Claims:We Claim:
1. A cleansing composition with three step colour Indication for dental appliance comprising:
a) a perborate compound,
b) a persulfate compound,
c) one or more effervescent agent,
d) one or more chelating agent and
d) a combination of indicator dye compound,
wherein said composition when immersed with the denture apparatus accurately indicates the initiation, cleansing and completion of the cleansing process.
2. A cleansing composition with three step colour Indication for dental appliance according to claim 1, wherein the perborate compound is sodium perborate monohydrate within the range of 5% to 25%.
3. A cleansing composition with three step colour Indication for dental appliance according to claim 1, wherein the persulfate compound is potassium monopersulfate within the range of 25% to 45%.
4. A cleansing composition with three step colour Indication for dental appliance according to claim 1, wherein the one or more chelating agent and one or more effervescent agent selected from EDTA, Sodium bi-carbonate, Sodium carbonate, Sulfamic Acid, Porphine within the range of 25% to 45%.
5. A cleansing composition with three step colour Indication for dental appliance according to claim 1, wherein the combination of indicator dye compound is Erythrosine (C.I.45430) within the range of 0.01% to 0.09% and brilliant blue (C.I.42090) within the range of and 0.007% to 0.021%.
6. A cleansing composition with three step colour Indication for dental appliance according to claim 1, wherein the said composition further comprises a TAED as bleaching activator within the range of 0.15% to 0.25%.
7. A cleansing composition with three step colour Indication for dental appliance according to claim 1, wherein the said composition is in the form of a tablet and/or powder and/or concentrated solution wherein the said composition is mixed with predetermined aliquot of water for use.
8. A cleansing composition with three step colour Indication for dental appliance according to claim 1, optionally comprises one or more binders, lubricants, fragrant, enzymes and/or surfactants.
9. A cleansing composition with three step colour Indication for dental appliance comprises 7% Sodium Perborate Monohydrate, 40% Potassium Monopersulphate, 21% Sodium Bicarbonate, 11% Trisodium Phosphate, 11% Sodium Carbonate, 0.25% EDTA, 0.25% TAED, 2% Polyvinylpyrrolidone, 1% Sodium Lauryl Sulphate, 0.02% Erythrosine (C.I.45430) and 0.009% brilliant blue (C.I.42090). , Description:TITLE OF THE INVENTION
Cleansing composition with Three Step Colour Indication for Dental Appliance

FIELD OF THE INVENTION
The present invention relates generally to a cleansing tablet for dental appliances, more particularly to a denture cleansing tablet composition comprising a colour indicator to indicate the three steps of the cleansing process, namely the initiation action, cleansing action and completion action of the cleansing process.

BACKGROUND OF THE INVENTION
Use of dental appliance has seen an increase in the recent years including removable braces, retainers, and dentures. The growth of the market is likely to driven by growing edentulous population, rising disposable income, increasing incidences of dental caries and other periodontal diseases.
According to the United Nation Concise Report on World Population Situation in 2014, the share of elderly population aged 60 years or older in the global population increased from 9.0% in 1994 to 12.0% in 2014; this figure is expected to reach 21% by 2050. The elderly are more prone to tooth related condition and tooth loss. As a result, with the growth in the geriatric population, demand for artificial teeth/ denture is expected to increase globally. Hence, there always exists a demand for better dental appliances that are easy, economical and safe for long term use in individuals.
Dentures, one of the highly used dental appliances are removable appliances that can replace missing teeth and help restore the smile of individuals. If an individual had lost all of their natural teeth, whether from gum disease, tooth decay or injury, replacing missing teeth will benefit the appearance and health. That’s because dentures make it easier to eat and speak better than one could without teeth. Like teeth, dentures and other dental appliances should be cleaned regularly to maintain good oral health and fresh breath. One of the major concerns in the use of dental appliances is the accumulation of residues on these (e.g., removable braces, retainers, dentures, etc.).
