Method for detecting biofilm in the oral cavity and detection medium therefor

Abstract

The invention relates to a biofilm detection medium, wherein the detection medium is water-based and comprises at least water, an organic solvent, a buffer system and a functional ingredient, wherein the functional ingredient is fluorescein-based and wherein the detection medium has a pH in the range of 6.5 and 7.5.

Description

[0001] The invention relates to a method for detecting biofilm in the oral cavity and a biofilm detection medium therefor.

[0002] In the field of dental cleaning, improvements are constantly being sought. Conventional cleaning with a toothbrush and toothpaste has numerous disadvantages.

[0003] Brushing with a toothbrush and toothpaste is not sufficient from an oral hygiene point of view, as the spaces between the teeth (up to 40% of the surface to be cleaned) and the gum pockets are not sufficiently cleaned because the toothbrush does not reach these areas.

[0004] Plaque, i.e. oral biofilm, which forms as a result of bacterial processes and which later develops into tartar, is a relatively well-adhering and cohesive film of dirt that cannot be easily removed, even if it is cleaned in direct contact with the toothbrush, and certainly not in the interdental spaces, into which the toothbrush can only partially or not at all penetrate.

[0005] In the past, numerous attempts have been made to provide alternative cleaning methods. For example, it is known to use water jet devices to clean the interdental spaces. This has shown that, while the water jet devices of earlier times were effective in cleaning, the force of the jet could easily damage the gums. Today's devices have significantly reduced their jet power, so that gum damage is no longer directly caused, but the cleaning performance has also become so poor that these devices are largely ineffective.

[0006] In addition, many attempts have been made to develop so-called ultrasonic toothbrushes, in which the vibration of the toothbrush, which serves to clean and ultimately, together with toothpaste, produces an abrasive cleaning action, is superimposed with ultrasonic vibrations that supposedly produce a cleaning effect. However, it has been shown that such toothbrushes are not capable of coupling the ultrasound into the oral cavity in such a way that any cleaning effect would be detectable. Such so-called ultrasonic toothbrushes are therefore not significantly better than a conventional manual toothbrush.

[0007] From DE 20 2016 101 191 U1 a brush head for an electric toothbrush is known, which is intended to encompass the tooth on all sides and on which bristles are arranged for cleaning.

[0008] From US 3,401,690 A a cleaning device is known in which ultrasound is applied to a surface via a liquid via a clamp which engages over at least one tooth.

[0009] From US 2005 / 091,770 A, a toothbrush is known which works like a normal electric toothbrush, but also has an ultrasonic generator which is intended to introduce acoustic energy into a cleaning fluid.

[0010] US 2017 / 0189,149 A1 discloses a system for whitening teeth using an ultrasonic device. A mouthpiece is provided for this purpose, each with a volume for the upper and lower jaws. Ultrasonic generators are arranged in the mouthpiece, facing the teeth, and can apply ultrasonic energy to the tooth surface.

[0011] This is intended to create an effect known as ultrasound streaming, whereby the temperature must be controlled and the formation of bubbles prevented, as these impede the transmission of ultrasound. A frequency of 20 kHz to 100 kHz is used, with the goal of deliberately inducing cavitation, causing vapor bubbles to form and implode on the surface of the tooth, creating local temperatures of up to 5000 Kelvin and local pressures of up to 1000 atmospheres.

[0012] The disadvantage here is that the energies applied are so high that tissue damage is practically unavoidable. However, below damaging energies, the cleansing effect is negligible.

[0013] It is also known to use an indicator fluid for plaque detection, whereby the indicator fluid is selectively applied. Only the biofilm is specifically stained. Teeth, soft tissue, or restorations are not stained with the indicator fluid, so only the plaque zones glow under the curing light. The indicator fluid is a composition containing a fluorescent dye and glycerin, water, potassium phosphates, ethylparaben, and sodium hydroxide. This fluid is not long-term stable.

[0014] WO2007 / 060644 A2 discloses a method and device for removing biofilm by so-called microstreaming. This involves causing gas bubbles to resonate using ultrasound, which is intended to result in a cleaning effect. The ultrasonic excitation is intended to cause the gas bubbles to vibrate, inducing an acoustic flow in a small area near the bubble. This acoustic flow is also known as "microstreaming." This microflow is intended to generate shear forces capable of removing the biofilm. The corresponding gas bubbles can be prefabricated and, in particular, these bubbles can also be generated in a phospholipid or protein environment to stabilize them.

[0015] WO2009 / 077291 A2 also discloses a method for introducing antimicrobial reagents to a biofilm. This involves introducing gas bubbles in a plastic casing into a treatment chamber. The plastic casing is then destroyed with ultrasound, releasing the bubbles. The gas bubbles, in turn, are excited by the ultrasonic frequency so that they vibrate and, after reaching a maximum vibration amplitude, collapse, thereby disrupting the biofilm.

