JP2003522776A - Oral therapeutic drug delivery device - Google Patents

Abstract

(57) Summary The present invention relates to an oral therapeutic drug delivery device. By using this oral therapeutic drug delivery device, it is possible to deliver the drug to oral soft tissues where the drug is easily absorbed. To facilitate delivery of the drug to the oral soft tissue, the oral therapeutic drug delivery device contains a therapeutic drug reservoir where the drug can be placed. Oral therapeutic drug delivery devices may be used to treat or facilitate various oral diseases, such as periodontal disease (ie, gum disease), as well as other bodily and systemic diseases (eg, drug (Diabetes and other chronic diseases that require either single, intermittent or constant dosing).

Description

Detailed Description of the Invention

The present invention relates to dentistry oral appliances, and more particularly to drug delivery devices for using the appliances to administer drugs in the oral cavity. The present invention also requires methods of treating various oral diseases such as periodontal disease (ie, gum disease), as well as other bodily and systemic diseases (eg, single, intermittent or constant administration of drugs). Diabetes and other chronic diseases).

BACKGROUND OF THE INVENTION Dental instruments or trays have been used in various dental procedures for many years.
For example, dental appliances have been used to whiten teeth (see US Reissue Pat. No. 34,196, Munro). Alternatively, dental appliances (called night guards) are used to prevent the patient from gritting during sleep. They have also been used with fluoride as prophylaxis against caries (cavities). Dental appliances have also been used with drugs to treat oral pain (M. Pad).
illa, C.I. T. Glenn and M.M. L. Robert, Topical
medicines for orofacial neuropathi
c pain: a review, 131 Journal of the A
american Dental Association 185 (Febru
ary 2000), see).

A common method of manufacturing these dental appliances is to register the entire tooth surface in the jaw (
forming the mold cavity of the alginate. Next, using an alginate-type hole in the mouth, a stone cast model (stone cast mo
del) is created. In the case of tooth whitening agents, the receptors for holding the whitening agents are made by forming a layer of hard material on the treated tooth surface in a plaster model (US Pat. No. 5,985). , 249).

Dental trays are then vacuum formed from this model using conventional techniques. Once molded, the tray is trimmed on both the buccal and lingual surfaces, just at the gingival margin. The resulting tray provides a perfect fit between the pool receptor and the patient's tooth at the tooth surface to be treated.

A drawback of current dental appliances is that they only deliver (and thereby treat) the composition to hard tissues (ie, teeth), and soft tissues (ie, to treat it).
That is, it is not delivered to the periodontal tissue or gingiva). Oral soft tissue
It has been demonstrated to readily absorb all types of substances, such as nitroglycerin for treating angina. These old dental appliances are limited to treating a patient's teeth.

SUMMARY OF THE INVENTION In view of the foregoing, it is an object of the present invention to provide an oral appliance and drug delivery device that preferentially delivers a composition to the gums and soft tissues of the mouth.

Another object of the invention is to provide methods and devices for treating oral disorders and other bodily and systemic disorders.

These and other objects of the present invention are accomplished by providing a delivery device that extends to the mucosal-gingival junction in accordance with the principles of the present invention. The oral drug delivery device
Although it is effective whether it extends beyond the mucosa-cheek folds or does not reach the mucosa-gingival junction, it is believed to be the most effective and comfortable at the mucosal-gingival junction. To be

Further, the oral therapeutic agent delivery device includes a therapeutic agent pool receptor at the gingival margin.
g reservoir). Once the drug is placed in the oral therapeutic delivery device, and the device is placed in the patient's mouth, the drug is received by the therapeutic agent pool by a close fit of the device to the teeth and mucosa-gingiva. It is placed in the container. The term drug as used herein includes all drugs, pharmaceuticals and pharmacological agents.

[0010] Oral therapeutic drug delivery devices not only mechanically lock themselves around the teeth and soft tissues, but also rest in the mouth due to adsorption caused by saliva and drugs.
The close fit of the oral therapeutic delivery device further not only pools the drug into the gingival margin, but also compresses and delivers the drug into the gingival sulcus and the periodontal pocket.
This is precisely where there is active periodontal disease and where the drug is delivered. This is also an area with much capillary blood flow and absorption.

