Concurrent tooth repositioning and substance delivery

(Background of invention) The present invention generally relates to the fields of medical methods and devices. More specifically, the present invention relates to oral delivery of a substance at the same time as tooth readjustment.

Orthodontics involves repositioning teeth in the wrong dentition to improve meshing alignment in order to improve orthopedics and tooth function. Repositioning the tooth is achieved by applying a gentle, controlled force to the tooth over an extended period of time. Due to the limited space in the oral cavity and because some teeth must withstand widespread movement, teeth often go through a series of intermediate patterns to align correctly. For example, molars can temporarily move posteriorly (distal) to create ample space for incisor movement. Therefore, one patient may encounter an average of 25-30 steps or matching patterns before finally reaching the desired sequence.

Recently, it has been found that such repositioning can be achieved using a series of removable elastic positioning instruments. Such instruments include a thin shell of elastic material, which generally matches the patient's teeth, but is slightly inconsistent with the initial or previous tooth arrangement. When this elastic positioner is placed on the tooth, a controlled force is applied at a specific position to gradually move the tooth to the correct alignment. Repeating this process with a continuous instrument containing the new sequence eventually causes the tooth to go through a series of intermediate or matching patterns to the final desired sequence. A detailed description of a typical elastic polymer positioning device is described in Patent Document 1 and Patent Document 2 (which designates the United States and has been assigned to the assignee of the present application). The contents of both of these documents are incorporated herein by reference.

In addition to being easy to use, polymer positioning appliances are generally transparent and, due to the rigidity of the appliance, give considerable force to the teeth. The rigidity of elastic positioning instruments is a result of the modulus of elasticity of the thermoforming polymer material in which they are manufactured. The higher the elastic modulus of these materials, the greater the rigidity of the device. When a patient places such a device on a given group of teeth, one or more of those teeth provide the basis or anchor area for holding the positioning device in place. Due to the rigidity of the polymer material, an elastic repositioning force is generated in the remaining part of the tooth. By designing this device to cover the teeth, a much larger contact surface area is obtained compared to traditional spring holders and wire-based devices.

As mentioned above, these instruments are only effective in repositioning the teeth when placed on the patient's teeth. Removing this device for any reason interrupts the treatment plan and increases the overall treatment time. Therefore, removal of this device should be as small as possible for effective and timely treatment. However, many dental and periodontal treatments that patients desire or demand cannot be effectively utilized with the device in place. Such treatment may be treated by the dentist to improve oral hygiene or may be requested by the patient for orthopedic purposes.

Oral hygiene problems often include dentition, gingival inflammation and periodontitis. Fluoride can be largely prevented or blocked by fluoride treatment. Treatments include toothpaste, gels, rinses and varnishes. Gingival disease (eg, gingival or periodontitis) is caused by the growth of bacteria associated with plaque and tartar. The most commonly recommended to prevent the growth of such bacteria is to mechanically remove plaque from the tooth surface. However, in reality, many people who have adequate oral hygiene and plaque removal also suffer from chronic periodontitis and dentition. There may be many factors responsible for this, including genetic disease predisposition, illness, mouth breathing and medical procedure programs.

In such cases, bacterial control can be achieved using antibacterial agents. A common antibacterial agent that has been shown to be effective in reducing the activity of strains common to many oral flora is chlorhexidine. Chlorhexidine is a cationic biguanide fungicide and has a broad spectrum of activity against many forms of bacteria and fungi. Therefore, it has become a widely used reagent in many studies of periodontitis reversal. Chlorhexidine is traditionally delivered to the oral environment by using a rinse solution (eg, Peridex® (Procter and Gamble)). Sustained delivery to the gingiva has also been attempted using dental floss impregnated with chlorhexidine and dental instruments (eg, trays or mouthguards).

Another frequently prescribed antibacterial agent is tetracycline. Tetracycline is a broad spectrum antibiotic that is effective against virtually all common groups of pathogens (both Gram-positive and Gram-negative). Tetracycline can be combined with antifungal agents (eg, amphotericin) to confer activity against fungi. Tetracycline has traditionally been delivered to the oral environment by systemic administration, but uses dental instruments (eg, trays and mouthguards) loaded with tetracycline or a hollow fiber device filled with tetracycline inserted into the periodontal pocket. Local delivery has been attempted. In addition, a number of other antibacterial agents are available for dental and periodontal treatments.

Orthopedic treatments often include tooth bleaching or whitening and breath freshening products. Enamel and dentin discoloration is associated with aging, consumption of stains (coffee, tea, cola, tobacco), trauma, staining with systemic tetracycline (antibiotic) therapy, excess fluoride, neurodegeneration and old age. It can happen because of dental restoration. Bleaching dilutes these discolorations to give them a whiter or brighter appearance. Typically, the bleaching gel is placed in a thin custom tray that fits into the teeth. This tray is adhered at night, usually for 10-14 days, and may require regular rebleaching every 6 months for about 1 or 2 nights. Breath refreshing products are often used by patients to treat bad breath or to enjoy the taste sensation. These include various sprays, rinses, mint, gums or candies and the like.

Many of these therapies require access to the teeth and gingival margins, which are typically covered with elastic repositioning instruments during use. In addition, some of these treatments can best be given by topical delivery over long periods of time, which can significantly interrupt treatment planning with repositioning devices. For example, low-level delivery of antibiotics by sustained-release method is often desirable for treating periodontal disease. Similarly, treatments such as bleaching and whitening may require the above treatment plan to be interrupted for up to 2 weeks. Removing the device during these periods will increase its overall treatment period. In addition, many of these therapies require the use of specific devices, gels, rinses, coating tools and instructions (for the management of each therapy). These accessories can be expensive, bulky, or difficult to use. Although the removal of this device should be as small as possible, it should be removed during daily oral hygiene tasks (eg, brushing teeth and brushing teeth with dental floss). Similarly, this device can be removed from time to time when exercising or for ease (eg, during a meal). Temporary removal of these devices allows the patient to continue normal oral hygiene work, but periodontal disease and dental illness still occur because the teeth are covered with these devices for extended periods of time. The risk of getting sick can be high.

