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    公开号:BR112012027538B1
    申请号:R112012027538-0
    申请日:2011-04-29
    公开日:2018-04-03
    发明作者:Piergallini Remigio；Loupis Nikolaos
    申请人:Klox Technologies Inc.；
    IPC主号:
    专利说明:

    (54) Title: COMPOSITION, USE OF COMPOSITION, METHOD FOR WHITING A TOOTH IN VIVO ON THE PATIENT'S GUM, KIT FOR DENTAL WHITENING AND USE OF THE KIT (73) Holder: KLOX TECHNOLOGIES INC .. Address: 275 BOULEVARD ARMAND-FRAPPIER, LAVAL, QUEBEC H7V 4A7, CANADA (CA) (72) Inventor: REMIGIO PIERGALLINI; NIKOLAOS LOUPIS
    Validity Period: 20 (twenty) years from 04/29/2011, subject to legal conditions
    Issued on: 03/04/2018
    Digitally signed by:
    Júlio César Castelo Branco Reis Moreira
    Patent Director
    1/31
    COMPOSITION, USE OF COMPOSITION, METHOD FOR WHITING A TOOTH IN VIVO ON THE PATIENT'S GUM, KIT FOR DENTAL WHITING AND USE OF THE KIT
    CROSS REFERENCE TO RELATED ORDER
    The present patent application claims priority and is a continuation of US serial N- patent application 12 / 771,105, filed on April 30, 2010, which is a partial continuation of US serial N- 2 patent application 11 / 598,206 , filed on November 9, 2006, the contents of which are hereby incorporated by reference.
    FIELD OF THE INVENTION
    The present invention generally relates to compositions that evolve oxygen and / or activated oxygen, which are useful in applications such as tooth whitening. More specifically, the invention relates to tooth whitening compositions and kits that can be employed to provide a whitening effect
    wanted (for example, fur any less two-tone bleaching) in less than fence 5 minutes of exposure total light actinic without post sensitivity treatment substantial. BACKGROUND TO INVENTION
    Peroxide and peroxyacid compounds, such as hydrogen peroxide and carbamide peroxide, have been shown to be useful in tooth whitening compositions. The application of UV or visible light from, for example, argon lasers, has been used to accelerate whitening after the application of peroxide compositions to teeth. In addition, bleaching compositions have been described and include compounds capable of absorbing light and converting it to heat or chemical energy, such as metal-binder complexes and metal chelate precursors
    2/31 described in US patent 6,343,933 to Montgomery et al.
    Red dyes have also been used to absorb visible or UV energy and produce heat in a bleaching composition as described, for example, in U.S. Patent No. 2 6,485,709 to Banerjee et al. This patent also describes attempts to further improve such compositions by adding metal ions, or an organo-metallic enzyme (eg, catalase), or using high pH (eg, above 7) to destabilize or activate the decomposition of hydrogen peroxide. Dental bleaching compositions have also been described that include violet or blue violet dyes to negate yellow staining on teeth in U.S. Patent No. 2 6,030,222 to Tarver. Rhodamine dye BK has been used in a tooth whitening composition as described in document No. 2 WO 02/22097 to Verheyen et al.
    Dental sensitivity after treatment and the time required for tooth whitening compositions (typically requires about an hour of time or multiple applications or both), however, remains a substantial disadvantage.
    SUMMARY OF THE INVENTION
    The present invention provides innovative compositions and methods that evolve oxygen and / or activated oxygen and are capable, for example, of whitening teeth in a surprisingly small amount of time (for example, less than 1 minute to about 10 minutes) and with minimal or no post-treatment sensitivity. The invention is based, in part, on a finding that the use of the dyes described in this document dramatically accelerates the bleaching process.
    Without sticking to any particular theory,
    3/31 it is believed that the inclusion of these dyes significantly improves the compositions of the invention at least since the dentin is believed to transmit green light and absorb blue light. Consequently, the dyes of the present invention enhance whitening not only on the tooth surface, but can also transmit light into the tooth to enhance the change of color agents by radicals that have penetrated the interior of the tooth surface.
    Another advantage of the present invention is that the compositions can be effective when applied only for a short period of time (for example, 1 minute in some embodiments). Consequently, the sensitivity due, for example, to the percolation of hydrogen peroxide in the dental pulp tissue (for example, the inflammation of the dental pulp), can be minimized or eliminated. Another advantage of the present invention is that the compositions do not require compounds that generate heat and, therefore, the discomfort associated with compositions that generate heat can be minimized or eliminated. Yet another advantage is that dyes (for example, eosin) can be used that are less toxic than dyes like rhodamine B.
    In one aspect, the present invention features a tooth whitening composition that includes an oxidizing agent and an activating agent that have an emission wavelength between about 400 nm and about 570 nm.
    In one embodiment, the activating agent is capable of emitting green light, blue light or green and blue light, and / or absorbing green light, blue light or green and blue light. In another embodiment, the activating agent comprises eosin (for example, eosin Y, eosin B), erythrosine, or both.
    In another embodiment, the composition additionally includes a stabilizing agent.
    In one embodiment, the stabilizing agent is acetate
    4/31 sodium composition.
    In one embodiment, it is additionally a thickening agent.
    In one embodiment, the thickening agent is silicon dioxide and / or pyrolysed silica that has a particle size less than one micron.
    In one embodiment, the composition additionally includes a hydrophilic gelling agent.
    In another embodiment, the composition additionally includes an accelerating agent. In some embodiments, the accelerating agent includes sodium perborate.
    In one embodiment, the pH of the composition is between about 8 and about 10.
    The invention also features a method for tooth whitening which includes applying the tooth whitening composition of the present invention to at least one tooth and exposing the tooth whitening composition to actinic light so that the tooth is whitened at least about one shade. In one embodiment, the tooth is bleached in at least two shades in less than about 10 minutes or in less than about 5 minutes.
    In one embodiment, post-treatment sensitivity is negligible or eliminated.
    In one embodiment, the tooth is exposed to the tooth whitening composition for less than 5 seconds per application.
    The invention also features tooth whitening which includes a tooth whitening of the invention and an apparatus for preparing and / or applying the composition.
    The invention also features a tooth whitening kit that includes a tooth whitening composition of the invention and instructions for determining includes a tooth whitening kit.
