Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2002-11-05
2004-02-10
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C433S215000, C433S216000
Reexamination Certificate
active
06689343
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
Not applicable.
BACKGROUND OF THE INVENTION
1. The Field of the Invention
The present invention is in the field of hemostatic and acid etch compositions, more particularly hemostatic compositions for use in providing hemostasis in oral tissues and etching compositions used in etching teeth.
2. The Relevant Technology
In the course of performing certain dental procedures it is often desirable to use a hemostatic composition in order to stop the bleeding of oral tissues. For example, during dental reconstruction or preparation of dental crowns it is common for dentists to cut gingival or gum tissue in order to fully expose the tooth prior to taking an impression of the tooth. In order to make an accurate impression of the tooth it is advantageous for it to be clean and dry. For this reason, a hemostatic composition may be used to reduce or eliminate bleeding so that a more accurate impression of the patient's tooth can be taken.
In the case of invasive dental procedures, such as preparing the tooth to receive a crown or forming a deep dental preparation that is to be filled with a restorative composition, sufficient enamel and dentin may be removed so as to expose the pulp chamber. It may be desirable in some cases to apply a hemostatic composition to stop or slow bleeding of the exposed pulp.
Whereas hemostatic compositions of various types have been used successfully to stop or slow the bleeding of oral tissues during a variety of dental or oral procedures, hemostatic compositions can be very unpleasant tasting. Hemostatic compositions tend to be quite acidic (i.e., typically having a pH of about 1-2), which makes them have a profound sour or bitter flavor. It is therefore preferable to avoid contacting the patient's tongue with the hemostatic composition during the procedure in question. Allowing the hemostatic composition to contact the person's tongue is not only unpleasant to the patient, it may even cause the patient to flinch or experience a gag reflex, both of which can hinder the dental procedure.
A similar problem exists in the case of dental etching compositions used to etch a patient's tooth during a dental procedure. Dental etching compositions are typically used to create a superior bonding surface in dentin, enamel or both to which a restorative composition can better adhere. However, since dental etching compositions are by nature very acidic (i.e., typically having a pH of about 0-2), they also have a profound sour or bitter flavor and cause similar problems associated with hemostatic compositions.
In view of the foregoing, it would be an advancement in the art to provide better tasting hemostatic and dental etching compositions. More particularly, it would a an important advancement in the art to provide hemostatic and dental etching compositions that were more palatable to the patient in order to reduce the tendency of such compositions to startle the patient or induce a gag reflex if such compositions happen to contact the patient's tongue.
SUMMARY OF THE INVENTION
The present invention is directed to hemostatic compositions and dental etching compositions that contain sucralose, which is a non-nutritive sweetener. The inclusion of sucralose adds a pleasant taste that at least partially offsets the otherwise sour or bitter taste of the acidic hemostatic and/or acidic dental etching agents. This, in turn, reduces the chance that a patient will be surprised or startled in the event the hemostatic composition or dental etching composition were to contact the patient's tongue. Thus, an advantage of including sucralose within such compositions is that it creates a more pleasant experience for the patient. It may also reduce the tendency of the patient to flinch or gag if the otherwise sour or bitter composition were to contact the patient's tongue.
One advantage of sucralose is that it is many times sweeter than sugar, which greatly reduces the amount of sweetener that must be added to offset the sour or bitter taste of the hemostatic or dental etching agent. This results in less residue that must otherwise be removed from the patient's tooth. Another advantage of using sucralose over certain sweeteners (e.g., aspartame) is that sucralose has been found by the inventors to be stable in the presence of hemostatic or dental etching agents, both of which are highly acidic in water. Thus, sucralose is effective in disguising the sour or bitter taste of such agents even after being mixed and stored with such agents over time (e.g., weeks, months or even years). Sucralose has also been found by the inventors to leave no bitter or unpleasant after taste, which is an advantage over certain non-nutritive sweeteners, such as sodium saccharine.
The sucralose and hemostatic or dental etching agent are mixed together within an appropriate carrier, such as an aqueous liquid or gel. Water is typically used as part of the carrier in order to dissolve the sucralose, hemostatic agent and/or dental etching agent within the carrier. In the case where a sticky or viscous composition is desired, one or more thickening or tackifying agents may be included, examples of which include finely divided gel-forming metal oxides (e.g., fumed silica, precipitated or fumed aluminum oxide), organic thickeners (e.g., pemulen), or other gelling agents known in the art.
The inventive compositions may also include other adjuvents and active ingredients such as flavorants, desensitizing agents (e.g., KNO
3
), anticariogenic agents (e.g., fluoride compounds), antimicrobial agents (e.g., antibiotics), stabilizing agents (e.g., EDTA), and the like. The carrier is preferably substantially free of abrasives.
Depending on the desired treatment regimen, the hemostatic or dental etching compositions according to the invention may vary as desired in potency, fluidity or stickiness in order to optimize the performance of the composition for a given treatment regimen.
Examples of hemostatic agents that may be used within the inventive hemostatic compositions include, but are not limited to, ferric sulfate, ferric subsulfate, ferric chloride, zinc chloride, aluminum chloride, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, alum, salts of manganese, salts of bismuth, permanganates, and tannin.
Examples of dental etching agents include, but are not limited to, mineral acids, such as phosphoric acid, nitric acid, hydrochloric acid and sulfuric acid, and organic acids, such as glycolic acid, malic acid, maleic acid, acetic acid, citric acid, and EDTA.
Hemostatic compositions according to the invention will typically have a pH of less than about 3, preferably less than about 2.5, more preferably a pH less than about 2, and most preferably a pH in a range of about 1-2. Dental etching compositions according to the invention will preferably have a pH of less than about 2, more preferably a pH less than about 1, and most preferably a pH in a range of about 0-1.
These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
I. Introduction
As summarized above, the invention is generally related to acidic hemostatic compositions and dental etching compositions that contain sucralose, a chlorinated sucrose derivative that has greatly enhanced sweetness compared to sucrose. The purpose of the sucralose is to mask or disguise the extremely sour or bitter taste associated with hemostatic agents and/or dental etching agents.
Hemostatic compositions within the scope of the invention encompass virtually any hemostatic composition suitable for providing hemostasis in oral tissues so long as it contains sucralose. Likewise, dental etching compositions within the scope of the invention encompass virtually any dental etching composition suitable for etching teeth so long as it contains sucralose. The inventive compositions generally comprise at leas
Allred Peter M.
Jensen Steven D.
Rose Shep K.
Ultradent Products Inc.
Workman Nydegger
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