This invention relates to medication delivery systems, and more particularly to a device and a method for the efficient therapeutic application of sodium chloride or another therapeutic agent to dental tissues.
Periodontal disease affects millions of Americans and is a major public health concern worldwide. It is estimated that 15% to 20% of the adult population in the United States is afflicted with periodontal disease. The hallmarks of this condition are inflammation, infection, and bone regression. In advanced stages this may result in tooth loss.
Periodontal disease starts with gingivitis produced by bacterial plaque buildup along the gum line. Plaque, a mixture of food, saliva and bacteria, relentlessly grows if left unchecked and produces clefts or open pockets surrounding teeth. Toxins produced by bacteria weaken the ligaments binding teeth to gums.
Putative bacteria, or perio-pathogens, implicated in periodontal disease are mainly anaerobes and facultative anaerobes. Porphyromanas, Prevotela, Bacteriodes, Actinobacillus, fusiforms and spirochetes, Streptococcus, and Veillonella are regularly found in periodontal lesions.
Periodontal concretions are sources of microbial organisms that are rarely found elsewhere in the body. Capnocytophaga and Rothia, for example, once released in the circulation, are capable of producing bacteremias and infecting various organ systems as in infective endocarditis. It is therefore important to hold periodontal disease in check. Especially important is also the avoidance of bacteremias following dental procedures.
The therapy for periodontal disease consists of aggressive oral hygiene including scaling. Scaling is a procedure involving the scraping of plaque from the tooth. At times, scaling requires the penetration of dental instruments deeply below the gum line, resulting in irritation and bleeding. With the resultant disruption in tissue integrity and the presence of pathogens, bacterial invasion of the blood stream may ensue with possible ominous seeding into various organ systems.
Antibiotics are prescribed for dental infections including abscess formation. Serial antibiotics, however, may pose disadvantages to overall health, with the possible occurrence of gastro-intestinal dysfunction, fatigue, and the weakening of immune resilience. Gargles are prescribed to inhibit infection, to reduce the swelling of gums, and to relieve pain. Gargles reduce the need for serial antibiotic prescriptions.
Sodium chloride is a universal bacteristatic, bacteriocidal, anti-viral, and anti-fungal agent. It possesses anti-inflammatory properties and has a well-known safety profile when applied topically. All the above bacterial species are inhibited and inactivated by sodium chloride.
Sodium chloride gargles are often prescribed for purposes of enhancing oral hygiene. Importantly, they are indicated as adjunctive therapy in the management of periodontal disease, dental abscesses, and post dental surgery including endodontic procedures. Gargles, however, exert limited effectiveness because of the relatively low tolerance patients have for them.
While the strategy of applying therapeutic solutions to control periodontal and oral infections—as in gargles—has solid value, its effectiveness is only marginally exploited.
The reason for this is that gargle solutions have only a limited time of patient tolerability. Patients can keep solutions in their oral cavities for limited time frames, usually counted in terms of seconds, before they feel the need to expel them. Within that time, the solutions cannot adequately perfuse the dental pockets and penetrate deeply into the gum tissues to exert their therapeutic effects.
In the case of sodium chloride gargles, for example, gargling will rapidly stimulate and then irritate receptors within the throat that will induce expulsive reflexes.
Sodium chloride solutions, in addition, require sufficient time of exposure to perform their anti-inflammatory, bacteriostatic, bactericidal, and anti-fungal actions. Gargling alone cannot achieve this task since the required time for effective sodium chloride exposure to effectively diffuse through layers of dental tissues ranges from several minutes to at least half an hour or more.
To avoid the foregoing disadvantages of known NaCl delivery systems, the invention provides a sodium chloride applicator pad and a method for the primary, or the adjunctive treatment of periodontal disease, gingival infections, and other dental conditions.
The pad renders possible the prolonged application of sodium chloride to oral tissues.
The pad is impregnated with sodium chloride, in either its solid or liquid form. Several options for this impregnation are described. Other therapeutic agents may also be included. This pad may maintain its long-term integrity by enclosure in a hermetic package.
When the pad is applied to dental tissues, the sodium chloride diffuses within the tissues to exert its therapeutic functions.