<p><patcit num="1"><text>U.S. Pat. No. 5,975,893</text></patcit><patcit num="2"><text>International Publication No. 98/58596 Pamphlet</text></patcit></p>

<p> It is desired to provide improved devices, systems and methods that utilize elastic repositioning instruments that can and / or improve dental and periodontal therapies simultaneously. Similarly, it is desired to provide devices, systems and methods that reduce or eliminate the need for additional accessories and / or protocols for applying such therapies. In addition, these devices, systems and methods should be economical and manageable. At least some of these objectives are met by the designs and methods of the invention described below.</p>

<p> To solve the above problems, the present invention provides, for example: (Item 1) A system that repositions teeth and releases reagents into the oral environment. At least three tooth positioning devices, wherein the device comprises a polymeric shell having a cavity, the shell is removable to the tooth, where the cavity of the continuous shell is. , A polymer shell that is shaped to reposition teeth from one sequence to the next; Means that release the reagent into the oral environment when the device is in place with teeth and are linked to at least a portion of the device. The system.</p><p> (Item 2) The system according to item 1, wherein the release means comprises a layer containing the reagent, and the layer is formed on at least a part of the surface of the instrument.</p><p> (Item 3) The system according to item 2, wherein the surface is a hollow surface.</p><p> (Item 4) The system according to item 2, wherein the surface is an outer surface.</p><p> (Item 5) The system according to item 2, wherein the layer is essentially composed of the reagents.</p><p> (Item 6) The system according to item 2, wherein the layer contains the reagent present in or on a carrier or binder.</p><p> (Item 7) The system according to item 2, wherein the reagent is encapsulated in the layer.</p><p> (Item 8) The system according to item 6 or 7, wherein the reagent contains the reagent microencapsulated in a polymer material.</p><p> (Item 9) The system according to item 7, wherein the layer contains a rate control substance, wherein the rate control substance controls the rate at which the reagent is released from the layer.</p><p> (Item 10) The system according to item 9, wherein the rate control substance contains a polymer matrix.</p><p> (Item 11) The system according to item 10, wherein the reagent is released from the layer by diffusion through the polymer matrix.</p><p> (Item 12) The system according to item 10, wherein the reagent is released from the layer by decomposition of the polymer matrix.</p><p> (Item 13) The system according to item 9, wherein the rate control substance is porous, and the reagent is released from the substance by elution from the pores.</p><p> (Item 14) In item 1, at least some of the polymeric shell is formed from a rate control substance, wherein the rate control substance controls the rate at which the reagent is released from the shell. Described system.</p><p> (Item 15) The system according to item 14, wherein the rate control substance contains a polymer matrix.</p><p> (Item 16) The system according to item 15, wherein the reagent is released from the layer by diffusion through the polymer matrix.</p><p> (Item 17) The system according to item 14, wherein the rate control substance is porous, and the reagent is released from the substance by elution from the pores.</p><p> (Item 18) The system according to item 1, wherein the releasing means comprises a reservoir formed in the shell in addition to the cavity for accommodating the teeth.</p><p> (Item 19) The system of item 18, further comprising a speed control membrane disposed on the reservoir, wherein the speed control membrane controls the rate at which the reagent is released from the reservoir.</p><p> (Item 20) The system of item 19, wherein the reservoir is prefilled with the reagents to be released.</p><p> 21. The system of item 19, wherein the reservoir can be replenished with the reagents released.</p><p> (Item 22) The system according to item 1, wherein the reagent contains a substance selected from the group consisting of fluorides, antibiotics, bleaches, flavoring agents and fragrances.</p><p> (Item 23) The system according to item 22, wherein the reagent contains at least two substances selected from the above group.</p><p> (Item 24) The system according to item 22, wherein the substance is a fluoride selected from the group consisting of acidified fluoride gel phosphate, neutral sodium fluoride, hydrogen fluoride and tin fluoride.</p><p> (Item 25) The system according to item 22, wherein the substance is an antibiotic selected from the group consisting of tetracycline and chlorhexidine.</p><p> (Item 26) The system according to item 22, wherein the substance is carbamide peroxide.</p><p> (Item 27) The system according to item 22, wherein the substance is a flavoring or fragrance selected from the group consisting of essential oils, natural flavoring and flavoring agents.</p><p> (Item 28) Oral appliances, below: A polymer shell, the polymer shell having a cavity, the polymer shell being shaped to fit into a finger-arranged tooth mold; and Means that release the reagent into the oral environment when the device is in place with teeth and are linked to at least a portion of the device. Oral appliances equipped with.</p><p> 29. The device of item 28, wherein the release means comprises a layer containing the reagent, the layer being formed on at least a portion of the surface of the device.</p><p> (Item 30) The device according to item 29, wherein the layer is essentially composed of the reagents.</p><p> 31. The device of item 29, wherein the layer contains the reagent present in or on a carrier or binder.</p><p> (Item 32) The device according to item 29, wherein the layer contains the reagent encapsulated in the layer.</p><p> (Item 33) The instrument of item 29, wherein the layer contains a rate control substance, wherein the rate control substance controls the rate at which the reagent is released from the layer.</p><p> (Item 34) In item 28, at least some of the polymeric shell is formed from a rate control substance, wherein the rate control substance controls the rate at which the reagent is released from the shell. Described equipment.</p><p> (Item 35) The device according to item 28, wherein the releasing means includes a reservoir formed in the shell in addition to the cavity for accommodating the teeth.</p><p> (Item 36) The device according to item 28, wherein the reagent contains a substance selected from the group consisting of fluorides, antibiotics, bleaching substances, flavoring agents and fragrances.</p><p> (Item 37) The apparatus according to item 36, wherein the reagent contains at least two substances selected from the above group.</p><p> (Item 38) Oral appliances, below: Polymer shells, the polymer shell having cavities, the polymer shell being removable and removable on the teeth; and A substance, which is a substance on or within the shell, which changes the visual characteristics of the shell in response to changes in the environment. Oral appliances equipped with.</p><p> (Item 39) The oral appliance according to item 38, wherein the visual feature is color.</p><p> (Item 40) The oral appliance according to item 38, wherein the substance is a dye, and the dye changes color in response to a temperature change.</p><p> (Item 41) A method of delivering a reagent to the patient's oral environment at the same time as repositioning the teeth, the method of which is as follows: The process of installing a first tooth position adjuster on a patient's tooth, where the tooth moves to the first tooth array; A step of installing a second tooth position adjusting device on a patient's tooth after moving the tooth to the first tooth arrangement, wherein the tooth is moved to the second tooth arrangement; The method in which the reagent is released into the oral environment from at least one of the first and second tooth positioning devices while the device is in place on the tooth.</p><p> (Item 42) The method of item 41, further comprising loading the first or second tooth positioning device with the reagent before placing the device on the tooth.</p><p> (Item 43) The method according to item 42, wherein the loading step comprises the step of inserting the reagent into the tooth containing cavity in the device immediately before the device is placed on the tooth.</p><p> (Item 44) The method according to item 42, wherein the loading step includes a step of putting the reagent into a reagent release reservoir in the device immediately before the device is placed on the tooth.</p><p> (Item 45) The method according to item 42, wherein the loading step includes a step of adhering a speed control substance containing the reagent to the surface of the device immediately before the device is placed on the tooth.</p><p> (Item 46) The method of item 42, wherein the loading step comprises the step of allowing a porous material on or in the appliance to absorb the reagent immediately prior to placing the appliance on the tooth. ..</p><p> (Item 47) The step of installing the first or second tooth position adjusting device is a step of periodically installing and removing the device until the tooth moves at least near the first or second tooth arrangement. 41, wherein the method further comprises the step of replenishing the reagent while removing the appliance from the tooth and before returning the appliance to the tooth. the method of.</p><p> (Item 48) The method according to item 47, wherein the instrument is replenished with the reagent each time the instrument is returned to the tooth.</p><p> (Item 49) The method of item 41, wherein each of the first and second instruments is preloaded with the reagents prior to placement on the teeth.</p><p> (Item 50) A method of introducing reagent delivery into a prescribed treatment regimen for repositioning teeth, the method of which is: A step of providing at least three tooth positioning instruments, wherein the instrument comprises a polymeric shell having a cavity, the instrument is removable and removable on the tooth, where a continuous shell. The cavity is shaped to reposition the teeth from one sequence to the next according to the treatment regimen, step; and A step of connecting a reagent to at least one device, wherein the reagent is released into the oral environment when the device is positioned by a tooth. Including, methods.</p><p> 51. The item 50, wherein the reagent incorporated is a layer, and the linking step comprises attaching the layer containing the reagent to at least a portion of the surface of the instrument. Method.</p><p> 52. The method of item 51, wherein the layer is essentially made from the reagent, and the attachment step comprises painting, spraying, dipping or coating the reagent on the surface.</p><p> 53. The method of item 51, wherein the layer contains the reagent present in or on a carrier or binder.</p><p> (Item 54) The method of item 51, wherein the layer comprises a reagent encapsulated in the layer.</p><p> (Item 55) The method of item 54, wherein the layer comprises a sheet of speed control material, wherein the speed control material controls the rate at which the reagent is released from the layer.</p><p> (Item 56) The method according to item 55, wherein the adhesion step comprises the step of bonding the sheet to the surface using an adhesive.</p><p> (Item 57) The method according to item 55, wherein the attachment step includes a step of attaching the sheet to the surface by press fitting.</p><p> (Item 58) The method of item 55, wherein the sheet is preformed into a shape adapted to fit the surface of the appliance or the surface of the tooth or gingiva.</p><p> (Item 59) A reagent delivery device used in combination with a dental instrument that fits in a tooth, and the device is as follows: A sheet, which is a preformed sheet of material that encapsulates the reagent, wherein the formation comprises a shape that is at least partially adapted to fit the surface of the dental instrument. A device that comprises.</p><p> (Item 60) The apparatus of item 59, wherein the substance comprises a rate control substance, wherein the rate control substance controls the rate at which the reagent is released from the layer.</p><p> (Item 61) The device according to item 60, wherein the speed control substance contains a polymer matrix.</p><p> 62. The device of item 61, wherein the reagent is released from the layer by diffusion through the polymer matrix.