WO2013030788A1 - Anti-cavity biocompound and application protocol - Google Patents

Anti-cavity biocompound and application protocol Download PDF

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Publication number
WO2013030788A1
WO2013030788A1 PCT/IB2012/054475 IB2012054475W WO2013030788A1 WO 2013030788 A1 WO2013030788 A1 WO 2013030788A1 IB 2012054475 W IB2012054475 W IB 2012054475W WO 2013030788 A1 WO2013030788 A1 WO 2013030788A1
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agent
compound
mixture
apply
tooth
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PCT/IB2012/054475
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Spanish (es)
French (fr)
Inventor
Francisco ZULUAGA CONSUEGRA
Francisco ZULUAGA DEL CASTILLO
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Zuluaga Consuegra Francisco
Zuluaga Del Castillo Francisco
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Publication of WO2013030788A1 publication Critical patent/WO2013030788A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/20—Protective coatings for natural or artificial teeth, e.g. sealings, dye coatings or varnish
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis

Definitions

  • the present invention involves a substance similar to and compatible with tooth enamel, so that, applied under a specific protocol in a single clinical application, it adheres to the enamel, thickening it.
  • the patient's teeth remain mineralized and increase their resistance to decay, as the Anticaries Biocomposite thickens and strengthens the surface of the tooth, as well as increases the concentration of crystals and gives protection on all surfaces of all teeth. It can delay the average gestation time from a decay to five (5) years.
  • This invention is related to compounds and compositions for use in the area of oral health, to be applied by any professional in said area in order to maintain the physiological conditions that favor the health of dental pieces and the quality of enamel, with in order to avoid cariogenic conditions.
  • Caries is a condition caused by the production of acids from the bacterial population that naturally inhabits the human mouth, particularly derived from refined sugars such as sucrose.
  • the main bacteria associated with this process are Streptococcus Mutans and S. Lactobacillus. When food is ingested, especially fermentable carbohydrates, these bacteria take this substrate and metabolize it into acids that demineralize the enamel.
  • the enamel initiates a process of disintegration or demineralizes when the pH of its surface falls below its critical value; that is, the enamel begins to weaken when the environment in which it is found is more acidic (lower pH, and faster between more acidic) than a commonly accepted critical value at 5.5 average.
  • fluoride To prevent tooth decay, the element of choice par excellence is fluoride. So far, salt fluoridation programs have been developed and in most of the aqueduct systems in many cities the water is fluoridated. This is a simple strategy to maintain an adequate supply of fluoride to people, mainly in children, where there are the greatest cases of tooth decay. There is also a wide variety of fluoride toothpastes. This has certainly helped to marginally reduce tooth decay rates by providing enamel with some protection, although they are alternatives that do not ensure any effectiveness or provide permanent protection, as statistics show. Beyond the above, statistics from the Oral Health Report of the World Health Organization do not distinguish between developed and developing countries, which could imply that caries rates are much higher in underdeveloped countries.
  • the conventional preventive method of caries is the intensive fluoridation practiced with some frequency in the dentist's office, which, as the literature and medical practice indicate long ago, tends to create a small layer of fluoroapatite from the enamel hydroxyapatite using the small amount that is released when the tooth naturally demineralizes and when some fluoride is still present on the surface.
  • the main disadvantage of this treatment is that the persistence of the reaction generated by Fluoroapatite is short, since the fluorine disappears quickly from the surface, being able to react with relatively little Hydroxyapatite from the enamel and therefore, achieving a protection through a very layer thin, inefficient and not very permanent.
  • fluoride varnishes which make the reaction take place in a somewhat more efficient way, however, this reaction continues only with the hydroxyapatite that the enamel naturally possesses and releases when demineralized.
  • FIG. 7 Occlusal area 40X
  • polished Figure 8 Vestibular zone 10X
  • polished Figure 9 Vestibular zone 10X, unpolished, with the aim of evaluating not only the penetration of Anticaries Biocomposite in enamel (and therefore the best in natural protection against caries), but also if there is a significant loss of the protective layer when polishing the surface with soft discs The result is satisfactory: The loss is negligible.
  • This invention is related to compounds and compositions obtained for use in the area of oral health, to be applied by any professional in said area in order to maintain the physiological conditions that favor the health of the teeth and the quality of the enamel, in order to avoid tooth decay.
  • the invention relates to a substance similar to and compatible with tooth enamel, which, applied under a specific protocol, adheres to the enamel, maintains the mineralized tooth and increases its resistance to decay by increasing the concentration of crystals in the enamel, thickening and strengthening said tooth enamel permanently and on the entire surface of all teeth, without generating sensitivity, without changes in the color tone scale or aesthetic appearance and with permanence even after routine abrasive procedures on the teeth.
  • this invention relates to the application protocol of said Anticaries Biocomposite, to the kits that can conform with its ingredients and to the formulations containing what is necessary to carry out said application protocol, either separately or aggregates.
  • the Anticaries Biocomposite has evolved, from its formulation, to its application procedure to efficiently prevent the formation of tooth decay on tooth enamel, getting a practical way to protect each and every tooth and molar, by controlling of the pH of the patient's saliva and the application of a Biocomposite based on:
  • An agent that opens the tooth's canaliculi to allow the penetration of Anticaries Biocomposite is preferably orthophosphoric acid.
  • a compound substitute for tooth enamel very similar to this, which after application results in an increase in the crystals of the same, which have penetrated 50% thanks to the previous agent and maintaining an additional 50% resulting in an increase of the thickness of the enamel.
  • Said tooth enamel substitute compound is preferably Hydroxyapatite.