    5/31 a time of application of the composition to achieve a desired bleaching effect.
    The invention also features a method for tooth whitening that includes at least an application of actinic light and a tooth whitening composition for at least one tooth so that the tooth is whitened by at least two shades with less than about 1 minute of total exposure to actinic light. In one embodiment, the tooth is bleached in at least about three shades in less than about 30 seconds. In another modality, there is no substantial post-treatment sensitivity.
    BRIEF DESCRIPTION OF THE DRAWINGS
    Figure 1 illustrates the compositions of the present invention in comparison to other compositions containing other dyes, exposure before and after (see arrows) to actinic light.
    Figure 2 illustrates the compositions of the present invention compared to other compositions containing other dyes, after a period of 5 hours following the extrusion of the compositions from a mixing syringe.
    DETAILED DESCRIPTION OF PREFERENTIAL MODALITIES
    In order to describe the subject matter of the claims more clearly and concisely, the following definitions are intended to provide a guide to the meaning of the specific terms used in the following written description, examples and attached claims.
    The term accelerating agent refers to any agent capable of accelerating and / or contributing to the completion of radical generation (for example, sodium perborate).
    actinic light refers to the energy of light capable of being absorbed by an activating agent.
    The term activating agent refers to any agent capable of absorbing actinic light. Preferably, the
    6/31 activating agent improves and / or accelerates the dispersion of light energy, or that otherwise improves and / or activates the decomposition of an oxidizing agent. Activating agents include agents capable of absorbing light energy and emitting light energy, for example, fluorochromes. Suitable activating agents include, for example, eosin, which refers to eosin B, eosin Y, or a combination thereof and erythrosine B (also known as erythrosine).
    The term eosin refers to the fluorescent red dye that results from the action of bromine on fluorescein. There are two closely related compounds commonly called eosin. Eosin Y is a derivative of fluorescein tetrabromo (also known as eosin Y ws, yellowish eosin, acid red 87, CI 45380, bromoeosin, bromofluoresceic acid, D&C Red N 2 22); which has a very slightly yellowish tint. The other eosin compound, eosin B, derived from fluorescein dibromo (eosin blue, acid red 91, CI 45400, safrosine, scarlet eosin, or imperial red); which has a very faint bluish tint.
    The term erythrosine refers to the 2,4,5,7-tetraiodofluorescein disodium fluorescent pink-cherry fluorone food color.
    known as FD&C Red N 2 3, Food Red 14 and acid red 51. Erythrosine is also known as Erythrosine B.
    And salt is also
    The term oxidizing agent refers to any agent capable of oxidizing and also includes precursors to compounds capable of oxidizing. Examples of oxidizing agents include, but are not limited to, peroxide, peroxide acid, hydrogen peroxide, carbamide peroxide, metal-alkali peroxides, metal-alkali percarbonates, peroxyacetic acid and metal-alkali perborates.
    7/31
    The term post-treatment sensitivity refers to the immediate sensitivity or pain experienced by an individual after a tooth whitening procedure. Sensitivity may include, but is not limited to, stimulus such as temperature and pressure. Immediate pain typically occurs without stimulation. The terms substantial sensitivity or substantial post-treatment sensitivity and the like, refer to substantial post-treatment discomfort, which includes immediate sensitivity and / or pain for more than four hours. The term insignificant pain refers to the minimum sensitivity to the stimulus such as temperature and / or pressure for less than four hours after treatment.
    The term stabilizing agent refers to any agent that stabilizes one or more agents of the composition (for example, an oxidizing agent such as hydrogen peroxide). The stabilizing agent can function to stabilize the agent or agents against spontaneous or unwanted reactivity during use and / or during storage. Suitable stabilizing agents include sodium acetate. In some cases, the stabilizing agent can stabilize hydrogen peroxide for about a year.
    The term total exposure to actinic light refers to the total time that a tooth is exposed to actinic light that includes multiple applications of actinic light over the course of a treatment session.
    The term transparent refers to a composition capable of at least 70% light transmission. The term translucent refers to a composition capable of at least about 40% light transmission. The mentioned light can be, for example, actinic light (for example, from a laser), emitted light (for example, from a fluorochrome), or both.
    The term translucency agent refers to
    8/31 wave, pH ranges, minus one or one or more used in the open sense any agent capable of increasing the translucency of a composition. Such agents can increase translucency, for example, by adding to the composition, by activating (for example, by heat, actinic light and / or emitted light), or both.
    When the ranges are shown in the present document (for example, concentration length, particle sizes and bleaching) and all individual values and ranges within the ranges shown are considered to be part of and covered by the present invention. All concentrations are given in% by weight of the composition unless otherwise indicated.
    Where one, one (numeral) or the like is used in this document, these articles are used in an open and non-restrictive sense, for example, to indicate by the Similar way, the term is or is not restrictive, that is, to mean and /or. Consequently, the terms or and and / or are used interchangeably and are intended to have the same meaning.
    In one aspect, the present invention provides tooth whitening compositions that include an oxidizing agent (for example, hydrogen peroxide) and an activating agent that has an emission wavelength between about 400 nm and about 570 nm (for example , eosin B, eosin Y, erythrosine B or combinations thereof). The composition can also include additional agents that include, but are not limited to, pH adjusting agents, thickening agents, stabilizing agents, accelerating agents, gelling agents, translucency agents.
    oxidizing agent can be any oxidizing agent known in the art. In one embodiment, the oxidizing agent
    9/31 includes hydrogen peroxide or sodium perborate or both. In addition or alternatively, the oxidizing agent may include carbamide peroxide, metal alkali peroxides, metal alkali percarbonates, metal alkali perborates or combinations of the same compounds. The oxidizing agents can be, for example, liquid, gel or ointment compositions capable of interacting with the activating compound when exposed to actinic light.
    The concentration of the oxidizing agent can be varied in the present invention. In one embodiment, the oxidizing composition includes hydrogen peroxide, for example, in the range of about 1% to about 70%. In an additional embodiment, the oxidizing composition includes about 50% hydrogen peroxide.