[0016] WO2010 / 076705 A1 discloses a toothbrush that, in addition to bristles, contains an ultrasonic generator that introduces ultrasound into a treatment chamber, while also introducing microbubbles. This can, but does not necessarily, generate cavitation.

[0017] WO2020 / 212214 A1 discloses a method in which a toothbrush is coupled to a water jet device. The water jet device is controlled in such a way that a water jet rinses the interdental areas when the toothbrush is moved past them. Suitable acceleration, speed, or displacement sensors are to be used for this purpose.

[0018] From WO 2020 / 212248 A1 a method is known in which a water jet device is also coupled to a toothbrush, wherein a control device is present which makes an assumption as to where the cleaning device is located in the mouth, wherein predetermined data and user-specific data are used, wherein the data include, among other things, data relating to the cleaning activity of the user or the operation of the cleaning device and are used to make an assumption as to the location in order to rinse an interdental area with the water jet when it is reached.

[0019] From DE 42 08 664 A1 a nozzle head arrangement for oral irrigators is known with a nozzle head forming a tunnel, wherein the nozzle head is formed on the inside with a plurality of spray nozzles which are successively supplied with pressurised liquid from a pressure pump by control valves.

[0020] US 2012 / 0003601 A1 discloses a tooth cleaning device with a device for generating a spray jet, which pressurizes a liquid by means of a piezo element and can direct it onto a tooth to be cleaned, as well as a detection device for detecting a dental hygiene marker. The device is very bulky and hardly suitable for end-user use.

[0021] US 2019 / 0110875 A1 discloses a method for cleaning teeth in which a fluid is alternately expelled and sucked in. The fluid is expelled from one side of a row of teeth and alternately sucked in from the other side. This is controlled by valves that alternately open one or the other transport path. The disadvantage of this method is that it doesn't work, as the desired rapid alternation fails due to the inertia of the fluid on the one hand and the frictional resistance in the lines on the other.

[0022] US 2019 / 0236236 A1 discloses a mechanically driven oral irrigator that generates pulsed jets of fluid and is directed over the teeth in the conventional manner using a manually operated nozzle. As with manually operated toothbrushes, the disadvantage is that a variety of user errors are possible, which can lead, among other things, to severe damage to the gums.

[0023] Oral biofilm is a functionally and structurally organized polymicrobial community embedded in an extracellular matrix of exopolymers and generally found on mucosal and dental surfaces. Biofilm formation begins within minutes of oral cleansing with the formation of a thin layer of salivary glycoproteins and bacterial products, which facilitate microbial adhesion through proline-rich proteins.

[0024] This biofilm matures and goes through several stages that lead to caries and other periodontal diseases, finally dissolving into free-floating microbes that allow further colonization of other areas of the mouth.

[0025] It is therefore extremely important to prevent this biofilm maturation to prevent non-regenerative tooth damage and improve the user's quality of life. Therefore, biofilm removal must be repeated and performed thoroughly several times a day to maintain oral health.

[0026] Because biofilm is colorless in its early stages, proper cleaning can be difficult, especially in hard-to-reach areas such as the molars or interdental spaces. Improved visualization of biofilm not only simplifies removal but also alerts the user to prominent areas that are easily covered with biofilm.

[0027] It is known to use fluorescein as an active detection substance.

[0028] Similar to other biofilm detection media, fluorescein is incorporated into the biofilm and optically marks it when illuminated with blue light. This makes the biofilm significantly more visible to the user and therefore easier to remove.

[0029] Due to the fluorescent nature of fluorescein, only blue light can strongly excite the substance, making it barely visible in daylight. Furthermore, the fluorophore is removed within minutes through bleaching and general physiological degradation.

[0030] Conventional biofilm detection media (e.g. Mira-2-Ton), on the other hand, are difficult to remove from the tooth, gum, or tongue surface without intensive brushing or cleaning and stain the oral cavity intensively for several hours.

[0031] The object of the invention is to create a biofilm detection medium which has good long-term stability and ensures effective and reliable biofilm detection.

[0032] The problem is solved with a biofilm detection medium having the features of claim 1.

[0033] Advantageous further training is indicated in the dependent subclaims.

[0034] It is a further object of the invention to provide a method which ensures reliable and targeted biofilm detection in the oral cavity.

[0035] The problem is solved by a method having the features of claim 20.

[0036] Advantageous further training is indicated in the dependent subclaims.

[0037] Unless otherwise stated, percentages given below refer to weight percentages based on the total composition of a detection medium.

[0038] Where ranges are specified, the specified range limits are explicitly included up to the next higher whole number, e.g. 20 = 20.0 to 20.99 unless otherwise stated.

[0039] If lower limits and upper limits or a number of possible lower limits and upper limits are specified, this means that any combination of one of the mentioned lower limits with one of the mentioned upper limits is within the scope of the invention and is disclosed equally.

