RELATED APPLICATIONS

[0001] This application claims priority to Australian provisional application no. 2019903440 filed 16 September 2019, the entire content of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This invention relates to oral health improving products.

BACKGROUND TO THE INVENTION

[0003] Tooth decay is a common global disease that affects almost everyone and is estimated to affect up to 12 million Australians each year. In a recent survey of the numbers of decayed missing or filled teeth (see Fig. 1) for baby teeth at age 6 (item 2) and permanent teeth at age 12 (item 4). This shows although water fluoridation has decreased the incidences of caries in general, tooth decay increases with age to involve an average of 23.7 teeth in a lifetime for permanent teeth. This data unfortunately fails to shows the causes behind these alarming statistics and indicates the need for whole of population data to be regularly collected on a national database.

[0004] The lack of adequate quality oral health data, for all age groups, results in poor policy and tooth care advice issues which has the consequences of increased need for treatment, more equipment and more qualified staff. In 2013-14, there were 63,910 preventable hospitalisations of children under the age of 9 due to dental causes. Also, the cost to the Child Dental Benefits Scheme was $20.5 million for tooth extractions and $96.1 million for fillings in 2014/15. Thus widespread tooth decay has a massive effect on government and private health funding, as well as the overall oral health of the population.

[0005] While brushing with a toothpaste is typically advised for both children and adults, it is difficult to remove food trapped in the pit and fissure development faults in the back teeth. The food, especially sugary food, serves as a nutrient for bacteria in those pits and faults and bacterial degradation products such as lactic, formic or acetic acid are formed, which causes tooth decay. Further the fluoride toothpaste during tooth brushing, mouthwash or chewing sugar free gum, cannot be forced into the pit and fissure development faults, given the size of the faults, and therefore tooth-brushing does little to neutralise acid build-up and aid remineralisation there. In particular the applicant considers cavities mainly form in the pits and faults and are caused by repeated acid demineralization of teeth that exceed saliva and fluoride remineralisation.

[0006] These cavities can be prevented by the application of sealants over these pit and fissure development faults by dentists which prevents acid demineralisation there. Unfortunately this can be costly, labour-intensive and is not easily applicable to younger children.

[0007] Examples of the invention seek to solve or at least ameliorate one or more disadvantages of previous methods and desirably prevents tooth decay in an effective form that is easy for anyone, including children, to use and can form part of a daily routine.

[0008] The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the above prior art discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

SUMMARY OF THE INVENTION

[0009] According to an aspect of the present invention there is provided an oral health improving product comprising a composition of an orally acceptable base and poorly soluble salts, wherein the composition is adapted to be receivable into fissures in teeth thereby sealing opening(s) thereof. The product can be adapted to substantially fill the fissures.

[0010] Preferably, the product is adapted to allow the poorly soluble salts to combine with saliva before being received in the fissure openings. More preferably, in the composition the poorly soluble salts comprises no more than 10% by weight of the orally acceptable base.

[0011] The product or the orally acceptable base can be chewable to facilitate combining of the salts and saliva.

[0012] The orally acceptable base can be gelatine based or edible food base having a low or no carbohydrate content. Preferably, the orally acceptable base is cheese or a chewable confectionary. [0013] The product can be configured to be in a solid size and/or shape for being receivable in an oral cavity. Preferably, the product is in the form of a strip. At least one surface of the product/strip is arranged so as to increase surface area thereof. The arrangement can comprises depressions or holes on the surface(s).

[0014] The depressions or holes can be configured to measure a dose of at least one dental agent applied thereto.

[0015] The strip can have at least one weakened portion intermediate the strip ends for enabling portions either side of the weakened portion to be foldable or separated. Preferably, the strip has at least one locating portion for aiding in positioning the strip at the back teeth.

[0016] In an embodiment the at least one locating portion is in the form of a pin, a flange or ridge extending laterally from or near an edge of the strip.

[0017] Alternatively, the product/strip has elastomeric properties for facilitating forceful injection of dental agent received on the product/strip into said fissures. The strip preferably has a handle for facilitating positioning of a portion of the strip which is received in an oral cavity.