  • the duration of the film varies according to the pH conditions of the patient's saliva, a factor that, as mentioned above, is controlled under the application protocol. If chronically below this pH value, the patient would require reinforcement applications, which follow exactly the same procedure. With the follow-up of the cases where it has been applied, the film continues to show its effectiveness after 3 years of being applied.
  • the anticaries Biocomposite consists of:
  • the components necessary to be applied under a specific protocol can be combined in a single formulation and / or product to simplify the application process.
  • the composition or formulation comprising said Anticaries Biocomposite consists of the above components, mixed in their proper measure, taking care of their stability and maintaining an adequate pH to avoid automatic photoreaction.
  • the components of the formulation described above can be applied following a specific application protocol through a kit comprising said Anticaries Biocomposite consisting of:
  • the unique formulation comprises two options: OPTION 1: Active Solid and Aggregates.
  • OPTION 2 Active Solid, preparer and Union Aggregates.
  • the optional components can be included separately together with the unique formulation of Biocarp Anticaries.
  • the specific application protocol for the kit (and the single formulation) containing said Anticaries Biocomposite consists of:
  • Control according to the pH measurement In cases of pH below 6.0, formulate bicarbonate rinses, a digestive cleaning or any other method that helps raise the pH of the saliva and keep it acid free.

Abstract

The invention relates to a substance similar to, and compatible with, dental enamel, such that, when applied according to a specific protocol in a single clinical application, it adheres to the enamel, increasing the thickness thereof. In this way, the patient's teeth remain mineralised and cavity resistance is improved since the anti-cavity biocompound increases the thickness of the tooth and strengthens same, as well as increasing the concentration of crystals and providing protection on every surface of every tooth. With the invention, the average cavity development time is extended to five (5) years.

Description

PATENTE DE INVENCIÓN  PATENT OF INVENTION
BIOCOMPUESTO ANTICARIES Y PROTOCOLO DE APLICACIÓN. RESUMEN: BIOCOMPUESTO ANTICARIES AND APPLICATION PROTOCOL. SUMMARY:
La presente invención involucra una sustancia similar al esmalte dental y compatible con éste, de forma que, aplicado bajo un protocolo específico en una sola aplicación clínica, se adhiere al esmalte, engrosándolo. Así, las piezas dentales del paciente se mantienen mineralizadas y aumentan su resistencia a la caries, pues el Biocompuesto Anticaries engrosa y fortalece la superficie del diente, así como aumenta la concentración de cristales y da protección en todas las superficies de todos los dientes. Puede retardar el tiempo medio de gestación de una caries a cinco (5) años. SECTOR TECNOLÓGICO: The present invention involves a substance similar to and compatible with tooth enamel, so that, applied under a specific protocol in a single clinical application, it adheres to the enamel, thickening it. Thus, the patient's teeth remain mineralized and increase their resistance to decay, as the Anticaries Biocomposite thickens and strengthens the surface of the tooth, as well as increases the concentration of crystals and gives protection on all surfaces of all teeth. It can delay the average gestation time from a decay to five (5) years. TECHNOLOGICAL SECTOR:
Esta invención está relacionada con compuestos y composiciones para uso en el área de la salud oral, para ser aplicado por cualquier profesional de dicha área con la finalidad de mantener las condiciones fisiológicas que favorecen la salud de las piezas dentales y la calidad del esmalte, con el fin de evitar condiciones cario-génicas. This invention is related to compounds and compositions for use in the area of oral health, to be applied by any professional in said area in order to maintain the physiological conditions that favor the health of dental pieces and the quality of enamel, with in order to avoid cariogenic conditions.
ANTECEDENTES: BACKGROUND:
La caries es una condición causada por la producción de ácidos de la población bacteriana que naturalmente habita en la boca humana, en particular derivada de azúcares refinados como la sacarosa. Las principales bacterias asociadas a este proceso son el Streptococcus Mutans y el S. Lactobacillus. Cuando se ingieren alimentos, en especial carbohidratos fermentables, estas bacterias toman este sustrato y lo metabolizan en ácidos que desmineralizan el esmalte. El esmalte inicia un proceso de desintegración o se desmineraliza cuando el pH de su superficie cae debajo de su valor crítico; es decir, el esmalte empieza a debilitarse cuando el ambiente en el que se encuentra es más ácido (de pH más bajo, y más rápido entre más ácido) que un valor crítico comúnmente aceptado en 5.5 promedio. Cuando hay buena alimentación, buenos procesos de higiene dental y buena salud, el pH de la saliva es mayor que ese valor, de forma que el esmalte se mantiene mineralizado y no se presentan caries. Sin embargo, aún si el pH de la saliva mayor a 6.0 i puede pasar que en puntos específicos de la dentadura (entre los dientes, y atrás en los molares) las bacterias sobrevivan y colonicen, caso en el que en esos puntos la metabolización de azúcares generará ácidos que, localmente, desmineralizan el diente lentamente, causando caries en un tiempo promedio comúnmente aceptado de seis (6) meses. Aún cuando la higiene oral sea aceptable, en lugares de difícil acceso puede presentarse caries y por tanto morbilidad. Por eso la necesidad de crear soluciones eficaces y permanentes que la puedan prevenir. Caries is a condition caused by the production of acids from the bacterial population that naturally inhabits the human mouth, particularly derived from refined sugars such as sucrose. The main bacteria associated with this process are Streptococcus Mutans and S. Lactobacillus. When food is ingested, especially fermentable carbohydrates, these bacteria take this substrate and metabolize it into acids that demineralize the enamel. The enamel initiates a process of disintegration or demineralizes when the pH of its surface falls below its critical value; that is, the enamel begins to weaken when the environment in which it is found is more acidic (lower pH, and faster between more acidic) than a commonly accepted critical value at 5.5 average. When there is good nutrition, good dental hygiene processes and good health, the pH of the saliva is higher than that value, so that the enamel remains mineralized and there are no cavities. However, even if the pH of the saliva is greater than 6.0 i It can happen that at specific points of the denture (between the teeth, and back on the molars) the bacteria survive and colonize, in which case in those points the metabolism of sugars will generate acids that, locally, slowly demineralize the tooth, causing decay in a commonly accepted average time of six (6) months. Even when oral hygiene is acceptable, in places of difficult access, caries and therefore morbidity can occur. That is why the need to create effective and permanent solutions that can prevent it.
