WO2001060278A2

WO2001060278A2 - Oral therapeutic delivery appliance

Info

Publication number: WO2001060278A2
Application number: PCT/US2001/005197
Authority: WO
Inventors: Peter J. Zegarelli
Original assignee: Zegarelli Peter J
Priority date: 2000-02-18
Filing date: 2001-02-16
Publication date: 2001-08-23
Also published as: EP1257232A2; WO2001060278A3; JP2003522776A; CA2400209A1; AU2001243185A1

Abstract

This invention relates to an oral therapeutic delivery appliance. By using this oral therapeutic delivery appliance medicaments may be delivered to oral soft tissues, where medicaments are easily absorbed. To aid the delivery of medicaments to oral soft tissues the oral therapeutic delivery appliance contains a therapeutic pooling reservoir where the medicaments may be placed. The oral therapeutic delivery appliance may be used to treat or aide in the treatment of various oral maladies such as periodontal disease (i.e., gum disease) as well as treating or aiding the treatment of other physical ailments and systemic diseases (e.g., diabetes and other chronic diseases which require either single, intermittent or constant dosing of medicament).

Description

ORAL THERAPEUTIC DELIVERY APPLIANCE

This invention relates to a dental medical oral appliance, and more specifically a drug delivery device for the administration of medicaments orally by means of this appliance. This invention also relates to the methods for treating various oral maladies such as periodontal disease (i.e., gum disease) as well as treating other physical ailments and systemic diseases (e.g., diabetes and other chronic diseases which require either single, intermittent or constant dosing of medicament) .

Background of the Invention

Dental appliances or dental trays have been used in various dental procedures for many years. For example, dental appliances have been used to whiten teeth (See U.S. Pat. No. Re. 34,196 to Munro) . Or, dental appliances (referred to as night guards) have been used to prevent patients from grinding their teeth while asleep. They have also been used in conjunction with fluoride as a caries (cavity) preventative. And, dental appliances in conjunction with medication have been used to treat oral pain. (See M. Padilla, C.T. Glenn and M.L. Robert, Topical medi cations for orofaci al neuropa thi c pain : a revi ew, 131 Journal of the American Dental Association 185 (February 2000) .

A general process for preparing these dental appliances is by forming an alginate impression which registers all teeth surfaces in a jaw. Next, a stone cast model is made using the alginate impression of the mouth. In the case of tooth whitening agents, the reservoirs for holding whitening agents are formed by building a layer of rigid material on the teeth surface (s) to be treated of the stone cast (See U.S. Pat. No. 5, 985,249) .

A dental tray is then vacuum formed from the cast using conventional techniques. Once formed, the tray is trimmed just at the gingival margin on both the buccal and lingual surfaces. The resulting tray provides a perfect fit of the patient' s teeth with pooling reservoirs at the teeth surfaces to be treated.

A disadvantage with the current dental appliances is that these dental appliances deliver compositions to (and thereby treat) only the hard tissues (i.e., teeth) and not to the soft tissues (i.e., periodontiu or gums) . It is well documented that oral soft tissues readily absorb all types of substances, e.g. nitroglycerine to treat angina. These old dental appliances are limited to treating the patient's teeth.

Summary of the Invention

In view of the forgoing, it is an object of this invention to provide an oral appliance and drug delivery device that predominantly delivers compositions to the gingival and soft tissues of the mouth. It is another object of this invention ro provide methods and the apparatus for treating oral maladies as well as other physical ailments and systemic diseases. These and other objects of the invention are accomplished m accordance with the principles of the invention by providing a delivery appliance that extends to the muco-gmgival junction. It is maintained that the oral therapeutic delivery appliance would also be effective if it were to be extended beyond to the muco-buccal fold or short of tne muco-gmgival junction, but would be most effective and comfortable at the muco-gmgival junction.

Furthermore, the oral therapeutic delivery appliance contains a therapeutic pooling reservoir at the gingival margin. Once the medicament is placed the oral therapeutic delivery appliance and the appliance is placed m the patient's mouth, the medicament will be forced to settle the therapeutic pooling reservoir due to the snug fit of the appliance to the teeth and the muco-gmgiva. As used herein the term medicament includes all medicaments, medic als and pharmacological agents .