[0018] The composition can be in the form of a gelatine-based capsule encapsulating at least one dental agent.

[0019] In a preferred embodiment there is provided an oral health improving product including phosphoric acid and soluble fluoride wherein the product is configured such that the phosphoric acid, poorly soluble salts and soluble fluoride are separated and only combine in the oral cavity to form an acidulated calcium fluoride and saliva reactive paste.

[0020] The at least one dental agent is toothpaste or at least two dental agents which combine to form a toothpaste or the calcium fluoride reactive paste as described above or mouthwash or a UV-curable dental sealant. Most preferably, the or each dental agent includes poorly soluble salts.

[0021] The poorly soluble salts can comprise one or more of the following: calcium phosphate, calcium bicarbonate, calcium carbonate, calcium hydroxide, calcium caseinate and barium sulphate. Preferably the insoluble salts are in the form of particles having a diameter less than 0.25 mm in diameter. More preferably, the insoluble salts in the form of particles having a diameter between 0.1 and 0.25 mm in diameter. [0022] According to another aspect of the present invention, there is provided an oral health improving product for simulating fissure faults in teeth, comprising at least two glass plates, and the product being configured such that the faces of the at least two glass plates being fixable together by means for clamping and being arranged so as to provide at least one slot therebetween wherein the slot(s) have a thickness substantially the thickness of a molar fissure fault for simulating fissure faults, and wherein the slots are arranged by means of grooves formed in at least one of the inner faces of the glass plates or spacing portions arranged so as to form said slot(s) therebetween. The plates can be arranged to vary the thickness of the fissure and indicate penetration.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present invention will now be described, by way of non-limiting example, with reference to the accompanying drawings in which:

[0024] Fig. 1 is a chart showing the average number of decayed, missing or filled teeth at age

6 and age 12 showing a decrease from 1977 to 2000 thereafter fluctuating to increase till 2010;

[0025] Fig. 2 is a graphical representation of fissures in a healthy molar taken with X-ray tomography;

[0026] Fig. 3 is a perspective view of an arrangement for modelling fissures comprising a pair of attached plates;

[0027] Fig. 4 is a front view of the arrangements of Fig. 3;

[0028] Fig. 5 is a perspective view of an oral health improving product in the shape of a strip according to a preferred embodiment of the present invention;

[0029] Fig. 6 is a perspective view of another oral health improving product having depressions according to another preferred embodiment of the present invention;

[0030] Fig. 7 is a perspective view of another oral health improving product having depressions according to yet another preferred embodiment of the present invention; and

[0031 ] Figs. 8 and 9 are perspective view of alternative oral health improving products having locating portion(s) according to yet further preferred embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0032] Preferred features of the present invention will now be described with particular reference to the accompanying drawings. However, it is to be understood that the features illustrated in and described with reference to the drawings are not to be construed as limiting on the scope of the invention.

[0033] Research conducted by the applicant indicates that up to 80% of cavities may occur inside pit and fissure developmental faults in back teeth. The applicant measured these faults 6 in extracted healthy molars by X-ray tomography (mXCT) (see Fig. 2 and Table 1 below), which indicated these faults were between 1 and 1.5mm deep and 0.105 to 0.252 mm wide.

[0034] Table 1: Calculated volume, measured depth and width of pits and fissures from mXCT data

[0035] With reference to Figs 3 to 9, there are shown oral health improving products 8, 10, 20, 22, 24, 26, 28 according to several preferred embodiments of the present invention. The oral health improving products 8, 10, 20, 22, 24, 26, 28 concern the issues discussed above in relation to the de-mineralization of the tooth enamel particularly where food is trapped and brushing is unable to reach, in the fissure faults and pits in back teeth and which lead to dental caries and accompanying poor dental health.

