Abstract:
A gingival isolation material that is pliable once cured or set. The isolation material can include components such as water, a thickening agent, a plasticizer, a dye and a preservative.

Description:
CLAIM FOR PRIORITY 
       [0001]    This patent application claims priority to and benefit of U.S. Provisional Patent Application Ser. No. 60/693,971 filed on Jun. 24, 2005. 
     
    
     BACKGROUND 
       [0002]    Gingival isolation is a procedure performed in dentistry, and there is some advantage found in using a pliable gingival isolation material. Materials commonly employed in the practice of dentistry contain components that while generally safe for contact with the tooth structure, these components can be anywhere from irritating to corrosive to soft oral tissues. Methods and materials are currently used to isolate or protect oral tissue adjacent to exposed tooth structure when such dental materials are in use. These isolation systems are generally designed to prevent the irritating materials from penetrating through the isolation material to reach the tissue. Generally, these isolation materials are flexible in nature when first applied. Some of these materials can be treated or cured to form a rigid barrier designed to prevent the accidental displacement of the isolation material during the dental procedure. In spite of these measures, whether the material remains flexible or takes a rigid form, these isolation materials often become displaced anyway, allowing the harsh materials to penetrate past the isolation and come in contact with soft tissue. A material is needed that adheres or remains in intimate contact with soft tissue that remains flexible, that resists penetration by dental materials, and that resists dissolution by the dental materials, until the removal of the isolation material is desired. 
     
    
     DETAILED DESCRIPTION 
       [0003]    The isolation material includes water, thickening agents, a plasticizer, a filler, and a dye or pigment. The material may also contain a pain management substance. 
         [0004]    Thickening agents that may be used include any of a variety of molecular weights of polyethylene glycol (polyethylene oxide), polypropylene glycol, polyvinyl pyrrolidone, polyacrylic acid (Carbopol), polyvinyl alcohol, cellulosic compounds such as hydroxyethyl cellulose and carboxymethyl cellulose, natural gums such as gum karaya, xanthan gum, Guar gum, gum arabic, and gum tragacanth, Pemulen® made by B. F. Goodrich Company, and any block copolymers of the above mentioned. 
         [0005]    Plasticizers may include glycerin, prolpylene glycol, low molecular weight polyethylene glycol, mineral oil, triethyl citrate, acetyltriethyl citrate, lauric acid, modified vegetable oils, diacetylated monoglycerides, castor oil, triacetin, liquid poly propylene glycols, dimethyl phthalate, diethyl phthalate, dipropyl phthlate, dibutyl phthalate, dioctyl phthalate, or polysorbates. 
         [0006]    Fillers may include small particulate or fumed silicon dioxide, titanium oxide, water insoluble particles of polycaprolactones, polyimide-imide, phenolic, nylon, fluoropolymers, acrylics, acrylonitrile-butadiene-styrene, cellulosics, polybutylene, polycarbonate, polyethylene, polyimides, polyphenylene oxide, polypropylene, polystyrene, polyurethanes, polyvinyl acetates, polyvinyl chloride, poly(vinyl alcohol-co ethylene), styrene acrylonitrile, and saturated or unsaturated polyesters. 
         [0007]    Dyes and pigments may include any of the U.S. FDA approved FD&amp;C dyes such as Blue #1 or Yellow #5. Substances for providing pain management may include benzocaine or lidocaine. 
         [0008]    The resulting composition features a viscosity sufficient to prevent the material from flowing away from the tissue to which it is applied to adjacent surfaces. The composition is of sufficient viscosity to prevent other dental materials from penetrating or ingressing into the gel to the extent that these other materials are capable of penetrating through the isolation material and coming into contact with the protected tissue. The composition features a surface adhesion sufficient to allow the composition to remain in intimate contact with the oral tissue, even when external force is exerted on portions of the gel distal to the isolation/tissue interface. The composition remains flexible or pliable during the course of the dental procedure. The composition resists dissolution by water or other solvents that come in incidental contact with the composition, but the application of a solvent such as water, combined with an applied mechanical action, is capable of removing the composition from the oral tissue with minimal irritation to the oral tissue. The isolation material is applied in a manner similar to other currently available tissue isolation systems. 
       Example Formula #1 
       [0009]    10-20%—water 
         [0010]    20-30%—thickening agent 
         [0011]    30-50%—plasticizer 
         [0012]    0.001-0.01%—dye 
       Example Formula #2 
       [0013]    0-10%—water 
         [0014]    35-50%—thickening agent 
         [0015]    40-60%—plasticizer 
         [0016]    0.05-0.2%—preservative 
         [0017]    0.001-0.01%—dye 
       Example Formula #3 
       [0018]    15-30%—water 
         [0019]    20-45%—thickening agent 
         [0020]    15-30%—plasticizer 
         [0021]    0.001-0.01%—dye 
         [0022]    While the present invention has been described and illustrated in conjunction with a number of specific embodiments, those skilled in the art will appreciate that variations and modifications may be made without departing from the principles of the invention as herein illustrated, described, and claimed. The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects as only illustrative, and not restrictive. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.