Methods for whitening teeth by applying a whitening composition and directing light radiation

Background to the invention

Many approaches are used to bleach teeth. One common approach employs abrasives (e.g., in toothpastes and toothpastes) for oral prophylaxis in combination with a polishing effect for polishing discolorations and stains on the tooth surface. Because the abrasives only act on the surface of the teeth, the internal color of the teeth remains substantially unchanged. Abrasives provide only limited effectiveness in teeth whitening.

Another approach is the use of whitening chemical active agents in the composition for internal and external tooth whitening.

Bleaching chemical active agents are applied to the teeth over a period of time to allow the active agents to act directly on the teeth and to improve the whiteness of the teeth. Bleaching agents are widely used on teeth using toothpastes, rinses, gums, dental floss, tablets, strips and tooth caps. The peroxide is a widely used whitening chemical active agent. Often, strips and overlays for teeth used to apply peroxide in the period of contact beyond that obtained in the case of typical tooth brushing. The concentration of the whitening active agent, the contact time and the number of applications are one of the basic parameters that dictate the speed and amount of teeth whitening obtained thanks to the peroxide based whitening compositions. Bleaching products using fabric strips in combination with a whitening active agent are described, for example, in US Pat. Nos. 5,891,453 and 5,879,691, the disclosures of which are incorporated herein by reference. The whitening composition described herein may contain an active agent containing a peroxide.

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Efforts to increase the effectiveness of bleaching products to provide greater satisfaction and satisfaction when using products by increasing the concentration of peroxide for faster whitening during use. The maintenance of peroxide on the tooth surface for a longer period of contact and / or to increase the number or frequency of applications have also been included for more effective whitening. However, increasing the concentration, maintenance and number of applications can be effective methods of achieving a higher level of teeth whitening using tooth whitening products, but any of these parameters may also have a negative impact on the consumer experience.

Increasing the concentration of peroxide in the tooth whitening composition, while maintaining the remaining parameters at a substantially constant level, may result in greater sensitivity of the teeth and irritation of the mucous tissues in the oral cavity. Sufficiently high concentrations of peroxide may require physical protection, such as rubber dams, to avoid contact and burn of soft tissues by the peroxide, thus making the use of peroxide in high concentrations uncomfortable and impractical under uncontrolled domestic conditions and with repeated use. In fact, even conventional teeth whitening compositions used by dental surgeries that have a balanced concentration of peroxide to the same level as 13% hydrogen peroxide, they often use cofferdam to protect soft tissues in the bleaching process. In general, prolonged use and / or frequency increases tooth hypersensitivity and irritation of the gums, and also causes consumers to experience discomfort when using this product.

Brief description of the invention

The present application describes a method of whitening teeth using light radiation for the photochemical activation of tooth discolorations to enhance bleaching by a bleaching or oxidizing agent according to claim 1.

According to the present application, in an exemplary method of whitening a tooth, the whitening composition is applied to at least one tooth. The whitening composition is maintained on at least one tooth for the first period. After the first period, the light radiation is directed towards at least one tooth for the second period. The first period lasts longer than approximately

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50% of the total duration of the first and second period. The whitening composition is removed from at least one tooth before, during and after the second period.

In accordance with another aspect of the present application, an exemplary tooth whitening set for whitening teeth includes a strip sized to include one or more teeth, and which comprises a tooth whitening composition layer. The kit further comprises a portable light source configured to emit light radiation with an intensity of not more than about 150 mW / cm².

Brief description of drawings

Further features and advantages of the invention will become more apparent from the following detailed description made with reference to the accompanying drawings, in which:

Figure 1 shows a tooth whitening kit enhanced by light;

Figure 2 is a cross-sectional top view of human dentition depicting the use of the tooth whitening kit enhanced by the light of Figure 1 in the treatment of the anterior tooth surface;

Figure 3 is a cross-sectional view of the lateral elevation of tooth 20 of figure 2, taken along line 3--3;

Figure 4 is a schematic illustration of the 1976 CIE LAB color space;

Figure 5 is a graph depicting the interdependencies between whitening efficacy, soft tissue tolerance, peroxide concentration, composition amount, and peroxide dosing, in a method involving the use of teeth whitening without the use of enhanced light;

Figure 6 is a graph showing interdependencies between the duration of the procedure which is light radiation and tooth whitening efficiency; and

Figure 7 is a graph showing the interrelations between the intensity of the treatment which is light radiation and the effectiveness of teeth whitening.

