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WO2024013320A1 - Procédé pour détecter un biofilm dans la cavité buccale et milieu de détection associé - Google Patents

Procédé pour détecter un biofilm dans la cavité buccale et milieu de détection associé Download PDF

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Publication number
WO2024013320A1
WO2024013320A1 PCT/EP2023/069526 EP2023069526W WO2024013320A1 WO 2024013320 A1 WO2024013320 A1 WO 2024013320A1 EP 2023069526 W EP2023069526 W EP 2023069526W WO 2024013320 A1 WO2024013320 A1 WO 2024013320A1
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WO
WIPO (PCT)
Prior art keywords
detection medium
liquid
medium according
cleaning
detection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2023/069526
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German (de)
English (en)
Inventor
Agnes Fischl
Bernhard Rieder
Moritz Pichler
Andrei SHMELEV
Vedran Nedelkovski
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Epitome GmbH
Original Assignee
Epitome GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Epitome GmbH filed Critical Epitome GmbH
Publication of WO2024013320A1 publication Critical patent/WO2024013320A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0071—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0088—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for oral or dental tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/25—Compositions for detecting or measuring, e.g. of irregularities on natural or artificial teeth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
    • A61K8/498—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom having 6-membered rings or their condensed derivatives, e.g. coumarin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/42—Colour properties
    • A61K2800/43—Pigments; Dyes
    • A61K2800/434—Luminescent, Fluorescent; Optical brighteners; Photosensitizers

Definitions

  • the invention relates to a method for detecting biofilm in the oral cavity and a detection medium for this.
  • Brushing with a toothbrush and toothpaste is not sufficient from an oral hygiene perspective, as the spaces between the teeth (up to 40% of the surface to be cleaned) and the gum pockets in particular are not cleaned sufficiently because the toothbrush does not reach these areas.
  • a cleaning device in which ultrasound is applied to a surface via a liquid via a cleat which engages over at least one tooth.
  • a toothbrush which works like a normal electric toothbrush, but also has an ultrasound generator that is intended to introduce acoustic energy into a cleaning liquid.
  • a system is known with which teeth are to be whitened using an ultrasound device.
  • a mouthpiece is provided, which each has a volume for the upper jaw and the lower jaw, with ultrasound generators being arranged in the mouthpiece, facing the teeth, which can apply ultrasound energy to the tooth surface.
  • Ultrasound Streaming This is intended to create an effect known as Ultrasound Streaming, whereby the temperature must be controlled and also the formation of bubbles must be prevented, as these hinder the transmission of the ultrasound.
  • a frequency of 20 kHz to 100 kHz should be used, whereby cavitation should be specifically brought about so that steam bubbles form which implode on the surface of the tooth, with local temperatures of up to 5000 Kelvin and local pressures up to 1000 Atmospheres should be created.
  • WO2007/060644 A2 a method and device for removing biofilm by so-called micro streaming is known.
  • the aim is to cause gas bubbles to resonate using ultrasound, which should lead to a cleaning effect.
  • the ultrasound excitation is intended to cause the gas bubbles to vibrate, which induces an acoustic flow in a small area near the bubble.
  • This acoustic flow is also known as “micro streaming”.
  • This microflow is intended to generate shear forces that are able to remove 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.
  • WO2009/077291 A2 a method for introducing antimicrobial reagents to a biofilm is also known, in which gas bubbles in a plastic casing are introduced into a treatment room, the plastic casing is then destroyed with ultrasound and the bubbles are thus released.
  • the gas bubbles are excited by the ultrasound frequency so that they vibrate and collapse after reaching a maximum amplitude of the vibration, thereby tearing open the biofilm.
  • WO2010/076705 A1 a toothbrush is known which, in addition to bristles, contains an ultrasound generator which introduces ultrasound into a treatment room, with additional microbubbles being introduced. Cavitation cannot, but does not necessarily have to be, generated here.
