Patent Description:
The present disclosure relates, in general, to dental devices for treatment and care of the teeth in an oral cavity, and more particularly, to a dental medicament applicator for treating interproximal caries and the like.

Dental caries, which are also referred to as tooth decay or cavities, are one of the most common and widespread persistent diseases in the oral cavity. When an individual eats certain food, bacteria in the oral cavity break down the food and produce acids that have the ability to seriously damage hard tissues of a tooth in the oral cavity. The result may be the formation of dental caries. In current clinical dentistry practice, interproximal caries are extremely difficult to treat due to the location of the dental caries between teeth. Previous efforts to address these issues have included various methods and devices for administering therapeutic agents within the oral cavity. For instance, <CIT> entitled "Dental Medicament Applicator" and filed in the name of Cav-Aid LLC (US) describes a method and device for delivering a therapeutic agent via a device affixed to the surface of a tooth, designed to release the agent over time and avoid the first pass effect, thus improving patient compliance and enabling localized treatment. <CIT> entitled "Method of Orally Administering a Treating Agent Over an Extended Period" and filed in the name of Irwin N. Boe (US) elaborates on methods of fixing a treating agent relative to at least one tooth and releasing it over an extended period, emphasizing device configurations such as reservoir-type carriers, coatings, and dissolvable matrices. <CIT> entitled "Method and Preparation for Administration to the Mucosa of the Oral or Nasal Cavity" and filed in the name of Teijin Limited (Japan) discusses mucosa-adhesive preparations for administering medicaments in the oral or nasal cavity, focusing on controlled release through a swelling adhesive matrix. However, despite these advancements, effectively treating interproximal caries remains a significant challenge. Accordingly, there is a need for improved systems and methods for effectively treating dental caries and, in particular, hard to reach interproximal caries.

The invention is defined by the attached set of claims. It would be advantageous to achieve systems and methods that would improve upon existing limitations in functionality with respect to treatment of dental caries and, in particular, interproximal caries. It would also be desirable to enable a mechanical-based and chemical-based medical solution that would provide simplified and accelerated treatment of interproximal caries. It would be further advantageous to enable a form factor-based solution that would provide for accurate delivery of substances for treating dental caries and, in particular, interproximal caries.

To better address one or more of these concerns, a dental medicament applicator is disclosed. In one embodiment of the dental medicament applicator, a placement device is sized for insertion at a dental site, such as an interproximal site. The placement device includes a central body and at least one matrix secured to the central body containing a topical substance, such as a fluoride-containing chemical agent, silver diamine fluoride, or a peptide-based chemical agent, for example. One or more wings extend from the central body to provide subterminal opposition surfaces to hold the placement device during placement. The one or more wings are non-active; that is, free of the topical substance. The active matrix, in response to being physically affixed to the dental site, delivers the topical substance at a controlled rate to the dental site while the placement device dissolves at a quicker controlled rate.

For a more complete understanding of the features and advantages of the present invention, reference is now made to the detailed description of the invention along with the accompanying figures in which corresponding numerals in the different figures refer to corresponding parts and in which:.

While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts, which can be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention, and do not delimit the scope of the present invention.

Referring initially to <FIG>, therein is depicted one embodiment of a dental medicament applicator that may be utilized to treat dental caries and interproximal caries, for example, which is schematically illustrated and designated <NUM>. A placement device <NUM> is sized for insertion at a dental site, such as an interproximal site. As shown, the placement device <NUM> includes a central body <NUM>, a wing <NUM>, and a wing <NUM>. The central body <NUM> may include a front <NUM>, a rear <NUM>, an upper end <NUM>, a lower end <NUM>, a lateral end <NUM>, and a lateral end <NUM>. The placement device <NUM> also includes a vertical axis <NUM> and a horizontal axis <NUM>, which includes a transverse axis <NUM> at the wing <NUM> and a transverse axis <NUM> at the wing <NUM>. The vertical axis <NUM> has a length LV and the horizontal axis has a length LH. The length LV may be about <NUM> to about <NUM> in some embodiments. The length LH may be about <NUM> to about <NUM>. The placement device may also have a thickness T of about <NUM> microns to about <NUM> microns.

The wing <NUM> includes a front <NUM>, a rear <NUM>, an upper end <NUM>, a lower end <NUM>, a proximal end <NUM>, and a distal end <NUM>. The wing <NUM> has a rectangular form, like a strip, in this embodiment, but it should be appreciated that the wing <NUM> may have other forms as well. Further, the wing <NUM> may be at least partially integrated with the central body <NUM> or the wing <NUM> may be integral with the central body <NUM>.