Detailed description of the invention

This detailed description only shows embodiments of the invention and is not intended to limit the scope of the claims to any

EP 2 582 349 a method. In essence, the essence of the invention is broader and unlimited by preferred embodiments, and the terms used in the claims are fully inclusive.

In addition, although the embodiments described in this specification and shown in the drawings relate to methods of teeth whitening comprising a tooth whitening composition containing an active agent that is a peroxide, it should be understood that many aspects of the invention described herein can be used in other methods of whitening teeth, including for example, methods including the use of other tooth whitening compositions.

The term "whitening efficacy" as used herein is intended to refer to the amount of tooth color changes. The color change can be measured according to the color scale of the so-called CIELab space Figure 4 shows a 1976 CIE LAB color space model. The luminance or brightness value (L *) measures the brightness and changes from 100 for absolute white to zero for black, assuming that the a * and b * values ​​are equal to zero. The a * value is the measure of redness when it is positive, gray when it is zero and green when it is negative. The b * value is a measure of yellowness when it is positive, gray when it is zero, and blue when it is negative. In general, the teeth appear whiter when: the L value increases, the teeth become brighter, the a * value increases or decreases depending on if there were discolorations on the teeth, they have a green or red shade before bleaching, and when the b * value decreases, the teeth become less yellow. Although this is a general relationship to perceived whitening, the b * value may also slightly increase if it increasesst wartości L* jest wystarczająco duży.

Podobnie, wartość L* może również się zmniejszyć, jeśli spadek wartości b* jest wystarczająco duży, aby zniwelować mniej znaczące zmiany w L*. Ponieważ faktyczny kolor przebarwień na zębach zależy od różnych lokalizacji geograficznych, to czy wartość a* zwiększa lub zmniejsza się dla wybielania może być uzależnione od lokalizacji geograficznej. Na przykład, przebarwione zęby na brązowy lub czerwony odcień są charakterystyczne dla mieszkańców Stanów Zjednoczonych, podczas gdy przebarwione zęby na zielony odcień są charakterystyczne dla mieszkańców Chin.

Sposób pomiaru zmiany koloru zęba in-vivo został opisany w opisie patentowym Stanów Zjednoczonych Ameryki o nr 6,949,240 i ASTM E2466-06,

EP 2 582 349 których pełne ujawnienia zostały włączone do niniejszego opisu przez odniesienie. W takim sposobie, wykorzystany jest aparat cyfrowy w celu porównania koloru wyjściowego i koloru po wybielaniu zębów do przedstawionej standardowej przestrzeni barw RGB w celu ustalenia standardów kalibracyjnych i konfiguracji punktów odniesień. Wartości RGB po kalibracji są przekształcane w wartości L*a*b* przy użyciu przekształceń równań, a uzyskane dane wykorzystywane są do obliczania przedstawienia produktu wybielającego pod względem zmiany L* (luminancji), a* (równowagi czerwono-zielonej), oraz b* (równowagi żółto-niebieskiej). Całościowa zmiana koloru jest obliczana na podstawie równania ΔΕ = (AL*² + Δα*² + Ab*²)^1/2.

Gdy ΔL* jest dodatnia, Ab* jest ujemna i a* dąży do zera, ΔΕ oznacza polepszenie bieli zębów. AE jest wartością skalarną i dlatego oznacza wielkość zmiany koloru, ale nie kierunku. Z tego powodu kierunek zmiany poszczególnych składowych koloru L*, a* i b* muszą być oceniane w celu określenia, czy wartość

AE oznacza polepszenie bieli zębów.

