of a tooth, and the cementum, which covers the anatomical root of a tooth, meet.

[0039] “Concave” as used herein refers to an inwardly extending surface which forms an interior space. As applied to the medicament chambers of the present appliance, concave surfaces refer to inwardly extending surfaces which may or may not be curved or spherical.

[0040] “Dental tray” refers to a structure comprising a receptacle for receiving the maxillary or mandibular teeth of a subject, generally a U-shaped structure. PATENT

[0041] Attorney Docket No.: SML-1017PCT

[0042] “Downward” and “downwardly” mean in the direction of or toward a lower portion of a subject's body. “Upward” and “upwardly” mean in the opposite direction, i.e. in the direction of or toward an upper portion of a subject's body.

[0043] “Elastomeric” refers to a material that can return to its original shape after being deformed under conditions normally experienced by the present appliance during application and wear by a subject.

[0044] “Embrasure space” refers to the generally V-shaped spaces between adjacent teeth, i.e. the area adjacent to the interproximal contact area between tooth and gum. In subjects with receding gums, the embrasure space may include a sulcus and the CEJ of a tooth.

[0045] “Horizontal,” refers to a plane or direction which is approximately perpendicular to the sagittal and / or the coronal plane of a subject, and / or to a plane or direction which is approximately perpendicular to a surface on which a subject is supported.

[0046] “Labial” means in the direction of, toward, or adjacent to a subject's lips. In relation to a subject's teeth, this refers to the side of the front teeth facing the lips.

[0047] “Lateral” refers to a position at or toward a left side or left side of the present appliance.

[0048] “Lingual” means in the direction of, toward, or adjacent to a subject's tongue. In relation to a subject's teeth, this refers to the side of the teeth facing the tongue.

[0049] “Lower” refers to the relative position of a component in the present appliance which is closer to or toward a lower portion of a subject's body when the component is being used.

[0050] “Mandibular” refers to the lower jaw.

[0051] “Mandibular dentition” refers to the teeth of the lower jaw.

[0052] “Maxillary” refers to the upper jaw.

[0053] “Maxillary dentition” refers to the teeth of the upper jaw.

[0054] “Medicament” and “medication” refer to a substance that can be used for a medical treatment or which has a therapeutic effect. In some embodiments, the substance which is placed into the receptacle of the present appliance can be a substance having a cosmetic or other nonmedical use or effect. The use of such a non-therapeutic substance is understood to be included when the term “medicament” is used herein unless otherwise indicated.

[0055] “Occlusal surface” refers to the biting surface of a tooth or to the corresponding surface of a dental tray, i.e. to a lower exterior surface of an upper dental tray or to an upper exterior surface of a lower dental tray. PATENT

[0056] Attorney Docket No.: SML-1017PCT

[0057] “Outward” means in a direction away from an interior portion of the present appliance.

[0058] “Recess” refers to an area of the present appliance formed in an inner wall of the receptacle of the appliance which comprises a space for retaining a medicament. “Recessed” refers to surface which extends away from another surface so as to form a space having an interior volume. Recesses include an opening which provides access to the interior volume of the space.

[0059] “Soft plastic” refers to a polymer material which is elastically deformable, such as ethylene vinyl acetate (EVA). The soft plastics used for the present appliance are non-toxic and compatible for use in a human subject’s mouth.

[0060] “Subject” refers to a user of the present appliance, usually a human user.

[0061] “Sulcus” refers to an area of space (or potential space) between a tooth and the surrounding gingival tissue. A relatively deeper sulcus is commonly referred to as a “pocket.”

[0062] “Upper” refers to the relative position of a component in the present appliance which is closer to or toward an upper portion of a subject's body when being used.

[0063] “Vertical” refers to a plane or direction which is perpendicular to a horizontal plane or direction.

[0064] The terms "above," "below," "between," “interior,” “exterior,” and other terms of relative position or orientation as used herein refer to a relative position of one component of the present appliance in relation to another.

[0065] The term “comprise” and variations of the term, such as “comprising” and “comprises,” are not intended to exclude other additives, components, integers or steps. The terms "a," "an," and "the" and similar referents used herein are to be construed to cover both the singular and the plural unless their usage in context indicates otherwise. Ranges which are described as being “between” two values include the indicated values.