</p><p> (Item 63) The apparatus according to item 59, wherein the reagent contains a substance selected from the group consisting of fluorides, antibiotics, bleaching substances, flavoring agents and fragrances.</p><p> (Item 64) The device of item 59, further comprising an adhesive layer, wherein the adhesive layer binds the reagent delivery device to the device.</p><p> (Gist of the invention) The present invention uses a repositioning device (typically an elastic polymer shell) to provide, for example, dental and periodontal treatment and / or orthodontic treatment, while simultaneously delivering material to the tooth or gingiva. Provide devices, systems and methods for orthodontics. Such therapies traditionally involve the use of various accessories and devices, which are applied using separate instruments, materials, etc. The present invention eliminates the need for such additional devices by incorporating these therapies into repositioning devices. In addition, the ability to deliver therapeutic agents and other reagents is simultaneous with the process of repositioning procedures.</p><p> "Simultaneous" or "simultaneously" means that delivery of a substance or reagent to a tooth occurs for at least a portion of the duration of tooth repositioning. Therefore, this substance can be delivered continuously for the entire duration of this repositioning process, i.e., that this substance is released into the oral environment whenever this device is placed on the tooth. It may be present in or on each repositioning device in sufficient quantity to guarantee. Alternatively, the substance may be present in or on the repositioning device only at selected time points or over selected time intervals so that they are delivered at intervals within this repositioning time. For example, each continuous repositioning device may be preloaded with a bolus of this substance so that it is delivered to the patient at the beginning of each new device use. After exhausting its initial bolus, the material will not be delivered again until the next continuous instrument is used. As an alternative, the patient can apply a fixed amount of the substance at one time each day, in which case the substance will be released over a relatively short time interval and no further substance will be delivered until the next day. Many other specific patterns are also possible.</p><p> These instruments are specifically intended to reposition teeth, whereas in most cases when used in a multi-aligner system, in some cases without repositioning the teeth at the same time, the drug or It can be useful as a substance delivery device. In particular, many of the specific device configurations below are novel in their own right and useful for material delivery, and the present invention includes such devices.</p><p> In the first aspect of the invention, the oral delivery device comprises an elastic repositioning device, which supplies one or more substances or reagents for oral delivery. As described above, the elastic repositioning device contains a thin shell of elastic polymeric material, which has a cavity shaped to receive the teeth and elastically reposition from one sequence to the next. .. This is possible because the cavities are shaped to fit into a finger-shaped tooth mold in a continuous arrangement. A detailed description of a representative elastic repositioning device thus molded is described in US Pat. No. 5,975,893 and Published PCT Application WO 98/58596. When this elastic positioner is placed on the tooth, a controlled force is applied at a specific position to gradually move the tooth into a new shape. To apply sufficient force, this instrument generally covers the tooth surface and part of the gingival margin. Therefore, both the individual repositioning devices and systems of such elastic repositioning devices are on the underlying tooth surface and gingiva, which constitutes the oral environment while repositioning the teeth. It can be used to deliver reagents.</p><p> In the first embodiment, the oral delivery device delivers fluoride to the oral environment to prevent or treat rodents. Traditionally, fluoride has been delivered to the oral environment by using toothpaste, gels, rinses and varnishes. The present invention provides fluoride delivery that can be used in combination with traditional applications or can be replaced with specific applications. Such fluorides can be provided in a number of modes, such as neutral sodium fluoride, tin fluoride, hydrogen fluoride, or acidified fluoride phosphate (APF) gels. Fluoride can be releasably attached to this elastic repositioning device in a number of forms, as described in more detail in a later section, resulting in delivery to the oral environment.</p><p> In a second embodiment, the oral delivery device delivers an antibiotic or drug to the oral environment. In the case of antibiotics, delivery of such reagents can suppress or kill various microorganisms. Antibiotics often used to treat gingival and periodontitis include chlorhexidine and tetracycline. Such antibiotics can be releasably attached to this elastic repositioning device in a number of forms, resulting in delivery to the oral environment, as described in more detail in later sections.</p><p> In a third embodiment, the oral delivery device delivers the bleaching material to the oral environment. Tooth bleaching is a common plastic surgery that patients request from a dentist. A bleaching formula containing a whitening agent or a commercially available tooth whitening agent (eg, Nite White Excel, Opalescence or Nu-Pro) Gold) can be releasably attached to this elastic repositioning device in a number of forms, as described in more detail in a later section, resulting in delivery to the oral environment. Suitable active substances for whitening are selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxy acids and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, calcium peroxide, carbamide peroxide and mixtures thereof. Carbamide peroxide is most preferred. Suitable metal chlorites include calcium chlorite, barium chlorate, magnesium chlorate, lithium chlorite, sodium chlorite and potassium chlorite. Additional whitening activators can be hypochlorite and chlorine dioxide. A preferred chlorite is sodium chlorite. This tooth whitening active substance is present in an amount of about 0.01% to about 40% by weight of the substance. If a peroxide compound is selected as the active material, the peroxide compound may be from about 0.5% to about 10% by weight, most preferably from about 1% to about 10% by weight. An amount of hydrogen peroxide equivalent should be supplied. To deliver this amount of hydrogen peroxide equivalent, the peroxide compound (eg, carbamide peroxide) is generally about 0.1% to about 30% by weight, preferably about 3% by weight of the substance. It is present in an amount of ~ about 25% by weight. Typically, these active substances are gelling agents useful in the present invention, such as carboxymethyl cellulose, carboxypolymethylene, carboxypropyl cellulose, poroxamer, carrageenan, silica and natural rubbers (eg, karaya gum, xanthan gum, etc.). It is formulated in a highly viscous aqueous or non-aqueous gel formulated from guar gum, carrageenan and mixtures thereof). The level of gelling agent forming this gel composition is about 0. It is 1% by weight to about 15% by weight, preferably about 1% by weight to about 10% by weight. Suitable wetting agents in the present invention include glycerin, sorbitol, propylene glycol, polyethylene glycol and other food grade polyhydric alcohols. Typically, the wetting agent is present in an amount of about 10% to about 95% by weight, preferably about 20% to about 80% by weight of this material. A pH regulator may be added to optimize the stability of this gel and to make it safe for hard and soft tissues in the oral cavity. Suitable pH regulators include sodium hydroxide, sodium bicarbonate, sodium carbonate, hydrochloric acid, phosphoric acid, citric acid and combinations thereof.</p><p> In a fourth embodiment, the oral delivery device delivers a breath freshener to the oral environment. Breath refreshers are commercially available as a number of flavoring and flavoring agents, including mint and fruit flavoring flavors, which are derived from essential oils and / or natural or synthetic flavorings. Such expiratory coolers can be releasably attached to this elastic repositioning device in a number of forms, as described in more detail in a later section, resulting in delivery to the oral environment.</p><p> In the second aspect of the invention, at least a portion of the elastic repositioning device in the tooth repositioning system is coupled with a means of releasing the reagent into the oral environment when the device is placed on the tooth. Such means may include a layer containing this reagent. This layer can be formed on at least a portion of the surface of this repositioning device. These surfaces include a cavity surface, a surface that contacts the teeth when in a predetermined position within the cavity, and an outer surface, and a surface of the appliance that contacts the cheeks and lips when in a predetermined position. This layer can be composed of various substances and can take various forms. For example, this layer can essentially consist of this reagent. In other words, this reagent can be attached directly to the surface of the polymer shell of an elastic repositioning device. It uses a number of methods (eg, spraying, painting and / or dipping) to apply the reagent itself (which is optionally in an inert carrier or diluent) to this surface. It can be achieved by applying. When the repositioning device is placed on the patient's teeth, the reagent can be released into the oral environment.</p><p> Alternatively, the layer may contain reagents that are present in or on the carrier or binder, which facilitates adhesion or adhesion to the instrument and / or reagents from it. Creates a matrix that can be released by diffusion or dissolution. In one embodiment, the reagent is dissolved in the carrier or binder. In this case, the reagent is provided in powder or similar form and can be dissolved in a liquid solvent. The result can be a solution, which can be applied to the surface of the shell, typically by spraying, painting and / or dipping, to form a coating or coating. When the repositioning device is placed on the patient's teeth, the reagent can be released from this coating into the oral environment. Release is by activation or deactivation of this carrier, or by other release mechanism (eg, an enzyme or protein in saliva). Release is also obtained, for example, by degradation of the carrier upon contact with saliva. In some cases, the binder or carrier may evaporate when applied to this layer, leaving the reagent on its surface. In these cases, the reagent can be released in a manner similar to when attached directly to the surface as described above. It can be understood that any reagent, in particular fluoride, antibiotics, bleach and breath refreshing agents, can be delivered to the oral environment in this way.</p><p> In another embodiment, the reagent is encapsulated or suspended in this layer. Common substances for reagent suspensions include semi-solid substances (eg, gels, jellies or putties). Such materials can be applied to the surface of the shell by spraying, painting and / or dipping to form a coating or coating. Here, as is the case in all cases, suspension is not limited to scientific definition and can mean any situation in which the carrier holds, contains, supports or contains reagents. Alternatively, or in addition, this semi-solid material can be deposited in the cavities of a polymer shell shaped to receive teeth. These cavities can be filled to any desired level. When this repositioning device is positioned on the tooth, the tooth comes into direct contact with the semi-solid material in the cavity, moving any excess material as the tooth is inserted into the cavity. Therefore, it is desirable to fill these cavities to a level that avoids excessive outflow of material from this instrument. Delivery of reagents by using semi-solid suspensions is common, for example, in bleaching and fluoride treatments. However, such treatments apply this material using trays or general appliances that do not apply repositioning forces to the teeth. By improving the repositioning device as described above, orthodontic treatment can be continued from beginning to end of delivery of such reagents. In this way, it can be understood that any reagent, in particular fluoride, antibiotics, bleach and breath refreshing agents, can be delivered to the oral environment.