Several concentrations of sodium chloride are available, offering a spectrum of therapeutic options. Other salts, including magnesium chloride, potassium chloride, zinc chloride, and calcium chloride, among others, may be added to the sodium chloride to reach optimal therapeutic effects.
The pad, which is configured in different sizes—including configurations that are capable of treating an entire dentition—is directly applied to the gum tissues under treatment. According to one embodiment of the invention the pad may have incorporated micro suction cups to hold it in position.
As best understood, the mechanism of the invention's therapeutic action is as follows.
One of the proven and time-tested remedies for dental irritation, inflammation, and infection is the application of sodium chloride solution of various degrees of saturation. Indeed, bacteria and fungi cannot maintain their intracellular osmotic balance in the presence of salt solutions. Cellular functions cease, cellular membranes disintegrate, and pathogen death occurs.
The mechanisms of sodium chloride's anti-viral action are less clear. Viruses, however, like most organisms, need a hospitable milieu in which to thrive.
Sustained exposure to sodium chloride solution allows for deep penetration of a hyper-osmotic extra-cellular milieu to progressively perfuse ever further into gum tissues, eventually reaching the deepest gum pockets, inactivating their bacterial concretions.
The dental pad may be positioned on any gum or tissue within the oral cavity, possibly by means of incorporated micro-suction cups, adhesives, or other suitable means. The pad may be placed on the medial or on the lateral side of dental structures, or on both, and may extend far up into the palate. Importantly, its effects may thus reach into the peri-root regions of the teeth. Indeed, the root end opening is consistently prone to irritative and infective processes often produced by problems associated with root canal therapy, including apicoectomy.
Once the pad is put in place, the sodium chloride diffuses from its matrix into the tissues under treatment. The rate of diffusion is dependent upon the relationship between the matrix and its sodium chloride content.
According to various aspects of the invention, an applicator pad and a method are provided for applying salt solutions, allowing for the prolonged therapeutic exposure of the solutions to dental (gingival and teeth), and other tissues.
Preferred aspects of the pad may comprise the following:
Preferred aspects of the method may comprise the following:
Other features and advantages of the present invention will become apparent from the following description of embodiments of invention which refers to the accompanying drawings.
The dental pad is composed of a pliable matrix composed of materials capable of absorbing sodium chloride in its solid, gel, or liquid form.
The sodium chloride may exist in the form of a chemical bond with the chemical composition of the matrix. Such chemicals may include, but are not limited to, rubber-based compounds, plastic compounds, ceramic compounds, or fabrics.
Alternatively, the matrix holding the sodium chloride may do so through absorptive processes. The sodium chloride saturating the matrix may exist in its solid form, or in the form of solutions, or of gels. Absorptive materials may include fabrics, rubber-based compounds, ceramic compounds, or plastic compounds.
Therapeutic salt solutions may include, but are not limited to, sodium chloride. Other salts may be used alone, or in conjunction with sodium chloride including, but not limited to, potassium chloride, magnesium chloride, magnesium carbonate, zinc chloride, and calcium chloride.
The pad's sodium chloride concentrations are available in gradients of concentration. Specific gradients may be indicated for different clinical conditions. Sodium chloride concentrations may range from close to the physiological (0.9%), to peri-saturation levels in water (35%-to 40%). Incorporated within gels, the salt concentrations may be higher.
Suggested salt concentrations in pads start at 5% and are available in increments of 5%, up to 40%.
The sizes and configuration of the pads are adapted to dental needs.
The back of the pad is lined with a material impervious to fluids so that the sodium chloride application does not appose itself to tissues not intended for treatment.
The pad is disposable.
Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. Therefore, the present invention is not limited by the specific disclosure herein.
This application claims the benefit and priority of U.S. Provisional Application No. 60/678,892 filed May 9, 2005, and entitled SODIUM CHLORIDE PATCH FOR THE PRIMARY, OR THE ADJUNCTIVE TREATMENT OF PERIODONTAL DISEASE, GINGIVAL INFECTIONS, AND OTHER DENTAL CONDITIONS, the disclosure of which is incorporated herein by reference.
Number | Date | Country | |
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60678892 | May 2005 | US |