It is well known that microbiological deposition and proliferation on dentures and other dental appliances causes a number of problems for patients and their treating dentists. Such problems include odour, denture-induced stomatitis, staining and an unpleasant taste to the appliance as well as within the oral cavity. The depositions often consist of some combination of food particles and biofilm (i.e., plaque), the latter of which is a slime layer that naturally develops when bacteria attach to an inert support. Many of these bacteria produce volatile sulphur compounds as waste products.
If the dental appliance is not cleansed on a regular basis, the mal-odorous waste products will accumulate, causing the wearer to exhibit bad breath. Even more serious is the potential for pathogenic bacteria to inhabit the biofilm, increasing the likelihood of infection for the wearer. Over time, the biofilm will be converted into dental calculus, which consists of inorganic mineralized salts derived from saliva, bacteria, and food particles.
Although many individuals choose to brush their dental appliance with toothpaste (i.e., mechanical cleaning), others find it more convenient to soak their appliance in a cleansing solution. This cleansing solution is often generated by mixing a commercially available cleansing tablet or powder with water. Though such compositions have achieved considerable popularity and commercial success, these available powders and tablets do not provide means for indicating the completion of the cleaning process. One dis advantage of the existing cleansing agents are the use of strong oxidizing agents and bleaching agents in concert to remove visible stain and scale or plaque build-up. Another disadvantage of these cleansing agents that they do not have any particular indicating means to indicate the completion of the cleaning process, such that both the scales and microbial disinfection occurs effectively. Typically, Individuals who use these cleansing solutions tend to over soak the dentures overnight leads to many disadvantages such exposure to fungal infections, fading of the denture gum and teeth colour and spoilage of the denture apparatus, thus leading premature damage of the denture apparatus.
One solution that is effectively used in the prior art is the use of effervescence to indicate the duration of action of cleansing on the dentures. For the most part these compositions have employed a variety of sulfate salts, e.g., bi-sulfates and mono-persulfates, to serve as detergents and oxidizers, as well as alkali metal and alkali earth metal halides as bleaches. Perborate, carbonate, bicarbonate and phosphate salts were conventionally included to provide effervescence and activation. These references have focused on making powdered or tableted products which dissolve rapidly and effervesce when placed in water. These products clean dentures generally in 12-30 minutes or longer and require constant emersion during this period, followed by brushing and rinsing with water. However, these denture soak products is the lack of sustained effervescence which is desirable to effect complete cleansing of the dentures as well as act as an indicator of the completion of said cleansing action.
Further, prior art indicates the use of compositions such as a dye which produces coloration when the composition is first dissolved in water but which is bleached by the oxygen released by the per-oxygen compound and the intention is that the bleaching of the colour should indicate completion of the cleansing process. It is generally considered that satisfactory cleansing of dentures should be effected by immersing them in about an appropriate of the per-oxygen compound-containing composition in water for appropriate time thus when the dye indicator is required one must be so chosen that the disappearance of the original colour of the solution occurs satisfying all these features.
However, difficulty occurs in formulating a cleansing composition, wherein the composition provides effective cleansing of plaque and microorganisms and indicates the initiation, progress and completion of the cleansing with right composition of dye compounds. The present invention provides means and methods to achieve this composition to accurately indicate the three steps of the cleansing action for use in all possible dental applications.

SUMMARY OF THE INVENTION
The following presents a simplified summary of one or more embodiments in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments and is intended to neither identify key or critical elements of all embodiments nor delineate the scope of any or all embodiments. Its sole purpose is to present some concepts of one or more embodiments in a simplified form as a prelude to the more detailed description that is presented later.
In accordance with one aspect of the present invention provides means and methods for a dental cleansing apparatus, more particularly denture cleansing apparatus comprising an indicator added within the range of 0.075% to 0.099% of Tartarazine Supra and 0.012% to 0.021% of Colour Brilliant Blue FCF. In one embodiment, the present invention comprises addition of said indicator composition along with other oxidising, cleansing and effervescent compounds, wherein the said dental cleansing composition when added to water imparts a blue colour to the solution. In another embodiment, the solution prepared in accordance with this invention is immersed with the dental apparatus to be cleansed, wherein the cleansing action turns the solution from blue colour to green colour indicating the completion of the process accurately, such that the dental apparatus can be removed from the solution for use.