  • a toothbrush is to be coupled to a water jet device, the water jet device being controlled in such a way that when the toothbrush is guided past the interdental areas, a water jet rinses the interdental areas.
  • suitable acceleration, speed or distance sensors should be used.
  • a method is known in which a water jet device is also coupled to a toothbrush, with a control device being present which makes an assumption as to where the cleaning device is located in the mouth, using predetermined data and user-specific data , whereby the data includes, among other things, data relating to the cleaning activity of the user or the operation of the cleaning device and is used to make an assumption about the location in order to rinse it with the water jet when an interdental area is reached.
  • a nozzle head arrangement for oral irrigators is known with a nozzle head forming a tunnel, the nozzle head being formed on the inside with a plurality of spray nozzles, which are successively acted upon by control valves with pressurized liquid from a pressure pump.
  • a tooth cleaning device is known with a device for generating a spray jet, which puts a liquid under pressure by means of a piezo element and can direct it at a tooth to be cleaned and also a detection device for detecting a dental hygiene marker.
  • the device is very voluminous and hardly suitable for end user use.
  • an oral hygiene device which includes cleaning elements and an energy source, the energy source being able to deliver visible light with a wavelength of 380 nm to 700 nm. Further, the oral hygiene device includes a visible light filtering device for filtering visible light of predetermined wavelengths reflected from parts of an oral cavity, and a device for converting energy resulting from the fluorescence of a fluorescent agent.
  • the fluorescent agent is applied to the teeth so that existing contamination can be identified and highlighted through fluorescence.
  • the fluorescent agent is a component of an oral composition and is present in the oral composition from 0.001% by weight to 10% by weight.
  • a plaque detection medium is known which comprises dyes or fluorescent substances as active compounds.
  • active compounds examples include azo, acrydine, fluorescein, phenolphthalein, triphenylmethane dyes and methylene blue.
  • the dyes mentioned can be present in the detection medium at 0.1 wt.-% to 50 wt.-%.
  • the detection medium has a pH value of 4 to 12.
  • To detect plaque the detection medium is manually applied to the teeth using, for example, a toothbrush and rinsed off with water after 1.5 minutes. The plaque is colored by the dye used, making it visible to the naked eye.
  • a tooth cleaning medium which contains solids and in particular fibril particles. These are abrasive particles that are larger than 25 pm and smaller than 200 pm and have a hardness of less than 3 Mohns hardness. The abrasive particles are contained between 7 wt.-% and 90 wt.-% in the tooth cleaning medium.
  • the tooth cleaning medium is applied to the teeth and the teeth are cleaned with a conventional toothbrush.
  • the plaque is removed in particular by the abrasive particles.
  • a tooth cleaning medium which includes, among other things, dyes for coloring the tooth cleaning medium.
  • the dyes used are conventional food colorings and can be contained in the composition at 0.0005 wt.-% to 2 wt.-%.
  • the tooth cleaning medium also contains a carbonate-bicarbonate buffer and therefore has a pH value that is in the neutral range.
  • a method for cleaning teeth in which a toothbrush with an integrated LED is provided.
  • the LED is used to irradiate the tooth surface that has previously been treated with a fluorescent agent, such as fluorescein, so that the existing plaque is made visible.
  • a fluorescent agent such as fluorescein
  • the object of the invention is to create a method for cleaning surfaces, and in particular tooth and gum surfaces and interdental spaces, which reliably and specifically removes biofilm from gums, the interdental spaces and the teeth
  • the task is solved with the features of claim 1.
  • a detection medium for a device and a method for automatic tooth cleaning are proposed.
  • the detection medium can be in liquid form, for example as a rinsing solution or gargle solution or cleaning solution or as a spray.
  • it can be in gel or pasty form, e.g. as a gel that liquefies in the oral cavity or is applied to the surfaces to be detected, or as a tooth cleaning gel or toothpaste.
  • gel or pasty form e.g. as a gel that liquefies in the oral cavity or is applied to the surfaces to be detected, or as a tooth cleaning gel or toothpaste.