[0036] First, in the views illustrated in Figs. 3 and 4, there are shown oral health improving products 8, 10 comprising glass plates 12 for simulation of the pits and fissure faults 6 in the chewing surfaces of back teeth. In Figs. 3 and 4, the two glass plates 12 can be configured in a face-to-face spaced-apart configuration such that there are at least one slot 14 between the plates 12 which can be varied such that it is substantially the thickness/width of atypical fissure 6 (100- 200um) as measured by the applicant shown in the data provided in Fig. 2 and Table 1. These oral health improving products 8, 10 act as models for simulating fissures in teeth for aiding research and development. These products 8, 10 can also be used as educational models which can advantageously promote oral health strategies to the public, especially children, particularly in relation to how chewing traps the first bite of food in the fissures in back teeth and how traditional everyday dental care such as brushing, chewing sugar free gum and mouthwash has little or no effect and access to these faults where most cavities occur leading to tooth decay.

[0037] The oral health improving product 8, 10 can include clamping or fastening means for attachably fixing the plates together in the face-to-face configuration, such as clips. The slot arrangement can be provided in a variety of ways, including the provision of shallow channels or grooves 16 in one or more of the inwardly-directed faces of the glass plates.

[0038] Alternatively, the oral health improving products 8, 10 can include spacer portions positioned intermediate the plates which can be arranged so as to form said slots. For example, as illustrated in Fig. 4, the spacer portions can be in the form of adhesive tape 18 can be placed at the comers and centre of the plates 12 thereby providing four slots 14, each of which can simulate a fissure fault 6. This provides the simulation of much wider fissures that are easy to see and therefore use for demonstration purposes and for measurement of penetration.

[0039] In other embodiments, the spacer portions can be in the form of two pieces of adhesive tape 18, each of which can extend diagonally from corner to corner and where the two pieces of tape intersect at the centre of the plate thereby also providing four triangle-shaped slots which also act to simulate fissure faults.

[0040] The slots 14 are arranged such there is an opening is at the edge of the glass plates 12 for receiving any food or dental agents and the transparency of the glass plates 12 allows observation of the simulation as it progresses when the food and/or dental agents are so received and channel further into the slots to provide information for researchers or food manufacturers. When the demonstration or simulation has ended, the clamping/fastening means can be released so as to conveniently wash the plates in preparation for additional demonstrations.

[0041] In an alternative embodiment the glass plate arrangement can comprise three glass plates 12 where one plate 12 is placed intermediate the two other plates 12 such that each of the outer plates have an inwardly directed face which faces opposing faces of the intermediate plate. The intermediate plate can have holes or grooves which extend laterally between the two outer plates which can then show how food is received within the slots or pits formed by the arrangement. In one arrangement spacer portions can be placed between the intermediate plate and an outer place which simulates pits in teeth and shows how some food can still gain access in the smallest of faults, and further testing of dental agents could be conducted which could show if use of those agents prevent food access or otherwise improve dental health.

[0042] The arrangements described in Figs. 3 and 4 are examples only and it is expected it would be understood that slots 14 can be provided by a variety of means so as to allow simulation of fissure faults for oral health promotion or aiding research and development.

[0043] By use of the oral health improving product 8 for simulating fissures the applicant has been able to replicate the chewing surfaces in molar teeth with each slot of the four slots 14, in the example illustrated in Figs. 3 and 4 in a way that is easy and cost-effective to conduct without the need for long costly clinical trials and which is also easy to clean in preparation for subsequent trials. In particular, this oral health improving product 8, 10 allows the simulation of dental agent effectiveness in treating fissures in teeth and/or preventing food access.

[0044] Referring now to Figs. 5 to 9, the applicant has developed oral health improving products 20, 22, 24, 26, 28 according to other preferred embodiments of the present invention. The applicant has developed these products by research, testing and development using the oral health improving product 8 for simulating fissures as described above. In particular, the oral health improving products 20, 22, 24, 26, 28 comprise a composition of an orally acceptable base and poorly soluble salts, wherein the composition is adapted to be receivable into fissures in teeth thereby sealing opening(s) thereof.