Para prevenir la caries, el elemento de elección por excelencia es el Flúor. Hasta ahora se han desarrollado programas de fluorización de sal y en la mayoría de los sistemas de acueducto de muchas ciudades el agua es fluorizada. Ésta es una estrategia sencilla para mantener un suministro adecuado de flúor a la gente, principalmente en los niños, donde se dan los mayores casos de caries. También existe una gran variedad de cremas dentales con flúor. Esto ciertamente ha ayudado a reducir marginalmente los índices de caries por proveer al esmalte alguna protección, aunque son alternativas que no aseguran eficacia alguna ni brindan protección permanente, tal como las estadísticas lo demuestran. Más allá de lo anterior, estadística del Oral Health Report de Organización Mundial de la Salud no distingue entre países desarrollados y en desarrollo, lo cual podría implicar que los índices de caries son mucho mayores en países subdesarrollados. El método convencional preventivo de la caries es la fluorización intensiva practicada con cierta frecuencia en el consultorio del odontólogo, lo cual, como la literatura y la práctica médica indican hace tiempo, tiende a crear una pequeña capa de fluoroapatita a partir de la hidroxiapatita del esmalte usando la poca cantidad que se libera cuando el diente naturalmente se desmineraliza y cuando aún se encuentra presente algo de flúor en la superficie. La principal desventaja de este tratamiento es que la persistencia de la reacción que genera Fluoroapatita es corta, pues el flúor desaparece rápidamente de la superficie, logrando reaccionar con relativamente poca Hidroxiapatita del esmalte y por lo tanto, logrando una protección a través de una capa muy delgada, poco eficaz y poco permanente. En el mercado existen otras alternativas similares, como los barnices de flúor, que consiguen que la reacción se dé de una manera un tanto más eficiente, no obstante, dicha reacción sigue dándose solamente con la hidroxiapatita que el esmalte naturalmente posee y libera al desmineralizarse. To prevent tooth decay, the element of choice par excellence is fluoride. So far, salt fluoridation programs have been developed and in most of the aqueduct systems in many cities the water is fluoridated. This is a simple strategy to maintain an adequate supply of fluoride to people, mainly in children, where there are the greatest cases of tooth decay. There is also a wide variety of fluoride toothpastes. This has certainly helped to marginally reduce tooth decay rates by providing enamel with some protection, although they are alternatives that do not ensure any effectiveness or provide permanent protection, as statistics show. Beyond the above, statistics from the Oral Health Report of the World Health Organization do not distinguish between developed and developing countries, which could imply that caries rates are much higher in underdeveloped countries. The conventional preventive method of caries is the intensive fluoridation practiced with some frequency in the dentist's office, which, as the literature and medical practice indicate long ago, tends to create a small layer of fluoroapatite from the enamel hydroxyapatite using the small amount that is released when the tooth naturally demineralizes and when some fluoride is still present on the surface. The main disadvantage of this treatment is that the persistence of the reaction generated by Fluoroapatite is short, since the fluorine disappears quickly from the surface, being able to react with relatively little Hydroxyapatite from the enamel and therefore, achieving a protection through a very layer thin, inefficient and not very permanent. In the market there are other similar alternatives, such as fluoride varnishes, which make the reaction take place in a somewhat more efficient way, however, this reaction continues only with the hydroxyapatite that the enamel naturally possesses and releases when demineralized.