[0066] Appliance

[0067] The appliance of the present invention is a device for locally delivering medicaments or other substances to the gum and tooth tissue of a subject, in particular the gingiva, cementum, dentin, and / or enamel, of either or both of the maxillary and mandibular dentition. The present appliance 10 comprises at least one dental tray 15, which can be an upper tray fitted to a subject’s maxillary dentition, a lower tray fitted to the subject’s mandibular dentition or both an upper and PATENT

[0068] Attorney Docket No.: SML-1017PCT lower tray. The trays 15 of the present device are generally U-shaped and comprise a right side 12, a left side 14, a buccal side 13, a lingual side 15, an anterior portion 16, a posterior portion 18, and an exterior surface 17.

[0069] Each tray 15 includes two tray portions 70, a right side tray portion 72 and a left side tray portion 74, which together cooperate to deliver medicaments to a subject wearing braces. The right side tray portion 72 is worn over dentition on the right side of a subject’s mouth, while the left side tray portion 74 is worn on the left side of the subject’s mouth, and the two portions of the tray 15 are positioned adjacent to each other at a central junction 75 when the appliance is worn by a subject. The right side tray portion 72 has a right side central edge 71 which abuts a left side central edge 73 of the left side tray portion 74 so that the right side central edge 71 and left side central edge 73 are adjacent to each other and preferably contact each other over at least a portion of the surfaces of the right side central edge 71 and left side central edge 73 when the appliance is worn by a subject. Preferably, more than 50%, more than 70%, more than 80%, or more than 90% of the adj acent surfaces are in contact when the appliance is worn by a subj ect. Such contact forms a barrier or partial barrier and helps to prevent or limit the flow of medication from an interior of the tray, where it is needed, into a subject’s mouth, thus assisting in retaining the medication in areas of the appliance where it is needed.

[0070] Each tray portion 70 further includes a tooth-receiving receptacle 20 formed in an interior surface 19 of the tray 70 in order to fit a subject’s dentition. The receptacle 20 is configured to receive the teeth of a subject and to contact teeth on an interior surface 22. The receptacle includes an interior surface 22, a lingual side 27, and a buccal side 28. The surface of the receptacle 20 adapted to contact the occlusal surfaces of a subject’s teeth is referred to herein as the proximal or interior surface 22.

[0071] The tray further comprises lateral walls 30 extending from a proximal portion 36 adjacent the receptacle 20 apically to a distal portion 37 which extends over a user’s gum tissue when the appliance 10 is worn by a user. Each dental tray 15 includes a buccal wall 32 and a lingual wall 34, so as to cover the buccal and lingual sides of the subject’s teeth and gums. Specifically, the present appliance 10 includes a right side buccal wall 41, a right side lingual wall 42, a right side posterior wall 43 in the posterior portion of the right side of the tray, a left side buccal wall 51, a left side lingual wall 52, and left side posterior wall 53 in the posterior portion of the left side of the tray. The exterior portions of the tray portions 70 further comprise an outer surface formed on PATENT

[0072] Attorney Docket No.: SML-1017PCT the side of the tray opposite the receptacle 20, i.e. on the exterior of the tray 15.

[0073] In order to deliver a medicament to a subject, in particular a gel or liquid medicament, the medicament is placed in the receptacle 20 of the tray. The side walls 30 of the tray 15 are formed so as to be close to or in contact with the teeth and gum of a subject, and the distal end 37 of the buccal wall 32 and lingual wall 34 extend over the gum line. In particular, the distal end 37 of the buccal wall 32 and lingual wall 34 each extend over the bony height of contour 206 (Figure 8) of the teeth of a user of the present appliance 10, and are preferably in intimate contact with a user’s gingival tissue along the distal extents of each of the buccal wall 32 and lingual wall 34 so as to retain a medicament within the receptacle 20 of the appliance. Preferably, the distal ends 37 of each of the buccal wall 32 and lingual wall 34 extend distally of the bony height of contour 206 of all of a user’s teeth by between 3 mm and 7 mm, and the interior surfaces 19 of the buccal wall 32 and lingual wall 34 contact the surface of the user’s gingiva for between 3 mm and 6 mm between the bony height of contour 206 and the distal ends 37 of the buccal and lingual walls, preferably for about 5 mm.

[0074] The distal ends 37 of the buccal wall 32 and lingual wall 34 of each tray portion 70 preferably are joined in the posterior portion 18 of the tray portion by a posterior wall 33 and form a continuous wall structure between the buccal wall 41 and lingual wall 42, so that a seal 60 can be formed beyond the bony height of contour 206 of a subject’s teeth. The left side buccal wall 51 and the left side lingual wall 52 are connected by a left side posterior wall 53, and the right side buccal wall 41 and right side lingual wall 42 are connected by a right side posterior wall 43. This configuration allows a seal 60 to be formed at a distal end of the walls 30 on the interior surfaces of the walls in order to retain a medicament inside the receptacle 20 of the appliance.