W procedurach wybielania zębów zastosowano promieniowanie świetlne w połączeniu z zastosowaniem środka utleniającego na zęby. Jednak poprzednie wykorzystanie promieniowania świetlnego w procedurach wybielania zębów przy jednoczesnym zwiększeniu skuteczności wybielania zębów, może powodować zwiększoną wrażliwość zębów i tkanek miękkich i powodować dyskomfort lub inne szkodliwe skutki. Jeden przykład, w opisie patentowym Stanów Zjednoczonych Ameryki o nr 4,661,070 opisuje sposób, w którym stężony roztwór nadtlenku wodoru nakłada się na zęby, które następnie poddaje się działaniu światła podczerwonego i ultrafioletowego. Promieniowanie podczerwone przeznaczone jest do produkcji ciepła w celu penetracji zewnętrznej powierzchni zęba i ciepła, które aktywuje działanie nadtlenku, podczas gdy światło ultrafioletowe ma na celu zapewnienie bezpośredniego bielenia przebarwień na zębach. Jednak nadmierny wzrost temperatury w tkance (miazdze) może powodować uszkodzenia zębów, zwiększać wrażliwości i dyskomfort. Ponadto, zagrożenia zdrowotne związane z narażeniem na działanie promieniowania ultrafioletowego również powodują dolegliwości.

Wybielanie zębów przy użyciu fotoaktywacji substancji pochłaniającej energię promieniowania lub środka fotouczulającego (na przykład, kwas 1hydroksyetylideno-1,1-difosfonowy) stosowane na zęby pacjenta zostały opisane na przykład w patentach Stanów Zjednoczonych Ameryki o numerach 5,785,527,

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6,162,055 i 6,416,319. W takich przykładach środek fotouczulający może być stosowany przed lub w połączeniu ze środkiem utleniającym (na przykład, nadtlenkiem wodoru), tak, że promieniowanie świetlne stosowane na leczone zęby jest pochłaniane przez środek fotouczulający, co z kolei aktywuje związek utleniający aby wybielić zęby. Jednakże niezamierzona ekspozycja tkanek miękkich użytkownika na środek fotouczulający może spowodować podrażnienie i zwiększoną wrażliwość na zastosowanie promieniowania świetlnego.

Badania kliniczne nad wzmocnionym promieniowaniem świetlnym stosowanym przy zabiegach w gabinetach dentystycznych oraz wysoko stężonym nadtlenkiem w formie żelu do wybielania zębów wykazały wymierne wzrosty skuteczności wybielania zębów w porównaniu do samych zabiegów wybielania zębów nadtlenkiem w formie żelu. Patrz Gerard Kugel i wsp., Clinical Trial Assessing Light Enhancement of In-office Tooth Whitening, Journal of Esthetic and Restorative Dentistry, 1 października 2009, str. 336-346. Jednakże tym wzrostom skuteczności wybielania zębów towarzyszył znaczący wzrost wrażliwości zębów. W badaniu klinicznym sześciu spośród jedenastu badanych otrzymujących nadtlenek w formie żelu i promieniowanie świetlne zgłosiło umiarkowany lub silny ból zębów, a trzech badanych przerwało terapię z powodu silnego bólu zębów. Dla porównania, tylko trzech z jedenastu badanych leczonych za pomocą nadtlenku w formie żelu i bez promieniowania świetlnego zgłosiło umiarkowany ból, natomiast żaden z badanych nie doświadczył silnego bólu. Nie wiadomo, czy środek fotouczulający został wykorzystany w nadtlenku w formie żelu, który został użyty w badaniu, nie jest również znane czy wykorzystanie środka fotouczulającego zawierającego nadtlenek w formie żelu w połączeniu z dłuższą terapią z wykorzystaniem światła może przyczyniać się do znacznego zwiększenia wrażliwości zębów.

W innych przykładach promieniowanie świetlne może być wybierane w celu bezpośredniego aktywowania przebarwień na zębach, bez użycia środka fotouczulającego w celu zwiększenia bielenia przez związek utleniający. Światło o długości fal wybrane tak, aby odpowiadało chromogenowi zęba (lub przebarwieniu) częstotliwości fal pochłanianej cząsteczki, które mogą być zastosowane na zęby w celu aktywacji cząsteczek przebarwień do utleniania przez związek utleniający. W takim przykładzie, promieniowanie świetlne może nie aktywować lub nie wpływać na związek utleniający. Związek utleniający może

EP 2 582 349 być dostarczany w postaci przezroczystego lub półprzezroczystego materiału, aby umożliwić promieniowaniu świetlnemu dostęp do leczonych zębów. Pochłanianie promieniowania świetlnego przez przebarwienia, „uaktywnia” je poprzez sprzyjanie aktywności elektronów lub ich reaktywności tak, że środek bielący zastosowany na przebarwienia skuteczniej je utlenia, usuwając w ten sposób większą ich część w porównaniu z utlenianiem środkiem bielącym przebarwienia, które (przebarwienia) nie zostały aktywowane przez promieniowanie świetlne.