    The activating agent can include any agent with an emission wavelength between about 400 nm and about 570 nm. In another embodiment, the activating agent emits light in the range between about 435 nm and about 520 nm. In one embodiment, the activating agent emits light in the range between about 520 nm and about 565 nm. In certain embodiments, the agent both absorbs and emits light in the above bands. In one embodiment, the activating agent emits a green light. In another mode, the activating agent emits green and blue light. In one embodiment, the activating agent either absorbs or emits a green light.
    In one embodiment, the activating agent includes at least one of eosin B, eosin Y or erythrosine B or combinations thereof. In another embodiment, the bleaching composition ranges from about 0.5% to about 0.8%, or between about 0.02% and about 1.2% or less than about 12%. at least one of eosin B or eosin Y or combinations thereof, or from about 0.02% to about 12% (for example, 0.02 to 0.5%, 0.02 to 0.2%, 0 , 05 to 0.15%, 0.05 to
    10/31
    0.1%) of at least one of eosin B or eosin Y or combinations thereof. In yet another embodiment, the composition includes about 0.02% to about 12% eosin B or eosin Y or combinations thereof, and / or about 0.01% to about 1%, or about 0.005% and about 0.15%, or from about 0.005% to 1% erythrosine B. It is believed that the combination of eosin B and / or eosin Y and / or erythrosine B has a synergistic effect. It is believed that this synergistic effect may be related to the absorption peaks close to the dyes. It is further believed that since eosin B and / or eosin Y and erythrosine B re-emit green light and that green light has the capacity and can be additionally absorbed (or reabsorbed) by fluorochromes so that the light energy it is not dissipated as in conventional compositions. This absorbed and re-emitted light not only penetrates the entire bleaching gel, but is also transmitted within the enamel and dentin. Dyes such as eosin B and eosin Y are also advantageous since they are significantly less toxic than dyes like rhodamine B.
    Without sticking to any particular theory, it is believed that since dentin and enamel transmit green light, light in this band can be transmitted into the dentin and / or enamel of the tooth, which causes electron excitation in specific chemical bonds inside the activating agent and chromophores of the tooth, which makes the means more susceptible to being attacked by free radicals. Activating agents of the invention can include blue and green and / or blue emission dyes. Consequently, the present invention is based, at least in part, on the finding that the use of the activating agents of the invention improves and / or contributes significantly to the enhancement of a bleaching effect in a fraction of the
    11/31 time required by conventional compositions. Since teeth are only exposed to the whitening composition for a fraction of the time compared to conventional tooth whitening compositions, crevices and superficial cracks, caused by prolonged exposure to free radicals, can be reduced or eliminated. Since descaling can occur in cracks and crevices caused by prolonged exposure to free radicals, stains return more easily due to the fact that descaled enamel works like a sponge. In the present invention, the reduced time of exposure to free radicals reduces the possibility of cracks and crevices, which then leads to the effect of prolonged or permanent whitening significantly to deeper pigments. In addition, prolonged periods of exposure cause the enamel to become brittle. The composition and methods of the present invention are believed to prevent enamel compromise.
    In one embodiment, the activating agent or agents are not only capable of emitting light in the wavelength range from about 400 nm to about 5700 nm, but also absorb light in the wavelength range of about 400 nm at about 570 nm. Such an activating agent is activated by light in the wavelength range from about 400 nm to about 570 nm. Consequently, in one embodiment, the activating agent absorbs light in the wavelength range from about 400 nm to about 5 70 nm. In another embodiment, the activating agent absorbs light at a wavelength between about 470 nm and about 550 nm. This modality, therefore, allows the optimal absorption of energy from the actinic light and the optimal transmission through dentin and enamel.
    Without adhering to any particular theory, it is also believed that the activating agents of the present invention, when exposed to actinic light, can accelerate the dispersion of
    12/31 light energy which, consequently, leads to instantaneous and complete photochemical activation of the peroxide inside the gel. It is believed that the gel mass transmits better light in the wavelength range from about 400 nm to about 570 nm, so that when an activating agent is exposed to actinic light, the dispersion of light energy leads to an accelerated photochemical activation of peroxide. Together, these modalities allow the optimal absorption by the activating agent of the actinic light energy and the optimal transmission through the composition, the dentin and the enamel.
    In one embodiment, the composition also includes a stabilizing agent. In one embodiment, the stabilizing agent stabilizes the peroxide concentration in the composition for days, weeks, months, a year or several years. In one embodiment, the stabilizing agent not only stabilizes the oxidizing agent, but is also a pH modifier and / or stabilizer. In another embodiment, the stabilizing agent is sodium acetate. In one embodiment, sodium acetate is added until the desired pH is reached. In yet another embodiment, the composition includes between about 0.1% and about 50% of stabilizing agent. Any value or range within that range is intended to be covered.
    In one embodiment, the stabilizing agent is selected from the group consisting of antioxidants such as sodium sulfide, metal chelators (for example, EDTA) and stabilizers (for example, tin salts, phosphoric acid and tin sulfonate). In some embodiments, the stabilizing agent hijacks or otherwise isolates or removes metal ions from the solution that can potentially destabilize hydrogen peroxide.
    In one embodiment, the stabilizing agent is or includes sodium acetate (for example, sodium acetate trihydrate)
    13/31 sodium). Sodium acetate has been found to inhibit the spontaneous reactivity of hydrogen peroxide and, therefore, can provide improved stability.
    In one embodiment, the pH of the composition is or is adjusted to a range of about 4 to about 10. In alkaline conditions, with a pH of about 8 to about 10, the strongest free radical, perhydroxyl ions , can be generated. Perhydroxyl free radicals are able to react not only with yellow and brown spots, but even with gray chromophores located deeper in the tooth structure. In the additional embodiments, the pH of the composition is between about 5 and about 7, or between about 5 and about 6. In certain embodiments the pH is about 6.
    Suitable pH adjusting agents include, but are not limited to, sodium hydroxide, potassium hydroxide, ammonium hydroxide, sodium carbonate, potassium carbonate, TRIS and triethanolamine, or any other alkali-based salt that is used safely in the mouth. In another embodiment, the pH-adjusting agent is sodium perborate. In certain embodiments of the invention, a single component can function as a pH-adjusting agent or as a stabilizing agent or can act in both functions. In one embodiment, sodium acetate functions as a pH-adjusting agent and as a stabilizing agent. In the additional embodiments, the pH-adjusting agent belongs to the group consisting of sodium bicarbonate, calcium bicarbonate, sodium carbonate and calcium carbonate.