</p><p> Other substances commonly used for reagent encapsulation or suspension include controlled release substances. Therefore, the layer may be composed of a rate control material, where the rate control material controls the rate at which this reagent is released from the layer. The controlled release substance or rate controlled substance delivers a predetermined amount of reagent at a predetermined rate. Often, such deliveries maintain constant concentrations of reagents in the environment within the desired therapeutic range for extended periods of time. Therefore, a given dosage can be delivered. In addition, the ability to sustain delivery eliminates the need for repeated application of this reagent to deliver doses to the oral environment.</p><p> Although such controlled release materials can be supplied as semi-solid materials (eg, gels, jellies or putties) as described above, these materials are also solids attached to the polymeric shell of this repositioning device. It can be supplied as a substance. One controlled release material comprises a polymeric matrix membrane in which finely dispersed particles of the reagent are suspended. This reagent can diffuse through this matrix membrane according to a concentration gradient. Alternatively, or in addition, the reagent can be released by decomposition of this polymeric matrix membrane material. In either case, the controlled release material can be supplied as a sheet that can be laminated to the surface of the shell. The controlled release sheet can be layered with an elastomer polymer and vacuum formed in a mold to form this repositioning device. This controlled release material can be arranged as present on the inner or outer surface of the device, depending on the material and the desired application. Alternatively, the controlled release sheet may, after formation, be laminated or bonded to the surface of the polymeric shell to provide reagent delivery in the desired region. Alternatively, the controlled release material can be delivered as a tablet or similar mass, which can be inserted into the polymeric shell of this repositioning device. The reagent can then elute from the tablet into the oral environment over an extended period of time.</p><p> In another embodiment, the reagent can be retained in the pores of a substance and can be eluted from the pores at a controlled rate. The reagent can itself be absorbed into the pores of this substance, or the reagent can be suspended in carriers absorbed within the pores of this substance. In the latter case, the reagent can be released from the carrier by diffusion and / or by controlled degradation of the carrier material. It may incorporate a rate control mechanism in addition to the controlled release of reagents from these pores. As mentioned above, in some cases, enzymes in the patient's saliva either activate this release or break down the carrier material to release this reagent. It is understood that this reagent can be released by combining any of these release methods.</p><p> In yet another embodiment, the polymeric shell of the repositioning device itself comprises a controlled release material containing this reagent. In this case, at least some of the polymeric shells in the tooth repositioning system are formed from a controlled release material, where the controlled release material controls the rate at which this reagent is released from the shell. To do. As described above, this controlled release material may be provided in the form of a sheet. Therefore, the sheet of controlled release material can be vacuum formed with the patient's tooth mold to form the repositioning device itself. In this way, no additional elastomeric material may be required to form this instrument. This controlled release material can be a polymeric matrix membrane, a porous material of any suitable material. The controlled release can be designed so that the elution rate of this reagent corresponds to the tooth repositioning rate. The reagent elutes from beginning to end of this repositioning process and it is concluded that the teeth have reached the desired sequence defined by this instrument.</p><p> In yet another embodiment, the release means coupled to at least a portion of this repositioning device includes a cavity formed in the shell of the device in addition to a cavity that receives the teeth. Typically, the reservoir is provided with a velocity release membrane, where the velocity release membrane controls the rate at which the substance is released from the reservoir. The reservoir can be prefilled or loaded with the reagents or substances to be delivered. In this case, the device may be ready for insertion or use upon removal from any packaging without the need to load the device with delivery reagents. If the release means is designed for a single delivery period, the device may wear out during the predetermined repositioning period and then be discarded. If the release means is designed for multiple delivery periods, the reservoir may be replenished with reagents to release at any number of times over a predetermined repositioning period. In this way, it can be understood that any reagent, in particular fluoride, antibiotics, bleach and breath refreshing agents, can be delivered to the oral environment.</p><p> In some cases, it may be desirable to alter the visual characteristics of the polymeric shell of the oral appliance. Such appliances include a polymeric shell, which has a removable shaped cavity in the tooth, and on or within this shell a substance that alters the visual characteristics of that shell. Have. Such changes are typically responsive to changes in this environment. In some cases, this visual feature is color (eg, green, red or blue). Therefore, the device may appear colored or may appear to a particular color under certain environmental conditions (either in the oral environment or upon removal). The material described can be a dye that changes color in response to changes in temperature. For example, the dye can change color when the device is removed from the mouth and the temperature changes from body temperature (37 ° C) to room temperature (25 ° C). Similarly, the dye can change color when the device is rinsed with cold water.</p><p> In the fourth aspect of the present invention, there is provided a method of repositioning a tooth and simultaneously delivering a reagent to the patient's oral environment. For example, one method comprises the step of placing a first tooth position adjusting device on a patient's tooth, where the tooth moves to the first tooth array. After removing the first instrument, the patient's teeth are fitted with a second tooth position adjusting instrument, where the teeth move to the second tooth array. At the same time as repositioning the teeth, reagents or substances are released into the oral environment from at least one of the first and second tooth positioning devices while the device is in place on the patient's teeth.</p><p> This appliance can be preloaded with this reagent and can be ready for use when removed from any packaging, but unfilled or unloaded appliances are loaded before or just before the appliance is placed on the tooth. It may be necessary. Loading may include the step of placing this reagent in the tooth-receptive cavity. As described above, these cavities can be filled to any desired level. When the instrument is positioned on the tooth, the tooth comes into direct contact with the reagents in the cavity as it is inserted into these cavities. Alternatively, loading may include placing the reagent on a reagent release reservoir on the device just prior to placing the device on the tooth. The reagent then elutes from the reservoir into the oral environment when the instrument is in place on the tooth. Its elution rate can be controlled by a controlled release membrane, which separates this reservoir from the surrounding environment. Loading can also include the step of attaching a rate control material containing this reagent to the surface of the appliance prior to placing the appliance on the tooth. Such a substance may contain a polymer matrix membrane, which may be removable or permanently attached to the polymeric shell of the instrument in the area desired for delivery of this reagent. And finally, loading may include the step of allowing the porous material on or in the appliance to absorb the reagent immediately prior to placing the appliance on the tooth.</p><p> Tooth repositioning using a positioning device involves the placement of this device on the tooth. However, this instrument is regularly removed to perform daily tooth hygiene and other tasks from beginning to end of its repositioning protocol, at least until the tooth has moved closer to the desired tooth arrangement. While the device is being removed from the tooth, the reagent or substance to be delivered may be replenished to the device. Replenishment can be performed immediately prior to each replacement of this appliance in the tooth, or can be performed according to any predetermined protocol.</p><p> A fifth embodiment of the present invention provides a method of introducing reagent delivery until a predetermined tooth repositioning treatment has been made. The treatment plan is determined by the orthodontist or physician at the beginning of the orthodontic treatment. The scheme includes the step of moving the tooth through a series of intermediate arrangements or arrangements to the final desired arrangement using a system of tooth positioning instruments. Each instrument contains a polymeric shell with cavities, which shells can be detachably placed on the teeth, where the continuous shell cavities place the teeth from one array to the next according to this treatment plan. It is shaped to change its position. At the start of treatment, a full series of instruments may be provided, or a subset of instruments may be provided. In any case, the need or requirement for delivering the reagent to the oral environment can occur at any time during treatment. In such cases, reagents and / or means of releasing the reagents into the oral environment can be linked to the device at any time during treatment.</p><p> Means for releasing this reagent may include a number of embodiments, including any means as described above. Typically, the means for releasing the reagent comprises a layer containing the reagent, as described above, and the linkage comprises the step of attaching the layer to at least a portion of the surface of the instrument. .. If this layer consists essentially of this reagent, adhesion can involve painting, spraying, dipping or simply applying the reagent to the surface of the instrument. Therefore, the preformed instrument can be painted with this reagent prior to insertion into the patient's mouth. If this layer contains reagents that are present in or on top of the carrier or binder, attachment may involve attaching the carrier or binder to the surface of the instrument. Similarly, if the reagent is encapsulated in a layer, the layer can be attached to the surface of the instrument. The layer may comprise a sheet of rate control material, where the rate control material controls the rate at which this reagent is released from the layer. In this case, the sheet can be bonded to the surface of the instrument using an adhesive. Alternatively, the sheet can be attached to this surface by press fitting. The sheet and the surface, respectively, can be shaped so that they snap together or fit together when pressed together. For example, the sheet may have a molded overhang, and the surface may have a molded insert, where the overhang fits into the insert when pressed onto the insert and the sheet. Is held in place. In many cases, the device can be porous or have a reservoir, which will contain the desired reagents at any time the treating physician and / or patient has determined to be appropriate. Can be loaded. For example, an instrument can be immersed in a solution of this reagent, which will be able to absorb or adsorb the reagent at a particular point in time.</p><p> In addition, the sheet can be preformed into a shape adapted to attach to the surface of the instrument or the surface of the teeth or gingiva. For example, the sheet may be preformed, especially along the gingival margin, to reflect the shape of the surface of one or more teeth or gingiva. The preformed sheet can then be held in contact with its surface when the sheet is attached to the instrument and the instrument is placed on the tooth. The connection can involve any means of attaching this sheet to the device. In particular, the preformed sheet may further include an adhesive layer, which allows the sheet to be bonded to the surface of the instrument.</p>