As shown in the illustrated embodiment, the wing <NUM> of the placement device <NUM> of the dental medicament applicator <NUM> includes the transverse axis <NUM> from the distal end <NUM> of the wing <NUM> through the proximal end <NUM> of the wing <NUM>. The transverse axis <NUM> has a transverse length LW1, which is sufficient to provide subterminal opposition surfaces <NUM>, <NUM>, <NUM>, <NUM> in which palmar surfaces of a thumb and an index finger can hold the wing <NUM> therebetween. Further, the transverse axis <NUM> provides a proximal viewing area <NUM> interposed between the central body <NUM> and the subterminal opposition surfaces <NUM>, <NUM>, <NUM>, <NUM>. The transverse length LW1 of the transverse axis <NUM> is greater than twice the mean width for a human tooth, which may be less than <NUM>. In some embodiments, the transverse length LW1 may be greater than <NUM> and in some other embodiments, the transverse length LW1 of the transverse axis <NUM> may be about <NUM> to about <NUM>. The wing <NUM> may also have a thickness T of about <NUM> microns to about <NUM> microns in some embodiments.

The wing <NUM> may include a structure similar to the structure of the wing <NUM>. More particularly, the wing <NUM> includes a front <NUM>, a rear <NUM>, an upper end <NUM>, a lower end <NUM>, a proximal end <NUM>, and a distal end <NUM>. The wing <NUM> has a rectangular form, like a strip, in this embodiment, but it should be appreciated that the wing <NUM> may have other forms as well. Further, the wing <NUM> may be at least partially integrated with the central body <NUM> or the wing <NUM> may be integral with the central body <NUM>.

As shown in the illustrated embodiment, the wing <NUM> includes the transverse axis <NUM> from the distal end <NUM> of the wing <NUM> through the proximal end <NUM> of the wing <NUM>. The transverse axis <NUM> has a transverse length LW2, which is sufficient to provide subterminal opposition surfaces <NUM>, <NUM>, <NUM>, <NUM> in which palmar surfaces of a thumb and an index finger can hold the wing <NUM> therebetween. Further, the transverse axis <NUM> provides a proximal viewing area <NUM> interposed between the central body <NUM> and the subterminal opposition surfaces <NUM>, <NUM>, <NUM>, <NUM>. The transverse length LW2 of the transverse axis <NUM> is greater than twice the mean width for a human tooth. In some embodiments, the transverse length LW2 may be greater than <NUM> and in some other embodiments, the transverse length LW2 of the transverse axis <NUM> may be about <NUM> to about <NUM>. The wing <NUM> may also have a thickness T of about <NUM> microns to about <NUM> microns in some embodiments.

The placement device <NUM>, which, as previously discussed, includes the central body <NUM> and the wings <NUM>, <NUM>, may include biodegradable materials, bioresorbable materials, or resorbable materials, for example. The placement device <NUM> may be a polymeric membrane or strip. By way of example and not by way of limitation, the placement device <NUM> may comprise a synthetic polymer or a natural polymer which may be at least one of polysacaccharides, lipids, polyisoprene, gum and proteins, or any mixture thereof. The natural polymer may be a protein selected from collagen and gelatin, for example. Preferably, the polymer is cross-linked, typically by at least one of glutaraldehyde, formaldehyde, glycol dimethacrylate, tannic acid, and allyl methacrylate. With respect to collagen, by way of example, collagen utilized in the placement device <NUM> may be untreated or treated with fixing agents to prolong its resistance to digestion. By way of further example, denatured collagen can be impregnated with chromium salts to enhance its tensile strength and retard its absorption. With respect to cross-linking a polymer, a polymeric matrices, such as gelatin matrices, have efficacy when texture is taken into consideration. Gelatin matrices, like collagen, may be lysine-cross linked with glutaraldehyde to address these issues.

Alternatively, the placement device <NUM> is made of an organic or natural material, such as a macromolecule like acidic proteins, glycoproteins or sulfated polysaccharides, or smaller molecules such as xylitol, polyaspartic acid or polyglutamic acid, for example. More particular examples of natural products include polysaccharide polymers (e.g., pullulan, agar, alginates, carboxymethylcellulose, carrageenan, cellulose, gellan gum, Kelcogel®, Kelcogel® F, Kelco Biopolymers, starches and retted flax extracts), lipids, polyisoprenes (e.g., latex rubber and gutta percha), resins and gums (e.g., tragacanth and storax) and proteins (e.g., alpha or beta chitin, soluble elastin and collagen or denatured collagen in the form of gelatin).

It should be appreciated, however, that a completely natural matrix of gelatin without cross-linking can also be utilized in the placement device <NUM>. Furthermore, natural cross-linkings are also feasible, for example calcium and hydroxylysin or leucine, dihydroxylysine or leucine, lysine, arginine, proteins, polysaccharides such as dextran, lipids such as sodium docusate and dehydrodihydroxylysine or leucine.