The oral therapeutic delivery appliance stays the mouth not only mechanically by locking itself about the teeth and soft tissues but also by the suction created by the saliva and the medicament. The tight fit of the oral therapeutic delivery appliance further forces the medicament not only to pool at the gingival margin but also to compress it and force it into the gingival sulcus and into the peπodontal pockets. This is precisely where active peπodontal disease is and where the medicament will be delivered. It is also an area with tremendous capillar blood flow and absorption.

Further features of the invention, it's nature and various advantages will be more apparent when viewing the accompanying drawings and tne following detailed descriptions of the preferred embodiments .

Brief Description of the Drawings

FIG. 1 s a simplified perspective view of an illustrative embodiment of a stone cast of a patient's mouth.

FIG. 2 is a simplified perspective view of an illustrative embodiment of a stone cast of a patient's mouth with a composite applied at the soft tissue at or near the gingival margin.

FIG. 3 is a simplified cross-sectional view along line 3-3 of the stone cast shown FIG. 2.

FIG. 4 is a simplified top view of the stone cast with a oral tnerapeutic delivery appliance formed over the cast and trimmed near the muco-gmgival junction.

FIG. 5 is a simplified perspective view of FIG. 4.

FIG. 6 is a simplified cross-sectional view along line 6-6 of FIG. 5.

FIG. 7 is a simplified perspective view of the oral therapeutic delivery appliance.

FIG. 8 is a simplified cross-sectional view along line 8-8 of FIG. 7. Detailed Description of the Preferred Embodiments

As summarized above, the present invention generally relates to a delivery appliance, and more particularly to the administration of medicaments by means of this appliance. This invention also relates to methods and apparatus for treating oral maladies as well as other physical ailments and systemic diseases (e.g., gum disease, diabetes, etc.) .

The illustrative embodiment m FIGS. 1 and 2 show a solid stone cast model of a patient's mouth with bead 5 of flowable composite placed at or near the gmgival margin 1 area, henceforth referred to as the junctional therapeutic zone (JTZ) .

Any method known m the art may be used to form the solid stone cast of patient's mouth (see

U.S. Pat. No. 5,985,249) and for taking an impression of the upper and/or lower aws. For the present invention care must be taken not only to register the hard tissues (i.e., teeth) but also the adjacent soft tissue areas buccally, lmgually and palatally. All gmgival areas to be treated should be included m this impression. Preferably, the impression should extend at least up to 5 mm beyond the gmgival margin 1 onto the soft tissues and preferably to the muco-gmgival junction 3. More preferably, the impression should extend beyond the muco-gmgival junction. Next, dental stone is poured into the dental impression and a solid stone cast model is fabricated. This model is then trimmed and prepared for forming the oral therapeutic delivery appliance 4.

To prepare the stone cast model of the patient's mouth for fabricating the oral therapeutic delivery appliance 4, bead 5 of flowable composite is added at the gmgival margin 1. The preferred placement of flowable composite 5 is 1, the JTZ. The JTZ encompasses both the tooth at the gingival margin and the gingiva at the gingival margin.