Further features of the invention, its nature and various advantages will be more apparent when considering the accompanying drawings and the following detailed description of the preferred embodiments.

Detailed Description of the Preferred Embodiments As summarized above, the present invention relates generally to delivery devices, and more specifically to administering drugs using the devices. The present invention also relates to methods and devices for treating oral disorders and other bodily and systemic disorders (eg, gingival disorders, diabetes, etc.).

The exemplary embodiment of FIGS. 1 and 2 is a patient having a bead of flowable composite material 5 placed at or near the gingival margin 1 region (hereinafter referred to as the Joint Treatment Zone (JTZ)). 3 shows a solid gypsum model model of the mouth.

Any method known in the art for forming a solid gypsum model of a patient's mouth (
U.S. Pat. No. 5,985,249) and upper and / or lower jaw mold cavities. It should be noted that the present invention registers not only hard tissue (eg teeth), but also adjacent soft tissue regions of the buccal, lingual and palate. All of the gingival area to be treated is contained within this mold cavity. Preferably,
The mold cavity extends beyond the gingival margin 1 and up to at least 5 mm on the soft tissue, preferably to the mucosa-gingival junction 3. More preferably, the mold cavity extends beyond the mucosa-gingival junction. The dental plaster is then poured into the dental mold cavity to produce a solid gypsum model. The model is then trimmed and prepared to form the oral therapeutic delivery device 4.

To prepare a plaster model model of the patient's mouth for making this oral therapeutic delivery device 4, beads 5 of flowable composite material are added to the gingival margin 1. The preferred placement of the flowable composite material 5 is 1, ie JTZ. The JTZ includes both gingival and gingival gums.

A preferred flowable composite material 5 that is placed in the JTZ on the plaster model and used to form the therapeutic agent pool receptor 20 is the Jeneric Pentro.
n Inc. Is a gel-like viscous paste sold under the tradename Flow-it by the company. Other similar composite materials from other manufacturers may also be used. The flowable composite material 5 is then a solid that is photocured by standard curing light found in the art. Other materials that can be applied in the gypsum model JTZ to make the therapeutic pool receptor 20 include, but are not limited to, high melting point brazes, modeling clays, acrylics or other polymerizable materials. Not done. The material placed in the JTZ of the plaster model to form this therapeutic pool receptor 20 covers the JTZ of all periodontal regions treated both buccal and lingual, and its oral therapeutic agent. It has a width and depth sufficient to form a therapeutic agent pool receptor that is large enough to hold the dose of drug delivered through the delivery device 4. Furthermore, the material follows the contour of the gingival margin along the papillae in the bifurcation along the gingival margin, in the abutment area and in the saddle and over the tooth. JT to form therapeutic pool receptor 20
The volume of this material used on Z is similar to the volume of drug delivered. The preferred width of the flowable composite material 5 added to the gypsum model JTZ is at least about 1 mm.
˜about 5 mm; the flowable composite material 5 forms its corresponding therapeutic agent pool receptor on the oral therapeutic agent delivery device 4 with a width of about 1 mm to about 5 mm. The preferred thickness of the flowable composite 5 in JTZ is from about 1 mm to about 3 mm;
Forms about 1 mm to about 3 mm thick of its corresponding therapeutic agent pool receptor on the oral therapeutic agent delivery device 4. Changes from these ideals still yield effective results. Calibrating a precise volume of the flowable composite material 5 to better ensure that the therapeutic agent pool receptor 20 is appropriately sized to deliver the dose of drug required by the patient. It is suggested that it could hold a similar volume of drug when placed in a syringe and applied to a plaster model JTZ so that therapeutic pool receptor 20 is formed.

The flowable composite 5 can be placed in the gypsum model JTZ such that it forms a therapeutic pool receiver 20 around the entire mouth, as shown in FIG. Or alternatively, the flowable composite material 5 may be used in JTZ when topical treatment is required.
Can be placed on the plaster model in a specific area of.

