Patent Publication Number: US-2011052510-A1

Title: Tooth Movement Activating Compound

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This is a continuation, under 35 U.S.C. §120, of copending International Application No. PCT/ES2008/000312, filed May 6, 2008, which designated the United States and which is herewith incorporated by reference in its entirety. 
    
    
     OBJECT OF THE INVENTION 
     The present invention is aimed at defining a new food composition derived from oleic type fatty acids to reduce friction or frictional force between orthodontic wires and brackets, thereby preventing unwanted force components. Lower friction means low forces, and it has been proved that by reducing the friction a biologically compatible tooth movement and a significant reduction (up to 60%) of the duration of the orthodontic treatment are possible. 
     Low forces throughout the entire orthodontic treatment also mean greater comfort for the patient. 
     BACKGROUND OF THE INVENTION 
     Orthodontics is the specialty of dentistry that is concerned with the movement, position and development of the masticatory apparatus. It also relates to the science in charge of the study, prevention, diagnosis and treatment of dentomaxillofacial structure anomalies. 
     The technological progress in this specialty of dentistry is fundamentally aimed at solving the main needs put forth by society in this science field, such as achieving a comfortable and long-lasting dentition, suitable aesthetics, the reduction of discomfort in the patient, shorter duration of the orthodontic treatment and lower cost thereof. 
     Most of the aforementioned needs are being solved by reducing the bracket-wire friction and therefore minimizing the negative effect of force components. 
     One of the methods has been to use conventional surface chemistry techniques, such as the implantation of ions, plasma and carbon, although up until now it has not been possible to introduce it into clinical practice, fundamentally due to the low persistence thereof in the mouth, doubtful result and high cost. 
     Another route undertaken to reduce this bracket-wire friction is to study the physicochemical parameters affecting the structural morphology and composition of the elements involved in the orthodontic treatment, such as the study of the roughness of the surfaces in contact, the rigidity of the wire and its hardness, studying the different coefficients of friction between the various combinations of the acting elements. Thus, different alloys for manufacturing wires are being made, such as alloys of austenitic refractory stainless steel alloyed with chromium-nickel and low carbon content, austenitic ferritic stainless steel alloyed with chromium, molybdenum and low nickel content, cobalt-chromium alloys (the latter are mainly of cobalt with significant amounts of chromium to improve the corrosion resistance), cobalt-chromium-molybdenum alloys, titanium alloys, widely used due to their exceptional biocompatibility and corrosion resistance, furthermore, the surfaces of titanium oxide and the alloys thereof are well tolerated in contact with bone, β-titanium alloys, these alloys have concentrations of molybdenum greater than 10%, to stabilize the β phase at room temperature. 
     The design, conformation and composition of bracket materials are also being researched for the purpose, as has been stated, of reducing the coefficient of friction. 
     In relation to the design, increasingly smaller brackets are being manufactured, whereby the surface of contact between the latter and the orthodontic wire is reduced, and therefore friction is reduced, brackets with bevelled angles in the channel where the orthodontic wire is housed, also to reduce the roughness of the walls of the bracket, and therefore the friction, are also being manufactured with injection-mouldable materials. 
     Low-friction self-ligating brackets are currently being developed. 
     The research of bracket materials for reducing friction has taken placed in parallel with that of orthodontic wires. 
     Brackets are traditionally made of stainless steel, alloys of this material with titanium, but the latter are relatively soft and therefore susceptible to wear and rubbing on the surface of contact with the wire and consequently cause abrasion and release of toxic materials. Furthermore, they have the drawback that, since the orthodontic wires are made of stainless steel alloys containing chromium and nickel or titanium and nickel alloys, both chromium and nickel being toxic, they may be carcinogenic. In order to partly prevent this abrasion, layers of titanium, zirconium or hafnium compounds are incorporated. 
     Low-friction ligatures consisting of mixtures of medical use polyurethane are also being developed. 
     In addition, lubrication assays with elastic ligatures and a search for efficient lubricants, up until now with an aqueous or alcoholic base, are being conducted. 
     A clear example of the latter is patent US2004101489, which uses a polyvinyl alcohol polymer, or other patents which use water as the base element base and which are dental treatments rather than dental lubricants. 