    In addition or alternatively, the composition may include a thickening agent to improve the ease of application of the composition to the teeth so that uniform and effective coverage is more readily achieved. Suitable thickening agents include, but are not limited to mixed silica and aluminum oxides,
    14/31 long-chain hydrocarbons such as synthetic carbomers (for example, Carbopol), triethanolamine (for example, Trolamine) and water-soluble poly resins (ethylene oxide) (for example, Polyox ™). Suitable thickening agents also include amide starches.
    It has been found that through the use of an agent that has a particle size in the range of about 0.2 microns (pm) to about 0.7 pm provides more widely distributed dispersion of the oxidizing agent on the surface of the particle.
    Consequently, in one embodiment, the activating agent has a particle size below about 2 microns or below about 1 micron. In other embodiments, the agent has a particle size below about 0.8, 0.7, 0.6, 0.5,
    0.4, 0.3, or 0.2 microns. In other embodiments, the activating agent has a particle size between about 0.1 and about 0.8, between about 0.2 and about 0.7, or between about 0.3 and about 0, 6 microns.
    Additionally or alternatively, the thickening agent can include pyrolyzed silica and / or any other inert inorganic material that can be used as a carrier and can assist in the delivery of active oxygen to the tooth surface. Pyrolyzed silica with a small particle size (for example, between about 0.2 microns and about 0.4 microns), can provide efficient dispersion of hydrogen peroxide and the reflection of light energy within the oxidizing composition.
    In some embodiments, the compositions of the invention include a reaction accelerator or an accelerating agent. In one embodiment, the composition includes sodium perborate. Sodium perborate has selective reactivity with hydrogen peroxide in the formation of free radicals (reacts with water to release hydrogen peroxide). The use of one or more of the activating agents (for example, perborate
    15/31 sodium) can be advantageous since they can absorb or retain the heat generated in the composition by, for example, actinic light, which thus restricts any such heat to the gel in order to accelerate the reaction without heating the tooth, which generates sensitivity. In addition, the acceleration of the reaction means that the composition can be removed more quickly than conventional compositions, thereby decreasing the patient's exposure to the composition and thus resulting in sensitivity and / or other damage to tissues and teeth.
    In one embodiment, the compositions of the invention include between about 0.8% and about 15%, or between about 0.3% and about 18% of accelerator.
    In additional embodiments, the compositions of the invention include a gelling agent. Preferably, the gelling agent is also a translucency agent. For example, a hydrophilic gelling agent can be employed to increase the translucency of the resulting composition or gel.
    In some embodiments, the nature of the gelling agent (for example, its hydrophilic nature) prevents vaporization of the gel when it is exposed to actinic light, thereby improving the hydration of the coated tooth area. Increased hydration of teeth and surrounding tissues is associated with decreased discomfort and sensitivity. In one embodiment, the gelling agent can include, for example, one or more modified starches and / or glucose. In one embodiment, the modified starches and / or glucose are activated in cold water. In some embodiments, the gelling agent further improves the consistency of the composition, which facilitates application to the tooth surface.
    The translucency agent can improve the
    16/31 translucency or transparency by adding to the composition and / or by activating, for example, actinic light, emitted light and / or heat. In one embodiment, it minimizes the vaporization of the composition. Additionally or alternatively, the gelling and / or translucent agent minimizes any thermal effects by absorbing any heat generated in the composition.
    In one embodiment, the composition is a translucent composition. In another embodiment, the composition is a transparent composition. In certain embodiments, the composition is translucent or transparent to the actinic light it will be exposed to (for example, green, blue and green or blue light).
    In one embodiment, the composition includes an oxidizing agent (eg, hydrogen peroxide), an accelerating agent (eg, sodium perborate), an activating agent (eosin B, eosin Y, erythrosine B or combinations thereof), an stabilizing agent (for example, sodium acetate trihydrate), a pH-adjusting agent, a thickening agent (for example, pyrolyzed silica or silicon dioxide or both) and a gelling agent. In one embodiment, the pH of the composition is about 6 to about 10, In some embodiments, the pH of the composition is about 8 to about 10, In other embodiments, the pH of the composition is about 4 to about 10.
    Another aspect of the invention provides a method for tooth whitening which includes applying a tooth whitening composition of the present invention to at least one tooth and exposing the tooth whitening composition to actinic light to activate the oxidizing agent. The composition can be any of the compositions described in this document.
    In one embodiment, the method for whitening teeth is performed in a dentist's office or
    17/31 dental operations under ordinary conditions. The composition can be mixed next to the chair and applied to the surfaces of as many teeth as desired to be bleached. Alternatively, the composition can be supplied without the need for mixing beside the chair. Therefore, the composition can be exposed to actinic light to accelerate the decomposition of the oxidizing agent and the formation of free radicals. In one embodiment, pre-mixes can be prepared with some or all of the ingredients and then mixed next to the chair and applied to the teeth. In one embodiment, a premix of a hydrogen peroxide / sodium acetate solution can be prepared and stored before use. Additionally or alternatively, some or all of the remaining ingredients can also be pre-mixed separately and stored before use. Such premixes can be stored, for example, for at least about a year.
    The compositions of the invention can be used to whiten teeth discolored by any agent or disease. For example, the compositions can be used to lighten discoloration due to stains (for example, tobacco, coffee, tea and / or food stains), fluorosis, developmental disorders, bacteria, genetics, tetracycline antibiotics, trauma, decomposition of the blood, pigments present during tooth development, etc.
    Any actinic light source can be used and preferably it is capable of emitting light at a wavelength appropriate for the activating agent employed in the composition. In one embodiment, for example, an argon laser is used. In another embodiment, a titanyl potassium phosphate (KTP) laser (for example, a GreenLight ™ laser) is used as a light source. In one embodiment, the light source emits light at or near the
    18/31 absorption wavelength of the activating agent or at least one of the activating agents, if several are included in the composition.