Synthetic products may also serve as a composition of the placement device <NUM> include homopolymers or copolymers with a wide molecular weight range formed by condensation, additional anionic, cationic, and/or catalytic polymerization systems. Examples of such synthetic products for use in the placement device <NUM> are acrylamide based polymers and a cationic monomer, cyanoacrylates, polycarbonates, polyurethane, polyester urethane dimethacrylate, polycaprolactones, ethyl triglycide methacrylate, polysulphides, povidone, polyacrylic methacrylic acid, acrylic and modifications such as poly(hydroxyethyl methacrylate), poly(methylmethacrylate) modified with small amounts of ethyl, butyl, or other alkyl methacrylates, polyethylene glycol, sodium polyacrylate PEG <NUM> and PEG <NUM>, and other carbomers. Some of these are indeed commercial or laboratory products such as polymethylvinylether-co-maleic anhydride and polyvinylether-co-maleic anhydride and polyvinyl pyrrolidone, carboxymethylcellulose, silated hydroxyethylcellulose or hydroxypropyl methylcellulose, hydroxy-propyl methyl cellulose (HPMC, including pharmacy grade HPMC), glycerin, and aqueous methacrylic polymer formulations for sustained and controlled release of dental and other products (e.g., Eudragit® Rohm). These polymers may require activators and cross-linking. However, other agents are at times required, for example retarding agents such as hydroquinone and eugenol. Other yet different examples are zinc eugenolate, petrolateum, and stearyl alcohol. Other gels may be included, such as Carbopol polymers or sodium-based solutions mixed with phosphoric acid and hydrofluoric acid.

The placement device <NUM> may also include, by way of example, and not by way of limitation, a starch-based polymer selected from the group consisting of native starches, modified starches, and thermoplastic starch polymers. The placement device <NUM> may also include, by way of further example, and not by way of limitation, at least one synthetic polymer selected from the group consisting of polyvinyl alcohols (PVOHs), polyester amides, polyester urethanes, aliphatic polyesters, aromatic polyesters, and copolymers of aliphatic polyesters and aromatic polyesters.

It is to be appreciated that the degree of cross-linking is of major significance to the rate of release of the active or auxiliary agents, including topical substances, that form a portion of the dental medicament applicator <NUM>. The determination of the degree of cross-linking of the polymeric matrix or matrices in the placement device <NUM> is informed by the desired application of the dental medicament applicator <NUM>. Examples of factors that may inhibit the biodegradation of the matrix or matrices include are the use of antimicrobial agents, preservatives, sterilizing agent inhibitors, such as inhibitors of matrix metalloptoteinases, and enzyme inhibitors, for example.

The matrices within the placement device <NUM> may be strengthened not only by cross-linking, but also by other techniques as well. Polymer composite compositions may be utilized in which the polymer fibers, e.g., collagen fibers and gelatin, are strengthened by adding particular catechol-containing compounds, particularly compounds which have two or more catechol groups, to the polymeric material and forming a polymer of the compounds that intercalate within the polymeric material, e.g., forming a polymer composite. The resulting polymer that forms may be a scaffold-like structure throughout the polymeric material without the necessity of cross-linking the individual polymeric materials, e.g., collagen or gelatin polypeptides. This scaffolding provides synthetic polymer fibers having a tensile strength, stiffness, and strain at failure that is comparable to or better than natural polymeric material fibers.

In some embodiments, at least one active matrix <NUM> is secured to the front <NUM> of the central body <NUM> and the at least one active matrix <NUM> contains a topical substance. The at least one active matrix <NUM> may have a length and width similar too, including smaller, than the central body <NUM>. With respect to thickness, the active matrix <NUM> may have a thickness or width W of about <NUM> microns to about <NUM> microns or <NUM> microns in some embodiments. The thickness of the dental medicament applicator <NUM> in some embodiments is therefore about <NUM> microns to about <NUM> microns. In other embodiments, the thickness of the placement device <NUM> and the active matrix <NUM> may be adjusted to provide a total thickness of about <NUM> microns to about <NUM>,<NUM> microns. It should be appreciated that the selection of the topical substance, which will be discussed in further detail hereinbelow, in the active matrix <NUM> impacts the thickness of the active matrix <NUM> and therefore the thickness of the placement device <NUM>.

The active matrix <NUM> may have a composition similar to that of the placement device <NUM>, which may include biodegradable materials, bioresorbable materials, or resorbable materials, for example. By way of example and not by way of limitation, the active matrix <NUM> may comprise a synthetic polymer or a natural polymer which may be at least one of polysacaccharides, lipids, polyisoprene, gum and proteins, or any mixture thereof. The natural polymer may be a protein selected from collagen and gelatin, for example. Preferably, the polymer is cross-linked, typically by at least one of glutaraldehyde, formaldehyde, glycol dimethacrylate, tannic acid, and allyl methacrylate. With respect to collagen, by way of example, collagen utilized in the active matrix <NUM> may be untreated or treated with fixing agents to prolong its resistance to digestion. By way of further example, denatured collagen can be impregnated with chromium salts to enhance its tensile strength and retard its absorption. With respect to cross-linking a polymer, a polymeric matrices, such as gelatin matrices, have efficacy when texture is taken into consideration. Gelatin matrices, like collagen, may be lysine-cross linked with glutaraldehyde to address these issues.