In order to form the oral therapeutic delivery device 4 of FIG.
Mold around the plaster model. The thermoplastic sheet can be heat softened, and FIG.
Can be vacuum wrapped around the plaster model model. The thermoplastic sheet may vary in thickness from about 0.04 inches to about 0.2 inches depending on the rigidity of the desired device 4. The preferred thickness of the thermoplastic sheet is about 0.06 inch. The thermoplastic sheet can be either rigid or flexible. Such sheets are available from various vendors (eg, Dental Resources Inc.). The thermoplastic sheet is then heat softened and vacuum wrapped around a gypsum model (vacuum former manufactured by Buffalo Dental, Inc., etc.) so that the sheet fits very closely. Forming a thermoplastic wrap delivery device 4. Various other types of standard instrument materials can be used according to patient comfort.

The oral therapeutic agent delivery device 4 is then removed from the plaster model model and trimmed. To maximize delivery of the drug used with this delivery device 4 and to obtain a secure seal, the oral therapeutic drug delivery device 4 is trimmed well beyond the JTZ therapeutic pool receiver. Ideally this is trimmed at the mucosa-gingival junction, but can be trimmed longer or shorter than to the mucosa-gingival junction. The oral therapeutic drug delivery device 4 is effective without the JTZ therapeutic drug pool receptor, but its effectiveness is considered to be reduced.

The oral therapeutic agent delivery device 4 may cover the hard palate. Here, the oral therapeutic agent delivery device 4 may be trimmed about 5 mm from the JTZ or the entire hard palate may be
You get a cover just like a full upper denture.

As a result of the custom fit, the oral therapeutic agent delivery device 4 caused the drug to contact the gingiva due to mechanical pressure without the aid of auxiliary adhesives (eg xanthan gum and polyols). It remains in the mouth, as it does. In addition, the therapeutic agent pool receptor 20 formed by 5 on the oral therapeutic agent delivery device 4 includes a simple ballpoint pen or an indelible marker for the therapeutic agent to assist the patient in properly placing the agent. By delineating the pool receptor, it is distinguished and highlighted from the rest of the device 4.

A preferred method of placing the drug in the oral therapeutic drug delivery device 4 uses a graduated syringe. The syringe contains the exact amount of drug the patient requires in that particular disease. Other systems such as tubes or vials containing the drug may also be used. The close fit of the oral therapeutic agent delivery device 4 around the adjacent teeth and gingiva keeps most of the agent in the therapeutic agent pool receptor 20, providing the agent in the gingival sulcus and periodontal pocket. So the drug, therapeutic drug pool receptor 20
You don't have to put it exactly on. Here, soft tissues readily absorb the drug, and hard tissues (teeth) are also covered and treated.

The oral therapeutic agent delivery device 4 may be used to treat a variety of diseases. For example,
Antibiotics and / or antimicrobial agents may be added to the oral therapeutic agent delivery device 4 to treat or aid in the treatment of gum disease. Currently, dentists place impregnating cords, injectable medications or soluble tips under the gingiva to treat gum disease. These procedures require hospital visits, are time consuming, can treat only a limited area, and are often uncomfortable and painful both during and after the procedure. Oral rinses and toothpastes are also currently used to treat gingival disorders. They have the disadvantage that they only come into contact with the gums for only a short time, are diluted with saliva and are immediately exhaled. Also, Water-Pi
Household appliances such as k have been used to treat gingival disorders but have the same drawbacks as rinses and are sloppy and cumbersome to use. Both household appliances and oral rinses also cannot consistently and easily deliver the drug into the gingival sulcus and gingival pocket where the disease is located. Using the present invention, the drug may be in contact with the patient's gingiva for the time required for proper treatment, and the drug is diluted with little or no saliva of the patient. For example, the drug may take from several minutes to several hours.
The patient's gingiva may be contacted overnight and comfortably in the patient's home. The oral therapeutic agent delivery device 4 is comfortable, easy to deploy and easy to remove. At the end of the procedure, the patient exhales and / or rinses to flush the drug out of the patient's mouth (unlike US Pat. No. 5,985,249, where the drug does not dissolve in saliva).