The preferred flowable composite 5 placed at the JTZ on the stone cast and used to form therapeutic pooling reservoir 20 is a gel like viscous paste sold under the trademark Flow-it by Jeneric Pentron Inc. Other similar composites by alternate manufacturers may also be used. Flowable composite 5 is then light-cured solid with a standard curing light found in the art. Other materials that may be applied at the JTZ of the stone cast to create therapeutic pooling reservoir 20 include, but are not limited to, high melting waxes, modeling clay, acrylics or other polymerizable materials. The material placed at the JTZ of the stone cast to form therapeutic pooling reservoir 20 should be of sufficient width and depth to cover the JTZ of all the periodontal areas to be treated both buccally and lingually, and to form a therapeutic pooling reservoir of sufficient size to hold the dose of medicament to be delivered via the oral therapeutic delivery appliance 4. Furthermore, this material should follow the contours of the gingival margin along the dental papillae, into furcations, interproximal areas and cols and onto the teeth along the gingival margins. The volume of the material used on the JTZ to form therapeutic pooling reservoir 20 should be similar to the volume of the medicament to be delivered. The preferred width of flowable composite 5 added at the JTZ of the stone cast is from at least about 1 mm to about 5 mm; flowable composite 5 forms a corresponding therapeutic pooling reservoir on the oral therapeutic delivery appliance 4 of a width of about 1 mm to about 5 mm. The preferred thickness of flowable composite 5 at the JTZ is about 1 mm to about 3 mm; flowable composite 5 forms a corresponding therapeutic pooling reservoir on the oral therapeutic delivery appliance 4 of a depth of about 1 mm to about 3 mm. Variations from these ideals will still provide an efficacious result. To better assure that therapeutic pooling reservoir 20 is of an appropriate size to deliver the dose of medicament that the patient may need, it is suggested that a precise volume of flowable composite 5 be placed into a calibrated syringe and applied at the JTZ of the stone cast so that when therapeutic pooling reservoir 20 is formed it is able to hold a medicament of similar volume.

Flowable composite 5 may be placed at the JTZ of the stone cast so that it forms therapeutic pooling reservoir 20 around the entire mouth as shown FIG. 5. Or, alternatively, flowable composite 5 may be placed on the stone cast at specific areas of the JTZ when localized treatment is required. To form the oral therapeutic delivery appliance 4 of FIG. 3, a standard thermoplastic sheet is molded about the stone cast. The thermoplastic sheet may be heat softened and vacuum wrapped about the stone cast model of FIG. 1. The thermoplastic sheet may vary m thickness from about 0.04 inches to about 0.2 inches depending on the stiffness of the appliance 4 desired. The preferred thickness of the thermoplastic sheet is about 0.06 inches. The thermoplastic sheet may be either rigid or flexible. Such sheets are available from various suppliers (e.g., Dental Resources Inc.) . The thermoplastic sheet is then heat softened and vacuum wrapped (vacuum former manufactured by Buffalo Dental, Inc and others) aoout the stone cast so that it forms a very tight fitting thermoplastic wrap delivery appliance 4. Various other types of standard appliance materials may be used according to the patient's comfort.

The oral therapeutic delivery appliance 4 is next removed from the stone cast model and trimmed. In order to maximize the delivery of the medicaments that will be used in conjunction with this delivery appliance 4 and to obtain a secure seal, the oral therapeutic delivery appliance 4 is trimmed well beyond the JTZ therapeutic pooling reservoir. Ideally, it is trimmed at the muco-gmgival junction, however, it can be trimmed either longer or shorter to the muco-gmgival junction. It is maintained that the oral therapeutic delivery appliance 4 would be effective without the JTZ therapeutic pooling reservoir, but less so .

The oral therapeutic delivery appliance 4 may cover the hard palate. Here the oral therapeutic delivery appliance 4 can be trimmed approximately 5mm from the JTZ or alternatively the entire hard palate can remain covered much like a full upper denture. As a result of the custom fit, the oral therapeutic delivery appliance 4 will remain m the mouth so that the medicament remains m contact with the gums due to mechanical pressure and without the aid of any auxiliary adhesive agents, such as xanthan gum and polyols . Furthermore, therapeutic pooling reservoir 20 formed by 5 on the oral therapeutic delivery appliance 4 may be distinguished and highlighted from the rest of the appliance 4 m order to assist the patient m the proper placement of the medicament by outlining the therapeutic pooling reservoir with a simple ball point pen or indelible marker . The preferred method of placing the medicament m the oral therapeutic delivery appliance 4 is via a calibrated syringe. This syringe will contain the precise amount of medicament that the patient requires for his specific ailment. Other systems, such as tubes or vials containing the medicament may also be used. The medicament need not be placed precisely at the therapeutic pooling reservoir 20, since the snug fit of the oral therapeutic delivery appliance 4 about the adjacent teeth and gums will force the majority of the medicament to settle the therapeutic pooling reservoir 20 and force the agent into the gmgival sulcus and periodontal pockets. Here, the soft tissues will readily absorb the medicaments and the hard tissues (teeth) will also be coated and treated.