Alternatively, the active matrix <NUM> is made of an organic or natural material, such as a macromolecule like acidic proteins, glycoproteins or sulfated polysaccharides, or smaller molecules such as xylitol, polyaspartic acid or polyglutamic acid, for example. More particular examples of natural products include polysaccharide polymers (e.g., pullulan, agar, alginates, carboxymethylcellulose, carrageenan, cellulose, gellan gum, Kelcogel®, Kelcogel® F, Kelco Biopolymers, starches and retted flax extracts), lipids, polyisoprenes (e.g., latex rubber and gutta percha), resins and gums (e.g., tragacanth and storax) and proteins (e.g., alpha or beta chitin, soluble elastin and collagen or denatured collagen in the form of gelatin).

It should be appreciated, however, that a completely natural matrix of gelatin without cross-linking can also be utilized in the active matrix <NUM>. Furthermore, natural cross-linkings are also feasible, for example, calcium and hydroxylysin or leucine, dihydroxylysine or leucine, lysine, arginine, proteins, polysaccharides such as dextran, lipids such as sodium docusate, and dehydrodihydroxylysine or leucine.

Synthetic products may also serve as a composition of the active matrix <NUM> include homopolymers or copolymers with a wide molecular weight range formed by condensation, additional anionic, cationic, and/or catalytic polymerization systems. Examples of such synthetic products for use in the placement device <NUM> are acrylamide based polymers and a cationic monomer, cyanoacrylates, polycarbonates, polyurethane, polyester urethane dimethacrylate, polycaprolactones, ethyl triglycide methacrylate, polysulphides, povidone, polyacrylic methacrylic acid, acrylic and modifications such as poly(hydroxyethyl methacrylate), poly(methylmethacrylate) modified with small amounts of ethyl, butyl, or other alkyl methacrylates, polyethylene glycol, sodium polyacrylate PEG <NUM> and PEG <NUM>, and other carbomers. Some of these are indeed commercial or laboratory products, such as polymethylvinylether-co-maleic anhydride, polyvinylether-co-maleic anhydride, and polyvinyl pyrrolidone, carboxymethylcellulose, silated hydroxyethylcellulose or hydroxypropyl methylcellulose, hydroxy-propyl methyl cellulose (HPMC, including pharmacy grade HPMC), glycerin, and aqueous methacrylic polymer formulations for sustained and controlled release of dental and other products (e.g., Eudragit® Rohm). These polymers may require activators and cross-linking. However, other agents are at times required, for example, retarding agents such as hydroquinone and eugenol. Other yet different examples are zinc eugenolate, petrolateum, and stearyl alcohol. Other gels may be included such as Carbopol polymers or sodium-based solutions mixed with phosphoric acid and hydrofluoric acid.

The active matrix <NUM> may also include, by way of example, and not by way of limitation, a starch-based polymer selected from the group consisting of native starches, modified starches, and thermoplastic starch polymers. The active matrix <NUM> may also include, by way of further example, and not by way of limitation, at least one synthetic polymer selected from the group consisting of polyvinyl alcohols (PVOHs), polyester amides, polyester urethanes, aliphatic polyesters, aromatic polyesters, and copolymers of aliphatic polyesters and aromatic polyesters.

It is to be appreciated that the degree of cross-linking is of major significance to the rate of release of the active or auxiliary agents, including topical substances, that form the active matrix <NUM>. The determination of the degree of cross-linking of the polymeric matrix or matrices in the active matrix <NUM> is informed by the desired application of the dental medicament applicator <NUM>. Examples of factors that may inhibit the biodegradation of the matrix or matrices include the use of antimicrobial agents, preservatives, sterilizing agent inhibitors, such as inhibitors of matrix metalloptoteinases, and enzyme inhibitors, for example.

The matrices within the active matrix <NUM> may be strengthened not only by cross-linking, but also by other techniques as well. Polymer composite compositions may be utilized in which the polymer fibers, e.g., collagen fibers and gelatin, are strengthened by adding particular catechol-containing compounds, particularly compounds which have two or more catechol groups, to the polymeric material and forming a polymer of the compounds that intercalate within the polymeric material, e.g., forming a polymer composite. The resulting polymer that forms may be a scaffold-like structure throughout the polymeric material without the necessity of cross-linking the individual polymeric materials, e.g., collagen or gelatin polypeptides. This scaffolding provides synthetic polymer fibers having a tensile strength, stiffness, and strain at failure that is comparable to or better than natural polymeric material fibers.