The oral therapeutic agent delivery device 4 can also be used to administer an anesthetic. Current,
The dentist administers the anesthetic by buccal injection or by applying local anesthesia.
Injections are uncomfortable and painful. Local anesthesia is usually given by the physician to the desired location in an insufficiently short time and quickly diluted with saliva. By using the present invention, by placing an anesthetic in this oral therapeutic delivery device 4 prior to going to the dentist, the anesthetic is self-administered comfortably and painlessly before surgery ( That is, depending on the patient). Upon arrival at the dental office, the patient is fully anesthetized for procedures such as periodontal scaling and root surface smoothing, crown and denture template, injection, light surgery, and the like. Conversely, the oral therapeutic agent delivery device 4 may also be used post-operatively to place anesthetic at the surgical site to reduce pain.

As a further application, use of steroids, antibiotics, analgesics and antibacterial agents for postoperative healing of surgical sites such as extraction of third molars (molar teeth), periodontal surgery, implant placement. But is not limited to these. Here, the therapeutic agent pool receptor of the oral therapeutic agent delivery device 4 is placed at its intended surgical site.

There are various oral dermatological diseases such as lichen planus and exfoliative gingivitis that respond to various treatments such as topical application of steroids. Traditionally, dilution has always been a problem, as well as the ability of drugs to remain at the site of lesions for any period of time. With the oral therapeutic delivery device 4, the therapeutic pool receptor can be customized to treat specific sites of lesions on the palate, adherent gingiva or adjacent soft tissue.

Patients undergoing radiation treatment of the head and neck of the cancer often suffer from a high incidence of caries that results from xerostomia (dry mouth). Dry mouth can also be caused by salivary gland diseases, various drugs and other causes. Topical application of fluoride is
Root caries (these are typically in the area of JTZ (ie, gingiva or subgingival)
Formation). Fluorides and other agents can also be used to treat root sensitivity and post-periodontal susceptibility by administering them via the oral therapeutic delivery device 4.

Application of anti-plaque agents that counter the periodontal disease and gingivitis microbiota may be added to oral therapeutic delivery. These include chlorohexidine, fluoride, metronidazole, minocycline, tetracycline, and peroxides,
It is not limited to these.

Applications to reduce or reduce pain may also be added to the oral therapeutic delivery device. These include, but are not limited to, lidocaine and benzocaine.

Among the oral conditions, the application of an antiviral agent (eg, Zovirax) to treat acute herpes gingival stomatitis, among others, is now described by including the therapeutic agent pool receptor to include the entire gingival and palate zone. Can be easily applied locally to the gingiva via the present invention by spreading.

The oral therapeutic drug delivery device 4 is a patient undergoing chemotherapy or otherwise immunocompromised (eg HIV), or a patient having a low platelet and / or white blood cell count, And can be used by patients suffering from common oral infections. The use of chlorohexidine, anesthetics, antibiotics, antifungals, antivirals, etc. is indicated. Here and in other uses, the therapeutic agent pool receptor of the oral therapeutic agent delivery device 4 may be expanded to cover all soft tissue to be treated.

The oral therapeutic agent delivery device 4 may also be used for other physical and systemic diseases, including, but not limited to, those requiring daily administration of the drug.
Diabetes can be treated with absorbable insulin, giving a more average dose of drug, instead of an injection giving a large bolus in one go. Chemotherapeutic agents, hypertensive and cardiotonic agents, long-dose antibiotics and other pharmacotherapeutic agents can also be administered via the oral therapeutic agent delivery device 4.

The application of antibiotic prophylaxis for mitral valve prolapse and other conditions can be found here:
This can be accomplished with an oral therapeutic agent delivery device by placing an antibiotic and / or antimicrobial agent into the oral therapeutic agent delivery device prior to surgery. Currently, patients receive large amounts of antibiotics systemically prior to surgery. With the use of the oral therapeutic agent delivery device 4, the dose of antibiotic is reduced and the antibiotic can be applied to the precise area where treatment is needed.