<figref num="1">FIG. 1 is a schematic view of a typical elastic repositioning device.</figref><figref num="2">FIG. 2 is a cross-sectional view of the repositioning instrument of FIG. 1 along line 2-2, which has a reagent-containing layer on its surface.</figref><figref num="3">FIG. 3 is a cross-sectional view of an instrument having a semi-solid substance containing a reagent applied to its surface.</figref><figref num="4">FIG. 4 is a cross-sectional view of an instrument having a cavity filled with a semi-solid substance containing a reagent.</figref><figref num="5">FIG. 5 illustrates layering a sheet of controlled release material containing reagents with a polymeric sheet for use in the formation of oral delivery devices.</figref><figref num="6">FIG. 6 illustrates the attachment of controlled release material to the polymer shell of the instrument and the insertion of the controlled release tablet into a portion of the polymer shell.</figref><figref num="7">FIG. 7 illustrates a reservoir-type release means having a sealed end.</figref><figref num="8">FIG. 8 illustrates a user-friendly reservoir-type release means so that the reservoir can be replenished with reagents.</figref><figref num="9">FIG. 9 is a cross-sectional view of an instrument having a binding material and a releasably bound reagent applied to its surface.</figref><figref num="10">FIG. 10 is a cross-sectional view of an instrument composed of a controlled release material containing reagents.</figref><figref num="11">FIG. 11 illustrates a gradual color change that changes from transparent to colored as the temperature of the instrument changes.</figref><figref num="12">Figure 12 illustrates the use of colorants or dyes localized in specific areas; some examples of streaks formed with this instrument and colorants applied to the surface are shown.</figref><figref num="13">FIG. 13 illustrates the positioning of the instrument of the invention on the patient's teeth.</figref><figref num="14">FIG. 14 is a perspective view of the preformed sheet 60 of the reagent-containing substance, which may have a contoured shape that fits in contact with the surface of the instrument.</figref><figref num="15">FIG. 15 is a perspective view of the preformed sheet of FIG. 14 fitted on the outer surface of the instrument.</figref><figref num="16">FIG. 16 is a side view of the preformed sheet containing the reagent, along with a side view of the instrument that can be joined, the sheet being contoured to fit in contact with the surface of the tooth and gingiva.</figref><figref num="17">FIG. 17 is a side view of the preformed sheet and instrument of FIG. 16 joined with an adhesive layer.</figref>