Otra alternativa corresponde a los sellantes aplicados sobre la zona oclusal los cuales actúan proporcionando una capa sintética protectora sobre tal superficie, la cual no se desmineraliza. Así ofrece protección a la parte oclusal. Su principal desventaja es caerse con frecuencia. La estructura del diente es más flexible y resistente. Es común para el paciente reponer estos sellantes cada dos años en promedio. Su efectividad, aparte del tiempo, se limita al área oclusal de los molares. Por todo lo anterior, era indispensable desarrollar una alternativa que permitiera de manera eficaz y permanente, la protección constante de las piezas dentales, así como mantener las condiciones fisiológicas que favorecen la salud y la calidad del esmalte, con el fin de evitar la caries. DESCRIPCIÓN DE LOS DIBUJOS: Another alternative corresponds to the sealants applied on the occlusal area which act by providing a synthetic protective layer on such surface, which is not demineralize. Thus it offers protection to the occlusal part. Its main disadvantage is to fall frequently. The structure of the tooth is more flexible and resistant. It is common for the patient to replenish these sealants every two years on average. Its effectiveness, apart from time, is limited to the occlusal area of the molars. For all the above, it was essential to develop an alternative that would allow the permanent protection of dental pieces in an efficient and permanent way, as well as maintaining the physiological conditions that favor the health and quality of enamel, in order to avoid tooth decay. DESCRIPTION OF THE DRAWINGS:
En la Figura 1 se puede apreciar el esquema de un diente convencional. En la Figura 2 se presenta en corte histológico el grupo control a 1 X. En la figura 3 se presenta el mismo grupo control aumentado 10X. En la Figura 4 se puede apreciar diente al que se le ha aplicado la capa protectora del Biocompuesto Anticaries in vitro, sobre corte histológico. Igual en la figura 5, aumentado 10X. Estas pruebas in-vitro se realizaron con el fin de evaluar la adherencia del Biocompuesto Anticaries. La adherencia se pudo comprobar al 100%, y la mejora en opacidad nos permite estimar un aumento en la concentración de cristales de Hidroxiapatita. En las figuras 6, 7, 8 Y 9 se exponen dos dientes a los cuales se les ha aplicado Biocompuesto Anticaries in vivo. Son muestras de un paciente que inició tratamiento de ortodoncia y consintió colaborar con la prueba. La ortodoncista diagnosticó extracción de premolares inferiores, sobre los cuales se hizo la fase 2 de esta prueba. Luego de recibir la protección del Biocompuesto Anticaries, los dientes permanecieron en boca 6 meses, se extrajeron y se realizaron cortes histológicos para analizar en laboratorio. La figura 6 y 9 muestran a uno de ellos que se pulió luego de la aplicación, y las figuras 7 y 8 muestran el otro que se dejó tal cual (Figura 6: Zona oclusal 40X, sin pulir. Figura 7: Zona oclusal 40X, pulido. Figura 8: Zona vestibular 10X, pulido. Figura 9: Zona vestibular 10X, sin pulir. Esto con el ánimo de evaluar no solo la penetración de Biocompuesto Anticaries en el esmalte (y por tanto la mejor en la protección natural anticaries), sino también si se da una pérdida significativa de la capa protectora al pulir la superficie con discos suaves. El resultado es satisfactorio: La pérdida es despreciable. DESCRIPCIÓN DETALLADA DE LA INVENCIÓN In Figure 1 you can see the scheme of a conventional tooth. In Figure 2 the control group at 1 X is presented in histological section. In Figure 3 the same 10X augmented control group is presented. In Figure 4 you can see a tooth to which the protective layer of the Anticaries Biocomposite has been applied in vitro, on histological section. Same in figure 5, increased 10X. These in-vitro tests were performed in order to evaluate the adherence of the Anticaries Biocomposite. The adhesion could be checked at 100%, and the improvement in opacity allows us to estimate an increase in the concentration of Hydroxyapatite crystals. In Figures 6, 7, 8, and 9, two teeth are exposed to which Biocarp Anticaries has been applied in vivo. They are samples of a patient who started orthodontic treatment and agreed to collaborate with the test. The orthodontist diagnosed lower premolar extraction, on which phase 2 of this test was done. After receiving protection from the Anticaries Biocomposite, the teeth remained in the mouth for 6 months, were extracted and histological cuts were made for laboratory analysis. Figures 6 and 9 show one of them that was polished after application, and Figures 7 and 8 show the other that was left as is (Figure 6: Occlusal area 40X, unpolished. Figure 7: Occlusal area 40X, polished Figure 8: Vestibular zone 10X, polished Figure 9: Vestibular zone 10X, unpolished, with the aim of evaluating not only the penetration of Anticaries Biocomposite in enamel (and therefore the best in natural protection against caries), but also if there is a significant loss of the protective layer when polishing the surface with soft discs The result is satisfactory: The loss is negligible. DETAILED DESCRIPTION OF THE INVENTION
Esta invención está relacionada con compuestos y composiciones obtenidos para la utilización en el área de la salud oral, para ser aplicado por cualquier profesional de dicha área con la finalidad de mantener las condiciones fisiológicas que favorecen la salud de los dientes y la calidad del esmalte, con el fin de evitar la caries. This invention is related to compounds and compositions obtained for use in the area of oral health, to be applied by any professional in said area in order to maintain the physiological conditions that favor the health of the teeth and the quality of the enamel, in order to avoid tooth decay.
Específicamente la invención se refiere a una sustancia similar al esmalte dental y compatible con éste, que aplicado bajo un protocolo especifico, se adhiere al esmalte, mantiene el diente mineralizado y aumenta su resistencia ante la caries al aumentar la concentración de cristales en el esmalte, engrosando y fortaleciendo dicho esmalte dental en forma permanente y en toda la superficie de todos los dientes, sin generar sensibilidad, sin cambios en la escala de tono de color o en la apariencia estética y con permanencia aun después de procedimientos abrasivos rutinarios sobre los dientes. De la misma manera, esta invención se refiere al protocolo de aplicación de dicho Biocompuesto Anticaries, a los kits que puedan conformar con sus ingredientes y a las formulaciones que contienen lo necesario para llevar a cabo dicho protocolo de aplicación, sea por separado o agregadas. Specifically, the invention relates to a substance similar to and compatible with tooth enamel, which, applied under a specific protocol, adheres to the enamel, maintains the mineralized tooth and increases its resistance to decay by increasing the concentration of crystals in the enamel, thickening and strengthening said tooth enamel permanently and on the entire surface of all teeth, without generating sensitivity, without changes in the color tone scale or aesthetic appearance and with permanence even after routine abrasive procedures on the teeth. In the same way, this invention relates to the application protocol of said Anticaries Biocomposite, to the kits that can conform with its ingredients and to the formulations containing what is necessary to carry out said application protocol, either separately or aggregates.
