Device and method for delivering an oral care agent

Abstract

An oral care agent delivery device is provided which comprises a permanently deformable backing layer, an oral care layer, and a non-woven binding material with a first part that is substantially invested in the oral care layer and a second part that is substantially invested in the backing layer. The device is sized to fit over a plurality of teeth in an upper or lower dental arch of a subject. The oral care layer comprises at least one oral care agent and at least one hydrophilic polymer. When hydrated, the oral care layer has an adhesiveness relative to the surface of a user's teeth that is sufficient to retain the device on the user's teeth when placed thereon. The device can also have an oral care agent which is activated on hydration of the oral care layer, or an oral care layer which releases the oral care agent over time.

Description

FIELD OF THE INVENTION [0001] This invention relates to the field of delivering an oral care agent, especially a tooth whitening agent, with a dental device. BACKGROUND OF THE INVENTION [0002] A variety of devices and methods have been developed to deliver a therapeutic or cosmetic agent to surfaces in the oral cavity. In particular, many systems which deliver a whitening agent to the teeth are available. [0003] A person desiring whiter teeth can choose from professional whitening systems, or can purchase an over-the-counter tooth whitening device for use in the home. In the professional teeth bleaching market, dentists have traditionally used devices for delivery of home bleaching agents which are rigid and custom-fitted to an individual patient's dental arches. One type of delivery device is molded to closely fit a patient's dental arches. Another type of device is an “oversized” rigid custom dental appliance, which is formed by augmenting the facial surfaces of the teeth on stone...

AI Technical Summary

Problems solved by technology

However, the rigid, custom-fabricated dental appliances used in professional tooth whitening systems require time-consuming and expensive office visits, laboratory tests and the fitting of each patient's dentition.

Furthermore, any changes in the surface of the patient's teeth (such as fillings, crowns, and other accidental or therapeutic alterations of the dentition) affect the fit of the rigid custom dental appliance, and may warrant repeating the entire fabrication procedure.

Moreover, patients who are inexperienced and unaware of the importance of precision often dispense an improper amount of bleaching agent into the appliance.

Dispensing an excessive amount of bleaching agent into the appliance can cause the agent to be displaced from the appliance into the oral cavity when the device is placed on the teeth, where the agent can be ingested.

In addition to such displacement, the bleaching agent can spill or leak from these appliances into the oral cavity, causing, for example, an unpleasant taste sensation, gingival irritation, burning, edema, nausea or allergic reactions.

The risk of the more serious side effects increases with the number of treatments, and becomes most significant after the multiple treatments typically required to attain acceptable clinical results.

Patients who self-administer bleaching or other medicinal agents may also fail to provide the careful maintenance, cleaning, and storage necessary to ensure that the rigid custom dental appliance performs adequately throughout its entire service life.

There are additional drawbacks with custom bilaminated dental appliances, including occlusion and retention of bleaching agent.

Furthermore, cleaning and maintenance of foam-lined dental appliances may be problematic, due to the high surface area and pore volume of the foam materials typically used in such appliances.

Oversized rigid custom dental appliances also have additional drawbacks, including occlusions in the augmented region, increased appliance fabrication time and cost, irritation from the lip of the appliance contacting the gingival region, and decreased retention of the bleaching agent within the target area.

However, such generic appliances often have a greater void between the interior walls of the appliance and the teeth as compared to most professionally fitted appliances.

Furthermore, the poorer fit of the generic device means a greater loss of bleaching gel into the oral cavity, with the attendant problems described above for the professional tooth whitening appliances.

Thus, the leakage problems of professional tooth whitening systems are exacerbated by over-the-counter systems in which the user dispenses the whitening agent into the device.

The generic over-the-counter devices also tend to be bulky and uncomfortable in the mouth.

Over time, the inherent instability of hydrated peroxide bleaching agents reduces the efficacy of tooth whitening systems with pre-dispensed bleaching agents.

The shelf-life of such systems is therefore limited.

The bleaching agent migrates from the composition to the gums and tooth surfaces, rather than being directly in contact with them, which significantly increases the required wearing time.

The putty also tends to slip off the teeth, further reducing the efficacy of this type of system.

It has been observed that the Fontenot device frequently has the problems of bulk and compromised fit.

This device has drawbacks similar to those described above for professional tooth whitening systems using custom bilaminated dental devices.

Such drawbacks include occlusion and retention of bleaching agent in the foam, and extrusion of the bleaching agent into the oral cavity upon application of the pressure required to form the device to the user's teeth.

However, the strip does not adhere well to the tooth surface, and the device tends to slip off the teeth in use.

The bleaching gel is also poorly attached to the Sagel et al. flexible strip, and often adheres to the user's fingers during the manipulations required to fold the strip in place over the dental arch.

The potential for contamination of the strip by the user's fingers during routine manipulation is high.

Moreover, the bleaching gel can be transferred from the user's fingers to the clothes (which may then be stained or bleached), or to sensitive areas of the body like the eyes, which may cause extreme discomfort.

Such delamination of the bleaching gel reduces the efficacy of the whitening system.

This leftover bleaching agent leaves an unpleasant taste in the mouth, and is easily ingested.

Moreover, most of the bleaching gel content of the Sagel et al. strip is delivered and begins to degrade as soon as the strip is placed in the mouth, resulting in reduced efficacy of the whitening system.

Here again, the bleaching gel is poorly adhered to the wax strips, and the Dirksing et al. system likely suffers from the same problems of difficulty of use and reduced efficacy as described above for the Sagel et al. strips.

The device is less bulky than the pre-formed over the counter devices, but still has a substantial bulk due to the thickness of the foam anchor layer.

The bulk causes potential comfort and conformability problems.

The bulk also adds to the expense of the die cutting operations used in making the devices.

In addition, the foam anchor layer readily absorbs water, thereby diluting the oral care active, which in turn may reduce the efficacy of the device.

The layered structure of the device increases the possibility of delamination during use or removal.

However, the drawbacks described above for the tooth whitening systems are also present when the systems are used to deliver other oral care agents.

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