     The patent project object of this specification attempts to introduce a new variable which has not been used up until now in the orthodontics field, such as the use of lubricants of oleic origin applied on dental apparatuses to reduce friction and achieve more continuous physiological forces, and which shortens certain orthodontic treatment phases. 
     A lubricant is understood as a substance which, when placed between two mobile parts, forms a film preventing the contact thereof, thereby preventing the friction or appearance of unwanted force components and therefore a more physiological tooth movement. 
     The synthesized composition has been proved as non-toxic and as a food composition and, as indicated in the title, it is referred to as tooth movement activating composition. 
     The technical problem solved by this patent is the reduction of friction between the walls of the bracket and the orthodontic wire by means of a food or edible composition which is easy to apply, has consistency and is long-lasting. 
     The persistence and stability of the tooth movement activating composition have been proved. In orthodontic treatment, the section of the orthodontic wire is normally varied, having a smaller section in the first phases and it is gradually increased as the treatment progresses. In this respect, the tooth movement activating composition can act in any phase since there are different degrees of density. 
     Tribological studies demonstrate that a reduction of friction by 54%, using wires made of stainless steel alloyed with titanium, and by 61% with wires made of stainless steel, shorten the levelling period by approximately eight months, whereby the total reduction of the orthodontic treatment can be 45%. 
     Practical preliminary studies confirm the clinical usefulness, verifying significant differences between the groups of patients who are treated with the tooth movement activating composition and those who are not. 
     Documents are known in the state of the art such as the one published in the International Journal of Pharmaceutics, 2004, volume 278, pages 391-406, in which an oral lubricant formulation containing olive oil (lubricant), xylitol (antiseptic agent), sodium fluoride (enamel protector), triclosan (anti-inflammatory, antibacterial and fungicidal agent) and carbopol-water (mixing agent) is disclosed. Olive oil is in the composition at 13%, xylitol at 10%, triclosan at 0.007%, carbopol at 0.7% and water at 67%. The composition is prepared by a previous solubilization of the water-soluble components in water and the subsequent formation of the emulsion with vegetable oil. 
     Patent WO 2007/136586 A2 is also known in the state of the art, which discloses aqueous compositions for dental care formed by different active and inactive ingredients. The active ingredients which the composition may have include triclosan, sodium fluoride and the inactive ingredients include glycerol (lubricant), polysorbate 80 (mixing agent), aloe vera, sorbitol and xylitol. 
     None of these documents discloses a composition suitable for being used in orthodontics formed by a food oil or fat, an antiseptic compound, an antibacterial compound, an enamel protector, an anti-inflammatory agent and a mixing agent which does not contain water, with which a good lubrication and a reduction in the friction of dental apparatuses are achieved. 
     In a preferred embodiment, the present invention is a tooth movement activating composition for use in orthodontics, comprising: 
     from 10% to 95% of a food type oil or fat, food type oil or fat which acts as a base of said composition; 
     from 5% to 70% of an antiseptic compound; 
     from 2% to 70% of a stabilizing or mixing agent; 
     from 0.05% to 2% of an antibacterial and fungicidal compound; 
     from 0.05% to 2% of an enamel protector; 
     from 0.05% to 2% of an allantoin type anti-inflammatory agent; said composition is free of any addition of water. 
     The composition has a food type oil or fat. The food type oil r fat may be fatty acid glycerides, castor oil, coconut oil, cottonseed oil, fish oil, grape seed oil, peanut oil, hydrogenated oils, linseed oil, corn oil, olive oil, olive pomace oil, palm oil, palm olein, palm stearin, palm kernel oil, rapeseed oil, safflower oil, sesame oil, sunflower oil, soybean oil, apricot kernel oil, babassu oil, mustard seed oil, turnip rape or ravison oil, lard, illipe butter, Shea butter, tallow, synthetic edible fats or oils, liquid petroleum jelly, glycerol, and combinations thereof. 
     The present invention can include an activating composition which may be fatty acid glycerides obtained from any of plant, animal, marine origin, or combinations thereof. In one embodiment, the fatty acid glycerides are from animal milk. 
     The antiseptic agents in compositions of the present invention include triclosan, chlorophenylbiguanidine and derivatives, such as chlorhexidine, chlorhexidine digluconate, benzalkonium chloride, povidone-iodine molecular complex, mercurial antiseptic, merbromin, cetylpyridinium chloride, mouthwashes with hexidine, choline hexasalicylate, cetalkonium chloride, calcium carbonate, sodium citrate, dimethicone, nicomethanol hydrofluoride, 2nd generation fluoroamines, and combinations thereof. 