El Biocompuesto Anticaries ha evolucionado, desde su formulación, hasta su procedimiento de aplicación para prevenir en forma eficiente la formación de caries sobre el esmalte dental, consiguiendo una manera práctica de dar protección a todos y cada uno de los dientes y molares, mediante el control del pH de la saliva del paciente y la aplicación de un Biocompuesto a base de: The Anticaries Biocomposite has evolved, from its formulation, to its application procedure to efficiently prevent the formation of tooth decay on tooth enamel, getting a practical way to protect each and every tooth and molar, by controlling of the pH of the patient's saliva and the application of a Biocomposite based on:
1. Un agente que abre los canalículos del diente para permitir la penetración de Biocompuesto Anticaries. Dicho agente preferiblemente es Ácido Ortofosfórico. 1. An agent that opens the tooth's canaliculi to allow the penetration of Anticaries Biocomposite. Said agent is preferably orthophosphoric acid.
2. Un compuesto sustituto del esmalte dental, muy similar a éste, que luego de la aplicación resulta en un aumento de los cristales del mismo, los cuales han penetrado un 50% gracias al agente anterior y manteniendo un 50% adicional redundando en un aumento del grosor del esmalte. Dicho compuesto sustituto del esmalte dental es preferiblemente Hidroxiapatita.  2. A compound substitute for tooth enamel, very similar to this, which after application results in an increase in the crystals of the same, which have penetrated 50% thanks to the previous agent and maintaining an additional 50% resulting in an increase of the thickness of the enamel. Said tooth enamel substitute compound is preferably Hydroxyapatite.
3. Fijado con una sustancia que sirve como unión entre el esmalte natural y el compuesto anterior, formando una película que mantiene más bajo el pH crítico del diente, e incrementa sensiblemente su resistencia a la desmineralización y por tanto al ataque por caries. Dicha sustancia es preferiblemente un polímero a base de ésteres, fotoiniciado. 4. Refuerzo de Flúor en Gel y Barniz 3. Fixed with a substance that serves as a union between natural enamel and the previous compound, forming a film that keeps the critical pH of the tooth lower, and significantly increases its resistance to demineralization and therefore to caries attack. Said substance is preferably an ester based polymer, photoinitiated. 4. Fluorine Reinforcement in Gel and Varnish
La duración de la película varía según las condiciones de pH de la saliva del paciente, factor que como se ha mencionado anteriormente, se controla bajo el protocolo de aplicación. De ser crónicamente bajo éste valor de pH, el paciente requeriría de aplicaciones de refuerzo, las cuales siguen exactamente el mismo procedimiento. Con el seguimiento de los casos donde se ha aplicado, la película sigue mostrando su efectividad después de 3 años de haber sido aplicada. The duration of the film varies according to the pH conditions of the patient's saliva, a factor that, as mentioned above, is controlled under the application protocol. If chronically below this pH value, the patient would require reinforcement applications, which follow exactly the same procedure. With the follow-up of the cases where it has been applied, the film continues to show its effectiveness after 3 years of being applied.
De acuerdo con la invención el Biocompuesto anticaries consiste en:  According to the invention, the anticaries Biocomposite consists of:
Figure imgf000006_0001
De acuerdo con la invención, los componentes necesarios para aplicarse bajo un protocolo específico se pueden reunir en una sola formulación y/o producto para simplificar el proceso de aplicación. La composición o la formulación que comprende dicho Biocompuesto Anticaries consiste de los componentes anteriores, mezclados en su justa medida, cuidando su estabilidad y manteniendo un pH adecuado para evitar la fotorreacción automática.
Figure imgf000006_0001
According to the invention, the components necessary to be applied under a specific protocol can be combined in a single formulation and / or product to simplify the application process. The composition or formulation comprising said Anticaries Biocomposite consists of the above components, mixed in their proper measure, taking care of their stability and maintaining an adequate pH to avoid automatic photoreaction.
De acuerdo con la invención, los componentes de la formulación descrita anteriormente se pueden aplicar siguiendo un protocolo de aplicación específico a través de un kit que comprende dicho Biocompuesto Anticaries que consiste de: In accordance with the invention, the components of the formulation described above can be applied following a specific application protocol through a kit comprising said Anticaries Biocomposite consisting of:
1. Medidores de PH (Opcional). 1. PH meters (Optional).
2. Aislante de Encías (Opcional).  2. Gum Insulator (Optional).
3. Preparador.  3. Preparer.
4. Sólido Activo.  4. Active Solid.
5. Unión.  5. Union.
6. Agente reforzante (Flúor) (Opcional).  6. Strengthening agent (Fluorine) (Optional).
La formulación única comprende dos opciones: OPCIÓN 1 : Solido Activo y Unión Agregados. The unique formulation comprises two options: OPTION 1: Active Solid and Aggregates.
1. Medidores de PH (Opcional). 1. PH meters (Optional).
2. Aislante de Encías (Opcional).  2. Gum Insulator (Optional).
3. Preparador.  3. Preparer.
4. Incorporar Sólido Activo y Unión en un solo componente.  4. Incorporate Active Solid and Union into a single component.
5. Agente reforzante (Flúor) (Opcional).  5. Strengthening agent (Fluorine) (Optional).
OPCIÓN 2: Solido Activo, preparador y Unión Agregados. OPTION 2: Active Solid, preparer and Union Aggregates.
1. Medidores de PH (Opcional). 1. PH meters (Optional).
2. Aislante de Encías (Opcional).  2. Gum Insulator (Optional).
3. Incorporar Preparador, Solido Activo y Unión en un solo componente.  3. Incorporate Preparer, Active Solid and Union in a single component.