Other issues and advantages of the present invention, along with the accompanying drawings, will become apparent from the following detailed description.

(Description of a specific embodiment) The oral delivery device of the present invention includes an elastic repositioning device, which simultaneously provides orthodontic repositioning force and dental therapy. FIG. 1 depicts a typical elastic repositioning device 10 used in orthodontic treatment. The instrument 10 includes a polymeric shell 12 having a cavity 14, which is shaped to accommodate teeth and elastically reposition from one tooth arrangement to the next. Instrument 10 is preferably a suitable elastomeric polymer (eg, Tru-Tain 0.03 inch thermoforming dental material (Tru-Tain Plastics, Rochester, MN) or Essix A-Type or Essix B-Type thermoforming material (Raintree-). Essix, New It is made of a thin sheet of Orleans, LA)). An overall method of making gradual alignment is provided in US Pat. No. 5,975,893, the content of which is previously incorporated herein by reference. However, in general, the shell 10 is typically manufactured by heating a thermoformable polymeric sheet and by vacuum forming or pressure forming the sheet on the tooth members of the mold. Therefore, the shell 12 directly represents the characteristics of this mold. If the device 10 is worn by the patient as a step in orthodontic repositioning, the shell 12 is preferably (but not required) supported by all the patient's teeth or dental arch. Fits the characteristics of the teeth. The teeth to be repositioned are slightly displaced by this instrument so that they can be moved by applying force to the desired position.

Dental and periodontal therapies are performed simultaneously with such elastic repositioning devices so as not to interfere with orthodontic treatment while treating other illnesses. Such therapies include fluoride treatments to treat or prevent rodents, antibiotic or drug therapies to treat gingitis and periodontitis, bleaching and / or bad breath to improve the orthopedic appearance of teeth. Breath refreshing for the treatment of periodontal disease. In addition, such elastic repositioning devices may also contain substances that alter the visual characteristics of the shell in response to changes in the environment, as previously mentioned.

Each of the therapies identified above involves one or more therapeutic agents delivered to the oral environment. The present invention provides a tooth positioning device linked to a means for releasing one or more of these therapeutic agents into the oral environment. The therapeutic reagents identified above include various forms of fluoride (eg, neutral sodium fluoride and tin fluoride), various antibiotics (eg, chlorhexidine and tetracycline), and bleaching ingredients (eg, excess). Oxidized carbamide) and breath refreshing agents or flavoring agents, but not limited to these. The means for releasing this reagent may include a number of embodiments.

In one embodiment, the means for releasing this reagent into the oral environment comprises a layer containing the reagent formed on at least a portion of the surface of the polymeric shell. Such a layer may contain reagent 15 itself. It is illustrated in FIG. 2, which has a cavity 14 (which is shaped to accommodate and elastically reposition teeth) and a reagent 15 attached to its surface. A cross-sectional view of the molecular shell 12 (along 2-2 in Figure 1) is depicted. It can be understood that the description of this reagent is for illustrative purposes only and does not necessarily reflect the actual shape, size relationship or distribution of the reagent particles. This applies to all depictions of the following reagents. Such attachment or formation of this layer can be achieved by applying reagent 15 to the surface of the shell 12 by a number of methods (including spraying, painting and / or dipping). Therefore, when the oral delivery device 20 is placed on the patient's teeth, this reagent can then be released into the oral environment. As shown in FIG. 2, when reagent 15 adheres to the inner surface of instrument 20, it may come into direct contact with the teeth and / or gingiva. This may best be suitable for treatments that help with direct contact with the teeth and / or gingiva (eg, fluoride therapy or antibiotic therapy). However, other treatments (eg, breath refreshing) can be most beneficial as they adhere to the outer surface of the device 20. Thus, reagent 15 may adhere to any or all surfaces of instrument 20.