     The antibacterial agent utilized in the present invention include potassium nitrate, xylitol, preparations with benzydamine HCl, chlorhexidine digluconate, hexetidine, Oralkin hexetidine, and combinations thereof. 
     The fungicidal composition utilized in the present invention includes sodium hypochlorite, acetic acid, alkaline peroxides, chlorhexidine gluconate, and combinations thereof. 
     The composition of the present invention may further include additional components including ethanol, propanol, benzoic chloride, antiviral agents, aloe vera, antiprotozoal agents, sporicides, anti-inflammatory agents, mucosal protectors, flavoring agents, antiplaque agents, such as zinc acetate, cetylpyridinium chloride, zinc lactate, fluorine derivatives such as sodium fluoride, sodium monofluorophosphate, antihalitosis agents, zinc chloride, cetylpyridinium chloride, zinc lactate, anticavity agents, and combinations thereof. 
     The composition of the present invention includes a stabilizing or mixing compound which can be polyglycosylated saturated hydrogenated palm oil glycerides, polyethylene glycol esters of apricot kernel oils or polyethylene glycol stearates, and combinations thereof. 
     The present invention also includes a process for manufacturing a tooth movement activating composition for use in orthodontics, comprising the steps: 
     mixing aloe vera and polyoxyethylene-20 sorbitan monooleate to form a first component, said first component is mixed to a homogenous foam by suitable stirring at 45° C. to effect homogenous foam formation; 
     providing a food type oil or fat as a second component; 
     forming a stable lipophilic cream with low to medium viscosity by slowly adding said second component to said homogeneous foam of said first component, 
     stirring for at approximately thirty minutes after said adding said second component to a said homogeneous foam of said first component; 
     incorporating at least one other component including stabilizing agents, mixing agents, antibacterial compounds, fungicidal compounds, enamel protectors, and combinations thereof to said composition formed after said thirty minutes of stirring has completed; 
     cooling said composition, during said cooling process, allantoin is dispersed into said composition. 
     In one embodiment, the present invention includes a process for manufacturing a tooth movement activating composition for use in orthodontics, comprising the steps: 
     forming a first component comprising a two-phase mixture of oil, aloe vera, triclosan, NaF, allantoin and corresponding additives; 
     selecting a second component being a stabilizing or mixing agent; 
     forming a stable cream with consistency by slowly adding component said second component to said two-phase system, under mechanical stirring and at room temperature. 
     In a preferred embodiment, the composition of the present invention consisting of an antiseptic preparation of aloe vera; a stabilizing or mixing agent of hydrogenated palm oil; an antibacterial preparation of triclosan; an enamel protector of sodium fluoride; and an anti-inflammatory agent of allantoin. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The work consisted of synthesizing a new product from food or edible fats or oils used as a base, a stabilising or mixing compound and additives for different purposes or functions for the application thereof as a lubricant in the orthodontic treatment with fixed apparatuses for maximum tooth control, for which it was necessary to take comparative tribological measurements on model systems and materials. 
     Food or edible fats and oils are understood as those which are included in the definition of the Codex Committee on Fats and Oils, i.e., those which are made up of fatty acid glycerides and are of a plant, animal, including milk, or marine origin such as castor oil, coconut oil, cottonseed oil, fish oil, grape seed oil, peanut oil, hydrogenated oils, linseed oil, corn oil, olive oil, olive pomace oil, palm oil, palm olein, palm stearin, palm kernel oil, rapeseed oil, safflower oil, sesame oil, sunflower oil, soybean oil, apricot kernel oil, babassu oil, mustard seed oil, turnip rape or ravison oil, lard, stearin, illipe butter, Shea butter, tallow, synthetic edible fats or oils, liquid petroleum jelly, glycerol, the mixture thereof and also the fats and oils which have been subjected to modification treatments, such as transesterification or hydrogenation or fractionation and those which must be subjected to a subsequent preparation in order to make them suitable for human consumption and food or edible synthetic fats and oils. 
     Polyglycosylated saturated hydrogenated palm oil glycerides, polyethylene glycol esters of apricot kernel oils or polyethylene glycol stearates are used as a stabilising or mixing element. 