[0040] According to the invention, a biofilm detection medium, in particular for a device, and a method for biofilm detection are proposed.

[0041] For this purpose, a formulation was developed that ensures optimal detection performance and exhibits good long-term stability. This particularly enables use in automated procedures and storage in device capsules inserted into a device. This significantly increases user convenience.

[0042] The detection medium can be in liquid form, e.g. as a rinsing solution or gargle solution or cleaning solution or as a spray.

[0043] A liquid detection medium can be used as follows: • Liquid-filled capsule (shot) • Spray • Container with drinking straw • Mouthwash

[0044] A liquid-filled capsule can be swallowed and then either dissolved (quickly) in the mouth or chewed. The liquid can be, for example, a water-based or oil-based liquid.

[0045] A device capsule, similar to those used in vending machines, can be inserted into a device, and its contents can be automatically removed and dispensed. Using keypads such as barcodes located on the device capsule, it is possible to read the expiration date, the frequency of use, and whether the original liquid is being used as opposed to substitute products from third-party suppliers.

[0046] If the liquid is a cleaning liquid, it is introduced, for example, into a handpiece or a tank of a device, in particular a cleaning device, and sprayed via small nozzles or jets of the device in a mouthpiece onto the surface to be cleaned, for example teeth, or at least an area around the teeth is flooded with it.

[0047] The liquid can also be sprayed into the mouth via a spray device, for example a pump spray container or a spray can filled with pressurized medium, for example in the manner of a mouth freshener spray.

[0048] The liquid can also be administered via a container with a straw or a straw simply filled with the liquid.

[0049] In addition, the liquid can also be poured from a bottle into a cup or cap, similar to a mouthwash, and then administered. The volume used is 5-80 ml, preferably 5-50 mL, further preferably 5-25 mL, further preferably 5-10 mL.

[0050] The biofilm detection medium according to the invention can also be a rheologically viscoelastic hydrogel. The detection fluid is preferably filled and packaged in a capsule.

[0051] This capsule comprises, for example, a volume of 5-80 ml, preferably 5-50 mL, further preferably 5-25 mL, further preferably 5-10 mL 40-80 ml and is preferably introduced into a chamber provided in the handpiece or a mouthpiece directly before use of the device, in particular a cleaning device.

[0052] The biofilm detection medium is a water-based formulation.

[0053] The biofilm detection medium comprises at least a solvent, a buffer system and an active ingredient.

[0054] It may also contain other ingredients such as preservatives, sweeteners such as sugar substitutes and flavorings.

[0055] Glycerin can be used as a solvent.

[0056] A fluorescent dye, preferably fluorescein, further preferably sodium fluorescein, can be used as the active ingredient.

[0057] A phosphate-based buffer, in particular a system of sodium phosphate (dibasic) and sodium dihydrogen phosphate, can be used as a buffer system.

[0058] Phenoxyethanol, benzyl alcohol and / or methylparaben can be used as preservatives.

[0059] The inventors have recognized that the known compositions, in particular fluorescein-containing compositions, often have the disadvantage that phase separation occurs after some time.

[0060] Such compositions therefore exhibit poor long-term stability. They cannot be stored for long periods and must be replaced with a fresh composition after some time. This increases the economic costs of the process.

[0061] If the stored composition is not replaced with a fresh composition in a timely manner, successful detection of the biofilm and thus cleaning can no longer be guaranteed.

[0062] They have recognized that the pH value of the overall composition in particular has an influence on long-term stability.

[0063] The invention thus relates to a biofilm detection medium, wherein the detection medium is water-based and comprises at least water, an organic solvent, a buffer system and a functional ingredient, wherein the functional ingredient is fluorescein-based and wherein the detection medium has a pH in the range of 6.5 and 7.5.

[0064] A further development stipulates that the functional ingredient is sodium fluorescein.

[0065] A further development provides that the functional ingredient is present at 0.0001-0.5 wt.%, preferably 0.01-0.4 wt.%, particularly preferably 0.05-0.3 wt.%, and further particularly preferably 0.06-0.09 wt.%. A further development provides that the water content is 70-90 wt.%, preferably 75-85 wt.%, particularly preferably 78-82 wt.%.

[0066] A further development stipulates that the organic solvent is glycerin.

[0067] A further development provides that the organic solvent is contained at 10-20 wt.%, preferably at 12-18 wt.%, particularly preferably at 13-15 wt.%.

[0068] A further development provides that the buffer system is phosphate-based and includes in particular sodium phosphate and sodium dihydrogen phosphate.

[0069] A further development provides that the buffer system is contained in the biofilm detection medium at 0.1-1.0 wt.%, preferably at 0.2-0.7 wt.%, particularly preferably at 0.3-0.6 wt.%.

[0070] A further development stipulates that the biofilm detection medium has a pH value in the range of 6.8-7.20.

