Oral appliance for treating inflamed tissue of the oral cavity using the top-down method
An oral appliance for delivering a medicament to an inflamed tissue inside an oral cavity is provided. The oral appliance has an interior surface configured to contour at least a portion of teeth and/or soft tissue areas inside the oral cavity, the interior surface of the oral appliance having a medicament disposed at a discrete region of the interior surface of the oral appliance, the medicament configured to contact a top portion of the inflamed tissue inside the oral cavity when the oral appliance is worn to cause delivery of the medicament to at least the top portion of the inflamed tissue. A method of making the oral appliance and a method of treating an inflamed tissue inside an oral cavity using the oral appliance is also provided.
1 . An oral appliance for delivering a medicament to an inflamed tissue of an oral cavity, the oral appliance having an interior surface configured to contour at least a portion of teeth and/or soft tissue areas of the oral cavity, the interior surface of the oral appliance having a medicament disposed in a porous material at a region of the interior surface of the oral appliance, the porous material having a projection configured to contact the soft tissue of the oral cavity including a top portion of the inflamed tissue of a gingival and/or periodontal pocket of the oral cavity when the oral appliance is worn to cause delivery of the medicament to at least the top portion of the inflamed tissue, wherein the oral appliance, when worn, is configured to compress the porous material against the gingival and/or periodontal pocket and form a seal at an entrance of the gingival and/or periodontal pocket so as to allow the projection which is sized and shaped to extend into the gingival and/or periodontal pocket to prevent oral fluid from entering therein and to allow a gap to form between the projection of the porous material and the inflamed tissue within the gingival and/or periodontal pocket so as to allow delivery of the medicament from the projection inside the seal to the inflamed tissue within the gingival and/or periodontal pocket and also allow wicking of oral fluid into the projection, and wherein the porous material has an upper surface having a low concentration of the medicament, a middle surface having a high concentration of the medicament and a lower surface having a low concentration of the medicament such that when the oral appliance is worn, the middle surface having the high concentration of medicament is located immediately adjacent to the gingival and/or periodontal pocket and the upper surface and the lower surface having the low concentration of medicament are located away from the entrance of the periodontal pocket.
2 . The oral appliance of claim 1 , wherein the porous material is sized to be greater than the height, width, and length of the entrance of the gingival and/or periodontal pocket to cause the medicament to be released inside the seal within the gingival and/or periodontal pocket compared to outside the periodontal pocket.
3 . The oral appliance of claim 1 , wherein the porous material that forms the seal at the entrance of the gingival and/or periodontal pocket has a higher concentration of the medicament as compared to porous material opposite and outside the seal.
4 . The oral appliance of claim 1 , wherein the inflamed tissue comprises periodontal disease.
5 . The oral appliance of claim 1 , wherein the porous material absorbs crevicular, sulcular fluid, exudate or a combination thereof from the inflamed tissue.
6 . The oral appliance of claim 1 , wherein the porous material is a hydrogel.
7 . The oral appliance of claim 1 , wherein the oral appliance comprises an exterior surface that is non-porous.
8 . The oral appliance of claim 1 , wherein the medicament comprises an antimicrobial agent, an anti-inflammatory agent, an antiseptic agent, a probiotic, an immunologic agent, an astringent agent, or a mixture thereof.
9 . The oral appliance of claim 8 , wherein the probiotic comprises a bacterium which comprises L. brevis, B. lactis, B. longum, L. acidophilus, L. reuteri, L. salivarius, L. sporogens, S. oralis, S. uberis, S. rattus, L. rhamanosus or a mixture thereof.
10 . The oral appliance of claim 8 , wherein the medicament is free of hydrogen peroxide.
11 . The oral appliance of claim 8 , wherein the antiseptic is chlorhexidine.
12 . The oral appliance of claim 1 , wherein the oral appliance is disposable.
13 . The oral appliance of claim 1 , wherein the medicament is chlorhexidine, which is disposed in a porous material comprising a polymer.
14 . A system for delivering a medicament to an inflamed tissue of an oral cavity, the system comprising a first set of oral appliances, each of the first set of oral appliances having an interior surface configured to contour at least a portion of the teeth and/or soft tissue areas of the oral cavity, the interior surface of each of the first set of oral appliances having a medicament disposed in a porous material at a region of the interior surface of each of the first set of oral appliances, the porous material having a projection configured to contact the soft tissue of the oral cavity including a top portion of the inflamed tissue of a gingival and/or periodontal pocket of the oral cavity when the oral appliance is worn to cause delivery of the medicament to at least the top portion of the inflamed tissue, wherein the oral appliance, when worn, is configured to compress the porous material against the gingival and/or periodontal pocket and form a seal at an entrance of the gingival and/or periodontal pocket so as to allow the projection which is sized and shaped to extend into the gingival and/or periodontal pocket to prevent oral fluid from entering therein and to allow a gap to form between the projection of the porous material and the inflamed tissue within the gingival and/or periodontal pocket so as to allow delivery of the medicament inside the seal to the inflamed tissue within the gingival and/or periodontal pocket; and a second set of oral appliances, each of the second set of oral appliances having an interior surface configured to contour at least the portion of teeth and/or soft tissue areas of the oral cavity, the interior surface of each of the second set of oral appliances having a medicament disposed in a porous material at a region of the interior surface of each of the second set of oral appliances, the porous material having a projection configured to contact the soft tissue of the oral cavity including a middle portion of the inflamed tissue of a gingival and/or periodontal pocket of the oral cavity so as to allow the projection which is sized and shaped to extend into the gingival and/or periodontal pocket when the oral appliance is worn to cause delivery of the medicament from the projection to at least the middle portion of the inflamed tissue and also allow wicking of oral fluid into the projection, and wherein the porous material has an upper surface having a low concentration of the medicament, a middle surface having a high concentration of the medicament and a lower surface having a low concentration of the medicament such that when the oral appliance is worn, the middle surface having the high concentration of medicament is located immediately adjacent to the gingival and/or periodontal pocket and the upper surface and the lower surface having the low concentration of medicament are located away from the entrance of the periodontal pocket.
15 . The system of claim 14 , wherein the system further comprises a third set of oral appliances, each of the third set of oral appliances having an interior surface configured to contour at least the portion of teeth and/or soft tissue areas of the oral cavity, the interior surface of each of the third set of oral appliances having a medicament disposed at a region of the interior surface of each of the third set of oral appliances, the medicament configured to deliver to a bottom portion of the inflamed tissue inside the oral cavity when the oral appliance is worn to cause delivery of the medicament to at least the bottom portion of the inflamed tissue.
16 . The system of claim 15 , wherein the system further comprises a fourth set of oral appliances, each of the fourth set of oral appliances having an interior surface configured to contour at least the portion of teeth and/or soft tissue areas inside the oral cavity, the interior surface of each of the fourth set of oral appliances having a medicament disposed at a region of the interior surface of each of the fourth set of oral appliances, wherein the medicament is a probiotic.
17 . The system of claim 14 , wherein the medicament comprises an antimicrobial agent, an anti-inflammatory agent, an antiseptic agent, a probiotic, an immunologic agent, an astringent agent, or a mixture thereof.