4. Flúor (Opcional).  4. Fluorine (Optional).
En cualquiera de los casos anteriores, los componentes opcionales se pueden incluir por separado junto con la formulación única de Biocompuesto Anticaries. De acuerdo con la invención, el protocolo específico de aplicación para el kit (y la formulación única) que contiene dicho Biocompuesto Anticaries consiste en: In any of the above cases, the optional components can be included separately together with the unique formulation of Biocarp Anticaries. In accordance with the invention, the specific application protocol for the kit (and the single formulation) containing said Anticaries Biocomposite consists of:
1. Tomar el pH con las tiras para medir la acidez de la saliva. A un menor pH de la saliva, mayor velocidad de desmineralización se tendrá. a. Si el valor está arriba de 6.0 (Idealmente 6.5) es una boca sana y no se prevén contratiempos. Se controla al paciente una vez al año. b. Si el valor está entre 5.5 y 6.0 hay bajo riesgo de caries. Se debe ser más exhaustivo con la aplicación y controlar al paciente cada seis meses. 1. Take the pH with the strips to measure the acidity of the saliva. At a lower saliva pH, the higher demineralization rate will be. to. If the value is above 6.0 (Ideally 6.5) it is a healthy mouth and no setbacks are anticipated. The patient is monitored once a year. b. If the value is between 5.5 and 6.0 there is a low risk of tooth decay. It should be more thorough with the application and monitor the patient every six months.
c. Si el valor es menor y está entre 4.5 y 5.5 es un paciente en alto riesgo de caries que, en condiciones normales (sin Biocompuesto Anticaries) debe o está a punto de presentar múltiples y frecuentes casos de caries. Debe aplicarse copiosamente y con refuerzo y controlar al paciente cada 3 meses. d. Si este valor está debajo de 4.5 es un paciente con muy alto riesgo de caries.  C. If the value is lower and it is between 4.5 and 5.5, it is a patient at high risk of caries that, under normal conditions (without Biocarp Anticaries) must or is about to present multiple and frequent cases of caries. It should be applied copiously and with reinforcement and monitor the patient every 3 months. d. If this value is below 4.5 it is a patient with a very high risk of caries.
Aunque es un caso atípico y Biocompuesto Anticaries retardará el proceso de degeneración del esmalte (como en todos los demás casos), el estrés sobre el compuesto es tal que no se pueden garantizar resultados en estas condiciones.  Although it is an atypical case and Anticaries Biocomposite will delay the enamel degeneration process (as in all other cases), the stress on the compound is such that results in these conditions cannot be guaranteed.
e. Realizar detrartaje (Remover Cálculos) y profilaxis (Limpieza convencional) profunda de los dientes a tratar.  and. Perform detracting (Remove Calculations) and prophylaxis (Conventional cleaning) deep teeth to be treated.
A. USANDO EL KIT: A. USING THE KIT:
Secar las piezas a tratar. Dry the pieces to be treated.
Aislar encías.  Isolate gums
Aplicar Preparador (1 .5 minutos).  Apply Preparer (1 .5 minutes).
Lavar exhaustivamente.  Wash thoroughly.
Secar y mantener aislado.  Dry and keep isolated.
Mezclar 5gr de Solido Activo y con el mínimo de Unión (0.1 mL) para lograr una mezcla uniforme.  Mix 5gr of Active Solid and with the minimum of Union (0.1 mL) to achieve a uniform mixture.
Aplicar con pincel, cubriendo todas las superficies del diente. Dejar caer una gota consistente sobre la zona oclusal.  Apply with brush, covering all tooth surfaces. Drop a consistent drop on the occlusal area.
Aplicar luz halógena azul por 2 minutos.  Apply blue halogen light for 2 minutes.
Reforzar con flúor por 5 minutos (opcional). B. USANDO LA FORMULACIÓN UNICA, OPCION 1 : a. Secar las piezas a tratar. Reinforce with fluoride for 5 minutes (optional). B. USING THE ONLY FORMULATION, OPTION 1: a. Dry the pieces to be treated.
b. Aislar encías.  b. Isolate gums
c. Aplicar Preparador (1 .5 minutos).  C. Apply Preparer (1 .5 minutes).
d. Lavar exhaustivamente.  d. Wash thoroughly.
e. Secar y mantener aislado.  and. Dry and keep isolated.
f. Aplicar formulación agregada de Biocompuesto Anticaries cubriendo todas las superficies del diente. Dejar caer una gota consistente sobre la zona oclusal. g. Aplicar luz halógena azul por 2 minutos.  F. Apply aggregate formulation of Biocomposite Anticaries covering all tooth surfaces. Drop a consistent drop on the occlusal area. g. Apply blue halogen light for 2 minutes.
h. Reforzar con flúor por 5 minutos (Opcional - Preferiblemente en Barniz). C. USANDO LA FORMULACIÓN UNICA, OPCION 2: a. Lavar exhaustivamente.  h. Reinforce with fluoride for 5 minutes (Optional - Preferably in Varnish). C. USING THE ONLY FORMULATION, OPTION 2: a. Wash thoroughly.
b. Aislar encías.  b. Isolate gums
c. Secar las piezas a tratar y mantener aislado.  C. Dry the pieces to be treated and keep isolated.
d. Aplicar formulación agregada de Biocompuesto Anticaries cubriendo todas las superficies del diente. Dejar caer una gota consistente sobre la zona oclusal. e. Aplicar luz halógena azul por 2 minutos.  d. Apply aggregate formulation of Biocomposite Anticaries covering all tooth surfaces. Drop a consistent drop on the occlusal area. and. Apply blue halogen light for 2 minutes.