[0071] A further development provides that the biofilm detection medium comprises at least one additive selected from the group of sugar substitute, steviol glycoside, menthol, natural flavors, nature-identical flavors, artificial flavors, foaming agents, preservatives, stabilizers and acid buffers.

[0072] A further development provides for xylitol and / or sodium saccharin to be included as sugar substitutes.

[0073] A further development stipulates that the biofilm detection medium has a composition in the following areas: Deionized water 70-90 wt% Glycerin 10-20 wt.% Sodium phosphate dibasic 0.05-0.5 wt% Sodium dihydrogen phosphate 0.05-0.5 wt% Sodium fluorescein 0.0001-0.1 wt% Methylparaben 0.01-0.4 wt% Benzyl alcohol 0.01-0.4 wt% Xylitol 0.5-5.0 wt% Sodium saccharin 0.005-0.05 wt% Flavoring 0.005-5,000 wt%

[0074] A further development provides that the liquid biofilm detection medium is a cleaning liquid for use with a device, in particular a cleaning device, wherein cleaning particles are contained, wherein the particles are small solids with a defined hardness, size distribution and shape, wherein the particles are preferably finely dispersed with a diameter of 1 to 250 µm, preferably 10-100 µm, wherein preferably 0.1 to 15 wt.%, more preferably 0.5 to 10 wt.% of particles are present in the liquid

[0075] A further development provides that the particles are formed from at least one material selected from the group consisting of: materials of plant origin, cellulose, mineral materials, silicates, aluminates, borates, aluminosilicates, metal oxides.

[0076] A further development provides for the addition of dispersants such as microcrystalline cellulose, silica, proteins or other surface-active substances to utilize the Pickering effect.

[0077] A further development provides for the dispersant to be included in amounts of 0.2 - 2.0 wt.%.

[0078] A further development provides that the liquid detection medium is designed to be shear-liquefiable with a non-Newtonian behavior, whereby the liquid has the properties of a gel in the resting state, which counteracts both short- and long-term sedimentation of the particles.

[0079] A further development provides that the biofilm detection medium is provided in a capsule, wherein the capsule comprises a water-soluble capsule material, preferably hydroxypropylmethylcellulose.

[0080] A further development provides that the biofilm detection medium is provided in a device capsule which can be inserted into the device.

[0081] A further development provides that the biofilm is colored with the biofilm detection medium and is detected after coloring, whereby the colored areas are scanned with sensors and an abstract image is generated from which control data for the or a cleaning device is generated.

[0082] A further development provides that after detection with the sensors, the device, for example a cleaning device, is inserted and provided with the device capsule which contains a cleaning liquid, and cleaning is carried out by the device, wherein the control data are used to carry out the cleaning locally adapted according to the contamination.

[0083] A further development provides that the device is used as the only device for carrying out the method, wherein the device for coloring, detection and cleaning uses a basic device with different mouthpieces each adapted for the respective intended use.

[0084] A further training course provides for the coloring and cleaning to be carried out using a mouthpiece.

[0085] A further development provides for the image files and / or control data to be stored in the basic device and / or in a cloud.

[0086] A further development provides that the liquid detection medium described above is used in a device, for example a cleaning or detection device, for detecting biofilm in the oral cavity.

[0087] The invention is explained by way of example with reference to a drawing. It shows: Fig.1: a possible operational procedure for the administration and use of the detection medium; Fig. 2: a composition for a liquid detection medium; Fig. 3: an oil-filled capsule for application of the detection medium; Fig. 4: the visible discoloration of the lip with conventional coloring agents; Fig. 5: the visible discoloration of artificial tooth material with conventional coloring agents; Fig. 6: non-discolored lip when using the detection medium according to the invention; Fig. 7: non-discolored artificial tooth material when using the detection medium according to the invention; Fig. 8: the staining of biofilm with the detection medium according to the invention under light of a predetermined wavelength; Fig.9: The staining of biofilm with the detection medium according to the invention under light of a predetermined wavelength in a detailed view.

[0088] The biofilm detection medium is applied to the surface to be detected and / or cleaned. Preferably, 2.5–20 ml of the biofilm detection medium is used. The contact time is approximately 10 seconds. The biofilm detection medium is then removed from the oral cavity, for example, by spitting, and rinsed with water, preferably 5–20 ml ( Fig. 1). Detection is performed using blue light.

[0089] Detection can be performed using a device with integrated blue light. The device comprises at least one holder and at least one mouthpiece. Advantageously, several interchangeable mouthpieces can be provided. The various mouthpieces are adapted accordingly for the respective application.

[0090] The different mouthpieces can be used for different operations. For example, one mouthpiece can be used for applying the biofilm detection medium. Another mouthpiece can be used for detecting the biofilm. Another mouthpiece can be used for subsequent cleaning.

[0091] It's also possible to use the same mouthpiece for different operations. With appropriate equipment, the entire procedure can even be performed using a single device. One mouthpiece can be used for both inking and cleaning.