    The most intense fluorescence (for example, emission) from a fluorochrome dye occurs when it is irradiated with wavelengths close to the peak of the absorption wavelength (ie, excitation curve). Consequently, in one embodiment, the actinic light is at a wavelength close to the wavelength of absorption of the activating agent. In one embodiment, actinic light has a wavelength in the range of about 470 nm to about 550 nm. In another embodiment, actinic light has a wavelength in the range of about 470 nm to about 520 nm. In yet another embodiment, an argon laser provides actinic light in the wavelength range from about 470 nm to about 520 nm. In an additional embodiment, the actinic light has a wavelength of about 530 nm to about 535 nm. In yet another embodiment, the actinic light source that is in the wavelength range of about
    530 nm at about 535 nm is a KTP laser. In this mode, the source is a KTP laser adjusted to about 532 nm. In another embodiment, a photocure device is the actinic light source.
    In one embodiment, the tooth is exposed to actinic light for less than 20 minutes, in another for less than 10 minutes, in another for less than 5 minutes. In one embodiment, the tooth is exposed to actinic light for less than 4, 3, 2, or 1 minute. In one embodiment, the invention provides a method for whitening teeth in at least 2 shades in about 1 minute. In some modalities, there is no substantial post-treatment sensitivity. In other modalities, there is no post-treatment sensitivity.
    In one embodiment, the bleaching composition
    19/31 dental is applied and the tooth is exposed to multiple applications of actinic light, for a time of about 4 to about 6 seconds on each tooth per exposure. In some embodiments, the tooth is exposed to actinic light at least two, three, four, five or six times. In some embodiments, a new application of the tooth whitening composition is applied before each exposure to actinic light. In some embodiments, total exposure to actinic light is less than about a minute. In other embodiments, total exposure to actinic light is less than about 60, 40, 30, or 20 seconds.
    In one embodiment, the tooth is bleached in at least 7 shades, 6 shades, 5 shades, 4 shades, 3 shades, 2 shades or 1 shade. The tones can be determined before and after treatment through the use of numerous tone guides, which include, for example, VITA® tone guides (Vita Zahnfabrik H. Rauter GmbH & Co., KG), CHROMASCOP® (lvoclar Vivadent , Inc.) or BIODENT (Dentsply Intenational). Optionally, a tone acquisition system, for example, the ShadeEye NCC dental chroma meter, can be employed to determine the tone before and / or after treatment.
    In one embodiment, the tooth is bleached in at least two shades, three shades, four shades, five shades, six shades or seven shades in less than about a minute of total exposure time to actinic light. In some embodiments, the tooth is bleached in at least two shades, three shades, four shades, five shades, six shades or seven shades in less than about 40 seconds of total exposure time to actinic light. In some embodiments, the tooth is bleached in at least two shades, three shades, four shades, five shades, six shades or seven shades in less than about 30 seconds of total exposure time to actinic light. In some embodiments, the tooth is bleached in at least two shades,
    20/31 three tones, four tones, five tones, six tones or seven tones in less than about 20 seconds or even less than about 10 seconds of total exposure time to actinic light.
    In one embodiment, the risk of transient inflammation of the dental pulp by percolating hydrogen peroxide is reduced, is not substantial and / or is eliminated. Without sticking to any particular theory, it is thought that inflammation of the dental pulp is caused by the percolation of hydrogen peroxide within the tissue of the dental pulp. In some embodiments, the synergistic effect of activating agents (eg, eosin B and / or eosin Y and / or erythrosine B) and actinic light results in an instant and complete photochemical reaction. Consequently, exposure of the tooth, dental pulp, and / or surrounding tissues to the oxidizing agent and / or the other components in the composition is drastically reduced.
    In yet another aspect, the invention provides a tooth whitening method that comprises applying actinic light and a composition of the invention (any of the compositions described in this document) on at least one tooth, so that the tooth is whitened at least minus about two tones in less than about 10 minutes. In another embodiment, the tooth is bleached in at least two shades in less than about 5 minutes, less than about 4 minutes, less than about 3 minutes, less than about 2 minutes or in about 1 minute. In some modalities, the teeth are whitened in at least about 3 shades, 4 shades or 5 shades. In some modalities, there is no substantial post-treatment sensitivity or any post-treatment sensitivity.
    In yet another aspect, the invention provides a kit for preparing or applying a tooth whitening composition according to the present invention. In one mode,
    21/31 the kit includes an oxidizing agent and an activating agent that has an emission wavelength between about 400 nm and about 60 nm. The composition can be any of the compositions of the present invention. In one embodiment, the composition is not combined and can optionally include an apparatus for combining two or more components or premixes of the composition. In another embodiment, the composition does not require any combination (that is, it is ready for use and does not require any pre-mixing beside the chair).
    In another embodiment, the kit includes a composition of the invention and instructions for application. Additionally or alternatively, the kit may include an appliance for application (for example, brushes or trays or both). The kit may also include graphics or other information useful in assessing the desired bleaching effect and / or achieved by the methods and compositions of the invention. The kit can also include an actinic light source.
    The identification of equivalent compositions, methods and kits is well within the skill of the ordinary practitioner and would require no more than routine experimentation, in light of all the teachings in this presentation. The practice of the invention will be further understood from the following examples, which are presented in this document for illustration only and should not be construed as limiting the invention in any way.
    EXAMPLE 1
    Preparation of an Exemplifying Bleaching Composition and Activation Through Actinic Light
    A premix was prepared by mixing 4 mg of eosin B, 1 mg of erythrosine B, 450 mg of pyrolyzed silica and 45 mg of sodium perborate. Separately, the pH
    22/31 50% of a hydrogen peroxide solution was adjusted to pH 6 using a sodium acetate solution. Approximately 4 to 6 ml of the adjusted hydrogen peroxide solution was then added to the premix in a plastic mixing chamber and immediately applied.
    The gel was applied to the frontal surface of each individual's teeth, starting with the front frontal incisors, followed by the posterior ones and finally the posterior incisors. The gel was activated by a KTP laser adjusted on a continuous wave of 0.5 watts. The laser was applied to each tooth for 2 to 3 seconds. During that time, the gel changed from orange and red to transparent and eventually became matte. After 3 to 4 minutes for two complete arches from premolar to premolar, the gel was aspirated and the teeth were lightly rubbed with a cotton cylinder to clean the enamel surface. A second gel coating was applied using a new gel and activated with the KTP laser as described above. Up to six consecutive applications were performed to achieve the desired whitening effect for each patient. The duration of the sessions typically did not exceed 40 minutes.