The oral therapeutic delivery appliance 4 may be used to treat a variety of ailments. For example, antibiotics and/or antimicrobials may be added to the oral therapeutic delivery appliance 4 m order to treat or aide m the treatment of gum disease. Currently, the dental practitioner places impregnated cords, mjectable medicaments or dissolvable chips under the gums to treat gum diseases. These treatments require a dental visit, take time, can only treat a limited area and are most often uncomfortable and painful not only during the procedure but also post-operatively . Oral rinses and toothpastes as well are used presently to treat gum disease. They suffer from the drawback that they are m contact with the gums for only a short time and become diluted by the saliva and are quickly expectorated. Also, home appliances such as the Water-Pik are used to treat gum disease, but they suffer from the same drawbacks as the rinses and are sloppy and cumbersome to use. Both home appliances and oral rinses also can not readily deliver the medicaments consistently into the gingival sulcus and gum pockets where the disease is located. With the present invention, the medicament may be in contact with the patient's gums for as long as needed for the appropriate treatment and the medicament will suffer little or no dilution by the patient's saliva. For example, the medicament may be in contact with the patient' s gums for several minutes to several hours to overnight and in the comfort of the patient's home. The oral therapeutic delivery appliance 4 is comfortable, easy to place and easy to remove. When finished with the treatment, the patient may expectorate and/or rinse to flush the medicament from his mouth (unlike U.S. Pat. No. 5,985,249, whose medicament is not dissolvable in saliva) .

The oral therapeutic delivery appliance 4 may also be used to administer anesthetics. Currently, dentists administer anesthetics via oral injections or with the application of a topical anesthetic. The injections are uncomfortable and painful. The topical anesthetic is placed by the practitioner on the desired location for usually an inadequately short time and is quickly diluted by the saliva. With the use of the present invention, anesthetics may be self administered (i.e., by the patient) pre-operatively comfortably and painlessly by placing them in the oral therapeutic delivery appliance 4 prior to the dental visit. Upon reaching the dental office the patient is adequately anesthetized for procedures such as periodontal scaling and root planing, impressions for crown and bridge, injections, minor surgical procedures and others. Conversely, the oral therapeutic delivery appliance 4 may also be used post-operatively to reduce pain by placing the anesthetic at the surgical site.

Further applications include but are not limited to the use of steroids, antibiotics, analgesics and antimicrobials for the post-operative healing of surgical sites such as third molar (wisdom teeth) extractions, periodontal surgery, implant placement and others. Here, the therapeutic pooling reservoir of the oral therapeutic delivery appliance 4 will be placed at the anticipated surgical site.

There are various oral dermatologic diseases such as lichen planus and desquamative gingivitis which respond to various therapies such as the topical application of steroids. Previously, dilution was always a problem as was the ability of the medicament to stay at the site of the lesion for any period of time. With the oral therapeutic delivery appliance 4 a therapeutic pooling reservoir can be customized to treat the specific sites of the lesions on the palate, the attached gingiva or the adjacent soft tissues.

Patients undergoing head and neck radiation treatment for cancer often suffer from high incidences of dental caries because of xerostomia (dry mouth) . Xerostomia may also be caused by salivary gland disease, various medications and other causes. The topical application of fluorides helps to prevent root caries where they typically form (i.e., gingivally and sub-gingivally) at the area of the JTZ. Fluoride and other medicaments may also be used to treat root sensitivity and post-periodontal surgical sensitivity by administering them via the oral therapeutic delivery appliance 4.

Applications of anti-plaque agents to combat the flora of periodontal disease and gingivitis may be added to the oral therapeutic delivery. These include but are not limited to chlorhexidme, fluoride, metronidazole, mmocyclme, tetracycl e and peroxide. Applications to reduce or relieve pain may also be added to the oral therapeutic delivery appliance. These include but are not limited to lidocame and benzocame.