The foregoing has outlined rather broadly the features and technical advantages of the present invention so that those skilled in the art may better understand the detailed description of the invention that follows. Additional features and advantages of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the art should appreciate that they may readily use the conception and the specific embodiment disclosed as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the invention in its broadest form.

DETAIL DESCRIPTION OF THE INVENTION
Applicants have recognized that there is a need for a system for a dental cleansing composition comprising an indicator means to indicate the completion of the cleansing action of dental apparatus. More particularly, the present invention relates to a dental appliance cleansing composition suitable for cleaning removable dental appliances.
Before undertaking the detailed description of the invention below it may be advantageous to set forth definitions of certain words and phrases used throughout this patent document: the terms “include” and “comprise ” as well as derivatives thereof mean inclusion without limitation;. Definitions for certain words and phrases are provided throughout this patent document those of ordinary skill in the art should understand that in many if not most instances such definitions apply to prior as well as future uses of such defined words and phrases.
The present invention discloses a denture apparatus cleansing composition comprising: a perborate compound, a persulfate compound, one or more chelating agent, one or more effervescent agent and a combination of indicator dye compound, wherein said composition when immersed with the denture apparatus accurately indicates the three steps namely initiation, progress and completion of the cleansing process.
The present invention provides means and methods of indicating the entire steps of the cleansing process, wherein the composition of the dye indicator used in the said denture cleansing apparatus, accurately indicates the initiation, progress and completion of the cleansing process when the appropriate pH of the cleansing solution is achieved in each of the said three steps. The said appropriate pH of the cleansing solution immersed with the denture apparatus is achieved when the said cleansing solution initiates the removal of microbial growth, progress of removal of microbial growth, and completion of the removal of the microbial growth in the said denture apparatus.
In one embodiment, the perborate compound is a perborate hydrate, more preferably, Sodium Perborate Hydrates. Sodium perborate undergoes hydrolysis in contact with water, producing hydrogen peroxide and borate. Sodium perborate monohydrate used in the present composition, serves as a stable source of active oxygen in this cleansing composition causing less interaction with the combination of indicator dyes. The total perborate compound is added in the said composition is about 5% to 20% by weight of the total composition.
In one embodiment the persulfate compound used in the composition a monopersulfate and is preferably an alkali metal monopersulfate or an alkaline earth metal monopersulfate. It is a strong oxidizing agent that is used as a cleaning and bleaching agent. The potassium monopersulfate compound added in the said composition is about 25% to about 45% by weight of the total composition.
In one embodiment, the perborate and the persulfate compound in the dental cleansing composition of the present invention acts as the oxidizing agents during the cleansing process.
In one embodiment, the chelating agent herein include any compounds that coordinate to or form complexes with a divalent or polyvalent metal cation, thus serving as a sequestrant of such cations. Accordingly, the term "chelating agent" herein includes not only divalent and polyvalent ligands (which are typically referred to as "chelators") but also monovalent ligands capable of coordinating to or forming complexes with the metal cation. Suitable biocompatible chelating agents useful in conjunction with the present invention include, without limitation, monomelic polyacids such as EDTA, cyclohexanediamine tetraacetic acid (CDTA), hydroxyethylethylenediamine triacetic acid (HEDTA), diethylenetriamine pentaacetic acid (DTPA), citric acid, sodium bicarbonate or the like. Furthermore any suitable chelating agent known in the art, which is biologically safe and able to chelate iron, calcium or other metals, is suitable for the invention. Further the chelating agent selected should have properties such as greater affinity, low toxicity, high water solubility and ability to form low toxic complexes for use in the denture cleansing composition in accordance to the present invention.
Without intending to be bound by theory, the chelating agents in the denture cleansing composition of the present invention, reacts with the calcium present in the calculus that accumulates on dentures during the day. Additionally, any stain attached to the said calculus deposits are also removed in the process providing effective cleansing of the denture apparatus.