[0075] The seal 60 is formed between the appliance and a subject’s gums, and preferably is formed by between 3 mm and 7 mm, such as about 5 mm, above the CEJ and / or the bony height of contour of the subject’s teeth when the appliance is worn. The seal 60 is generally placed at a distal end of the tray walls. Medications placed into the receptacle 20 and / or chamber 40 are generally retained in the interior of a tray portion 70 by the seal 60 and the close contact between the right side central edge 71 of the right side tray portion 72 and the left side central edge 73 of the left side tray portion 74.

[0076] In one embodiment, a second seal (comfort seal) can be formed at the distal end of the receptacle, i.e., between the receptacle 20 and the primary retaining seal 60, and the previously PATENT

[0077] Attorney Docket No.: SML-1017PCT described retaining seal 60 can be formed proximally with respect to the comfort seal. The comfort seal is formed by removing a depth of material of about 1 mm of the interior surfaces of the tray walls, i.e. the interior surfaces of the right side buccal wall, the right side posterior wall, the right side lingual wall, the left side buccal wall, the left side posterior wall, and the left side lingual wall, , so that a depth of material is removed from around the circumference of the interior of the receptacle 20.

[0078] In one or more areas of the interior surfaces of the tray walls 30 and / or the receptacle 20, one or more chambers or recesses 40 are formed. Each chamber 40 extends outwardly away from the area of a subject’s teeth, gums, and / or braces when the present appliance 10 is worn, such as by a distance of between about 3 millimeters (mm) and 7 mm, or about 5 mm, to provide a space where a medicament can be retained when the appliance 10 is worn by a subject. Preferably, the teeth adjacent to the chamber only make contact with the receptacle 20 on their occlusal surfaces, so that there is space for a medicament in the chambers 40 and so that there is room for teeth to move. The chambers 40 of the present appliance are formed in or adjacent to one or more of the right side buccal wall 41 and / or the left side buccal wall 51 and have an interior surface 45, which can be concave, and an interior volume.

[0079] Chambers 40 can be adapted to be located adjacent to an embrasure space between teeth of a user of the appliance when the appliance 10 is worn by a subject using the appliance. When the tray 15 of the present appliance is formed from an elastomeric material, the recess 40 can be pressed inwardly by a subject wearing the appliance in order to temporarily reduce the volume of the recess and urge a medicament into the adjacent space where tooth or gum tissue to be treated is located.

[0080] In one embodiment, a chamber 40 in the buccal wall (41 or 51) can extend from an anterior portion 16 of a tray portion 70 to a posterior portion 18 on the buccal side 11, adjacent to the brackets 300 and wires 302 of a subject’s braces. In this embodiment a single chamber is formed in which the adjacent teeth and gums of the subject are in fluid communication along the length of the chamber 40. In this embodiment, a chamber 40 is formed only on the buccal side 11 of a tray portion 70.

[0081] The medicament can be in any form which can be retained in the chambers of the appliance, such as a liquid, gel, paste, other fluid. The medicament can be any substance known for treating teeth or gums, including antimicrobial agents (such as hydrogen peroxide), antibiotics, sodium PATENT

[0082] Attorney Docket No.: SML-1017PCT fluoride (NaF), mono-fluoro-phosphate (MFP) stannous fluoride (SnF), and / or potassium nitrate (KNO3).

[0083] Method of Manufacture and Use

[0084] The present appliance can be formed from elastomeric materials, typically polymer materials, known to the art. One such material is ethylene vinyl acetate (EVA), though other polymer materials compatible for oral use can be used. In one embodiment, the appliance can be made from a laminate of two or more layers of material, in order to provide strength to the appliance. One such material is the vacuum forming material sold as PRO-FORM by Keystone Industries (Myerstown, PA), which is a soft EVA laminate having a thickness of 4 mm. Another such material is ERKOLOC-PRO, a bi-layer copolyester / polyurethane material having two layers and used for thermoforming.

[0085] In one embodiment, the present appliance can be formed by vacuforming the appliance on a model of a subject’s teeth. After a dentist or other care provider obtains an impression of the subject’s teeth (preferably with braces), the impression is used to form a model of the subject’s teeth and gums, and a polymer material is vacuum sealed around the model to form a dental tray as described herein. Model material is removed circumferentially from the area where the seal 60 is to be formed, and additional material is provided around the buccal tooth areas of the model where the chamber or chambers 40 are to be formed. Vacuum forming is then performed, for example by clamping a sheet of plastic material into a frame, heating the material to soften it and render it pliable using a heat source, lowering the sheet of material over the model and then pulling the sheet over the model with a vacuum on the other side of the mold.