[0092] The application and / or cleaning can be accomplished using nozzles. At least one nozzle is provided in the device for this purpose.

[0093] The surface to be detected and / or cleaned is exposed to a liquid, such as the biofilm detection medium or a cleaning fluid. The detection fluid or a combined detection and cleaning fluid can be used.

[0094] For this purpose, the pressure jet and / or pressure pulse emerging from the nozzle is sent with a defined strength and speed in the direction of the surface to be cleaned.

[0095] The corresponding device has a chamber or tank to hold the biofilm detection medium and / or the cleaning fluid.

[0096] Of course, a device capsule containing the biofilm detection fluid can also be inserted into this chamber instead of a cleaning fluid.

[0097] Oil-filled capsules are another possible application form, whereby Fig. 3 shows such a capsule.

[0098] This application method uses water-soluble capsule packaging that slowly dissolves in saliva. Hydroxypropylmethylcellulose is cited as an example of the capsule material.

[0099] The capsule is filled with a flavored vegetable oil in which sodium fluorescein is dispersed.

[0100] Sodium fluorescein is insoluble in oil. It only dissolves in the saliva present after the capsule is bitten open. Saliva thus acts as a solvent and helps distribute the sodium fluorescein throughout the oral cavity.

[0101] The cleaning fluid can also be in the form of a capsule.

[0102] Cleaning particles can be added to the cleaning fluid as a functional ingredient. These particles are small solids with a specifically selected hardness, size distribution, and shape. Particles with a defined size of 50-100 µm should be finely dispersed in this matrix. The particle size should not exceed 200 µm. The particle content should be between 2-10%. The particles are granular and fibrous structures with irregular surfaces.

[0103] The materials used are preferably of plant origin (cellulose), but the use of mineral particles is not excluded.

[0104] To ensure even particle distribution, dispersants such as microcrystalline cellulose, proteins, or other surfactants should be used. This is achieved by exploiting the so-called Pickering effect. This effect describes the stabilization of two-phase systems through the use of surface-active particles.

[0105] The dosage of these dispersants should be between 0.2 - 2.0%.

[0106] Another important characteristic of the cleaning fluid is its potential shear-liquefaction (non-Newtonian) behavior. At rest, it exhibits the properties of a gel. This counteracts both short- and long-term particle sedimentation. However, when exposed to high shear forces, the cleaning fluid begins to liquefy, and the properties of a liquid become significantly more prominent.

[0107] The advantage of this shear liquefaction results in easier pumpability and thus lower energy requirements.

[0108] For this application form, the addition of prophylactic substances or substances to achieve a lightening effect may also be provided.

[0109] For example, fluid mechanics effects are used for cleaning. In particular, annular flows or vortices are used in the broadest sense. The effects that such flows and vortices can produce are described below.

[0110] By means of appropriate nozzle geometries on the one hand and by observing certain boundary conditions regarding the quantity and speed of an ejected medium, torus-shaped closed vortex threads, hereinafter simply called torus or in the plural tori, can be generated.

[0111] In the simplest case, such a flow or vortex leads to a flow occurring transversely to a surface to be cleaned after the torus has passed through the surrounding medium to the surface to be cleaned.

[0112] If solid particles are present within the ejected cleaning fluid according to the invention and / or in the surrounding medium, they are entrained by the vortex and accordingly also moved over the surface to be cleaned, which naturally enhances the cleaning effect. Such solid particles can simply be entrained or carried by the torus, so that a particle is moved over a surface several times. In this case, the particle or particles rotate with or in the torus or around the torus. Thus, a particle can move over the surface several times and remove biofilm using shear forces. This is in contrast to a beam or jet, in which a particle is moved over the surface only once.

[0113] Depending on the relative velocity through the surrounding medium or the rotational speed of the torus, cold vapor can also form within the torus. In this case, in addition to the effects already described, the torus or the cold vapor bubbles at the surface will also collapse, causing a further flow effect through crossflows.

[0114] Torus-shaped, closed vortex threads also exist without cold steam. Particles are also moved along the surface to be cleaned by their flow resistance. The flow resistance of the particles increases with their size, and thus the shear forces acting on the biofilm also increase when a particle is moved along its surface.

[0115] The nozzles of the device can generally be circular in cross-section, but can also have any other shape, for example, elliptical, narrow slit-shaped, star-shaped, or generally irregular. Accordingly, the closed vortex threads are not necessarily circular and therefore not tori according to the definition.

[0116] For these nozzle geometries, the hydraulic diameter Dh=4*A / P can be used as a substitute diameter, where A=cross-sectional area, P=wetted circumference.

[0117] The circular torus is advantageous because it is particularly stable and extends far into the liquid without noticeable change in shape.

[0118] However, the stability of the closed vortex threads of other geometries can be sufficient for the required cleaning distance and allow adaptation to the tooth geometry.

[0119] It was recognized that these tori form when the ratio of the length of the ejected liquid cylinder to its diameter is up to a maximum of 4.