The active matrix <NUM>, in response to being physically affixed to the dental site, delivers the topical substance at a controlled rate to the dental site. The topical substance may be a fluoride-containing chemical agent. By way of example, and not by way of limitation, the topical substance within the active matrix <NUM> may be any one of inorganic or organic fluoride-containing chemical agents, including sodium fluoride, stannous fluoride, stannous hexafluorozirconate, calcium fluoride, difluorosilane, hydrogen fluoride, sodium monofluorophosphate, ytterbium trifluoride, sodium hexafluorosilicate, ammonium fluoride, amine fluoride, and fluoroaluminosilicate glass, as well as any mixture thereof. The period of fluoridation required by the chemical agent is dependent on the type of fluoride, concentration, and period of delivery. It should be appreciated that other chemical or physical interventions and the type of surface or lesion being treated may also impact the period of fluoridation. Further, chronic toxicity due to fluoride (F) may be reached at <NUM> F/Kg of body weight. Thus, the weight of the patient impacts fluoride concentration as well. By way of example, and not by way of limitation, in applications where sodium fluoride is selected, the applicable concentration will be <NUM>% - <NUM>%. By way of further example, and not by way of limitation, the sodium fluoride will have a concentration of about <NUM>% to <NUM>% or, in further examples, the concentration may be <NUM>% to <NUM>%.

That is, with respect to fluoride, the active matrix <NUM> may have a topical substance having about <NUM> to about <NUM> of fluoride with some embodiments having about <NUM> to about <NUM>. It should be appreciated that the amount of fluoride may vary and, in general, a lower amount of fluoride in the topical substance will translate into a thinner active matrix and make placement easier in tight interproximal spaces.

In another implementation, the topical substance may be silver diamine fluoride. Silver diamine fluoride (SDF), a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children and those with special care needs. SDF has only recently become available in the United States. SDF may also have the name "silver-diamine fluoride" or "silver hydrazine fluoride. " SDF is frequently utilized as an aqueous SDF, <NUM>% to <NUM>% weight/volume, with <NUM>% weight volume being preferred in many cases, with a presentation as a light-sensitive liquid with ammonia odor and blue coloring having a specific gravity of about <NUM>. When the silver in SDF is applied to a dental site on a tooth, it oxidizes and leaves a black stain on the damaged cavity portion of the tooth and may cause staining in other areas of the oral cavity. Therefore, SDF must be delivered at a controlled rate to the desired dental site. The dental medicament applicator <NUM> accomplishes this goal as will be discussed in further detail hereinbelow.

As mentioned, the body <NUM>, in response to being physically affixed to the dental site, delivers the topical substance at a controlled rate to the dental site. The topical substance may be a peptide-based chemical agent. The peptide-based chemical agent may include, by way of example and not by way of limitation, polypeptides, or the composition may further comprise one or more other active agents suitable for an intended use, including but not limited to antimicrobial polypeptides (inhibiting bacterial infection), biomineralization-promoting polypeptides (i.e., any polypeptides that are useful for controlling or promoting biomineralization), inorganic material-binding polypeptides, three-dimensional scaffold-forming polypeptides, collagen, chitosan, amphiphilic peptides, protein-binding polypeptides, enamelin-derived polypeptides, tuftelin-derived peptides, statherin-derived polypeptides, dentin-derived polypeptides, bone sialoprotein-derived polypeptides, osteocalcin-derived polypeptides, osteopontin-derived polypeptides, proteins with caries inhibitory activity, casein, and bone morphogenetic-derived polypeptides.

By way of further example, and not by way of limitation, the topical substance, when including the peptide-based chemical agent, may be a combination of amelogenin, an inorganic or organic fluoride-containing chemical agent, an inorganic or organic calcium-containing chemical agent, and an inorganic or organic phosphate-containing chemical agent. By way of further example, and not by way of limitation, the topical substance may be at least one of amelogenin, an inorganic or organic fluoride-containing chemical agent, an inorganic or organic calcium-containing chemical agent, and an inorganic or organic phosphate-containing chemical agent.

Amelogenins are a group of protein isoforms produced by alternative splicing or proteolysis from the AMELX gene, on the X chromosome, and also the AMELY gene in males, on the Y chromosome. Amelogenins are involved in amelogenesis, the development of enamel. Amelogenins are type of extracellular matrix protein, which, together with ameloblastins, enamelins and tuftelins, direct the mineralization of enamel to form a highly organized matrix of rods, interrod crystal and proteins. As previously discussed, the inorganic or organic fluoride-containing chemical agent may be sodium fluoride, Stannous fluoride, Stannous hexafluorozirconate, calcium fluoride, difluorosilane, hydrogen fluoride, sodium monofluorophosphate, ytterbium trifluoride, sodium hexafluorosilicate, ammonium fluoride, amine fluoride, and fluoroaluminosilicate glass, as well as any mixture thereof.