[0086] When the present appliance is formed by vacuforming, a retaining seal 60 can be formed by removing a depth of material of about 3 mm from the model at a distance of between 3 mm and 7 mm distal of the cementoenamel junction of the subject’s teeth (on the model), where the material is removed from the right side buccal wall, the right side posterior wall, the right side lingual wall, the left side buccal wall, the left side posterior wall, and the left side lingual wall, as well as the posterior walls, i.e., a depth of material is removed from around the circumference of the interior of the tray. In this way, when the subject wears the present appliance, the tray walls will be adapted to grip the subject’s gums because the gums have a greater exterior surface area than the area of PATENT

[0087] Attorney Docket No.: SML-1017PCT the seal 60 along the interior surface of the seal.

[0088] Following the formation of a tray 15, the two tray portions 70 are separated into a right side tray portion 72 and a left side tray portion 74 by cutting through a central area of the formed tray in an anterior-posterior direction (or vice-versa) to separate the tray into two tray portions. The cut to separate the tray portions preferably removes a minimum amount material, for example by using a very thin diamond disc, so that the two tray portions intimately fit at the central junction 75 with the right side central edge 71 touching the left side central edge 73 to the greatest extent possible when the tray portions are both being worn by a subject.

[0089] In use, a medicament is placed in the interior of each portion 70 of the dental tray 15, such as in the receptacle 20 and specifically in the chamber 40. The right side tray portion 72 and left side tray portion 74 are then sequentially placed onto the subject’s teeth on the right or left side, as the case may be. In order to fit over braces on the subject’s teeth, a tray portion 70 can be rolled in, such as by placing the lingual wall 42 into the subject's mouth and onto the teeth first. Pressure can then be applied on the buccal wall 41 to elastically move it outwardly, e.g., by pulling the buccal wall outwardly, in order to widen the distance between the buccal wall 41 and the lingual wall 42 and provide a clearance space between the buccal wall 41 and the subject’s braces. The buccal wall 41 can then be moved upwardly over the braces, and removal of outward pressure on the buccal wall will allow the buccal wall to return to its original conformation and form a seal around the subject’s gums. To remove a tray portion 70, a subject can reach into the mouth and pull on the lingual wall 42 to apply pressure in a lingual direction, then roll the tray portion 70 outward (buccally) until it is removed from the mouth. In this way, the appliance rolls onto or away from the subject’s orthodonture and doesn’t grab brackets or wires.

[0090] If treatment of both upper and lower teeth and / or gums is desired, then an upper tray and lower tray are applied in this manner. Treatment of periodontal disease can be accomplished with the present appliance in this way, for example, through use of an appliance with chambers adjacent at least to any area of tooth of gum that has periodontal disease (e.g., pockets greater than 3mm). Medicaments are circulated in the chamber or chambers of the tray and placed into contact with an affected tooth or gingival sulcus.

[0091] The present appliance can also be used as an occlusal surface bruxism splint, covering the maxillary and / or mandibular teeth of a subject in order to reduce nighttime clenching and to prevent tooth wear and bone loss. Bruxism can cause bone loss to occur in the presence of bacteria, PATENT

[0092] Attorney Docket No.: SML-1017PCT so use of the present appliance to both treat infection and address bruxism can be highly beneficial to patients. In order to provide a bruxism splint, a clinician will evaluate a subject’s needs and determine an appropriate thickness for the occlusal portion 35 of the dental tray, in order to provide an appropriate amount of vertical separation between the maxillary and mandibular dentition.

[0093] The examples set forth herein are provided to illustrate certain concepts of the disclosure. The apparatus, devices, or components illustrated above may be configured to perform one or more of the methods, features, or steps described herein. Those of ordinary skill in the art will comprehend that these are merely illustrative in nature, and other examples may fall within the scope of the disclosure and the appended claims. Based on the teachings herein those skilled in the art should appreciate that an aspect disclosed herein may be implemented independently of any other aspects and that two or more of these aspects may be combined in various ways. For example, an apparatus may be implemented or a method may be practiced using any number of the aspects set forth herein. In addition, such an apparatus may be implemented or such a method may be practiced using other structure, functionality, or structure and functionality in addition to or other than one or more of the aspects set forth herein. The various features and processes described above may be used independently of one another, or may be combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure. In addition, certain steps or features may be omitted in some implementations. All patents, patent publications, and other publications referred to herein are incorporated by reference in their entireties.