Also, the application of antibiotics and / or antibacterial agents for treating acute necrotizing ulcerative gingivitis is here replaced by systemic antibiotic uptake and / or rinsing with hydrogen peroxide. Can be accomplished by placing the drug in the oral therapeutic drug delivery device 4.

The oral therapeutic drug delivery device 4 allows a patient to self-administer a wide variety of drugs comfortably, painlessly and conveniently at the patient's home.

It is understood that the above is merely exemplary of the principles of the invention and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention.

[Brief description of drawings]

[Figure 1]   FIG. 1 is a simplified perspective view of an exemplary embodiment of a plaster model of a patient's mouth.

FIG. 2 is a composite material applied to the gingival margin or to soft tissue near the gingival margin,
1 is a simple perspective view of an exemplary embodiment of a patient's mouth plaster model.

[Figure 3]   FIG. 3 is a simple cross-sectional view of the gypsum model shown in FIG. 2, taken along line 3-3.

FIG. 4 is a simple top view of a gypsum model with an oral therapeutic delivery device formed on the model and trimmed near the mucosal-gingival junction.

[Figure 5]   FIG. 5 is a simple perspective view of FIG.

[Figure 6]   FIG. 6 is a simplified cross-sectional view taken along line 6-6 of FIG.

[Figure 7]   FIG. 7 is a simple perspective view of an oral therapeutic drug delivery device.

[Figure 8]   FIG. 8 is a simplified cross-sectional view taken along line 8-8 of FIG.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE, TR), OA (BF , BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, G M, KE, LS, MW, MZ, SD, SL, SZ, TZ , UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, B Z, CA, CH, CN, CR, CU, CZ, DE, DK , DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, J P, KE, KG, KP, KR, KZ, LC, LK, LR , LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, R O, RU, SD, SE, SG, SI, SK, SL, TJ , TM, TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW

Claims (70)