[0045] The applicant has found that by sealing the openings of the fissures in back teeth with compositions having an orally acceptable base that can prevent sugary food from being trapped within said fissures that this can arrest the cycle of repeated acid demineralization of teeth. In a preferred embodiment, the sealing of the fissures by such a composition is done on a regular basis by the user themselves, such as before meals and the like, and without the attendance of a dental professional. In particular, low carbohydrate or sugar free edible or chewable substances are preferable for use as the orally acceptable base. Preferably, the orally acceptable base is a food safe and edible base. Examples of preferred orally acceptable bases include cheese or gelatine- based jelly sugar free confections which have qualities which can seal the fissure openings thereby preventing the food eaten immediately thereafter from being received in the fissures and contributing to acid demineralization. [0046] The oral health improving products 20, 22, 24 are preferably in a convenient size for easy delivery of the orally acceptable base to the oral cavity on a frequent basis, such as before meals. For example, as illustrated in Figs. 5 to 7 the oral health improving products 20, 22, 24, are in the form of discrete portions which are easy to be received in the oral cavity and is chewable, such as in strips or bite-sized portions. In a most preferred embodiment the strip is 3mm thick, 12 mm wide and 60 mm long, which is approximately the area of one side of adult back teeth. Although the oral health improving products 20, 22, 24, 26, 28 are exemplified as strips it is envisaged that the products can be produced into a variety of shapes and sizes which may appeal more to children or adults.

[0047] In one embodiment, the oral health improving product can be in the form of a gelatine- based gel capsule (not shown) where the gel capsule is formed of the orally acceptable base and poorly soluble salts. The gel capsule can encapsulate at least one dental agent, such as 1/1000 fluoride mouthwash or toothpaste or other dental pastes, as will be discussed further below.

[0048] The composition of each strip 20, 22, 24 or gel capsule or other conveniently shaped product also includes poorly soluble salts which mixes with saliva to advantageously neutralise acid and thereby reduce acid demineralisation. In preferred embodiments, the poorly soluble salts are salts of calcium such as calcium phosphate, calcium bicarbonate, calcium carbonate, calcium hydroxide or calcium caseinate. The applicant has found that the size of the poorly soluble salts is most effective when it is provided as particles of less than 0.25mm in diameter and most preferably between 0.1 and 0.25 mm in diameter so that they are easily receivable into the fissures and pits of the back teeth. In a preferred embodiment, the poorly soluble salts are incorporated into the orally acceptable base at no more than 10% by weight.

[0049] Furthermore by having an orally acceptable base which is chewable and/or edible and able to be delivered and conveniently on a regular basis such as before eating can allow a person to prevent potential caries within the home environment and further can be sufficiently portable to use when outside the home.

[0050] In alternate arrangement, the poorly soluble salts can be a barium salt which can be used by dentists to show where food is trapped in molars by use of an X-ray. Thus a piece of cheese or jelly sugar free confection including the barium salt can be provided by the dentist. The patient can receive the oral health improving product in the oral cavity for chewing and mixing with saliva the barium salts are received in the fissures and are radioactively opaque when viewed on an x-ray and which can be used by the dentist to show the fissures. [0051] To aid in the mixing of the poorly soluble salts, orally acceptable base and saliva, the surface of the oral improving product 20, 22, 24 can be configured so as to increase the surface area and/or allow saliva to be collected which can also aid to dilute any carbohydrates or sugar present. As illustrated in example of Figs. 5 to 7, the surface of the strips 20, 22, 24 have depressions 32. Alternatively the strip 20, 22, 24 can have holes which extend therethrough and which have openings on opposing sides of the strip. Once placed in the oral cavity, the depressions 32 (or holes) can collect saliva to aid in the mixing of the saliva and composition of orally acceptable base and insoluble salts thereby filling in the fissures of the back teeth to re-mineralize and prevent sugary food from collecting there.