By way of example, and not by way of limitation, the inorganic or organic calcium-containing chemical agent may be integrated into calcium phosphates, casein phosphopeptide/amorphous calcium phosphate nanocomplexes, casein phosphopeptide-amorphous calcium phosphate, octacalcium phosphate complexes, calcium phosphate crystal structures, dicalcium phosphate dihydrate-based compounds, calcium phosphate pastes, or in vitro calcium phosphate mineralizable compounds. Also, by way of example and not by way of limitation, the inorganic or organic phosphate-containing chemical agent may be integrated into calcium phosphates, casein phosphopeptide/amorphous calcium phosphate nanocomplexes, casein phosphopeptide-amorphous calcium phosphate, octacalcium phosphate complexes, calcium phosphate crystal structures, dicalcium phosphate dihydrate-based compounds, calcium phosphate pastes, or in vitro calcium phosphate mineralizable compounds.

As outlined hereinabove, the dental medicament applicator <NUM> consists of the placement device <NUM> including the central body <NUM> having the wings <NUM>, <NUM>. The active matrix <NUM> having the topical substance is connected to the central body <NUM>. Further, as discussed above, the placement device <NUM> and the active matrix <NUM> may be manufactured using a number of techniques appropriate to water-soluble polymers (synthetic, semi-synthetic, or natural) or polysaccharides including, but not limited to, as discussed above, polyethylene glycol, polyacrylamides, polyacrylic acid copolymer, polyvinyl alcohol, xanthan gum, pectines, chitosan derivatives, dextran, carrageenan, guar gum, hydroxy propyl cellulose, hydroxy ethyl cellulose, sodium carboxy methyl cellulose, and hyaluronic acid. Also, as previously discussed, with respect to polysaccharide polymers, pullulan, agar, alginates, carboxymethylcellulose, carrageenan, cellulose, gellan gum, Kelcogel®, Kelcogel® F, Kelco Biopolymers, starches and retted flax extracts are also suitable. Other examples of natural products that are suitable include lipids, polyisoprenes (e.g., latex rubber and gutta percha), resins and gums (e.g., tragacanth and storax) and proteins (e.g., alpha or beta chitin, soluble elastin, and collagen or denatured collagen in the form of gelatin).

Any method of sealing the water-soluble films, i.e., the active matrix <NUM> to the central body <NUM>, may be used during manufacturing. Such manufacturing methods include the use of an adhesive or heat sealing. Other methods include infra-red, radio frequency, ultrasonic, laser, solvent, and vibration and spin welding sealing. The seal desirably is water-soluble. A suitable heat-sealing temperature is, for example, <NUM> to <NUM>, especially <NUM> to <NUM>° C. A suitable sealing pressure is, for example, from <NUM> kPa to <NUM> kPa, especially <NUM> kPa to <NUM> kPa, more especially from <NUM> kPa to <NUM> kPa or from <NUM> kPa to <NUM> kPa, especially <NUM> kPa to <NUM> kPa, for example depending on the heat-sealing machine used. Suitable sealing dwell times are <NUM> to <NUM> seconds.

Using these techniques, the active matrix <NUM> is bonded to the central body <NUM> of the placement device <NUM> by simply applying water to the back of the active matrix <NUM> and then using pressure to adhere the active matrix to the central body <NUM>. Depending upon the desired composition of the active matrix <NUM>, an adhesive can also be substituted in lieu of water to moisten the active matrix <NUM> and then apply pressure to seal the active matrix to the central body <NUM>.

Referring now to <FIG>, in one operational embodiment, the dental medicament applicator <NUM> is being utilized within an oral cavity O having teeth T<NUM>, T<NUM>, T<NUM>, T<NUM>, T<NUM>, T<NUM>, T<NUM>, T<NUM>, T<NUM>, and T<NUM> as well as gum tissue G. The use of the dental medicament applicator does not form part of the claimed invention. Dental caries C, which represent the dental site, are located on an interproximal surface S of tooth T<NUM>. A dental professional having hands H is positioning the dental medicament applicator <NUM> with the use of the wings <NUM>, <NUM> in a direction of placement A between teeth T<NUM> and T<NUM>. Prior to the dental professional placing the dental medicament applicator <NUM>, various preparatory steps may have been taken. By way of example and not by way of limitation, an approach using dental separators to open the interproximal contact to allow the dental professional to more easily place the dental medicament applicator <NUM> may be utilized.