In another embodiment, this layer contains reagent 15 that is present in the carrier or binder. The usual carrier for a suspension of reagents is a semi-solid material (eg, gel, jelly or putty). As depicted in FIG. 3, such semi-solid material 22 can be applied to the surface of the shell 12 by spraying, painting and / or dipping to form a coating or coating. Alternatively, as depicted in FIG. 4, the semi-solid material 22 can be deposited in the cavity 14 of the polymeric shell 12 shaped to accommodate the teeth. The cavity 14 is filled at any level so that when the appliance 20 is positioned on the tooth, the tooth comes into direct contact with the substance 22 and pushes away any excess substance 22. Delivery of reagent 15 by using such substance 22 is most common in bleaching and fluoride therapies, but any type of reagent 15 can be used.

Another type of layer is a controlled release material impregnated with this reagent, where the rate control material controls the rate at which the reagent is released from the layer. The controlled release material, i.e. the speed controlled material, delivers the reagent at a predetermined rate. As described above, such delivery can be achieved by a number of methods. First, the reagent can be released by diffusion through this controlled release material. In this case, the reagent typically exists as finely dispersed particles in the polymeric matrix membrane. This is often referred to as a monolithic distributed system, a monolithic device or a matrix diffusion system. As the concentration of reagent in this matrix decreases due to diffusion delivery to the oral environment, so does the slope of its drug diffusion curve. The reagent delivery rate decreases over time as the substance is depleted. Therefore, the characteristic release profile of the monolithic system follows an asymptotic curve; after an initial burst of rapid release, its elution approaches a constant rate. Second, this reagent can be released by decomposition of the controlled release material. Degradation can be achieved by a number of mechanisms, including enzymatic degradation in saliva. This reagent can be encapsulated or contained in a biodegradable material (eg, a polymeric matrix). Any number of degradation rates can be achieved by manipulating the molar ratio of monomers in this matrix. In addition, this reagent is released by a combination of diffusion and decomposition of the release layer. Alternatively, or in addition, the reagent can be released by eluting from the pores within the release layer. Depending on the structure of this layer, elution from these pores can be achieved by a number of methods. This reagent, if contained in a controlled release material that fills these pores, can be released from this controlled release material by diffusion and / or degradation and then eluted from these pores themselves.

One attribute of the controlled release material can be provided in solid form (eg, thin film or sheet), which can be attached to the polymeric shell of the elastic repositioning device. With reference to FIG. 5, the controlled release material 24 containing the reagent 15 is provided as a sheet 25 and can be used in the formation of the instruments of the present invention. Here, the sheet 25 can be layered with the elastomeric polymer sheet 28 on the mold 30 of the patient's raw teeth. The sheets 25, 28 can be vacuum formed together on the mold 30 to form this repositioning device. As shown, by placing the controlled release material sheet 25 between the mold 30 and the polymer sheet 28, the controlled release material 24 covers the inner surface of the device and puts the device in place. , Positioned in contact with the patient's teeth and / or gingiva. This may be most beneficial for elution of reagent 15 (eg, fluoride, antibiotics or bleach).

Alternatively, the controlled release material 24 can be attached to the polymeric shell 12 of this device after forming the oral delivery device 20. As shown in FIG. 6, the controlled release material 24 containing the reagent 15 can be laminated, bound or adhered to the surface of the polymeric shell 12 in the desired region. Such adhesions can be removable, so that the substance 24 can be relieved when the reagent 15 is substantially eluted, or when its treatment is discontinued, or it is irremovable. Possible, as a result, substance 24 is present from the beginning to the end of the life of this device. Also shown in FIG. 6 is the use of controlled release tablets 34, which can be inserted into pocket 36 or part of the polymeric shell 12 of instrument 20. A portion of this pocket can be perforated or reticulated to facilitate delivery of this reagent. This reagent can then elute from Tablet 34 into the oral environment over an extended period of time. This design can best be applied to the decomposition elution of tablet 34, where tablet 34 can be replaced on a regular basis for new delivery.

In yet another embodiment, the release means comprises a reservoir formed in the polymeric shell in addition to the cavity that receives the teeth. The reservoir device or membrane diffusion system can supply reagents or substances at a constant rate in a sink state. These systems consist of three components: a reservoir containing this reagent, a low concentration sink (eg, oral environment) and a rate control membrane (which separates the reservoir from this sink). The system follows Fick's diffusion law for mass flux across this membrane. Therefore, the system is maintained at a constant delivery rate based on the diffusion coefficient through this membrane.

With reference to FIG. 7, this release means is shown to include a reservoir 60 formed in the polymeric shell 12 in addition to the cavity 14 that houses the teeth. The reservoir holds reagent 15 and is covered with a speed control membrane 62, which controls the rate at which reagent 15 is released from reservoir 60. Reservoir 60 is depicted as being substantially located within the wall of the polymeric shell 12 to elute into the cavity 14. However, it can be understood that the reservoir 60 can be located on any of the shells 12, outside the walls of the shells 12, and can elute in any direction. Reservoir 60 can be prefilled with the reagent 15 to be released. That is, the instrument 20 is equipped with a reservoir 60 filled with the reagent 15. In this case, the reservoir 60 can be sealed with a membrane 62, as depicted in FIG. However, Reservoir 60 can also be made accessible to the user so that it can be replenished with Reagent 15 as desired. In this case, the reservoir 60 cannot be sealed with the membrane 62, as depicted in FIG.

In other embodiments, reagent 15 is carrier-supported. As depicted in FIG. 9, this carrier contains a binding material 40, which binds reagent 15 to the surface of the polymeric shell 12 in a releaseable manner. The binding material 40 may release reagent 15 by a number of mechanisms, including dissolution of binding material 40, activation or inactivation of binding material 40, or any other release mechanism.

In yet another embodiment, as depicted in FIG. 10, the polymeric shell 12 of the oral delivery device 20 is composed of a controlled release material 42 containing reagent 15. In this case, the controlled release material 42 itself is formed to function as a repositioning device. This can be achieved by vacuum forming a sheet of controlled release material on the patient's tooth mold. Reagent 15 can then be eluted from Instrument 20 by a diffusion release mechanism or other release mechanism.

Means for releasing this reagent into the oral environment have been described in a number of embodiments described above with respect to the reagent itself. However, in each embodiment, the reagent can first be encapsulated or microencapsulated in a substance (typically a polymer). Such encapsulation may be desirable or necessary to protect this reagent from the effects of processing. For example, certain reagents can be hydrolyzed or modified by processes such as extrusion or thermoforming that may be involved in the manufacture of this instrument. Encapsulation can also protect the reagent from environmental factors from the beginning to the end of the shelf life of the device. Thus, throughout the description and herein, a "reagent" can correspond to the reagent itself or to an encapsulated reagent.

