Diclofenac and hyaluronic acid combination treatment for oral leukpoplakia

Abstract

An oral gel composition suitable for the treatment of oral leukoplakia comprising a combination of diclofenac with hyaluronic acid and methods of administering the oral gel that may include a device that prolongs contact time of the oral gel with the areas of the mucosa that are affected by oral leukoplakia.

What is claimed: 
     
         1 . A kit for treating oral leukoplakia, comprising:
 a therapeutically effective amount of the oral gel composition comprising a nonsteroidal anti-inflammatory drug (NSAID) or a pharmaceutically acceptable salt thereof, hyaluronic acid or a pharmaceutically acceptable salt thereof, a gelling agent or thickener, and a flavoring agent and/or sweetener to the mucosal tissue or an affected portion thereof;   an applicator to more accurately apply the medication onto the mucosa that is affected by oral leukoplakia;   a device, comprising:
 a fitting portion having an arcuate shape corresponding to the dental arche of a patient or subject; 
 at least one covering portion defined on the fitting portion, the covering portion having a respective outer surface, an upper wing portion and a lower wing portion; 
 at least one bite flange extending from an interior surface of the fitting portion; and 
 an upper ledge extending from the interior surface of the fitting portion and following the arc of the fitting portion, 
 wherein an upper surface of the upper ledge and an upper surface of the at least one bite flange are continuous with one another, and 
 wherein the at least one covering section is more flexible than the fitting portion; and 
   printed instructions on how to use the device to administer the oral gel composition to the mucosal tissue of a patient having oral leukoplakia or at risk of developing oral leukoplakia.   
     
     
         2 . An oral device, comprising:
 a fitting portion having an arcuate shape corresponding to the dental arche of the patient and at least one covering portion, the covering portion having a respective outer surface, an upper wing portion and a lower wing portion;   at least one bite flange extending from an interior surface of the fitting portion; an upper ledge extending from the interior surface of the fitting portion and following the arc of the fitting portion, wherein an upper surface of the upper ledge and an upper surface of the at least one bite flange are continuous with one another, wherein the at least one covering section is more flexible than the fitting portion, and wherein a portion of the respective outer surface of the at least one covering portion is in contact with the portion of the mucosal tissue, and wherein the at least one covering portion has a surface that contacts and rests against at least a portion of the tongue.   
     
     
         3 . The device of  claim 2 , wherein the at least one covering portion has a surface that contacts and rests against the ventral side of the tongue. 
     
     
         4 . The device of  claim 2 , wherein the at least one covering portion has a surface that contacts and rests against one or both sides of the tongue.