Reforzar con flúor por 5 minutos (Opcional - Preferiblemente en Barniz).  Reinforce with fluoride for 5 minutes (Optional - Preferably in Varnish).
Indicaciones Finales. Final Indications
Control según la medida de pH: En casos de pH debajo de 6.0, formular enjuagues con bicarbonato, una limpieza digestiva o cualquier otro método que ayude a subir el pH de la saliva y mantenerla libre de ácidos. Usar crema dental con concentración de flúor > 5.000 partículas x millón. Control according to the pH measurement: In cases of pH below 6.0, formulate bicarbonate rinses, a digestive cleaning or any other method that helps raise the pH of the saliva and keep it acid free. Use toothpaste with fluoride concentration> 5,000 particles per million.

Claims

REIVINDICACIONES:  CLAIMS:
Un compuesto compatible con el esmalte dental que se adhiere a dicho esmalte dental a través de por lo menos un agente preparador para permitir la penetración de dicho compuesto en dicho esmalte dental y en donde dicho compuesto se compone de por lo menos un sólido activo, de por lo menos una mezcla de unión para formar al menos una película sobre dicho esmalte dental y opcionalmente de por lo menos un agente reforzante. A compound compatible with tooth enamel that adheres to said tooth enamel through at least one preparation agent to allow penetration of said compound into said tooth enamel and wherein said compound is composed of at least one active solid, of at least one bonding mixture to form at least one film on said tooth enamel and optionally of at least one reinforcing agent.
El agente preparador para permitir la penetración del compuesto, de acuerdo con la reivindicación 1 en dicho esmalte dental es preferiblemente ácido ortofosfórico. The preparation agent for allowing the penetration of the compound according to claim 1 in said tooth enamel is preferably orthophosphoric acid.
El compuesto compatible con el esmalte dental de acuerdo con la reivindicación 1 , es por lo menos un sólido activo, que es preferiblemente Hidroxiapatita micronizada. The tooth enamel compatible compound according to claim 1 is at least one active solid, which is preferably micronized hydroxyapatite.
El agente preparador de acuerdo con la reivindicación 2, en donde la mezcla preparadora está compuesta de por lo menos un agente delicuescente, de por lo menos un agente viscosante y de por lo menos un vehículo farmacéuticamente aceptable. The preparation agent according to claim 2, wherein the preparation mixture is composed of at least one deliquescent agent, at least one viscosifying agent and at least one pharmaceutically acceptable carrier.
El agente preparador de acuerdo con la reivindicación 4, en donde el agente delicuescente es por lo menos un polietilenglicol, preferiblemente polietilenglicol 6000; en donde el agente viscosante es por lo menos un compuesto de silicio, preferiblemente dióxido de silicio; y en donde el vehículo farmacéuticamente aceptable es por lo menos un solvente acuoso, preferiblemente agua. The preparation agent according to claim 4, wherein the deliquescent agent is at least one polyethylene glycol, preferably polyethylene glycol 6000; wherein the viscosifying agent is at least one silicon compound, preferably silicon dioxide; and wherein the pharmaceutically acceptable carrier is at least an aqueous solvent, preferably water.
La mezcla de unión, de acuerdo con la reivindicación 1 , en donde dicha mezcla de unión está compuesta de por lo menos un polímero, de por lo menos un agente acelerante, de por lo menos un agente fotoiniciador, de por lo menos un agente sensibilizador y de por lo menos un vehículo volátil para solubilizar el polímero. The bonding mixture according to claim 1, wherein said bonding mixture is composed of at least one polymer, of at least one accelerating agent, of at least one photoinitiating agent, of at least one sensitizing agent and of at least one volatile vehicle to solubilize the polymer.
La mezcla de unión de acuerdo con la reivindicación 6 en donde el polímero es por lo menos un carboxilato, preferiblemente 3,4-epoxiciclohexilmetil-3,4-epoxiciclohexeno- carboxilato; en donde el agente acelerante es por lo menos un derivado de glicol, preferiblemente trietilenglicoldiviniléter; en donde el agente fotoiniciadores por lo menos una sal de (di)arilyodonio, preferiblemente Hexafluorofosfato de diarilyodonio; en donde el agente sensibilizador es por lo menos un compuesto de titanoceno, preferiblemente Bis-ciclopentadienil-bis((2,6-difluoro-3-pirrol-il)fenil)titanio; y en donde el vehículo volátil es por lo menos un solvente orgánico, preferiblemente acetona. The bonding mixture according to claim 6 wherein the polymer is at least one carboxylate, preferably 3,4-epoxycyclohexylmethyl-3,4-epoxycyclohexenecarboxylate; wherein the accelerating agent is at least a glycol derivative, preferably triethylene glycol dimethyl ether; wherein the photoinitiating agent at least one salt of (di) arilyodonium, preferably diarilyodonium hexafluorophosphate; wherein the sensitizing agent is at least one titanocene compound, preferably Bis-cyclopentadienyl-bis ((2,6-difluoro-3-pyrrol-yl) phenyl) titanium; and wherein the volatile vehicle is at least an organic solvent, preferably acetone.
8. El agente reforzante, de acuerdo con la reivindicación 1 , es por lo menos uno y es preferiblemente flúor, preferiblemente en composición de barniz. 8. The reinforcing agent according to claim 1 is at least one and is preferably fluorine, preferably in varnish composition.