As best seen in <FIG>, the dental professional positions the placement device <NUM> of the dental medicament applicator <NUM> over the dental caries C, such that the active matrix <NUM> will contact the dental caries C. As shown, the proximal viewing areas <NUM>, <NUM> provide line-of-sight corridors <NUM>, <NUM> that are utilized to correctly position the central body <NUM> of the dental medicament applicator <NUM> such that the wings <NUM>, <NUM> are adjacent to the dental caries C and in position to contact adjacent or proximate dental surfaces. The subterminal opposition surfaces <NUM>, <NUM>, <NUM>, <NUM> provide multiple contact points for the dental professional or other user to position the dental medicament applicator - whether using hands or self-locking tweezers, for example - while the dental professional or other user utilizes the line-of-sight corridors <NUM>, <NUM> for visual confirmation of correct placement. As also shown, the wings <NUM>, <NUM> may have a different and greater transparency than the central body <NUM> to create visual distinction therebetween. Such visual distinction further assists in placement and demarcates the wings <NUM>, <NUM> which have an absence of the topical substance from the active matrix <NUM>, which includes the topical substance therein. Further, to assist with placement, the wings <NUM>, <NUM> have a larger surface area than the active matrix <NUM> to provide sufficient space for maneuvering the dental medicament applicator <NUM> within the mouth, including avoiding unwanted contact with the check and tongue. Additionally, the wings <NUM>, <NUM> are sculptable and may each be appropriately cut to optimize placement.

As best seen in <FIG>, once the body <NUM> of the dental medicament applicator <NUM> is correctly positioned and affixed to the dental site, the dental professional selectively contacts the wings <NUM>, <NUM> to contact adjacent or proximate dental surfaces. As best seen in <FIG>, the placement device <NUM>, in response to being physically affixed at the dental site, dissolves at a controlled rate, while the active matrix <NUM> delivers the topical substance at a controlled rate to the dental caries C during a slower dissolving which involves a gelatinous stage. The active matrix <NUM> is then bio-reabsorbed leaving a treated dental carie CT, which is best seen in <FIG>. In this manner the dental medicament applicator <NUM> provides simplified and accelerated treatment of interproximal caries that is targeted to a specific dental site, thereby mitigating the risk of undesired contact between the topical substance and other bone or tissue.

The dental medicament applicator <NUM> provides resorbable, water-based polymers that can be impregnated with fluoride or other materials such as silver diamine fluoride (SDF) or amelogenin peptides, and bonded together, along with multiple other possible polymer compounds and ratios that produce varied times of release of the fluoride and that also allow better adherence and longer presence of the medicated active matrix to the tooth. These resorbable, water-based polymers also have handling properties for the clinician that avoid crumbling upon insertion.

The dental medicament applicator <NUM> may be placed by either a dental professional or a consumer into the affected interproximal space by simply removing a fresh dental medicament applicator <NUM> from a sealed pouch, grasping the wings <NUM>, <NUM> between each thumb and forefinger, gently pulling the placement device <NUM> taut and sliding the placement device <NUM> with the active matrix <NUM> facing the dental caries into the interproximal space. The dental professional or consumer will center the active matrix <NUM> over the incipient lesion and then bend the wings <NUM>, <NUM> around the interproximal areas comprising mesial and/or distal tooth surfaces. Once released, saliva from the mouth or a couple of drops of water from an air/water syringe onto the wings <NUM>, <NUM> will start the dissolution and/or resorptive process. The wings <NUM>, <NUM> may be completely dissolve in about <NUM> to about <NUM> seconds, during which time the active matrix <NUM>, which may be fluoride-impregnated, will begin to become gelatinous and begin to release sodium fluoride into the area with the lesion. In some embodiments, the active matrix <NUM> will release fluoride for about <NUM> to about <NUM> minutes after which the matrix will completely dissolve.

Patients may then be evaluated for risk level which will determine frequency of treatment. If a patient has two or more incipient lesions, then such a patient may be considered high risk by dental guidelines. High risk patients may require reapplication every three months until the dental professional confirms that the lesions have been arrested. If the patient is determined to be normal risk, the dental medicament applicator <NUM> should be reapplied every six months during routine check-ups. The patient requires no monitoring and is free to go once the procedure has been accomplished.

Other embodiments of the dental medicament applicator <NUM> will now be presented in <FIG>. Referring initially to <FIG>, the dental medicament applicator <NUM> includes the central body <NUM> with the wings <NUM>, <NUM>, as well as the active matrix <NUM>. The wing <NUM> has a polygon form <NUM>, which is shown as an isosceles trapezium. Similarly, the wing <NUM> has a polygon form <NUM>, which is also shown as an isosceles trapezium. The embodiment of <FIG> and the following embodiments in <FIG> all show the dental medicament applicator <NUM> having the wings <NUM>, <NUM> with both subterminal opposition surfaces, such as the subterminal opposition surfaces <NUM>, <NUM> in <FIG>, and proximal viewing areas, such as the proximal viewing areas <NUM>, <NUM> in <FIG>. Each of these embodiments shows one of the many varied forms of the dental medicament application <NUM> that fall within the teachings presented herein.