     The additives in the formulation of the tooth movement activating composition allow different compounds having the properties of: antiseptic agents such as triclosan, chlorophenylbiguanidine and derivatives, such as chlorhexidine, chlorhexidine digluconate, benzalkonium chloride, povidone-iodine molecular complex, mercurial antiseptic, merbromin, cetylpyridinium chloride, mouthwashes with hexidine, choline hexasalicylate, cetalkonium chloride, calcium carbonate, sodium citrate, dimethicone, nicomethanol hydrofluoride, 2 nd  generation fluoroamines, ethanol, propanol, benzoic chloride. Bactericides, for germs and bacteriostatic agents, potassium nitrate, xylitol, preparations with benzydamine HCl, chlorhexidine digluconate, hexetidine, Oralkin hexetidine. Fungicides such as, in addition to some of those mentioned above which have this property, sodium hypochlorite, acetic acid, alkaline peroxides, chlorhexidine gluconate. Antiviral agents, aloe vera, antiprotozoal agents, sporicides, anti-inflammatory agents, mucosal protectors, flavouring agents, antiplaque agents, such as zinc acetate, cetylpyridinium chloride, zinc lactate, fluorine derivatives such as sodium fluoride, sodium monofluorophosphate. Antihalitosis agents, such as triclosan, zinc chloride, cetylpyridinium chloride, zinc lactate. Anticavity agents. Most of these substances usually have more than one of the mentioned properties. 
     Once the initial objective was fulfilled, the successive research steps which completed the development of the product were conducted, and the clinical efficacy thereof was verified. 
     The assays have been extended to studying the influence of the application of amorphous carbon coatings in combination with the lubricant of oleic origin. 
     “In vitro” studies demonstrating their biomechanical usefulness are still being conducted, for which a numerical finite-element biomechanical device or model is being used. 
     Randomized clinical trials on patients have also been conducted. 
     The tooth movement activating composition object of this specification is approved by all the official organisms as a non-toxic food composition. 
     The project was completed with a tribological study, with which the coefficients of friction between different combinations of materials in the presence or absence of lubricants and always under physiological conditions were measured. Studies which determined the influence of surface polishing treatments and the application of lubricant carbon coatings on brackets and wires were also conducted. 
     Friction, as has been indicated, is a highly determining factor in the efficacy of an orthodontic apparatus. Friction increases the force required to move a tooth, slows down tooth movement and contributes to the anchorage loss. 
     Several physical and biological factors are involved in friction in orthodontics, the properties of the bracket, (material, manufacturing process, design), properties of the wire, (material and cross-section), ligating method, factors of the patient (bracket-wire angulation, intra-oral dynamic forces) and biological films. 
     Studies have demonstrated that the greater the contact between the wire and the bracket, the greater the friction. 
     The effect of the angulation in friction is more pronounced with dental arches or wires made of stainless steel in comparison with those made of nickel-titanium. This can be explained by the lower rigidity of the Ni—Ti wires. 
     The increased friction due to a greater angulation of the bracket is frequently attributed to the fact that the wires bend. 
     There is a continuous interest in improving the aesthetics of orthodontic apparatuses, such as ceramic brackets and the reduction of friction is one of the most important goals for the new generation of ceramic brackets. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION 
     According to the plan, samples of this tooth movement activating composition were prepared with different viscosity levels, using refined virgin olive oil as a base. 
     Variable amounts of polyoxyethylene-20 sorbitan monooleate, among others, are used as a stabilising or mixing agent. 
     Other substances which complete the qualities of this tooth movement activating composition have also been added. 
     The process carried out consisted of preparing lipophilic creams, emulsions in oil, the creamy base thereof being a food or edible oil, which acts as an emulsifier. Another requirement is that they were stable over time and allowed the incorporation of all the predetermined reagents and furthermore complied with the sanitary-hygienic and food conditions in force. 
     The order of the mixture was a determining factor in the formation of the emulsion. 
     Component A: Mixture of aloe vera and polyoxyethylene-20 sorbitan monooleate. 
     Component B: Food oil. 
     Component A is introduced in a 400 ml beaker and stirred mechanically at room temperature until the formation of a homogeneous foam, component B is slowly added to this mixture. Once the addition has ended, the emulsion is taken to a thermostated bath at 45° C. and the reagents sodium fluoride (NaF) and triclosan are added, maintaining the stirring for 30 minutes. After that time, the system is taken out of the bath and, without stopping the stirring, allantoin and the corresponding additive are dispersed. The stirring is maintained until room temperature is reached. 
     Various formulations with different viscosity values according to the percentage of polysorbate-80 have been made. The percentages are by weight. 
     First preferred embodiment: 
     Food oil: 76.05% 
     Aloe vera: 19.01% 
     Stabilising or mixing agent: 3.80% 
     Additives:
         Triclosan: 0.27%   Sodium fluoride: 0.27%   98% Maltylisobutyrate: 0.34%.       