[0120] A ratio above this, up to about 10, represents a mixed range, although the boundaries here are not sharp.

[0121] Exactly where the mixing area extends and where a pure jet is present is fluid and therefore cannot be determined exactly.

[0122] The pressures in the device are adjusted so that the biofilm is not damaged, so that the oral cavity or enclosed volumes within the oral cavity are more likely to be flooded.

[0123] However, to achieve particularly good staining, certain minimum pressures can be maintained to ensure good penetration and distribution of the fluorescein within the biofilm. Thus, nozzle flow velocities or pulse intensities below the threshold that would cause biofilm detachment but above the threshold of mere flooding are advantageous.

[0124] This can be done automatically, for example, by a device capsule with biofilm detection fluid having a code that can be read by the device and results in the corresponding drive values ​​for cleaning being lowered and adapted to the staining.

[0125] According to the invention, it can be provided to surround a surface to be detected or a partial area thereof with a closed liquid volume and to arrange one or more nozzles within this closed liquid volume.

[0126] The suction can occur inside or outside the enclosed volume. Thus, the suction can occur inside the created enclosed volume and / or outside, i.e., in the oral cavity. Fluid present in the oral cavity due to unavoidable leaks can be sucked back.

[0127] This can increase the dyeing time and effectiveness.

[0128] In addition, suction can also be applied to the oral cavity at the end of a staining procedure. In particular, suction from the oral cavity at the end of the staining procedure can also be used to remove saliva and cleaning fluid, allowing the cleaning device to be used safely and without soiling clothing or fluids running from the mouth.

[0129] The procedure involves first performing the coloring process. After coloring, which is confirmed to the user via suitable device dispensing means, the user removes the device and the used device capsule containing the detection fluid.

[0130] The user then uses a device to capture the biofilm. This device scans the colored area and creates an abstract image from which control data for the cleaning device or a cleaning device is generated.

[0131] The cleaning device is then reinserted, fitted with a device capsule containing cleaning fluid, and the cleaning process is carried out. The control data is used to adjust the cleaning process locally according to the level of contamination.

[0132] The image files and / or control data can be stored in the base unit but also in a cloud or both.

[0133] The invention thus relates in particular to a biofilm detection medium, wherein the detection medium is liquid or gel-like and wherein the biofilm detection medium has as respective lower limit 0.01 wt.% or 0.015 wt.% or 0.0175 wt.% or 0.02 wt.%, or 0.0225 wt.% or 0.025 wt.% and as respective upper limit 0.4 wt.% or 0.35 wt.% or 0.3 wt.% or 0.25 wt.% or 0.2 wt.% or 0.175 wt.% or 0.15 wt.% or 0.125 wt.% or 0.1 wt.% or 0.05 wt.% or 0.0075 wt.% sodium fluorescein based on the total composition of the biofilm detection medium.

[0134] In an advantageous embodiment, the biofilm detection medium may comprise the following ingredients: a) water, b) solvent (glycerol), c) phosphate buffer, d) fluorescent dye (acid yellow 73 sodium salt), e) preservatives (phenoxyethanol, benzyl alcohol, methylparaben), f) sweeteners, g) flavors and h) colorants.

[0135] The composition may contain at least 70-90% water and 10-20% glycerin. The amount of the sodium salt of Acid Yellow 73 (i.e., sodium fluorescein) is in the range of 0.05 to 0.40% by weight.

[0136] Glycerin can be used to stabilize sodium fluorescein. It also contributes to a slightly sweet taste. Another property of glycerin is its significantly higher viscosity than water. This results in a pleasant mouthfeel for the user after application of the biofilm detection medium.

[0137] The solubility of sodium fluorescein is highly dependent on pH. Solubility decreases significantly in acidic pH ranges, and the active component, fluorescein, precipitates from the solution.

[0138] With the biofilm detection medium according to the invention, it has been possible to create a composition which does not undergo phase separation - even over a long storage period - and whose long-term stability is guaranteed.

[0139] To achieve this, a composition with a substantially neutral pH range was used. For the purposes of the invention, the neutral pH range is approximately pH 7.00.

[0140] Essentially, within the meaning of the invention, values ​​of approximately ±0.5 are used. This means that the pH range can be between 6.5 and 7.5.

[0141] Particularly good long-term stability is achieved in the pH range 6.80 - 7.10.

[0142] At lower pH values, demineralization of the tooth material can occur. The critical range for tooth enamel is approximately pH 5.5.

[0143] pH values ​​that are in the alkaline range, on the other hand, can be perceived as very unpleasant (soapy).

[0144] In the pH range according to the invention, it is important to use a suitable buffer system in combination with at least one suitable preservative. This is due to the fact that a neutral pH value requires suitable pH buffer and preservative systems, especially in combination with each other.

[0145] To specifically control the pH value and to ensure adequate buffer capacity in the neutral pH range, a phosphate buffer is preferably added.