[0052] The depressions 32 can also be configured to aid in measuring a predetermined dose of at least one dental agent. For example, the user can be advised that a correct dose of a dental agent can be applied for example, within a depression 32 or hole, between two or more depressions or along a channel. The size of depression, hole or channel is predetermined to facilitate dispensing of a correct dose of dental agent and can be further configured to be able to indicate a child or adult dose. A dental agent can include toothpaste, mouthwash or two or more components which mix together, preferably with saliva, when the components are mixed or chewed to form a paste having poorly soluble salts including calcium salts or barium salts.

[0053] In an embodiment, the toothpaste is a calcium-enriched fluoride toothpaste however the applicant has found that the calcium and fluoride in pre-mixed form have already formed a bond and therefore is less likely to bond to a surface of the teeth. In another embodiment the toothpaste can be an edible calcium based toothpaste or barium sulphate based toothpaste.

[0054] The dental agent can also be a composition comprising three separate components of poorly soluble calcium salt, phosphoric acid and a soluble fluoride, for example sodium fluoride, provided separately in a non-Newtonian fluid Bingham plastic paste according to another preferred embodiment according to the present invention. The components only mix once received in the oral cavity and chewed or otherwise agitated to form an acidulated calcium, fluoride and saliva paste which can then deposit on or remineralise the tooth surface as fluorapatite Caio(P04) _fi (F)2, which is more acid resistant and much less soluble than the known hydroxyapatite (Caio(P04)6(OH)2). Preferably the poorly soluble calcium salt particles have diameters between 0.1 to 0.25mm for optimal mixing and re-mineralisation rates in the fissures.

[0055] Although the three-component paste composition can be provided separately in a variety of delivery options. In one example, the three-component tooth paste composition can be provided as a tri-coloured striped paste where each component is a separate stripe and only mixes when in the oral cavity. Other delivery options include that the three paste components are provided separately in a gelatine based capsule, gelatine based co-extrusion or in three separate capsules. Under chewing pressure, the three-component paste combines and mixes with saliva to form an acidulated calcium fluoride reactive paste which is received or forced into the fissures of the back teeth by the soft gel capsule or chewable strip to seal the opening of the fissures, neutralise acid and, remineralise and bond with other calcium particles and the tooth enamel surface. Remineralisation repairs non-cavitated lesions via the fluoride, calcium and phosphate ions to rebuild a new fluorapatite surface on demineralized crystals of the tooth, which are acid resistant and much less soluble than the known hydroxyapatite.

[0056] The strip 22 can include a weakened portion 36 intermediate the strip ends which is configured to allow the strip 22 to be torn into two portions for children or folded in half to provide a more desirable chewy experience for adults. The weakened portion 36, as exemplified in Fig. 6, can be in the form of a channel which extends from opposing side edges of the strip 22 and forms a pivot axis about which one portion of the strip to a side of the weakened portion 36 is foldable about the other. The weakened portion 36 or channel is about 2mm deep or 2 thirds the thickness of the strip 22 as illustrated in the example of Fig 6.

[0057] Furthermore, the strips 20, 22, 24 can have rounded corners at their ends to prevent any discomfort to the user when the strips 20, 22, 24 are received in the oral cavity. Preferably the corners at both ends of the strips 20, 22, 24 are rounded.

[0058] In another embodiment, the oral health improving product is an orally acceptable base which can be configured to receive said poorly soluble salts on a surface thereof. Preferably, the poorly soluble salts can be provided in the form of a dental agent such as a toothpaste or a sealing agent including poorly soluble salts. In another embodiment the toothpaste can be an edible calcium based toothpaste or barium sulphate based toothpaste. The base is configured to have elastomeric properties which allow the surface of the base to conform to the contours of the back teeth and sufficiently firm so as to forcibly inject the sealing or dental agent into the fissures of the back teeth of sealing thereof. In a more preferred embodiment, the poorly soluble salts are in the form of an acidulated calcium fluoride reactive paste as described above thereby being able to re mineralize the fissures when so received combined and received therein. The orally acceptable base can be composed of a food-safe polymer, rubber or silicon, in particular thermoplastic elastomer or neoprene. [0059] The base can be in the form of a strip, as exemplified in Figs. 8 and 9, which can then be received in the oral cavity, particularly at the back teeth, and chewing or biting down on the base forces the toothpaste or paste or sealing agent to mix with saliva and be forced into the fissures of the back teeth. The elastomeric properties of the base effects equal force over the entire chewing surface of the back teeth thereby facilitating optimal receipt of the poorly soluble salts into the fissures. The applicant considers that this method is able to force or forcibly inject the poorly soluble salts, toothpaste or paste or sealing agent deep into the fissures such that the poorly soluble salts are received into the fissures either wholly or substantially. In particular, the applicant considers that the poorly soluble salts, toothpaste or paste or sealing agent can be received into 80%, if not up to 100% of the fissure length.