Applications of anti-virals such as Zovirax to treat Acute Herpetic Gmgivo-Stomatitis among other oral conditions may now be easily applied to the gums topically via the present invention by extending the therapeutic pooling therapeutic pooling reservoir to include the entire zone of attached gmgiva and the palate . The oral therapeutic delivery appliance 4 may be used by patients who are undergoing chemotherapy or who are otherwise lmmunocompromised (e.g., HIV), or with low platelet and/or white blood cell counts and who suffer from generalized oral infections, the use of chlorhexidme, anesthetics, antibiotics, antifungals, antivirals and others are indicated. Here, and m other uses, the therapeutic pooling reservoir of the oral therapeutic delivery appliance 4 can be extended to cover all soft tissues to be treated. The oral therapeutic delivery appliance 4 also may be used for other physical ailments and systemic diseases that include but are not limited to those diseases which require a daily dosing of medication. It is possible to treat diabetes with absorbable insulin which will give a more even administration of drug instead of the injection which gives a large bolus at one time. Chemo-therapeutic agents, hypertensive and cardiac medications, long dosage administration of antibiotics and other pharmacotherapeutic agents can also be administered via the oral therapeutic delivery appliance 4.

Applications for antibiotic prophylaxis for mitral valve prolapse and other conditions may now be accomplished with the oral therapeutic delivery appliance by placing an antibiotic and/or antimicrobial m the oral therapeutic delivery appliance pre- operatively. Currently, patient's ingest large doses of systematic antibiotics pre-operatively . With the use of the oral therapeutic delivery appliance 4 antibiotic doses may be reduced and antibiotics may be applied to the precise area where treatment is needed.

Also, applications for antibiotics and/or antimicrobials to treat Acute Necrotizmg Ulcerative Gingivitis may now be accomplished by placing medicaments into the oral therapeutic deliver appliance 4 instead of taking systematic antibiotics and/or rinsing with hydrogen peroxide.

The oral therapeutic delivery appliance 4 allows the patient to self administer a wide variety of medicaments comfortably, painlessly and m tne convenience of their own home.

It will be understood that the foregoing is only illustrative of the principles of this invention and that various modifications can be made by those skilled m the art without departing from the scope and spirit of the invention.

Claims

The Invention Claimed Is

1. An oral therapeutic appliance for delivering medicament to soft tissue of the mouth, the appliance being formed from a sheet material molded to fit the contours of at least a portion of the teeth and adjacent buccal and lingual soft tissues, the appliance comprising one or more pooling reservoirs located on the oral therapeutic dental appliance corresponding to the oral soft tissue of a patient's mouth for holding the medicament to be delivered.

2. The oral therapeutic appliance of claim 1, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antimicrobial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof.

3. The oral therapeutic appliance of claim 1, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or combinations thereof.

4. The oral therapeutic appliance of claim 2, wherein the antibiotic compound to be delivered comprises tetracycline.

5. The oral therapeutic appliance of claim 2, wherein the antimicrobial compound to be delivered comprises chlorhexidine.

6. The oral therapeutic appliance of claim 1, wherein the pooling reservoirs are located on the oral therapeutic appliance corresponding to the soft tissue at or near a patient's gingival margin.

7. The oral therapeutic appliance of claim 1, wherein at least one of the pooling reservoirs has a width of from about 1 mm to about 5 mm.

8. The oral therapeutic appliance of claim 6, wherein at least one of the pooling reservoirs has a depth of from about 1 mm to about 3 mm.

9. The oral therapeutic appliance of claim 1, wherein at least one of the pooling reservoirs at the oral soft tissue extends substantially the length of the gingival margin where the medicament is to be delivered.

10. The oral therapeutic appliance of claim 1, wherein the sheet material is a thermoplastic sheet .

11. The oral therapeutic appliance of claim 10, wherein the thermoplastic sheet has a thickness of from about 0.04 inches to about 0.2 inches .