    EXAMPLE 2
    Composition Bleaching Effect
    A comparative study was conducted on 10 volunteers between an exemplary composition of the present invention and the SMARTBLEACH laser tooth whitening systems, which is a composition comprising rhodamine B and hydrogen peroxide. The tone of the teeth of each patient was recorded before applying the bleaching composition.
    The teeth were coated with the composition prepared in Example 1 and exposed to actinic light from a green laser set at 532 nm for one minute for the entire mouth (from 4
    23/31 to 5 seconds per tooth) and then the composition was removed. The comparative composition was applied to the teeth and exposed to the light of a green laser adjusted to 532 nm for 30 seconds per tooth and then left on the tooth surface for 10 minutes, according to the manufacturer's instructions provided with the composition. The comparative composition required at least 3 to 4 applications, for a total duration of about 1.5 hours for the entire mouth. The composition was removed from each volunteer and the teeth were irrigated with water. The teeth were then evaluated using the VITA scale to whiten the compositions. Patients were also assessed for any post-treatment sensitivity by asking them the rate of pain level experienced, if any.
    Smartbleach ™ treatment resulted in a shade change of one to two shades in the yellow group, while the exemplary composition of the present invention resulted in a shade change of 5 shades in the yellow group, for example, from A 4 to Bi on the VITA scale . In the yellow group (A 4 to Aj, treatment with the exemplary composition of the present invention resulted in tone changes of 4 to 5 tones, which result in tones in the white group (from B x to B 2 ). The treatment with the composition example for teeth in the gray (from C 4 to C x ) and gray and brown (from D 4 to D 2 ) groups exhibited changes of 2 to 3 shades in the first session.
    The following post-sensitivity rating scale was used:
    Level 0 No sensitivity to thermal stimulation or any type of pain after treatment. Level 1 Sensitivity to thermal stimulus that lasts for a few seconds. Level 2 Pain or discomfort that occurs due to thermal stimulation and lasts for more than a minute. Optional pain treatment with analgesics.
    24/31
    Level 3 Pain or discomfort that occurs automatically, which requires the use of analgesics to control the pain.
    After treatment with the Smartbleach ™ system, all ten subjects experienced pain from Level 1 to Level 3. After treatment with the exemplary composition of the present invention, nine subjects experienced no pain at all (for example, Level 0) and only one individual experienced Level 1 pain.
    EXAMPLE 3
    Actinic Light Source Effect
    A study was conducted on 28 volunteers comparing the effect of different actinic light sources on bleaching with the composition of Example 1. A prophylactic session was performed on each patient 3 to 4 days before the bleaching session. The tone of the teeth of each patient was recorded before applying the bleaching composition.
    The teeth were coated with the composition prepared in Example 1 and exposed to different sources of actinic light: a green laser (KTP) at 532 nm, a blue and green laser (argon) at 4 80 at 514 nm, a halogen lamp of photocure and an LED photocure device. Activation was performed on different patients on the left and right sides of their dental arches according to an activation randomization mode. Specifically, a first right side of the patient was activated with the green laser at 532 nm, while the left side was activated with the blue and green laser from 480 nm to 514 nm. A second patient's right side was activated with the halogen photocure lamp, while the left side was activated with the LED photocure device. A third patient's right side was activated with the 532 nm green laser, while the left side was activated with the
    25/31 halogen photocure lamp. A fourth patient's right side was activated with the 532 nm green laser, while the left side was activated with the LED photocure device. A fifth patient's right side was activated with the blue and green laser from 4 80 nm to 514 nm, while the left side was activated with the halogen photocure lamp. A sixth patient's right side was activated with the blue and green laser from 480 nm to 514 nm, while the left side was activated with the LED photocure device.
    The composition was removed from the teeth of each volunteer and the teeth were irrigated with water. The teeth were then evaluated using the VITA scale to whiten the compositions.
    Activation by different photocure devices produced comparable results. The activation speed with the green laser and the blue and green laser was 4 to 5 seconds per tooth, while the activation speed with the photocure devices was about 10 seconds per tooth. Consequently, a bleaching session that employs the green laser or the blue and green laser for the entire mouth would typically take approximately 30 minutes and a session with a photocure device would typically take approximately 40 minutes.
    EXAMPLE 4
    Preparation of the composition
    The tooth whitening compositions were prepared according to the following table:
    Table 1
    description Present invention Prior art Agentactivator 1. eosin Y (0.7 mg / g)2. erythrosine B (0.7 mg / g)3. eosin Y & erythrosine B 4. acid red388 (0.7 mg / g)5. acid red92 (0.7 mg / g)6. 388 acid red & red
    26/31
    (both 0.7 mg / g) acid 92 (both 0.7 mg / g)7. FD&C Red 40 (0.7 mg / g) Componentscommon(Reinforcerphotoactive) - Hydrogen peroxide- Silica- Starch- Sodium perborate - Sodium acetate - Distilled water
    EXAMPLE 5
    Clinical Evaluation of Light Absorption and Quantitative Measurement of Fluorescence Emission
    The samples of each dental bleaching composition described in Table 1 were extruded from a syringe after mixing and a portion of each extruded sample was exposed to actinic light for 60 seconds, while the rest was not. Visual assessment of the change in color was performed and a photograph of the composition was taken immediately after exposure to light.
    As shown in Figure 1, prior to exposure to actinic light, all compositions exhibited a clear and distinct color according to the dye used in the composition. During exposure to actinic light, the compositions of the present invention sharply fluoresced, as did the compositions containing acid red dyes, but the composition containing FD&C Red 40 appeared non-fluorescent (results not shown). After exposure to actinic light, the coloring of the compositions of the present invention changed differently: the composition containing eosin Y only became pure white, while the compositions containing erythrosine B and eosin Y + erythrosine B became a color bluish. Compositions containing acid red 388 or acid red 92 alone, or a mixture of these two dyes, did not change color. Finally, the
    27/31 compositions containing FD&C Red 40 were also unchanged. Thus, only the compositions of the present invention exhibited any robust photochemical targeting reactions.
