Periodontal (gum) disease affects a majority of adults at some time in their lives, usually having no warning signs until advance stages of the disease state exist. Treatment methods depend upon the type of disease and how far the condition has progressed. When periodontal pockets become greater than 3 mm between teeth and gums, it is difficult or impossible for the patient to thoroughly remove plaque and tartar. While professional dental cleanings can clean periodontal pockets that exist in the range less than 5 mm, surgery may be necessary to reduce the depth of the pockets or to restore or reshape bone that has been destroyed and create an architecture that is conducive to cleaning. In an attempt to avoid such invasive dental or dental surgical procedures, treating the affected areas with antibacterial or antimicrobial agents (i.e., chemical, antibiotic, or other pharmacological agents) to restore periodontal health have been developed and are being performed. Such antibacterial or antimicrobial agents have been found to control or stop the growth of bacteria that create toxins and cause periodontal disease and encourage normal healing, thereby reducing the necessity or the invasiveness of periodontal or oral surgery. Problems arise that the frequency of administration of these drugs is not practical, seeing they need to be done in the dental chair by a trained dentist or dental hygienist. Other means of cleaning these periodontal pockets include manual brushing of the periodontal pocket using small brushes or interdental brushes. Problems with current interdental brushes is that the patient has a very difficult time finding the periodontal defects, and even when found, access is not easy, due to their location, position, or depth. When multiple sites exist in various locations, the task becomes impossible to perform with accuracy and enough frequency.
Several methods have been developed for treating periodontal disease that enable medicament to be delivered to the infected site below the gingiva. For example, U.S. Pat. No. 5,085,585 discloses an applicator of dental medicament and method of use.
Additionally, as set forth in U.S. Pat. No. 5,330,357 describes medicaments that can be delivered in close proximity to the bone and supporting structure of the teeth by flossing using tufted floss, brushing using an interdental brush, injection using a syringe, or by hydrostatic or mastication pressure using a dental tray. Dental trays often are constructed from a soft plastic elastomeric material that is molded in place to a patient's teeth so as to firmly and closely fit in place on the patient's teeth, and a seal is made to hold the tray solidly against the dental tissues. Medicament is placed in recesses formed in the tray that are adapted to accommodate the patient's teeth, and then guided or forced along the teeth and into the gingiva by the sealing means to the infected site as the patient closes his jaw on the tray. A propulsion agent such as hydrogen peroxide also can be placed in the recesses to guide or force the medicament into the infected site as the hydrogen peroxide breaks down and increases the pressure within the recesses.
Other examples of dental trays are set forth in U.S. Pat. Nos. 4,902,227; 4,428,373; and 4,138,814. While these types of dental trays do allow for application of the medicament subgingivally, none of these references connect the periodontal pocket to a cannuli leading outside of the mouth.
U.S. Pat. No. 3,874,084 discloses a molded tooth cleansing and gingival therapeutic device that includes a plurality of bristles projecting inwardly from the inner walls of the upper and lower channels of a tray. The bristles are provided to clean food particles and bacteria from the surfaces of a user's teeth and the gingival crevices. The walls of the channels are of a sufficient thickness to form ridges or ledges extending away from the gingival lines. These ridges compress the gingiva to allow for cleansing of the gingival crevice between the teeth and gum and massaging of the free marginal gingival.
U.S. Pat. No. 6,966,773 discloses dental tray and method for treatment of periodontal disease that provides a seal around teeth associated with the infected area to guide or force medication onto the surface of the teeth and subgingivally into the infected area and a propulsive agent such as peroxide.
What all these systems do have failed to achieve is a true micro syringe that can be loaded like a similar syringe, and use force from a plunger to inject medicaments into multiple periodontal sites. One of the major failures of inventors of trays in the past is that their trays do not truly inject medicaments and rely on weak physical properties that do not allow medicaments to enter diseased pockets. Some systems of the prior art even rely on claims of propellants used to push medicaments into periodontal sites, relying exclusively on oxygen releasing compounds such as peroxide, which may not be desired to be mixed with other therapeutics such as antibiotics such as Arestin, or Atridox. Companies that sell drugs such as Arestin, or Atridox approved by the FDA for in-office administration have achieved little success due to the fact that these drugs were designed for in-office delivery with weeks between dosings. For example, systemic antibiotic dosing is 4 times per day for 10 days by the patients at home. This is impractical due to the patient's inability to go to the dentist for 40 visits over a 10 day period. Such a tray system and method of treatment easily and conveniently allows therapeutics to be administered by the patient, without special training or undue skill, and not need to be worn for extended periods of time at each application.
Given the above, there is a need in the art for an improved periodontal interdental tray and/or a syringe that permits the more effective treatment of periodontal conditions.
USPTO Backgrounds
USPTO Backgrounds