[0146] Phosphate buffer components are included in an amount of 0.1–1.0% by weight. Accordingly, the above-mentioned preservatives are effective in the neutral pH range.

[0147] For preservation, for example, a combination of phenoxyethanol, benzyl alcohol and / or methylparaben is used to suppress microbial growth and stabilize fluorescein and the buffer.

[0148] Flavors are used to make the application of the liquid pleasant for the user.

[0149] The biofilm detection medium can also be adjusted to a defined and / or desired rheology using xanthan, gellan or comparable thickeners.

[0150] In Fig. Table 2 provides a recipe with possible ranges of ingredients for the biofilm detection medium. The table provided here can include all ingredients except water individually, several of the listed ingredients, or all ingredients with the remainder being distilled water.

[0151] The biofilm detection medium can have the following composition ( Fig. 2): Deionized water 70-90 % Glycerin 10-20 % Sodium phosphate dibasic 0.05-0.5 % Sodium dihydrogen phosphate 0.05-0.5 % Sodium fluorescein 0.001-0.1 % Sodium methylparaben 0.01-0.4 % Benzyl alcohol 0.01-0.4 % Xylitol 0.5-5 % Sodium saccharin 0.005-0.05 % aroma 0.005-8 %

[0152] The biofilm detection medium described here consists of various formulations for various application forms, which have sodium fluorescein as the active ingredient.

[0153] The application of a liquid formulation is preferred, but alternative dosage forms such as gel are also possible.

[0154] The sodium fluorescein dosage should be at least 0.0001 wt%. The preferred range is 0.06–0.09 wt%. The maximum sodium fluorescein dosage should be 0.5–0.09 wt%.

[0155] The lower limit for the glycerin dosage is 5 wt.%. The preferred range is 10-20 wt.% glycerin in the formulation. A glycerin concentration of 50 wt.% is chosen as the upper limit.

[0156] The lower limit for xylitol dosage is 0.4 wt%. The preferred range is 0.5–5.0 wt% xylitol in the formulation. The upper limit is 6.0 wt% xylitol concentration.

[0157] Fluorescein molecules have the ability to absorb light at a specific wavelength and then re-emit it when light of a longer wavelength is emitted.

[0158] For this described fluorescence, an external light source is necessary to excite the fluorescein molecules at a specific wavelength.

[0159] This required light source is, for example, included in a detection device, thus resulting in a meaningful interaction between the detection medium and a detection device.

[0160] If only the detection medium were used, the fluorescein bound to biofilm would not be visible to the naked eye.

[0161] The fluorescein bound to the biofilm is washed out by regular saliva flow and after a short waiting time, no fluorescence is visible anymore.

[0162] This represents a decisive advantage over conventional means of making plaque visible, because under daylight no discoloration is visible to the naked eye, neither in the mouth nor on the teeth.

[0163] In contrast to products that use CI 45410 and CI 42090 for coloring, the use of these substances results in a discoloration of teeth, the entire oral cavity, and the lips that is difficult to remove and clearly visible to the naked eye. Fig. 4 and Fig. 5 shows a conventional coloring in which both the lips ( Fig. 4) as well as artificial tooth material ( Fig.5, upper incisors in the area of ​​the incisor edge) were stained. This is cosmetically undesirable, at least in the short term.

[0164] In contrast, in the Fig. 6 and Fig. Figure 7 shows how the detection medium according to the invention behaves under visible light. No visible coloration is observed, so there is no cosmetically disturbing effect.

[0165] In Fig. In Figure 8, the corresponding area is illuminated with blue light. The biofilm, which appears white and is stained with the detection medium according to the invention, can be seen. The visibility is so good and traceable that automated detection using a camera-based detection device is possible. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] DE 20 2016 101 191 U1

[0007] US 3,401,690 A

[0008] US 2005 / 091,770 A

[0009] US 2017 / 0189,149 A1

[0010] WO 2007 / 060644 A2

[0014] WO 2009 / 077291 A2

[0015] WO 2010 / 076705 A1

[0016] WO 2020 / 212214 A1

[0017] WO 2020 / 212248 A1

[0018] DE 42 08 664 A1

[0019] US 2012 / 0003601 A1

[0020] US 2019 / 0110875 A1

[0021] US 2019 / 0236236 A1

[0022]

Claims

[1] Biofilm detection medium, wherein the detection medium is water-based and comprises at least water, an organic solvent, a buffer system and a functional ingredient, wherein the functional ingredient is fluorescein-based and wherein the detection medium has a pH in the range of 6.5 and 7.