Reagents can be encapsulated or incorporated into a number of substances. Such substances may include polylactic acid, polycapric lactones, polyvinyl alcohol, polyacrylic acid, polyethylene oxide, polylactic acid glycol biodegradable polymer capsules and side chain crystalline polymers. Encapsulation can be achieved by a variety of processes. In particular, this reagent can be encapsulated by spray drying. For example, this reagent can be mixed or blended with a solvent (eg, polyvinyl alcohol) and then with a polymeric resin. After the solvent evaporates, polymeric microcapsules, each containing reagents dispersed throughout its matrix, are retained.

The material that is encapsulated or incorporated may or may not result in a controlled release of the reagent from its microspheres. If the encapsulated material results in controlled release performance, such a layer would be an addition to any controlled release means of the reagents described above. For example, the encapsulated reagent can be dispersed throughout a sheet of controlled release material, which is later attached to the polymeric shell of an elastic repositioning device. When the device is located in the patient's mouth, the reagent can elute at a controlled rate based on the release of the reagent from the sheet of substance encapsulating it and the controlled release substance.

Similarly, the material to be encapsulated can be an ion exchange resin. Such resins have a very large surface area and can absorb large amounts of controlled delivery reagents. Representative resins are sold under the trademark MICROSPONGE (Advanced Polymer Systems) and are described, for example, in US Pat. No. 5,145,675, the full disclosure of which is incorporated herein by reference. ing. In addition to serving as an encapsulating material, the ion exchange resin can be used as a controlled delivery material in any of the above embodiments.

In some cases, it may be desirable to alter the visual characteristics of the polymeric shell of the oral appliance. Such appliances include a polymeric shell 12, which has a cavity 14 shaped to be removable on the teeth, and also provides the visual features of this shell in or on the shell. Has a substance that changes. Such changes are typically responsive to changes in the environment. For example, this substance can be a dye that changes color when the device is removed from the patient's mouth, which changes in temperature due to changes in the environment. This gradual color change is illustrated in FIG. For example, as shown, the transparent oral delivery device 40 remains transparent when it is in the mouth and maintained at body temperature. When removed from the mouth, the device cools to room temperature. As the device begins to cool, its colorant gradually appears, as illustrated by the lightly shaded oral delivery device 42. As the device equilibrates to room temperature, the colorant becomes more apparent, as illustrated in the colored oral delivery device 44.

This color can be dispersed throughout the device or localized in a specific area inside or on the surface of the device, as shown in FIG. As shown in FIG. 12, the instrument 20 may include, for example, a colorant or dye stripe 46 at a particular location. Such streaks 46 can only be visible at any time or appear only when removed from the oral environment. In either case, the streaks 46 may be located so as to be hidden from the field of view, i.e., along the surface of the tongue, along the molars, or placed anywhere along the instrument 20. Similarly, some of the visual feature changing substances 48 may be removable, permanent, or adherent, bonded or laminated to the surface of the polymeric shell 12.

The method of delivering the reagent to the patient's oral environment and at the same time repositioning the tooth involves the use of at least one tooth positioning device having means for releasing the reagent. Typically, tooth repositioning involves placing a first repositioning device on the patient's teeth, where the teeth move to the first tooth arrangement. After the tooth has been moved to this array, the instrument is replaced with a second repositioning instrument, which is placed on the patient's tooth to transfer the tooth to the second tooth arrangement. This is continued using a series of instruments until the teeth are in the desired sequence. Simultaneous delivery of reagents is achieved by releasing the reagents from at least one of the repositioning instruments while keeping them in place on the patient's teeth. Means for releasing this reagent may include any of the means described above.

With reference to FIG. 13, simply positioning the instrument 20 on the patient's tooth 50 allows the reagent 15 to be delivered to the oral environment. Reagent 15 can be understood to be magnified in FIG. 13 to illustrate the presence of Reagent 15 in instrument 20. In many cases, the dispersed reagent 15 is so fine that the instrument 20 looks transparent. In other cases, reagent 15 may be present at a sufficiently high density to be visible. When the device 20 is preloaded or filled with reagent 15, the device 20 can be removed from its packaging and immediately inserted into the patient's mouth, as shown in FIG. However, unfilled instruments may need to be loaded prior to placement on the teeth. Loading can include the step of placing reagent 15 in the tooth containment cavity 14, as previously shown in FIG. Alternatively, loading comprises the step of placing reagent 15 in reagent release reservoir 60, as shown in FIG. Loading also includes the step of adhering the rate control or controlled release material 24 containing reagent 15 to the surface of the instrument 20, as shown in FIG.

Although some of these loading methods may require specially designed instruments, many of these methods can be applied to any positioning device. For example, a series of repositioning devices can be made according to a treatment plan and provided to the patient. Delivery of reagents to the oral environment may be desirable or necessary at any time in this treatment regimen. The physician or patient may then load the reagent or reagent delivery means into the device to continue the treatment regimen. This can be easily achieved using strips of release control material containing this reagent. The streaks can be glued to any surface of the instrument using an adhesive or any suitable adhesive means. Similarly, any type of reagent delivery layer may be attached to this device for this purpose. For example, a preformed sheet of material that encapsulates this reagent can be used, where the mold comprises one shape, where at least a portion of this shape is the surface of an instrument or the surface of a tooth or gingiva. It is contoured so that it fits in contact with. As shown in FIG. 14, the preformed sheet 60 of the material containing the reagent 15 may have a contour shape that fits in contact with the outer surface of the instrument 10. As shown in FIG. 15, the substance 60 can be glued or press-fitted to this surface and thus can be held in place by compressive force or friction. Similarly, the preformed sheet of this material may have a contoured shape that fits in contact with the surface of the tooth or gingiva. As shown in FIG. 16, the preformed sheet 62 containing the reagent 15 can be shaped to fit in contact with the gingival margin and therefore has a contour that reflects the gingival line. The sheet 62 can then be joined to the instrument 10 as illustrated by the joining arrow in FIG. With reference to FIG. 17, the sheet 62 and the instrument 10 can be combined together at the adhesive layer 64 to form an instrument that results in reagent delivery. The sheet 62 may be flexible to accommodate the easy attachment of the sheet 62 to the instrument 10 as well as the positioning and removal of the instrument in the patient's teeth.

These repositioning devices regularly perform daily dental hygiene and other tasks from beginning to end of the repositioning protocol or treatment plan until the tooth has moved at least near the desired tooth arrangement. Can be removed. The instrument may be replenished with reagents or substances to be delivered while being removed from the teeth. Replenishment can be performed immediately prior to each replacement of this appliance in the tooth, or can be performed according to any predetermined protocol.