  • It can also be in solid form, e.g. as a powder or tablet to be taken in the mouth.
  • a detection medium in liquid form can be used as follows:
  • a liquid-filled capsule can be taken and then either dissolve (quickly) in the mouth or be bitten into.
  • the liquid can be, for example, a water-based liquid or an oil-based liquid.
  • the liquid is a cleaning liquid
  • it is introduced, for example, into a handpiece or a tank of a cleaning device and sprayed onto the surface to be cleaned (teeth) via small nozzles or jets in a mouthpiece or at least an area around the teeth is flooded with it.
  • the liquid can also be sprayed into the oral cavity 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.
  • 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.
  • the liquid can also be administered via a container with a drinking straw or a drinking straw filled only with the liquid.
  • the liquid can also be filled from a bottle into a cup or cap like a mouthwash and then administered.
  • the detection fluid developed is, for example, a water-based formulation.
  • Glycerin can be used to stabilize sodium fluorescein.
  • the glycerin 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 consumer after using the detection liquid.
  • a buffer system that adjusts the pH to 5.0-6.0.
  • the buffer systems used are a citrate buffer, but other buffers can also be used.
  • a combination of benzoate and sorbate are used to suppress microbial growth.
  • Flavors are used to make the use of the liquid pleasant for the consumer.
  • the cleaning liquid can also be adjusted to a specific rheology with xanthan gum, gellan or comparable thickeners.
  • the desired pH value should be around 5.6.
  • the pH value is chosen so that it is above the critical value of 5.5 for tooth enamel.
  • Fluorescein is included as a functional ingredient. Fluorescein is known for its ability to emit green light when stimulated with blue light.
  • the fluorescein is used in a solution to which potassium dihydrogen phosphate is also added.
  • the liquid may also contain ethyl 4-hydroxybenzoate as a preservative.
  • preservatives dyes, flavors, humectants, sweeteners, solvents and ingredients with additional health benefits can also advantageously be used.
  • preservatives dyes, flavors, humectants, sweeteners, solvents and ingredients with additional health benefits can also advantageously be used.
  • the fluorescein is specifically bound to biofilm and optically marks it when illuminated with blue light. This makes the biofilm much more visible to the user and can therefore be removed more specifically.
  • the detection liquid according to the invention is used in particular in a method which preferably carries out cleaning fully automatically.
  • detection is first prepared using a device that will later also be used for cleaning.
  • a cleaning liquid itself is also used as a detection liquid, in particular in order to carry out detection and thus checking of the cleaning after cleaning has been carried out with it.
  • the statements made regarding the detection liquid apply accordingly.
  • a cleaning liquid including small particles to which sodium fluorescein is added is used.
  • the cleaning particles can be seen as a functional ingredient.
  • the particles are small solids with specifically selected hardness, size distribution and shape. Particles with a defined size of 50-100 pm should be finely dispersed in this matrix. The size of the particles should not exceed 200 pm. The proportion of particles should be between 2-10%.
  • the particles are granular and fibrous structures with irregular surfaces.
  • the materials used are preferably substances of plant origin (cellulose). However, the use of mineral particles is not ruled out either.
  • dispersants such as: B. Microcrystalline cellulose, proteins or other surface-active substances can be used. This is done using the so-called Pickering effect. This effect describes the stabilization of 2-phase systems through the use of surface-active particles.
  • the dosage of these dispersants should be between 0.2 - 2.0%.
  • ingredients such as buffer systems, preservatives, colors, flavors, humectants, sweeteners, solvents and ingredients with additional health benefits are used.
  • shear-liquefying not Newtonian
  • this cleaning fluid When at rest it has the properties of a gel. This counteracts both short- and long-term sedimentation of the particles. However, if this cleaning fluid is exposed to high shear forces, it begins to liquefy and the properties of a fluid come to the fore.
  • the detection medium can be present as follows:
  • the detection medium is in solid form, it can be a powder or a powder pressed into a tablet.