5. [2] The biofilm detection medium according to claim 1, wherein the functional ingredient is sodium fluorescein. [3] Biofilm detection medium according to claim 1 or 2, wherein the functional ingredient is contained at 0.0001-0.5 wt.%, preferably 0.01-0.4 wt.%, particularly preferably 0.05-0.3 wt.%, further particularly preferably 0.06-0.09 wt.%. [4] Biofilm detection medium according to one of the preceding claims, wherein the water content is 70-90 wt.%, preferably 75-85 wt.%, particularly preferably 78-82 wt.%. [5] Biofilm detection medium according to any one of the preceding claims, wherein the organic solvent is glycerol. [6] Biofilm detection medium according to one of the preceding claims, wherein the organic solvent is contained at 10-20 wt.%, preferably at 12-18 wt.%, particularly preferably at 13-15 wt.%. [7] Biofilm detection medium according to one of the preceding claims, wherein the buffer system is phosphate-based and in particular comprises sodium phosphate and sodium dihydrogen phosphate. [8] Biofilm detection medium according to one of the preceding claims, wherein the buffer system is contained in the biofilm detection medium at 0.1-1.0 wt.%, preferably at 0.2-0.7 wt.%, particularly preferably at 0.3-0.6 wt.%. [9] Biofilm detection medium according to any one of the preceding claims, wherein the biofilm detection medium has a pH in the range of 6.80-7.

20. [10] Biofilm detection medium according to one of the preceding claims, wherein the biofilm detection medium comprises at least one additive selected from the group of sugar substitute, steviol glycoside, menthol, natural flavors, nature-identical flavors, artificial flavors, foaming agents, preservatives, stabilizers and acid buffers. [11] Biofilm detection medium according to one of the preceding claims, wherein xylitol and / or sodium saccharin is / are contained as sugar substitute. [12] Biofilm detection medium according to any one of the preceding claims, wherein the biofilm detection medium has a composition in the following ranges: Deionized water 70-90 wt% Glycerin 10-20 wt.% Sodium phosphate dibasic 0.05-0.5 wt% Sodium dihydrogen phosphate 0.05-0.5 wt% Sodium fluorescein 0.0001-0.1 wt% Methylparaben 0.01-0.4 wt% Benzyl alcohol 0.01-0.4 wt% Xylitol 0.5-5.0 wt% Sodium saccharin 0.005-0.05 wt% aroma 0.005-8,000 wt% [13] Biofilm detection medium according to one of the preceding claims, wherein the liquid biofilm detection medium is a cleaning liquid for use with a device, in particular a cleaning device, wherein cleaning particles are contained, wherein the particles are small solids with a defined hardness, size distribution and shape, wherein the particles are preferably finely dispersed with a diameter of 1 to 250 µm, preferably 10-100 µm, wherein preferably 0.1 to 15 wt.%, more preferably 0.5 to 10 wt.% of particles are present in the liquid. [14] Biofilm detection medium according to claim 13, wherein the particles are formed from at least one material selected from the group consisting of: Materials of plant origin, cellulose, mineral materials, silicates, aluminates, borates, aluminosilicates, metal oxides. [15] Biofilm detection medium according to claim 13 or 14, wherein dispersants such as microcrystalline cellulose, silica, proteins or other surfactants are additionally present to utilize the Pickering effect. [16] Biofilm detection medium according to any one of claims 13-15, wherein dispersants are included at levels of 0.2 - 2.0 wt.%. [17] Biofilm detection medium according to any one of claims 13-16, wherein the liquid detection medium is shear-thinning with a non-Newtonian behavior, wherein the liquid has the properties of a gel in the resting state, which counteracts both short- and long-term sedimentation of the particles. [18] Biofilm detection medium according to any one of the preceding claims, wherein the biofilm detection medium is provided in a capsule, the capsule comprising a water-soluble capsule material, preferably hydroxypropylmethylcellulose. [19] Biofilm detection medium according to one of the preceding claims, wherein the biofilm detection medium is provided in a device capsule which can be inserted into the device. [20] A method for detecting biofilm in the oral cavity, using a biofilm detection medium according to any one of the preceding claims. [21] Method according to claim 20, wherein the biofilm is stained with the biofilm detection medium and is detected after staining, wherein the stained areas are scanned with sensors and an abstract image is generated from which control data for the or a cleaning device are generated. [22] Method according to one of claims 20 or 21, wherein after detection with the sensors, the device, for example a cleaning device, is inserted and provided with the device capsule which contains a cleaning liquid, and cleaning is carried out by the device, wherein the control data are used to carry out the cleaning locally adapted according to the contamination. [23] Method according to one of claims 20 to 22, wherein the device is used as the only device for carrying out the method, wherein the device for coloring, detection and cleaning uses a basic device with different mouthpieces each adapted for the respective intended use. [24] A method according to any one of claims 20 to 23, wherein the inking and cleaning are carried out with a mouthpiece. [25] Method according to one of claims 20 to 24, wherein the image files and / or control data are stored in the basic device and / or in a cloud. [26] Use of a liquid detection medium according to any one of claims 1 to 19 in a device, for example a cleaning or detection device, for detecting biofilm in the oral cavity.

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