Referring now to <FIG>, the dental medicament applicator <NUM> includes the central body <NUM> with the wings <NUM>, <NUM>, as well as the active matrix <NUM>. The wing <NUM> has a semi-elliptical form <NUM>. Similarly, the wing <NUM> has a semi-elliptical form <NUM>. Referring now to <FIG>, the dental medicament applicator <NUM> includes the central body <NUM> with the wings <NUM>, <NUM>, as well as the active matrix <NUM>. The wing <NUM> has a rectangular form <NUM>. Similarly, the wing <NUM> has a rectangular form <NUM>.

Referring now to <FIG>, in some embodiments of the dental medicament applicator <NUM>, a placement device <NUM> is sized for insertion at a dental site, such as an interproximal site. As shown, the placement device <NUM> includes a central body <NUM> having a front <NUM>, a rear <NUM>, an upper end <NUM>, a lower end <NUM>, a lateral end <NUM>, and a lateral end <NUM>. The body <NUM> also includes a vertical axis <NUM> and a horizontal axis <NUM>. A wing <NUM> includes a front <NUM>, a rear <NUM>, an upper end <NUM>, a lower end <NUM>, a proximal end <NUM>, and a distal end <NUM>. The wing <NUM> has the shape of a lobe <NUM> and includes subterminal opposition surfaces <NUM> and a proximal viewing area <NUM>. It should be appreciated that the embodiments of the dental medicament applicator <NUM> presented in <FIG> are exemplary and intended to show variations in the design of the dental medicament applicator <NUM>.

Relative terms, such as, but not limited to, "upper," "lower," "front," "rear," "lateral," "vertical," or "horizontal" have been used herein to describe one element's relationship to another element as illustrated in the figures. Such relative terms are intended to encompass different orientations of the device in addition to the orientation depicted in the figures and the use of such relative terms should not be construed as limiting. Further, the order of execution or performance of the methods and techniques illustrated and described herein is not essential, unless otherwise specified. The methods and techniques do not form part of the claimed invention. That is, elements of the methods and techniques may be performed in any order, unless otherwise specified, and that the methods may include more or less elements than those disclosed herein. For example, it is contemplated that executing or performing a particular element before, contemporaneously with, or after another element are all possible sequences of execution.

Claim 1:
A dental medicament applicator (<NUM>) comprising:
a placement device (<NUM>) sized for insertion at a dental site, the dental site being an interproximal site, the placement device (<NUM>) including a central body (<NUM>), a first wing (<NUM>), and a second wing (<NUM>);
the central body (<NUM>) having a front (<NUM>), a rear (<NUM>), an upper end (<NUM>), a lower end (<NUM>), a first lateral end (<NUM>), and a second lateral end (<NUM>);
the first wing (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), the first wing (<NUM>) being coupled to the first lateral end (<NUM>), the first wing (<NUM>) providing subterminal opposition surfaces (<NUM>, <NUM>, <NUM>, <NUM>) in which palmar surfaces of a thumb and an index finger can hold the first wing (<NUM>) therebetween, the first wing (<NUM>) having a transverse axis (<NUM>) from the distal end (<NUM>) to the proximal end (<NUM>), the transverse axis (<NUM>) having a transverse length (LW1) greater than twice the mean width for a human tooth, the first wing (<NUM>) being free of a topical substance for treating incipient lesions;
the second wing (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>), the second wing (<NUM>) being coupled to the second lateral end (<NUM>), the second wing (<NUM>) providing subterminal opposition surfaces (<NUM>, <NUM>, <NUM>, <NUM>) in which palmar surfaces of a thumb and an index finger can hold the second wing (<NUM>) therebetween, the second wing (<NUM>) having a transverse axis (<NUM>) from the distal end to the proximal end, the transverse axis (<NUM>) having a transverse length (LW2) greater than twice the mean width for a human tooth, the second wing (<NUM>) being free of the topical substance;
at least one active matrix (<NUM>) secured to the front (<NUM>) of the central body (<NUM>), the at least one active matrix (<NUM>) containing the topical substance;
each of the first wing (<NUM>) and the second wing (<NUM>) having a larger surface area than the at least one active matrix (<NUM>);
the placement device (<NUM>), in response to being physically affixed to the dental site, dissolving at a first controlled rate; and
the at least one active matrix (<NUM>), in response to being physically affixed to the dental site, delivering the topical substance at a second controlled rate to the dental site, the second controlled rate being slower in time than the first controlled rate.