[Claims] 1. An oral treatment device for delivering a medicament to soft tissue of the mouth, the device being formed from a sheet material shaped to fit the contours of at least a portion of a tooth and the cheek. Adjacent to the lateral and lingual soft tissues, the device comprises one or more pool receptors, the pool receptors corresponding to oral soft tissues of the patient's mouth,
An oral care appliance that is located on the oral care dental appliance and is for holding the medicament to be delivered. 2. The drug according to claim 1, wherein the drug to be delivered is selected from the group consisting of antibiotic compounds, antibacterial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof. The oral treatment device described. 3. The drug to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide,
Or the oral treatment instrument of Claim 1 which is these combinations. 4. The oral treatment device of claim 2, wherein the antibiotic compound to be delivered comprises tetracycline. 5. The oral care device of claim 2, wherein the antimicrobial compound to be delivered comprises chlorhexidine. 6. The oral care device of claim 1, wherein the pool receptor is located on the oral care device corresponding to the soft tissue at or near the gingival margin of the patient. 7. At least one of the pool receptors is from about 1 mm to about 5 mm.
The oral treatment device of claim 1, having a width of. 8. At least one of the pool receptors is from about 1 mm to about 3 mm.
The oral treatment device according to claim 6, which has a depth of. 9. The oral care device of claim 1, wherein at least one of the pool receptors extends substantially in the oral soft tissue to the length of the gingival margin to which the medication is to be delivered. 10. The oral treatment device according to claim 1, wherein the sheet material is a thermoplastic sheet. 11. The oral care device of claim 10, wherein the thermoplastic sheet has a thickness of about 0.04 inches to about 0.2 inches. 12. The oral care device of claim 11, wherein the thermoplastic sheet has a thickness of about 0.06 inches. 13. The oral care device of claim 1, wherein at least a portion of the shaped sheet material extends at least 2 mm beyond the gingival margin of the patient. 14. The oral care device of claim 1, wherein at least a portion of the shaped sheet material extends buccally over the patient's gingival margin by at least 2 mm. 15. The oral care device of claim 1, wherein at least a portion of the shaped sheet material extends lingually at least 2 mm beyond the gingival margin of the patient. 16. The oral care device of claim 10, wherein at least a portion of the shaped sheet material extends to a mucosal-gingival junction of a patient. 17. A method of delivering a medicament to soft tissue of the mouth, comprising: (a) teeth and at least a portion of adjacent buccal and lingual soft tissue;
Covering with a shaped contoured oral treatment device, wherein the treatment device is configured to extend beyond the gingival margin, the oral treatment device further comprising one or more pool receivers, The pool receptor is located on the oral treatment device corresponding to the soft tissue at or near the gingival margin to retain the medicament; (b) the medicament to be delivered to the oral cavity (C) positioning the oral treatment device over the teeth in the area where the medication is to be delivered, such that one or more of the pool receptors are placed. At least a portion of the medicament in contact with the soft tissue; and (d) the oral treatment device for a time sufficient to allow a therapeutically effective amount of the medicament to be absorbed by the soft tissue. Including the steps of maintaining in place The method. 18. At least one of the pool receptors is from about 1 mm to about 5 m.
18. The method of claim 17, having a width of m. 19. At least one of said pool receptors is from about 1 mm to about 3 m.
18. The method of claim 17, having a depth of m. 20. The method of claim 17, wherein the medication is placed in the pool receptacle via a syringe. 21. The method of claim 17, wherein the oral treatment device is held in place by a close fit. 22. The method of claim 17, wherein a majority of the medicament to be delivered is located within at least one or more of the pool receptors. 23. The method of claim 17, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antibacterial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof. The method described. 24. The method of claim 17, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or a combination thereof. 25. The method of claim 23, wherein the antibiotic compound to be delivered comprises tetracycline. 26. The method of claim 23, wherein the antimicrobial compound to be delivered comprises chlorhexidine. 27. An oral treatment appliance for delivering a medicament to soft tissue of the mouth, the appliance fitting the contour of at least a portion of a tooth and to soft tissue of the buccal and lingual sides. An oral care device formed from adjacently molded sheet materials. 28. The oral care device of claim 27, wherein the device is held in place primarily due to the close fit. 29. The method of claim 27, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antibacterial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof. The oral treatment device described. 30. The oral care device of claim 27, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or a combination thereof. 31. The oral care device of claim 29, wherein the antibiotic compound to be delivered comprises tetracycline. 32. The oral care device of claim 29, wherein the antimicrobial compound to be delivered comprises chlorhexidine. 33. The oral care device of claim 27, wherein the sheet material is a thermoplastic sheet. 34. The oral care device of claim 33, wherein the thermoplastic sheet has a thickness of about 0.04 inches to about 0.2 inches. 35. The oral care device of claim 34, wherein the thermoplastic sheet has a thickness of about 0.06 inches. 36. The oral care device of claim 27, wherein at least a portion of the molded sheet material extends at least 2 mm beyond the gingival margin of the patient. 37. The oral care device of claim 27, wherein at least a portion of the shaped sheet material extends buccal over the patient's gingival margin by at least 2 mm. 38. The oral care device of claim 27, wherein at least a portion of the shaped sheet material extends lingually beyond the patient's gingival margin by at least 2 mm. 39. The oral care device of claim 33, wherein at least a portion of the molded sheet material extends to a mucosal-gingival junction of a patient. 40. A method of delivering a medicament to soft tissue of the mouth, comprising: (a) teeth and at least a portion of adjacent buccal and lingual soft tissue;