  • the powder is taken from a packaging with a measuring spoon and taken, chewed, dissolved in saliva and moved in the mouth. Then spit it out and rinse with water if necessary. The same procedure is followed with a tablet, whereby the dosage is easier, but the tablet must be sufficiently crushed in the mouth.
  • a pasty application is, for example, toothpaste.
  • the toothpaste not only has a cleansing effect while brushing your teeth but also has a biofilm detecting property.
  • detection is carried out after spitting out the toothpaste or the foam produced and, if necessary, rinsing. This can be used in particular to highlight weak points in the cleaning process.
  • a gel-shaped detection medium In the case of a gel-shaped detection medium, this can be applied, for example brushed, onto the surfaces to be examined in the oral cavity. It is used in a similar way to known gel-like agents for mineralizing teeth. Here, too, spitting out and, if necessary, rinsing can take place after a predetermined exposure time.
  • a possible cleaning method in which the detection liquid or a combined detection and cleaning liquid is used and a corresponding device are discussed below.
  • a device or a method for cleaning provides for cleaning a surface to be cleaned with a liquid that is sent with a pressure jet or pressure pulse of a predetermined strength and speed in the direction of the surface to be cleaned.
  • the corresponding device has a chamber or a tank to hold the cleaning liquid.
  • toroidal closed vortex threads hereinafter referred to simply as torus or in the majority as tori, can be generated.
  • such a flow or vortex leads to a flow occurring across a surface to be cleaned after the torus has passed through the surrounding medium to the surface to be cleaned.
  • solid particles within the ejected cleaning liquid according to the invention and/or in the surrounding medium they are entrained with the vortex or torus and accordingly also moved over the surface to be cleaned, which naturally increases the cleaning effect.
  • such solid particles can be entrained in a simple manner or can be carried along by the torus, so that a particle can also be guided over a surface several times.
  • the particle rotates or the particles rotate with or in the torus or around the torus. This means that a particle can sweep over the surface several times and use the shear forces to remove biofilm. This is different from a beam or jet, in which particles are only guided over the surface once.
  • Torus-shaped, closed vortex threads also exist without cold steam. Particles are also moved along the surface to be cleaned due to their flow resistance. The flow resistance of the particles increases with their size and the shear forces acting on the biofilm also increase when a particle is moved along its surface.
  • the nozzles can basically be circular in cross section, but can also have any other shape, for example elliptical or narrow slot-shaped, star-shaped or generally irregular. Accordingly, the closed vertebral filaments are not necessarily circular and therefore not tori according to the definition.
  • A cross-sectional area
  • P wetted circumference
  • the circular torus is advantageous because it is particularly stable and spreads far into the liquid without any noticeable change in shape.
  • a device that works with the aforementioned method can be used, but the pressures are adjusted so that there is no damage to the biofilm, so that the oral cavity or closed volumes within the oral cavity are more likely to be flooded.
  • This can be done automatically, for example, by a capsule with detection liquid having a coding which can be read by the device and results in the corresponding drive values for cleaning being lowered and adapted to the coloring.
  • the invention can be provided to surround a surface to be detected or a portion thereof with a closed liquid volume and to arrange a nozzle or several nozzles within this closed liquid volume.
  • the back suction can take place inside and or outside the closed volume. The suction can therefore take place within the closed volume created and/or outside, i.e. in the oral cavity. Fluid that is present in the mouth due to unavoidable leaks can be sucked back.
  • suction back in the oral cavity can also take place at the end of coloring.
  • saliva and cleaning liquid can also be sucked out with suction back from the oral cavity at the end of the coloring in order to enable the cleaning device to be used safely and without soiling clothing with liquid running out of the mouth.
  • the procedure involves first carrying out the coloring. After the coloring has taken place, which is confirmed to the user via suitable dispensing means of the device, the user removes the device and the used capsule with the detection liquid from the device.
  • This device scans the colored area and creates an abstract image from which control data for the cleaning device or a cleaning device are generated.
