Methods of preparing polymerizable dental compositions with...

Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Processes of preparing a desired or intentional composition...

Reexamination Certificate

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C523S116000, C523S118000, C523S120000, C106S035000, C433S226000, C433S228100

Reexamination Certificate

active

06620859

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to the field of polymerizable materials, specifically including polymerizable materials used in the practice of dentistry, such as sealants. According to the invention, a barrier material is used to mask flavor of the polymerizable material, and/or to impart flavor and aroma, and to prevent oxygen from being exposed to the polymerizable material during polymerization, thereby preventing oxygen from inhibiting polymerization of the material.
BACKGROUND
Polymerizable materials and related procedures are central ideas in dentistry. Polymerizable adhesives are used in orthodontic treatments to adhere brackets to tooth enamel. Polymerizable resin-based materials such as pit and fissure sealants are bonded to tooth enamel (e.g., a vital tooth, while the tooth is in the patient's mouth) to provide a coating that protects the enamel from decay. Adhesives may be used to secure a tooth filling material at its margins, to enamel and dentin, and reduce or eliminate the penetration of microbial agents across these margins. Adhesive materials may also be used to restore teeth in a number of ways. When a minor restoration or repair is required, e.g., as when a tooth is missing an incisal edge, a polymerizable material can be bonded to the surface of the tooth to replace the lost tooth matter. Adhesive materials are also used where a greater amount of oral rehabilitation is required, as in the cementing of inlays, crowns and bridges, and in aesthetic dentistry, where veneers can be cemented on an enamel facing of a tooth to mask a defect or discoloration.
Pit and fissure sealants are adhesive dental materials used to prevent tooth decay. Pits and fissures are sites on teeth that my be difficult to clean, with the risk of plaque stagnation and consequent possible onset of decay (caries). Pit and fissure caries may account for up to 90% of the total caries experience in some child populations (Combe, E C, Burke F J T & Douglas W H, 1999, Dental Biomaterials, p. 165 Boston: Kluwer Academic Publishers). Accordingly, the concept of sealing pits and fissures with resin applied to an etched enamel surface, known as fissure sealing, was developed in the 1960s, after the introduction of the acid-etch technique in 1955 (Buonocore M G, 1955, Journal of Dental Research, 34: 849-853). Such treatment is of benefit to patients at risk of occlusal caries, because the sealant will protect the susceptible pits and fissures from plaque accumulation and substrates that may be metabolized into destructive acids.
Of course, dental procedures benefit from patient comfort and patient cooperation during treatment. This can be difficult considering that many polymerizable materials that must be placed in the mouth, such as sealants, have a disagreeable taste or odor. There is always a need to improve comfort and cooperation of patients during treatment, for example by finding new ways of eliminating disagreeable tastes and odors of such materials. Also, it is necessarily a continuing goal to identify and use dental materials and procedures that are safe and biocompatible.
Adhesive materials such as sealants commonly include polymerizable dental materials that cure or harden by chemical polymerization reactions. Another problem with some such polymerizable materials is that their reactions can be inhibited by oxygen. Oxygen is known to react with free radicals of free-radically-polymerizable dental materials to give peroxide radicals of low reactivity, and which can unite to an oxygen-containing polymer (Combe E C, in Concise Encyclopedia of Medical and Dental Materials, Editor: Williams D, p. 10 Oxford: Pergamon Press). This inhibits polymerization.
A result of oxygen inhibition can be the formation of a layer at the surface of the polymerized dental material that is not fully polymerized (referred to as an “oxygen-inhibited layer” because oxygen has inhibited some of the desired polymerization reaction). The oxygen-inhibited layer, having not been completely reacted, contains unreacted or not-fully-reacted components.
In dentistry, an incompletely-polymerized surface of a dental material can have undesirable consequences. For example, the taste of unpolymerized materials can be objectionable, especially to children. Also, there can be health concerns, including the risk of patient exposure to unreacted chemicals of polymerizable dental materials. Some such chemicals can exhibit in-vitro cytotoxicity and allergenic potential. One chemical often used in dental sealants, bis-DMA (bisphenol A dimethacrylate), is said to react with salivary esterases to form bisphenol A, which is known to be an estrogen-mimicking agent (Rueggeberg, F A, Dlugokinski M & Ergle J W, 1999, Journal of the American Dental Association, 130: 1751-1757).
Dental practitioners have attempted to minimize exposure of patients to unreacted chemicals from dental sealants. See, e.g., Rueggeberg, F. A., D.D.S., et al., “Minimizing Patients' Exposure to Uncured Components in a Dental Sealant,” JADA, Vol. 130, 1751 (December 1999). Rueggeberg et al, for example, found that treatments of cured dental materials with mechanical action and a mild abrasive yielded a reduction in uncured resin components.
There exists a need for methods of reducing dental patients' exposure to unreacted components of dental materials. Also, there is room for improving patient comfort and cooperation in dental procedures involving polymerizable dental materials.
SUMMARY
The invention relates to materials and methods involving polymerizable dental materials. The materials and methods can reduce or eliminate issues relating to the typically disagreeable taste of polymerizable dental materials. This is accomplished by the use of a barrier material preferably having desirable flavor and/or aroma, each of which can improve patient comfort and cooperation, with the aroma also having potential psychological benefits. The materials and methods also improve polymerization of the dental materials by preventing oxygen from inhibiting polymerization at the material surface. Improved polymerization provides the further benefits of reducing the amount of unpolymerized materials remaining in the mouth, which further eliminates disagreeable taste and also improves the strength of the polymerized material surface and simplifies procedures relating to application of the material in the mouth.
According to the invention, a barrier material is used to cover a polymerizable dental material placed in the mouth. Preferably, the barrier material can comprise an oil such as an essential oil. Preferred polymerizable dental materials include sealants, e.g., pit and fissure sealants. The barrier material covers up the taste of the polymerizable dental material and optionally provides its own desirable flavor and aroma, all of which add to patient comfort and cooperation during the procedure. At the same time, the barrier material prevents oxygen from reaching the polymerizable dental material where the oxygen would inhibit polymerization. This reduces the inhibitory effect that the oxygen would have on polymerization of the dental material and ultimately reduces the amount of unpolymerized material that will remain at the surface of the dental material, which can in turn reduce a patient's exposure to uncured materials.
An advantage of the invention is that the barrier material can be designed to allow for easy removal of the barrier material by rinsing, particularly if the barrier material contains an oil. Overall, the method is an improvement over past methods used for removing uncured polymerizable components from the mouth, such as by application of air or water from a syringe spray, the use of wet or dry cotton rolls, manual use of pumice with a cotton pellet, or the use of pumice in conjunction with a prophy cup in a dental hand-piece. See generally, Rueggeberg et al.
The methods can be used to prevent oxygen inhibition of any polymerizable dental material, but can be specifically useful with oral adhesives and pit and fissure sealant.
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