In one embodiment, the chelating agent is interchangeably used with and/or to one or more effervescent agents in the said dental appliance cleansing composition. The effervescent agents along with the chelating agents remove stain and deposits in the dental appliance, namely the dentures. Hence, the chelating agent along with the effervescent agents produces effervescence indicating the initiation of the cleansing action of the said denture cleansing composition.
In one embodiment, the total combination of both the chelating agent and effervesce agent added in the said denture cleansing composition is about 25% to 45%.
In one embodiment, the present invention comprises a combination of indicator dye compound comprising Erythrosine (C.I.45430) and colour brilliant blue (C.I.42090). In one embodiment, the combination of both the dye is added within the range of 0.01% to 0.09% of Erythrosine (C.I.45430) and 0.007% to 0.021% of colour brilliant blue (C.I.42090).
At this combination, the cleansing solution when mixed with a predetermined aliquot of water forms a pink colour prior to immersing any apparatus for cleansing. When the apparatus is immersed in the said solution, the cleansing action of the other ingredients begin and the microbial decontamination occurs wherein the colour of the solution turns to purple, thereby reducing the pH of the cleansing solution and when the completion of the cleansing process occurs, the solution turns blue in colour to indicate the achieving of pH 9 to pH 11, post which microbial decontamination process is completed. Hence, the said composition indicates the three-step cleansing process, wherein the initiation (Pink colour), cleansing action (Purple colour) and completion of the cleansing action (blue colour).
In one embodiment, the present invention advantageously indicates the initiation, cleansing and completion of the cleansing action by indicating the appearance of Pink to purple and blue colour in the cleansing solution as opposed to present technologies wherein the solution turns colourless. This embodiment is achieved by the exact combination of the indicator dye composition namely, Erythrosine (C.I.45430) and colour brilliant blue (C.I.42090).
In one embodiment, the present invention further comprises aroma agents to impart fragrance or flavour to the dental appliance cleansing composition.
In one embodiment, the denture cleansing composition of the present invention is a tablet and/or a powder capable of dissolving in an aliquot of water to produce a cleansing solution for cleaning of said dental appliance. In another embodiment, the denture cleansing composition is a solution which does not require the addition of water to improve the ease of use of cleansing said dentures.
In one embodiment, the denture cleansing composition is a tablet and/or powder, further comprises one or more lubricants well known in the art to ensure good release of the cleansing composition when dissolved in an appropriate solution. Sodium lauryl sulfate, sodium benzoate, polyethylene glycol, talc, metal stearates and polymeric fluorocarbons are all known and acceptable lubricant and compression aids. In one embodiment, the said lubricant and compression aid comprises from about 0.2% to about 3% by weight of the total composition.
In one embodiment, the present invention provides a superior denture cleansing tablet capable of removing non-stained plaque, stained plaque, non-stained tartar, stained tartar, and any residue or aftertaste which appears to result from a combination of plaque, stained plaque, tartar and stained tartar.
In one embodiment, rinsing the dentures apparatus post achieving green colour of the cleansing solution aids in the removal of any the residual denture cleansing solution and additional plaque, stain, and tartar. Further rinsing may also reduce the "slippery" or "slimy" feeling or the "metallic aftertaste" often associated with dentures immediately following the cleaning process in accordance with the present invention.
In addition to the ingredients set forth above, the present compositions may contain a variety of additional ingredients selected on the basis of desired end use. Thus, for example, the compositions may include detergent compounds, foaming agent, fragrant, enzymes and/or the like known at that time in the art for the purpose of effective cleansing of the denture apparatus.
In one embodiment, the present invention provides a composition with increased cleaning efficacy and fast dissolution as required of tablet cleansers. In addition, the components of this denture cleanser composition bleaches, disinfects, and deodorizes the appliance, while removing plaque that has accumulated on the appliance during wear
Although the invention has been described in terms of preferred embodiment it is not limited thereto. Those skilled in this technology can make various alterations and modifications without departing from the scope and spirit of the invention. Therefore the scope of the invention shall be defined and protected by the following claims and their equivalents.