Covering with a shaped contoured oral treatment device, wherein the treatment device is configured to extend beyond the gingival margin; (b) the oral treatment delivery device for delivering the medicament to be delivered. (C) positioning the oral treatment device over the teeth in the area where the medication is to be delivered, such that at least a portion of the medication is in the soft tissue. Contacting; and (d) maintaining the oral treatment device in place for a time sufficient for a therapeutically effective amount of the medicament to be absorbed by the soft tissue. 41. The method of claim 40, wherein the oral treatment device is held in place by a close fit. 42. The method of claim 40, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antibacterial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof. The method described. 43. The method of claim 40, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or a combination thereof. 44. The method of claim 42, wherein the antibiotic compound to be delivered comprises tetracycline. 45. The method of claim 42, wherein the antimicrobial compound to be delivered comprises chlorhexidine. 46. A method of forming an oral treatment device, comprising: (a) forming a mold cavity in a patient's mouth, wherein the mold cavity is a tooth, edentulous region or the like of the patient Correctly overlap with at least a portion of both and surround the gingival tissue,
(B) forming a gypsum model model of the mouth using the mold cavity; (c) an exact volume of a flowable composite material on the gypsum model model of the patient's oral soft tissue. (D) curing the gypsum model having the composite material; and (e) molding a thermoplastic sheet on the gypsum model, the result of which is:
The flowable composite material forms in the oral treatment device one or more pool receptors for holding a precise volume of medicament to be delivered to oral soft tissue, where:
The one or more pool receptors allow the transfer of a medicament. 47. The method of claim 46, wherein the mold cavity properly overlaps the gingival region of the patient. 48. The method of claim 46, wherein the mold cavity extends at least 5 mm beyond the patient's gingival margin. 49. The method of claim 46, wherein the mold cavity extends beyond the patient's mucosal-gingival junction. 50. The method of claim 46, wherein the flowable composite material is located in the gypsum model at a corresponding region at or near a gingival margin of a patient. 51. The method of claim 46, wherein at least one of the regions in which the flowable composite material is located has a width of about 1 mm to about 5 mm. 52. The method of claim 46, wherein at least one of the regions in which the flowable composite material is located has a width of about 1 mm to about 3 mm. 53. The method of claim 46, wherein the flowable composite material extends substantially the length of the gingival margin. 54. The method of claim 46, wherein the thermoplastic sheet has a thickness of about 0.04 inches to about 0.2 inches. 55. The method of claim 54, wherein the thermoplastic sheet has a thickness of about 0.06 inches. 56. The method of claim 46, wherein at least a portion of the shaped sheet material extends at least 2 mm beyond a patient's gingival margin. 57. The method of claim 46, wherein at least a portion of the shaped sheet material extends buccal over the patient's gingival margin by at least 2 mm. 58. The method of claim 46, wherein at least a portion of the shaped sheet material extends lingually at least 2 mm beyond the gingival margin of the patient. 59. The method of claim 55, wherein at least a portion of the shaped sheet material extends to a patient's mucosal-gingival junction. 60. The method of claim 46, wherein the gypsum model with the composite material is light cured. 61. The method of claim 46, wherein the flowable composite material is a high melting point braze, shaped clay, acrylic material or other polymerizable material. 62. The oral care device of claim 1 wherein at least a portion of the shaped sheet material extends at least 5 mm beyond the patient's gingival margin. 63. The oral care device of claim 1, wherein at least a portion of the molded sheet material extends buccally at least 5 mm beyond the gingival margin of the patient. 64. The oral care device of claim 1, wherein at least a portion of the molded sheet material extends lingually beyond the patient's gingival margin by at least 5 mm. 65. The oral care device of claim 27, wherein at least a portion of the shaped sheet material extends at least 5 mm beyond the gingival margin of the patient. 66. The oral care device of claim 27, wherein at least a portion of the shaped sheet material extends buccally over the patient's gingival margin by at least 5 mm. 67. The oral care device of claim 27, wherein at least a portion of the shaped sheet material extends lingually beyond the patient's gingival margin by at least 5 mm. 68. The method of claim 46, wherein at least a portion of the shaped sheet material extends at least 5 mm beyond a patient's gingival margin. 69. The method of claim 46, wherein at least a portion of the shaped sheet material extends buccal over the patient's gingival margin at least 5 mm. 70. The method of claim 46, wherein at least a portion of the shaped sheet material extends lingually beyond the patient's gingival margin by at least 5 mm.