  • the cleaning device is then reinserted, provided with a capsule containing cleaning liquid and the cleaning is carried out.
  • the control data is used to carry out cleaning locally according to the level of contamination.
  • a device which is used for coloring, Detection and cleaning has a basic device with mouthpieces that are adapted to the respective intended use.
  • a mouthpiece can be used for coloring and cleaning.
  • the image files and/or control data can be stored in the basic device but also stored in a cloud or both.
  • the invention therefore relates in particular to a detection medium for making biofilm visible in the oral cavity, the detection medium being solid, liquid, gel-like or pasty and the detection medium having a respective lower limit of 0.01 M-% or 0.015 M-% or 0.0175 M-%. % or 0.02 M-%, or 0.0225 M-% or 0.025 M-% and as a respective upper limit 0.4 M-% or 0.35 M-% or 0.3 M-% or 0.25 M -% or 0.2 M% or 0.175 M% or 0.15 M% or 0.125 M% or 0.1 M% or 0.075 M% or 0.05 M% sodium fluorescein based on the Overall composition of the detection medium.
  • the solid detection medium is a powder, a tablet or a chewing gum, with a sugar substitute being contained in addition to sodium fluorescein as an essential ingredient.
  • binders are present and, in particular, magnesium stearate is present as a binder.
  • a further development stipulates that one, several or all of the group steviol glycoside, menthol, natural flavors, nature-identical flavors, artificial flavors, foaming agents, preservatives, stabilizers, acid buffers are present.
  • the lower limits of the sugar substitute content are 75% by mass or 80% by mass or 85% by mass or 90% by mass or 95% by mass and the upper limits are 96% by mass or 97% by mass or 98 M% or 99.25 M%, preferably containing 95-98% sugar substitute.
  • the solid detection medium is the following
  • Composition in M% has:
  • liquid detection medium essentially comprises distilled water and glycerin in addition to sodium fluorescein.
  • a further development provides that a buffer system is present which buffers the liquid into an acidic area.
  • a further development provides that a buffer system is present which sets a physiologically harmless pH value, the buffer setting a pH value of 5.0-6.0, in particular above 5.5, preferably containing a citrate buffer.
  • glycerin 5% by mass or 6% by mass or 7.5% by mass or 8% by mass or 9% by mass or 10% by mass or 12.5% by mass or 15-M% and the upper limits are 50 M-% or 45 M-% or 40 M-% or 35 M-% or 30 M-% or 25 M-% or 20 M-% or 17.5 M-% , preferably containing 10-20% glycerol.
  • the detection medium has a composition in the following areas:
  • the liquid is a cleaning liquid for use with a cleaning device, containing cleaning particles, the particles being small solids with specifically selected hardness, size distribution and shape, the particles having a defined size of 25 to 250 pm , in particular 50-100 pm, are finely dispersed, with 1 to 15% by weight, in particular 2 to 10% by weight, of particles being present in the liquid.
  • the particles are formed from one or more of the following materials: materials of plant origin, cellulose, mineral materials, silicates, aluminates, borates, aluminosilicates, metal oxides.
  • a further development provides that additional dispersants such as microcrystalline cellulose, proteins or other surface-active substances are present to use the Pickering effect.
  • the liquid is designed to be shear-liquefying with non-Newtonian behavior, with the liquid having the properties of a gel in the resting state, which counteracts both short- and long-term sedimentation of the particles.
  • the liquid has a composition as follows:
  • the liquid detection medium is oil-based and is present as an oil-filled capsule, with a water-soluble capsule packaging being present, which is designed to slowly dissolve in saliva, in particular a capsule material made of hydroxypropylmethylcellulose, the capsule being filled with a flavored vegetable oil in which sodium fluorescein is dispersed.
  • oil-based liquid is the following
  • Composition has:
  • the detection medium is in the form of chewing gum, whereby a sugar-free chewing mass is mixed with powdered sodium fluorescein and then shaped.