     A polyglycosylated saturated hydrogenated palm oil glyceride has been used as a stabilising or mixing agent in this and the following embodiments. 
     Second preferred embodiment: 
     Oil: 73.26% 
     Aloe vera: 18.32% 
     Stabilising or mixing agent: 7.30% 
     Additives:
         Triclosan: 0.26%   NaF: 0.26%   Allantoin: 0.26%   99% D,L-menthol: 0.33%       

     Third preferred embodiment: 
     Oil: 71.94% 
     Aloe vera: 17.99% 
     Stabilising or mixing agent: 8.99% 
     Additives:
         Triclosan: 0.25%   NaF: 0.25%   Allantoin: 0.25%   98% Maltylisobutyrate: 0.32%       

     Fourth preferred embodiment: 
     Oil: 77.52% 
     Aloe vera: 19.38% 
     Stabilising or mixing agent: 1.94% 
     Additives:
         Triclosan: 0.27%   NaF: 0.27%   Allantoin: 0.27%   99% D,L-menthol: 0.35%       

     Fifth preferred embodiment: 
     Oil: 74.63% 
     Aloe vera: 18.66% 
     Stabilising or mixing agent: 5.60% 
     Additives:
         Triclosan: 0.26%   NaF: 0.26%   Allantoin: 0.26%   99% D,L-menthol: 0.34%       

     Sixth preferred embodiment: 
     Oil: 71.94% 
     Aloe vera: 17.99% 
     Stabilising or mixing agent: 8.99% 
     Additives:
         Triclosan: 0.25%   NaF: 0.25%   Allantoin: 0.25%   98% Maltysobutyrate: 0.32%       

     In addition, samples with a higher consistency have been prepared by means of a different process, which consisted of slowly adding the stabilising or mixing agent to a two-phase system, subjected to mechanical stirring, which contained the remaining components, until the formation of a cream with consistency.