    Figure 2 shows that after exposure to actinic light, all three compositions of the present invention became soft and moist and collapsed into a single mass of composition. The addition of sodium acetate to the gel composition accelerated the activation of the gel when exposed to actinic light. This acceleration can be caused by the increase in the pH of the photoactive reinforcer. Gas bubbles were observed emerging from the samples. This observation is consistent with a rapid and robust decomposition of hydrogen peroxide in water and oxygen (according to the known reaction: 2 H 2 O 2 -> 2 H 2 0 + 0 2 ) accelerated by the dispersion of light energy in the composition by the agents activators. The other sample compositions did not mix into a single mass, but, instead, preserved a more solid texture, with filament-like features, as generated during extrusion from the syringe. As shown in Figure 2, a second visual assessment was performed after the compositions were left unattended for 5 hours at room temperature. Interestingly, the compositions of the present invention remained moist and exhibited evidence of gaseous releases, while the other compositions hardened after that period. This result suggests that the compositions of the present invention are capable of causing an accelerated photochemical activation of the hydrogen peroxide present in the composition. None of the other tested compositions showed comparable results.
    EXAMPLE 6
    Dental whitening results
    Compositions containing eosin Y and erythrosine B and
    28/31 the compositions containing acid red 388 only, acid red 92 only and FD&C Red 40 were only prepared as in Table 1 above. Each of these sample compositions was directly and simultaneously tested on the teeth of a human subject. The mouth of each individual was divided into 4 quadrants (upper left, lower left, upper right and lower right). In order to maintain a fixed optical position to assess tooth whitening, the composition of the present invention was, in each case, applied to the right quadrants, while the comparative composition was applied to the left quadrants. The compositions were exposed to actinic light (a blue phase LED curing device) for 20 seconds per tooth. The effect of each composition was scored according to the Vita® luminosity scale and the results are shown in Table 2.
    Table 2
    Comparative Results of Dental Whitening
    Using the Composition of the Present Invention and Compositions Containing Acid Red Dyes or FD&C Red 40
    Patient Quadrantright Vita tone conversion Quadrantleft Tone ConversionVita 1 eosin Y and erythrosineB A3 to Al (7 tones) acid red 388 A3 to A2.5 (> 3 tones) 2 eosin Y and erythrosineB A3 to Al (7 tones) acid red 92 Nonechange 3 eosin Y and erythrosineB A3 to Al (7 tones) FD&CRed40 Nonechange
    Vita® BI light scale = lighter shade C4 darker shade
    29/31
    BI Al B2 D2 A2 Cl C2 D4 A3 D3 B3 A3.5 B4 C3 A4 C4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
    For each of the three treated patients, the use of the composition of the present invention resulted in a substantial improvement of 7 shades (A3 to Al), while the composition containing 388 acid red caused a modest improvement slightly better than 3 shades (A3 to Al). A2.5). Compositions containing acid red 92 or FD&C Red 40 had no effect. Thus, the composition of the present invention is the most efficient tooth whitening composition.
    The above scientific results have shown that based on exposure to actinic light, the red dyes used in the composition of the present invention are more readily activated. Also, these scientific results showed that under 20-second tooth whitening conditions, the use of acid red 388, acid red 92, or FD&C Red 40 does not result in an effect on whitening teeth as potent as that of the composition. of the present invention. In fact, acid red 92 and FD&C Red 40 are unable to cause any teeth whitening effect under the conditions used. These results indicate that these dyes do not contribute as efficiently (if at all) as to eosin Y or erythrosine B, for a teeth whitening effect.
    EXAMPLE 7
    Dental Whitening Results
    Compositions containing eosin Y only, erythrosine B only, both eosin Y and erythrosine B and compositions containing acid red 388, acid red 92 alone or in combination and
    FD&C Red 40 were prepared according to Example 4 above. Each of the sample compositions was tested directly
    30/31 on the teeth of a human individual. The compositions were exposed to actinic light (a blue phase LED curing device) for 20 seconds per tooth. The effect of each composition was scored according to the Vita® luminosity scale and the results are shown in Table 3.
    Table 3
    Comparative Results of Dental Whitening Using the Composition of the Present Invention and Compositions Containing Acid Red Dyes or FD&C
    Red 40
    Patient Dyes Vita® tone conversion 1 eosin Y and erythrosineB A3 to Al (7 tones) 2 eosin Y only A3 to Al (7 tones) 3 erythrosine B only A3 to C2 (2 tones) 4 acid red 388 A3 to A2 (4 tones) 5 acid red 92 No changes 6 FD&C Red 40 No changes 7 acid red 388 and acid red 92 A3 to A2 (4 tones)
    Vita® BI light scale = lighter shade C4 = darker shade
    BI Al B2 D2 A2 Cl C2 D4 A3 D3 B3 A3.5 B4 C3 A4 C4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
    For each of the three treated patients, the use of the composition of the present invention that contains eosin Y alone or eosin Y and erythrosine B resulted in a substantial improvement of 7 shades (A3 to Al), while the composition containing acid red 388 alone or in combination with acid red 92 it caused a modest improvement slightly better than 3 to 4 tones (A3 to A2.5 or A2). Compositions that contain red
    The acid 92 alone or FD&C Red 40 only had no effect. Thus, the composition of the present invention is a more efficient dental whitening composition.
    31/31
    The above scientific results show that based on exposure to actinic light, the red dyes used in the composition of the present invention are more readily activated. Also, these scientific results showed that under 20-second tooth whitening conditions per tooth, the use of acid red 388, acid red 92, or FD&C Red 40 does not result in a teeth whitening effect as potent as that of the present composition. invention. In fact, when used alone, acid red 92 and FD&C Red 40 are unable to cause any teeth whitening effect under the conditions used. These results indicate that these dyes do not contribute as efficiently (if at all) as to eosin Y or erythrosine B, for a teeth whitening effect.
    1/5
    权利要求:
    Claims (5)
    [1]
    I. COMPOSITION, characterized by comprising:
    1% to 70% by weight of a peroxide; and eosin Y.
    2. COMPOSITION according to claim 1, characterized in that it further comprises an accelerating agent.
    3. COMPOSITION, according to claim 2, characterized in that the accelerating agent is perborate of
    10 sodium.