  • the detection medium is designed as a toothpaste, with at least distilled water and xanthan gum being present in addition to sodium fluorescein to set the desired viscosity. Further training stipulates that a composition is trained in the following areas:
  • a further aspect of the invention relates to a method for detecting biofilm in the oral cavity, using a previously described detection medium.
  • a further development provides that a surface to be colored or detected is acted upon by a device with a pressure jet or pressure pulse of a predetermined strength and speed through at least one nozzle in the direction of the surface to be cleaned.
  • a further development provides that the outflow pressures or velocities from the nozzle are adjusted so that the biofilm is not damaged, so that nozzle outflow velocities or pulse strengths are set that are below the limit that causes the biofilm to be detached but above of pure flooding.
  • a further development provides that the detection liquid is arranged in a capsule which can be inserted into a chamber of the device.
  • a further development provides that a coded capsule is used, which specifies the drive parameters for the flow velocity, the pressure and the pulsation via a code that can be read by a device.
  • a further development provides that a surface to be detected or a partial area thereof is surrounded by a closed volume of liquid using the device and a nozzle or several nozzles are arranged within this closed liquid volume.
  • a further development provides that suction back is carried out, with the back suction taking place inside and or outside of the closed volume.
  • a further development provides that after the coloring has taken place, the biofilm is recorded, the colored areas being scanned with sensors, and an abstract image is generated from which control data for the cleaning device or a cleaning device are in turn generated.
  • a further development provides that the end of the coloring is confirmed to the user via suitable output means of the device.
  • a further development provides that after detection with the sensors, a cleaning device is used and is provided with a capsule which contains cleaning liquid and cleaning is carried out by the cleaning device, the control data being used to locally adapt the cleaning according to the contamination to carry out.
  • a further development provides that the method is carried out with a single device, which uses a basic device for coloring, detection and cleaning with different mouthpieces that are adapted to the respective intended use.
  • a further development provides that the image files and/or control data are stored in the basic device and/or in a cloud.
  • Another aspect relates to the use of a previously described liquid in a cleaning device or detection device for detecting biofilm in the oral cavity.
  • Another aspect relates to the use of a previously described solid or pasty detection medium, whereby the solid or capsule-shaped medium is chewed or the toothpaste is applied, spit out and rinsed with up to 20 ml of water and the discoloration is then optically detected.
  • Figure 1 a possible operating sequence for the administration and use of the
  • Figure 2a a composition for a liquid detection medium
  • Figure 2b a preferred composition for a liquid detection medium
  • Figure 3a a composition for a solid detection medium
  • Figure 3b a preferred composition for a solid detection medium
  • Figure 3c a tablet from the solid detection medium
  • Figure 4a a composition for a toothpaste with the detection medium
  • Figure 4b a preferred composition for a toothpaste with the
  • Figure 5 a composition for a cleaning liquid with the
  • Figure 6a a composition for an oil-based filled capsule with the
  • Figure 6b a preferred composition for an oil-based filled capsule with the detection medium
  • Figure 6c an oil-filled capsule for applying the detection medium
  • Figure 7 the visible discoloration of the lip with conventional coloring agents
  • Figure 8 the visible discoloration of artificial tooth material in conventional ones
  • Figure 10 non-discolored artificial tooth material when using the detection medium according to the invention
  • Figure 11 the coloring of biofilm with the detection medium according to the invention under light of a predetermined wavelength
  • Figure 12 the coloring of biofilm with the detection medium according to the invention under light of a predetermined wavelength in a detailed view.
  • the detection medium described here consists of various recipes for various application forms, which have sodium fluorescein as the active ingredient in common.
  • liquid formulation is preferred, but alternative dosage forms such as tablets, powder, gel, chewing gum or capsules are also possible.
  • Fluorescein molecules have the ability to absorb light at a certain wavelength and then release it again when light of a longer wavelength is emitted.
  • This required light source is included in a detection device, for example, and this results in a sensible interaction between the detection medium and a detection device.
  • the fluorescein bound to the biofilm is washed out by the regular flow of saliva and after a short waiting period, fluorescence is no longer detectable.