Claims

PATENTAttorney Docket No.: SML-1017PCTWHAT IS CLAIMED IS:

1. An oral appliance for delivering a medication to teeth and gums of a subj ect wearing braces which comprises a generally U-shaped dental tray formed from a right side tray portion and a left side tray portion, the right side tray portion and the left side tray portion being separate components, wherein the right side tray portion and the left side tray portion each comprise:(1) a receptacle on an interior surface of each tray portion for receiving teeth of the subject;(2) a lingual wall, a buccal wall, and a posterior wall, wherein: a) the lingual wall, the buccal wall, and the posterior wall each have a proximal end adjacent to the receptacle and a distal end, b) the lingual wall, the buccal wall, and the posterior wall each extend apically from the proximal to the distal end, wherein the buccal wall and the lingual wall are connected by the posterior wall at a posterior portion of the tray portion, c) the lingual wall and the buccal wall are adapted to extend over the gums of the subject and beyond a bony height of contour of teeth adjacent to the lingual wall and the buccal wall, respectively, when the appliance is worn by the subject, and d) the distal ends of the lingual wall, the buccal wall, and the posterior wall are adapted to form a seal between the tray portion and the gums of the subject;(3) a central edge in an anterior portion of the tray portion; and(4) one or more chambers between the seal of the buccal wall and the receptacle, each of the chambers comprising an interior surface and an interior volume for retaining the medication, each of the chambers being positioned on a buccal side of the tray portion adjacent to embrasure spaces of the subject’s teeth when the appliance is worn by the subject and being sized to accommodate braces of the subject, wherein the central edge of the right side tray portion abuts the central edge of the left side tray portion when worn by the subject in order to facilitate retention of medication within the chambers of each of the right side tray portion and the left side tray portion.PATENTAttorney Docket No.: SML-1017PCT2. The oral appliance of claim 1, wherein the one or more chambers of the right side tray portion is a single chamber, or wherein the one or more chambers of the left side tray portion is a single chamber.

3. The oral appliance of claim 1, wherein the seal is adapted to extend distally of the bony height of contour of the subject’s teeth by between 3 mm and 7 mm.

4. The oral appliance of claim 3, wherein the seal is adapted to extend distally of the bony height of contour of the subject’s teeth by about 5 mm.

5. The oral appliance of claim 1, wherein the receptacle is adapted to intimately contact occlusal surfaces of the teeth of the subject and thereby inhibit a flow of the medication between the buccal side and lingual side of the tray portion through the receptacle.

6. The oral appliance of claim 1, wherein the one or more chambers are elastically deformable, and wherein applying pressure to the exterior surfaces of the one or more chambers urges the medication into the receptacle.

7. The oral appliance of claim 1, wherein the medicament is a liquid, gel or paste.

8. The oral appliance of claim 1, wherein the right side tray portion and the left side tray portion are formed from an elastomeric material.

9. A method of treating periodontal disease, comprising the steps of: obtaining the appliance of claim 1; placing the medication into the one or more chambers of the right side tray portion; placing the right side tray portion in the subject’s mouth; placing the medication into the one or more chambers of the left side tray portion; and placing the left side tray portion in the subject’s mouth.PATENTAttorney Docket No.: SML-1017PCT10. The method of claim 9, wherein: placing the right side tray portion in the subject’s mouth comprises first placing the lingual wall of the right side tray portion into the subject's mouth and onto the subject’s teeth, applying pressure to the right side buccal wall to deform it elastically outwardly in order to widen the distance between the right side buccal wall and the right side lingual wall, and then urging the right side buccal wall over braces of the subject, and placing the left side tray portion in the subject’s mouth comprises first placing the lingual wall of the left side tray portion into the subject's mouth and onto the subject’s teeth, applying pressure to the left side buccal wall to deform it elastically outwardly in order to widen the distance between the left side buccal wall and the left side lingual wall, and then urging the left side buccal wall over braces of the subject.

11. The method of claim 9, further comprising the steps of: applying pressure to the right side buccal wall to deform it elastically outwardly in order to pull it outwardly and widen the distance between the right side buccal wall and the right side lingual wall, then urging the right side tray away from the subject’s teeth without removal of the right side tray being prevented by brackets or wires worn by the subject, and applying pressure to the left side buccal wall to deform it elastically outwardly in order to pull it outwardly and widen the distance between the left side buccal wall and the left side lingual wall, then urging the left side tray away from the subject’s teeth without removal of the left side tray being prevented by brackets or wires worn by the subject.

12. Use of the appliance of claim 1 to treat periodontal disease.

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