12. The oral therapeutic appliance of claim 11, wherein the thermoplastic sheet has a thickness of about 0.06 inches.

13. The oral therapeutic appliance of claim 1, wherein at least a portion of the molded sheet material extends at least 2 mm beyond a patient's gingival margin.

14. The oral therapeutic appliance of claim 1, wherein at least a portion of the molded sheet material extends at least 2 mm buccally beyond a patient's gingival margin.

15. The oral therapeutic appliance of claim 1, wherein at least a portion of the molded sheet material extends at least 2 mm lingually beyond a patient's gingival margin.

16. The oral therapeutic appliance of claim 10, wherein at least a portion of the molded sheet material extends to a patient's muco-gingival junction.

17. A method of delivering medicament to the soft tissue of the mouth comprising:

(a) covering at least a portion of the teeth and the adjacent buccal and lingual soft tissues with a molded contoured oral therapeutic appliance that is configured to extend beyond the gingival margin, the oral therapeutic appliance further comprising one or more pooling reservoirs located on the oral therapeutic appliance corresponding to the soft tissue at or near the gingival margin for holding medicament; (b) placing the medicament to be delivered within the oral therapeutic delivery appliance;

(c) positioning the oral therapeutic appliance over the teeth in the area where the medicament is to be delivered such that at least a portion of the medicament within one or more of the pooling reservoirs is able to contact the soft tissue; and

(d) maintaining the oral therapeutic appliance in position for a sufficient time to allow a therapeutically effective amount of the medicament to be absorbed by the soft tissue.

18. The method of claim 17, wherein at least one of the pooling reservoirs has a width of from about 1 mm to about 5 mm.

19. The method of claim 17, wherein at least one of the pooling reservoirs has a depth of from about 1 mm to about 3 mm.

20. The method of claim 17, wherein the medicament is placed in the pooling reservoir via a syringe .

21. The method of claim 17, wherein the oral therapeutic appliance is maintained in position by a tight 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 pooling reservoirs.

23. The method of claim 17, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antimicrobial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, steroids and combinations thereof.

24. The method of claim 17, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or combinations 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 therapeutic appliance for delivering medicament to the soft tissue of the mouth, the appliance being formed from a sheet material molded to fit the contours of at least a portion of the teeth and adjacent buccal and lingual soft tissues.

28. The oral therapeutic appliance of claim 27, wherein the appliance is held in place primarily due to a tight fit.

29. The oral therapeutic appliance of claim 27, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antimicrobial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof.

30. The oral therapeutic appliance of claim 27, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or combinations thereof.

31. The oral therapeutic appliance of claim 29, wherein the antibiotic compound to be delivered comprises tetracycline.

32. The oral therapeutic appliance of claim 29, wherein the antimicrobial compound to be delivered comprises chlorhexidine.

33. The oral therapeutic appliance of claim 27, wherein the sheet material is a thermoplastic sheet.

34. The oral therapeutic appliance of claim 33, wherein the thermoplastic sheet has a thickness of from about 0.04 inches to about 0.2 inches .

35. The oral therapeutic appliance of claim 34, wherein the thermoplastic sheet has a thickness of about 0.06 inches.

36. The oral therapeutic appliance of claim 27, wherein at least a portion of the molded sheet material extends at least 2 mm beyond a patient's gingival margin.

37. The oral therapeutic appliance of claim 27, wherein at least a portion of the molded sheet material extends at least 2 mm buccally beyond a patient's gingival margin.

38. The oral therapeutic appliance of claim 27, wherein at least a portion of the molded sheet material extends at least 2 mm lingually beyond a patient's gingival margin.

39. The oral therapeutic appliance of claim 33, wherein at least a portion of the molded sheet material extends to a patient's muco-gingival junction.

40. A method of delivering medicament to the soft tissue of the mouth comprising:

(a) covering at least a portion of the teeth and the adjacent buccal and lingual soft tissues with a molded contoured oral therapeutic appliance that is configured to extend beyond the gingival margin;

(b) placing the medicament to be delivered within the oral therapeutic delivery appliance;

(c) positioning the oral therapeutic appliance over the teeth in the area where the medicament is to be delivered such that at least a portion of the medicament is able to contact the soft tissue; and (d) maintaining the oral therapeutic appliance in position for a sufficient time to allow a therapeutically effective amount of the medicament to be absorbed by the soft tissue.