  • FIGS. 9 and 10 show how the detection medium according to the invention behaves under visible light. There is no visible coloring, so there is no cosmetically disturbing effect.
  • the corresponding area is illuminated with blue light. You can see the biofilm that appears white and has been colored with the detection medium according to the invention. The detectability is so good and comprehensible that automated detection using a camera-based detection device is possible.
  • the detection liquid according to the invention is a water-based formulation.
  • Glycerin is preferably used to stabilize the sodium fluorescein.
  • the glycerin 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 consumer after using the detection liquid.
  • a buffer system which buffers the liquid into an acidic area.
  • a buffer system is preferably used which also sets a physiologically harmless pH value.
  • the buffer should adjust the pH to 5.0-6.0.
  • the buffer systems used are, for example, a citrate buffer, but other buffers can also be used.
  • a combination of benzoate and sorbate can be used to suppress microbial growth.
  • FIG. 2a A recipe with possible ranges of possible ingredients of the detection liquid is given in FIG. 2a.
  • the table given should be understood to mean that all Ingredients other than water can be contained individually, several of the ingredients mentioned or all ingredients, with the rest being distilled water.
  • the dosage of sodium fluorescein should be at least 0.025% by mass. The preferred range is 0.050-0.075%. The maximum dosage of sodium fluorescein should be 0.200%.
  • the lower limit for the dosage of glycerin is 5% by weight.
  • the preferred range is 10-20% glycerin in the recipe.
  • a glycerin concentration of 50% was chosen as the upper limit.
  • This detection liquid described can be used as already described and as follows:
  • the main ingredient used here is a sugar substitute such as xylitol, which has an anti-cariogenic effect.
  • magnesium stearate for example, is used as a binding agent.
  • a combination of steviol glycoside as well as menthol and flavors can be provided.
  • the ingredients are mixed together homogeneously and formed into a tablet using a tablet press with a certain pressure.
  • the dosage of sodium fluorescein should be at least 0.025%.
  • the preferred range is 0.050-0.075%.
  • the maximum dosage of sodium fluorescein should be 0.200%.
  • the lower limit for the dosage of xylitol is 80%.
  • the preferred range is 95-
  • xylitol 98% xylitol is aimed for in the recipe.
  • the upper limit is a concentration of xylitol of
  • FIG. 3b A possible concrete exemplary embodiment is shown in FIG. 3b.
  • Figure 3c shows a corresponding tablet as an example.
  • it can also contain a foaming agent similar to a fizzy tablet, which increases the surface area.
  • Another application option is a combination of the detection medium with a toothpaste. As already stated, this combination makes it easy to check the teeth immediately after cleaning, without requiring a separate application step. This is particularly helpful for visualizing and correcting cleaning errors.
  • the dosage of sodium fluorescein should be at least 0.025%.
  • the preferred range is 0.050-0.075%.
  • the maximum dosage of sodium fluorescein should be 0.200%.
  • the xanthan gum content is desirable for setting the desired viscosity.
  • the aim is a dosage between 0.2-0.8%.
  • the minimum xanthan gum content is assumed to be 0.1%.
  • the maximum xanthan gum content is 2.0%.
  • a cleaning liquid is used, for example, in a device which achieves cleaning with the aid of bubbles present or generated in the cleaning liquid and their collapse on a surface to be cleaned. This cleaning effect is achieved through Currents are caused on the surface to be cleaned.
  • particles that interact with the flows can be used and used in the cleaning liquid. If such a cleaning liquid is additionally mixed with fluorescein in a suitable amount, a success check can be carried out after cleaning with the cleaning liquid and, if necessary, a device suitable for this purpose, in particular an application device similar to the toothpaste described. Since this success control can be carried out automatically, the data collected can also be used to carry out control when using an application device in such a way that in areas where the cleaning was incomplete, the duration or intensity of the cleaning can be increased in subsequent cleaning cycles.