[0060] The base can be arranged to aid the user in facilitating forcing of the poorly soluble salts, and/or any dental agent including said salts into the fissures. In particular the base can include at least two portions where each portion comprises opposing end portions of the strip. One of the portions can be received in an oral cavity while the other can be used as a handle. In a preferred embodiment the portions are of unequal length, in particular one portion being configured for being received in an oral cavity of an adult while the other portion is configured for being received in an oral cavity of an configured for being received in an oral cavity of a child. In a particularly preferred embodiment, one portion is double the length of the other; the shorter portion being configured for a child’s oral cavity and the longer portion being sized for an adult. The portions can be configured to be angled relative to each other as illustrated in Figs. 8 and 9 such that the portion which serves as a handle is an angle to the portion received in the oral cavity which is considered ergonomic and easy to use without strain.

[0061] The strips 26, 28 can also have at least one locating portion 38, 40 for aiding in positioning the strip 26, 28 at the back teeth. As shown in Fig. 8, the at least one locating portion 38 can be in the form of a brush bristle or ridge which extends laterally from or near an edge of the strip 26. In this example of Fig. 8, the ridge extends between opposing ends of the strip and for locating an edge of the back teeth for correct placement. Alternatively, as illustrated in Fig. 9, the locating portions can be in the form of pins 40 which extend laterally from a planar surface of the application for locating a side of the back teeth. In this embodiment the pins 40 located on a side edge about 1 cm from the either or both opposing ends. The locating portions 38, 40 are preferably composed of similar or same material to the base. [0062] The strips 26, 28 are rounded at at least one end thereof so as to prevent discomfort to the patient during insertion in the oral cavity as illustrated in Figs. 8 and 9. As both ends could be used for insertion in to the oral cavity, it is preferable that both ends be rounded.

[0063] The strip 26, 28 could have indicating members (not shown) which can aid the user in measuring a predetermined dose of the dental agent. In one embodiment, the indicating members can be in the form of depressions, holes or channels which act in a similar way that has been described for the products above. Alternatively the indicating members can be in the form of markings.

[0064] In yet another embodiment, the oral health improving product strip 26 and 28 comprising a base having elastomeric properties and which is also configured to be transparent to transmit radiation which can cure a sealing agent. Preferably, the sealing agent is a UV-curable sealing agent, and the strip is configured to have elastomeric properties for facilitating the sealing agent into the fissures by a dental health professional under the application of force applied when the user bites down on the strip. The deformable nature of strip ensures that an equal force is applied over the entire contact surface thereby optimising the depth to which the sealing agent is received in the fissures. A UV light source can then be applied to the sealing agent while under chewing pressure to cure the sealing agent and seal the fissures .

[0065] Through-out the specification and claims the word “comprise” and its derivatives is intended to have an inclusive rather than exclusive meaning unless the context requires otherwise.

[0066] Orientational terms used in the specification and claims such as vertical, horizontal, top, bottom, upper and lower are to be interpreted as relational and are based on the premise that the component, item, article, apparatus, device or instrument will usually be considered in a particular orientation, typically with the assembly uppermost.

[0067] It will be appreciated by those skilled in the art that many modifications and variations may be made to the methods of the invention described herein without departing from the spirit and scope of the invention.