9. El compuesto compatible con el esmalte dental de acuerdo a las reivindicaciones 1 , a 8 en donde dicho compuesto puede estar presente dentro de una formulación única o dentro de un kit para su aplicación. 10. Una formulación única que comprende el compuesto de acuerdo con las reivindicaciones 1 a 8 en donde dicha formulación única está compuesta por al menos el sólido activo y al menos la mezcla de unión. 9. The compound compatible with tooth enamel according to claims 1 to 8 wherein said compound may be present within a single formulation or within a kit for application. 10. A single formulation comprising the compound according to claims 1 to 8 wherein said single formulation is composed of at least the active solid and at least the binding mixture.
11. Una formulación única que comprende el compuesto de acuerdo con las reivindicaciones 1 a 8 en donde dicha formulación única está compuesta por al menos el sólido activo, por al menos la mezcla preparadora y por al menos la mezcla de unión. 11. A single formulation comprising the compound according to claims 1 to 8 wherein said single formulation is composed of at least the active solid, at least the preparation mixture and at least the binding mixture.
12. Un kit que comprende un compuesto de acuerdo con las reivindicaciones 1 a 9 en donde dicho kit está compuesto por: a. Opcionalmente y al menos un medidor de pH. 12. A kit comprising a compound according to claims 1 to 9 wherein said kit is composed of: a. Optionally and at least one pH meter.
b. Opcionalmente y al menos un aislante de encías.  b. Optionally and at least one gum insulator.
c. El agente preparador.  C. The preparing agent
d. El sólido activo.  d. The active solid.
e. La mezcla de unión.  and. The binding mixture.
f. Opcionalmente y al menos un agente de refuerzo.  F. Optionally and at least one reinforcing agent.
13. Un protocolo de aplicación para la formulación única de acuerdo con la reivindicación 13. An application protocol for the single formulation according to claim
10 que comprende: a. Secar las piezas dentales a tratar.  10 comprising: a. Dry the teeth to be treated.
b. Aislar encías.  b. Isolate gums
c. Aplicar el agente preparador.  C. Apply the preparation agent.
d. Lavar exhaustivamente.  d. Wash thoroughly.
e. Secar y mantener aislado. f. Aplicar formulación única del compuesto cubriendo todas las superficies del diente y dejando caer una gota consistente sobre las zonas oclusales. g. Aplicar luz halógena azul. and. Dry and keep isolated. F. Apply unique formulation of the compound covering all tooth surfaces and dropping a consistent drop on the occlusal areas. g. Apply blue halogen light.
h. Aplicar agente reforzante.  h. Apply reinforcing agent.
14. Un protocolo de aplicación para la formulación única de acuerdo con la reivindicación 1 1 que comprende: a. Lavar exhaustivamente. 14. An application protocol for the single formulation according to claim 1, comprising: a. Wash thoroughly.
b. Aislar encías.  b. Isolate gums
c. Secar las piezas a tratar y mantener aislado.  C. Dry the pieces to be treated and keep isolated.
d. Aplicar formulación única del compuesto cubriendo todas las superficies del diente y dejando caer una gota consistente sobre las zonas oclusales. e. Aplicar luz halógena azul.  d. Apply unique formulation of the compound covering all tooth surfaces and dropping a consistent drop on the occlusal areas. and. Apply blue halogen light.
f. Aplicar agente reforzante.  F. Apply reinforcing agent.
15. Un protocolo de aplicación para el kit de acuerdo con la reivindicación 13 que comprende: a. Secar las piezas dentales a tratar. 15. An application protocol for the kit according to claim 13 comprising: a. Dry the teeth to be treated.
b. Aislar encías.  b. Isolate gums
c. Aplicar la mezcla preparadora.  C. Apply the preparation mixture.
d. Lavar exhaustivamente.  d. Wash thoroughly.
e. Secar y mantener aislado.  and. Dry and keep isolated.
f. Mezclar el Sólido Activo con una mínima cantidad de la mezcla de Unión hasta conseguir una mezcla uniforme.  F. Mix the Active Solid with a minimum amount of the joint mixture until a uniform mixture is achieved.
g. Aplicar dicha mezcla uniforme con pincel, cubriendo todas las superficies de la pieza dental y dejar caer una gota consistente sobre la zona oclusal. h. Aplicar luz halógena azul.  g. Apply said uniform mixture with brush, covering all the surfaces of the tooth and drop a consistent drop on the occlusal area. h. Apply blue halogen light.
i. Opcionalmente, reforzar con aplicación de flúor.  i. Optionally, reinforce with fluoride application.
PCT/IB2012/054475 2011-08-30 2012-08-30 Anti-cavity biocompound and application protocol WO2013030788A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5139768A (en) * 1989-01-31 1992-08-18 Yissum Research Development Company Of The Hebrew University Of Jerusalem Dental composition for hypersensitive teeth
WO1995030402A1 (en) * 1994-05-05 1995-11-16 Oraleg Ab Photopolymerizable composition
US6689343B1 (en) * 2002-11-05 2004-02-10 Ultradent Products, Inc. Hemostatic and acid etch compositions containing sucralose
WO2011057180A2 (en) * 2009-11-06 2011-05-12 The Regents Of The University Of Michigan Compositions of apatite and methods of use

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5139768A (en) * 1989-01-31 1992-08-18 Yissum Research Development Company Of The Hebrew University Of Jerusalem Dental composition for hypersensitive teeth
WO1995030402A1 (en) * 1994-05-05 1995-11-16 Oraleg Ab Photopolymerizable composition
US6689343B1 (en) * 2002-11-05 2004-02-10 Ultradent Products, Inc. Hemostatic and acid etch compositions containing sucralose
WO2011057180A2 (en) * 2009-11-06 2011-05-12 The Regents Of The University Of Michigan Compositions of apatite and methods of use

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