  • 5 shows a recipe with possible recipe components and, as such, sensible contents, with effective ranges of individual components being specified, which can be contained individually, in groups or all, provided that sorbitol and water as well as fluorescein are included. If in doubt, the recipe is adjusted so that the fluorescein content is added after the composition of the recipe with the recipe ingredients and is topped up to a total of 100% water and sorbitol in the specified ratio range, which results from the percentages in the table.
  • a buffer in the acidic range and in particular a citrate buffer is used.
  • the desired pH value should be around 5.6.
  • the pH value was chosen so that it is above the critical value of 5.5 for tooth enamel. At lower pH values, demineralization of the tooth material can occur. The limit is therefore a physiologically meaningful limit.
  • Cleaning particles can be seen as a functional ingredient.
  • the particles are small solids with specifically selected hardness, size distribution and shape. Particles with a defined size of 50-100 pm should be finely dispersed in this matrix. The size of the particles should not exceed 200 pm. The proportion of particles should be between 2-10%.
  • the particles are granular and fibrous structures with irregular surfaces.
  • the materials used are preferably substances of plant origin (cellulose). However, the use of mineral particles is not excluded.
  • dispersants such as: B. Microcrystalline cellulose, proteins or other surface-active substances can be used. This is done using the so-called Pickering effect. This effect describes the stabilization of 2-phase systems through the use of surface-active particles.
  • the dosage of these dispersants should be between 0.2 - 2.0%.
  • ingredients such as buffer systems, preservatives, colorants, flavors, humectants, sweeteners, solvents and ingredients with additional health benefits are also used.
  • cleaning fluid Another important characteristic of the cleaning fluid is the possible shear-liquefying (not Newtonian) behavior of this cleaning fluid. When at rest it has the properties of a gel. This counteracts both short- and long-term sedimentation of the particles. However, if this cleaning fluid is exposed to high shear forces, it begins to liquefy and the properties of a fluid come to the fore.
  • prophylactic substances can also be added; Addition of substances to achieve a brightening effect may be provided.
  • FIG. 6a Another possible form of application are oil-filled capsules, with Figure 6a showing possible recipe components, Figure 6b showing an example formulation and Figure 6c showing such a capsule.
  • This form of application uses water-soluble capsule packaging, which slowly dissolves in saliva. Hydroxypropylmethylcellulose is given as an example of the capsule material.
  • the capsule is filled with a flavored vegetable oil in which sodium fluorescein is dispersed.
  • Sodium Fluorescein is insoluble in oil. It is only dissolved in the existing saliva after biting open the capsule in the mouth. The saliva therefore acts as a solvent and is used to distribute the sodium fluorescein in the oral cavity.
  • the dosage of sodium fluorescein should be at least 0.025%. The preferred range is 0.050-0.075%. The maximum dosage of sodium fluorescein should be 0.200%.
  • the detection can therefore take place before or after cleaning.

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Abstract

L'invention concerne un milieu de détection pour visualiser un biofilm dans la cavité buccale, le milieu de détection se présentant sous forme solide, liquide, de gel ou de pâte, et possédant une limite inférieure respective de 0,01 % en poids ou 0,015 % en poids ou 0,0175 % en poids ou 0,02 % en poids, ou 0,0225 % en poids ou 0,025 % en poids et possédant une limite supérieure respective de 0,4 % en poids ou 0,35 % en poids ou 0,3 % en poids ou 0,25 % en poids ou 0,2 % en poids ou 0,175 % en poids ou 0,15 % en poids ou 0,125 % en poids ou 0,1 % en poids ou 0,075 % en poids ou 0,05 % en poids de fluorescéine sodique par rapport à la composition totale du milieu de détection ; l'invention concerne également un procédé pour détecter un biofilm et l'utilisation du milieu de détection.
PCT/EP2023/069526 2022-07-15 2023-07-13 Procédé pour détecter un biofilm dans la cavité buccale et milieu de détection associé Ceased WO2024013320A1 (fr)

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