Topical anesthetic prophylaxis composition and the method...

Drug – bio-affecting and body treating compositions – Dentifrices

Reexamination Certificate

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C433S216000

Reexamination Certificate

active

06187294

ABSTRACT:

FIELD OF THE INVENTION
This invention relates generally to dental compositions and, more specifically, to a topical anesthetic prophylaxis composition and the method for use thereof in scaling and polishing teeth.
BACKGROUND OF THE INVENTION
The techniques of dental hygiene or prophylaxis are applied directly to the teeth, the gingiva, and the gingiva sulcus, anatomical structures well known to the professional oral health practitioner. Generally, the gingiva includes the free gingiva. The gingival sulcus is the crevice or groove between the free gingiva and the tooth.
Optimum oral health may be substantially attained and maintained by complete and regular supragingival and subgingival scaling by a professional oral health practitioner such as a dental hygienist or dentist. After treatment by scaling or other periodontal therapy, the teeth are routinely polished. Polishing removes stains and plaque. Accompanied by the patient's therapeutic bacterial-plaque removal on a daily basis, inflammatory gingival and periodontal diseases may thus be substantially prevented.
Scaling is the basic treatment procedure by which supragingival and subgingival calculus (tartar) is removed from the surfaces of the teeth. Dental calculus, which is mineralized bacterial plaque, is a hard, tenacious mass that forms on the clinical crowns of the natural teeth and other dental appliances. The rough surface of the calculus holds the disease-producing bacteria close to the gingival tissue and perpetuates inflamed states. Calculus has thus long been considered to have an important role in the development, promotion and recurrence of gingival and periodontal infections. Accordingly, its removal by scaling is advantageous for oral health.
Scaling must be thorough to be effective. When calculus is left on the teeth, gingival irritation and inflammation can persist which may lead eventually to extensive rehabilitative treatment or loss of teeth.
The scaling procedure is well known to professional oral health practitioners. It may be done manually by a metal scaling instrument (commonly referred to as “scalers”). Ultrasonic and sonic instrumentation may be adjuncts to manual scaling. The principal objective is to remove the calculus with a minimum of trauma to the gingival tissue. Calculus is removed by scaling each tooth. Each scaling stroke overlaps the previous stroke as the scaler is positioned progressively along the area of the deposit.
Following scaling, the practitioner routinely polishes the teeth to remove plaque and extrinsic stains caused by, for example, tea, coffee, tobacco, etc. Polishing is generally done with an abrasive polishing agent with a stroke away from the gingiva and from the back of the mouth forward.
For those patients who experience discomfort and/or pain when undergoing the above procedures, an anesthetic may be administered before and/or while the procedures are being performed. A local anesthetic requiring an injection may be used but it requires a waiting period before being effective and requires the use of a needle that may increase the discomfort and/or pain felt by the patient. One alternative, nitrous oxide, requires specialized equipment making the hygienic procedures more expensive and more intimidating. In addition, some patients are not comfortable with using nitrous oxide. Moreover, the mask required to be worn by patients sedated by nitrous oxide may impede the dental practitioner. Both of these anesthetic remedies are relatively invasive to the patient. Although topical or surface anesthetics have been used for short-duration desensitization of the gingiva, their use has not been site-specific requiring more generalized application. Unfortunately, the topical anesthesia sometimes has to be reapplied if the practitioner does not timely reach the anesthetized area. Topical or surface anesthetics are drugs applied to the mucous membrane to produce a loss of sensation.
The anesthetizing, scaling, and polishing procedures as performed above take an extended amount of time for the practitioner to complete, all the while causing distress and anxiety to the patient such that the practitioner may worry about the patient and not be as thorough as possible in deference to the patient.
Accordingly, there has been a need for a novel composition and method that are substantially effective at substantially removing extrinsic stains and plaque. There is a still further need for a composition and method that increase the thoroughness in the completion of treatment. There is another need for a composition and method that increase the ease and smoothness of the dental hygiene procedures. There is still another need for a composition and method that increase the efficiency of the procedures resulting in a decrease in time required to complete the treatment. There is also a need for a composition and method that increase the patient's confidence in the professional oral health practitioner. There is also need for a composition and method that direct anesthesia to the actual sites being worked on. There is a further need for a composition and method that substantially increase the dental patient's comfort. Additionally, a composition and method are needed that require no specialized equipment that may be intimidating to an already discomforted patient. There is a further need for a composition and method that are not invasive. The present invention fulfills these needs and provides other related advantages.
SUMMARY OF THE INVENTION
In accordance with this invention, it is an object of this invention to provide a composition and method that are substantially effective at substantially removing extrinsic stains and plaque.
It is another object of this invention to provide a composition and method that increase the thoroughness in the completion of the dental hygiene treatment.
It is another object of this invention to provide a composition and method that increase the ease and smoothness of the dental hygiene procedures.
It is another object of this invention to provide a composition and method that increase the efficiency of the dental hygiene procedures resulting in a decrease in time required to complete the treatment.
It is another object of this invention to provide a composition and method that increase the patient's confidence in the professional oral health practitioner.
It is another object of this invention to provide a composition and method that direct anesthesia to the actual sites being worked on.
It is another object of this invention to provide a composition and method that substantially increase the dental patient's comfort.
It is another object of this invention to provide a composition and method that require no specialized equipment that may be intimidating to an already discomforted patient.
It is another object of this invention to provide a composition and method that are not invasive to the patient.
The present invention resides in an improved topical anesthetic prophylaxis composition and method for use thereof in scaling and polishing teeth. The composition comprises, generally, at least one topical anesthetic, at least one humectant, at least one abrasive agent, and at least one sweetener. The composition may also include at least one coloring and/or flavoring agent. A method of using the dental composition for substantially comfortable, painless, and time-saving scaling by polishing is also provided.
In a preferred form of the invention, the dental composition comprises, in combination, at least one topical anesthetic, about 28-42 percent by weight Polyethylene glycol, about 55-65 percent by weight pumice, and up to about three percent by weight sweetener. At least one flavoring may be added in an amount about 1 to about 5 percent by weight. At least one coloring may be added in an amount of up to about 1% by weight.
The at least one topical anesthetic includes 5% Lidocaine in an amount about one to about six percent by weight. The at least one topical anesthetic may be 20% Benzocaine in an amount about six to about 10% by weight.
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