    COMPOSITION according to any one of claims 1 to 3, characterized in that it further comprises a thickening agent.
    COMPOSITION according to claim 4, 15 characterized in that the thickening agent is selected from silica and aluminum oxides, pyrolyzed silica, carbomers, triethanolamine, (poly) ethylene oxide, amide starches, and silicon dioxide.
    6. COMPOSITION according to any one of the claims 1 to 5, characterized in that it further comprises a gelling agent.
    COMPOSITION according to claim 6, characterized in that the gelling agent is hydrophilic.
    COMPOSITION according to claim 7, 25 characterized in that the gelling agent is a modified starch.
    COMPOSITION according to any one of claims 1 to 8, characterized in that the pH of the composition is between 8 and 10, 5 and 7, or 4 and 10.
    10. COMPOSITION according to any one of claims 1 to 9, characterized in that the composition is a transparent or translucent gel.
    II. COMPOSITION, according to any of the
    Petition 870170089680, of 11/21/2017, p. 7/13
    [2]
    2/5 claims 1 to 10, characterized in that it further comprises a stabilizing agent to stabilize the oxidant.
    12. COMPOSITION, according to the claim
    11, characterized by the stabilizing agent being an antioxidant, a metal chelator, or a pH modifier.
    13. COMPOSITION, according to the claim
    12, characterized by the stabilizer being selected from sodium acetate, EDTA, sodium sulfite, tin salts, phosphoric acid and tin sulfonates.
    COMPOSITION according to any one of claims 1 to 13, characterized by having 0.02% to 12% by weight of Eosin Y in the composition.
    15. USE OF THE COMPOSITION, as defined in any one of claims 1 to 14, characterized in that it is used for whitening or tooth whitening.
    16. METHOD FOR WHITENING A TOOTH IN VIVO IN A PATIENT'S GUM, the method characterized by comprising:
    apply to at least one tooth a tooth whitening composition comprising:
    1% to 70% by weight of peroxide, and eosin Y; and exposing the tooth whitening composition to actinic light to activate the oxidizing agent.
    17. METHOD according to claim 16, characterized in that the tooth whitening composition is exposed to actinic light for less than 20 minutes.
    18. METHOD according to claim 16 or 17, characterized in that the exposure to actinic light of the tooth whitening composition is less than 20 seconds per tooth.
    Petition 870170089680, of 11/21/2017, p. 8/13
    [3]
    3/5
    19. A method according to any one of claims 16 to 18, characterized in that the composition is exposed to multiple applications of actinic light.
    20. METHOD according to any one of claims 16 to 19, characterized in that the actinic light has a wavelength from 470 nm to 520 nm.
    21. KIT FOR DENTAL WHITENING, characterized by being selected because it comprises:
    a first component comprising eosin Y and a second component comprising an oxidizing agent.
    22. KIT according to claim 21, characterized in that it further comprises an apparatus for combining the first and second components, an apparatus for applying the first and second components combined in at least one tooth, a light source, information for evaluate the effectiveness of the composition, or any combination thereof.
    23. KIT according to claim 22, characterized in that the light source is capable of emitting light having a wavelength from 470 nm to 520 nm.
    24. KIT according to claim 21 or 22, characterized in that it further comprises instructions for determining a time of application of the first and second components combined to achieve a bleaching effect.
    25. KIT according to any one of claims 21 to 24, characterized in that, in combination, the first component and the second component form a transparent or translucent gel.
    26. KIT according to any one of claims 21 to 25, characterized by the oxidizing agent starting from peroxide, peroxy acid,
    Petition 870170089680, of 11/21/2017, p. 9/13
    [4]
    4/5 hydrogen peroxide, carbamide peroxide, alkali metal peroxides, alkali metal percarbonates, peroxyacetic acid and alkali metal perborates.
    27. KIT, in a deal with any of 5 claims 21 to 26 !, characterized by understanding additionally an agent accelerator. 28. KIT, in according to claim 27, featured fur accelerating agent be perborate of sodium. 10 29. KIT, in a deal with any of claims 21 the 28 , characterized by understanding additionally an agent thickener. 30. KIT, in according to claim 29, featured fur thickening agent be selected at 15 from oxides of silica and aluminum, pyrolyzed silica, carbomeres, triethanolamine, (poly) ethylene oxide, starches amide, and dioxide of silicon. 31. KIT, in a deal with any of claims 21 to 30 , characterized by understanding 20 additionally an agent gelling agent. 32. KIT, in according to claim 31, characterized by the agent gelling agent be hydrophilic. 33. KIT, in a deal with any of claims 21 The 32, characterized by the agent 25 gelling agent be a starch modified. 34. KIT, in a deal with any of claims 21 to 33 , characterized by understanding additionally an agent stabilizer to stabilize the oxidizing agent. 30 35. KIT, in according to claim 34, featured the stabilizing agent is a antioxidant, a metal chelator, or a modifier of
    Petition 870170089680, of 11/21/2017, p. 10/13
    [5]
    5/5
    36. KIT according to claim 35, characterized in that the stabilizing agent is selected from sodium acetate, EDTA, sodium sulfite, tin salts, phosphoric acid and tin sulfonates.
    37. USE OF THE KIT, as defined in any of claims 21 to 36, characterized in that it is used for whitening or tooth whitening.
    Petition 870170089680, of 11/21/2017, p. 11/13
    1/2 ο
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    FIG1
    Effect of exposure to light emitting diode (LED) on compositions
    2/2
    Eosin Erythrosine Acid Red 92 Acid Red 388
    Photoactive reinforcer with different colors 5 hours after extrusion from a syringe
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    法律状态:
    2017-08-22| B07A| Technical examination (opinion): publication of technical examination (opinion)|
    2018-01-23| B09A| Decision: intention to grant|
    2018-04-03| B16A| Patent or certificate of addition of invention granted|
    优先权:
    申请号 | 申请日 | 专利标题
    US12/771,105|2010-04-30|
    US12/771,105|US20100266989A1|2006-11-09|2010-04-30|Teeth whitening compositions and methods|
    PCT/CA2011/050261|WO2011134087A1|2010-04-30|2011-04-29|Photoactivatable oxygen-evolving compositions and methods for teeth whitening|
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