41. The oral therapeutic appliance of claim 40, wherein the oral therapeutic appliance is maintained in position by a tight fit.

42. The oral therapeutic appliance of claim 40, wherein the medicament to be delivered is selected from the group consisting of antibiotic compounds, antimicrobial compounds, antiviral compounds, antifungal compounds, anesthetic compounds, analgesic compounds, steroids and combinations thereof.

43. The oral therapeutic appliance of claim 40, wherein the medicament to be delivered is insulin, chlorhexidine, fluoride, metronidazole, minocycline, tetracycline, peroxide, or combinations thereof.

44. The oral therapeutic appliance of claim 42, wherein the antibiotic compound to be delivered comprises tetracycline.

45. The oral therapeutic appliance of claim 42, wherein the antimicrobial compound to be delivered comprises chlorhexidine.

46. A method of forming an oral therapeutic appliance comprising:

(a) forming an impression of a patient's mouth that registers at least a portion of the patient's teeth and surrounding gingival tissue;

(b) using the impression to form a stone cast model of the mouth;

(c) placing flowable composite on the stone cast model at a region corresponding to the soft tissue of a patient' s mouth;

(d) curing the stone cast; and

(d) molding a thermoplastic sheet over the stone cast.

47. The method of claim 46, wherein the impression registers the patient's gingival areas.

48. The method of claim 46, wherein the impression extends at least up to 5 mm beyond the patient's gingival margin.

49. The method of claim 46, wherein the impression extends beyond the patient's muco-gingival junction.

50. The method of claim 46, wherein the flowable composite is placed on the stone cast at a region corresponding to the soft tissue at or near a patient's gingival margin.

51. The method of claim 46, wherein, at least one of the regions where the flowable composite is placed has a width of from about 1 mm to about 5 mm.

52. The method of claim 46, wherein at least one of the regions where the flowable composite is placed has a width of from about 1 mm to about 3 mm.

53. The method of claim 46, wherein the flowable composite extends substantially the length of the gingival margin.

54. The method of claim 46, wherein thermoplastic sheet has a thickness of from 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 molded 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 molded sheet material extends at least 2 mm buccally beyond a patient's gingival margin.

58. The method of claim 46, wherein at least a portion of the molded sheet material extends at least 2 mm lingually beyond a patient's gingival margin.

59. The method of claim 55, wherein at least a portion of the molded sheet material extends to a patient's muco-gingival junction.

60. The method of claim 46, wherein the stone cast is light cured.

61. The method of claim 46, wherein the flowable composite is a high melting wax, molding clay, acrylic or other polymerizable material.

62. The oral therapeutic appliance of claim 1, wherein at least a portion of the molded sheet material extends at least 5 mm beyond a patient' s gingival margin.

63. The oral therapeutic appliance of claim 1, wherein at least a portion of the molded sheet material extends at least 5 mm buccally beyond a patient's gingival margin.

64. The oral therapeutic appliance of claim 1, wherein at least a portion of the molded sheet material extends at least 5 mm lingually beyond a patient's gingival margin.

65. The oral therapeutic appliance of claim 27, wherein at least a portion of the molded sheet material extends at least 5 mm beyond a patient' s gingival margin.

66. The oral therapeutic appliance of claim 27, wherein at least a portion of the molded sheet material extends at least 5 mm buccally beyond a patient's gingival margin.

67. The oral therapeutic appliance of claim 27, wherein at least a portion of the molded sheet material extends at least 5 mm lingually beyond a patient's gingival margin.

68. The method of claim 46, wherein at least a portion of the molded 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 molded sheet material extends at least 5 mm buccally beyond a patient's gingival margin.

70. The method of claim 46, wherein at least a portion of the molded sheet material extends at least 5 mm lingually beyond a patient's gingival margin.