Nawet bez środka fotouczulającego ekspozycja dziąseł i innych tkanek miękkich na promieniowanie świetlne może powodować aktywację tej tkanki. Może to prowadzić do zwiększenia wrażliwości i podrażnienia, gdy ta sama tkanka jest narażona na wyższe stężenie nadtlenku lub innego środka utleniającego.

Według wynalazczego aspektu niniejszego zgłoszenia, zastosowanie promieniowania świetlnego na zęby leczone za pomocą kompozycji wybielającą zęby zawierającą środek utleniający, może być ograniczone do opóźnionej lub końcowej części całkowitego czasu ekspozycji zębów na kompozycję wybielającą zęby. Podrażnienie i wrażliwość zębów oraz tkanki miękkiej narażonej na środek utleniający może być zmniejszone poprzez ograniczenie promieniowania świetlnego tylko do części całkowitego czasu trwania terapii. Dodatkowo, wzrost temperatury wewnątrz jamy ustnej użytkownika również może zostać zmniejszony. Ponadto, przez ograniczenie promieniowania świetlnego do końcowej części całkowitego czasu trwania terapii, stosowanie światła jest zapewnione w okresie, w którym pochłanianie środka utleniającego przez zęby jest zmaksymalizowane i zachodzi rozproszenie środka utleniającego na tkance miękkiej (na przykład przez rozpuszczanie w ślinie przez pacjenta). Jeszcze inna korzyść stosowania promieniowania świetlnego o krótszym czasie zmniejsza potrzebę utrzymania otwartej jamy ustnej lub cofniętej wargi przez pacjenta, tym samym zmniejszając ból i suchość w jamie ustnej.

Stosownie do niniejszego zgłoszenia, wcześniej określony czas trwania zabiegu jakim jest wybielanie zębów, podzielone jest na dwa okresy: opóźnienie lub pierwszy okres i promieniowanie świetlne lub drugi okres. Podczas okresu opóźnienia, chemiczna kompozycja wybielająca utrzymuje się na zębach pacjenta bez stosowania promieniowania świetlnego. Podczas kolejnego drugiego okresu (okresu promieniowania świetlnego), na zęby stosowane jest promieniowanie świetlne. Promieniowanie świetlne może być stosowane przy użyciu przezroczystej

EP 2 582 349 chemicznej kompozycji wybielającej (i jakiegokolwiek odpowiedniego przezroczystego nośnika dla kompozycji, takiego jak nakładki na zęby lub przylepne paski). W innym przykładzie wykonania kompozycja wybielająca zęby (i każdy odpowiedni nośnik), mogą być usunięte z zębów po okresie opóźnienia i przed okresem promieniowania light, as described in more detail below, or during the period of light radiation. The delay period is longer than the period of light radiation or more than 50% of the total length of the delay periods and light radiation, so that the teeth are exposed to light radiation for less than half the total duration of the treatment which is teeth whitening. The delay period may also be longer than about 60%, longer than about 70%, longer than about 80%, longer than about 90%, longer than about 95%, or more than about 96%, or more than about 97%, or greater than about 98%, or more than about 99%, or more than about 99.5%, or more than about 99.9%, or between about 80% and about 90% of the total duration of the retardation periods and light radiation.

The delay period, the period of light radiation, the total duration of the delay and the periods of light radiation can be chosen from a variety of appropriate numbers and ranges. For example, the delay period may be from about 2 minutes to about 480 minutes, or from about 5 minutes to about

55 minutes, or from about 15 minutes to about 25 minutes. In another embodiment, the delay period may be at least 1, 2, 5, 7, 10, 15, 20, 25, 30, 40, 50, or 60 minutes, but less than 480, 120, 90, 60, 50, 40, 30, 25, 20, 15, 10, 5 or 2 minutes.

The period of light radiation can last for example from about 3 seconds to about 30 minutes, or from about 30 seconds to about 10 minutes, or from about 2 minutes to about 5 minutes. In another embodiment, the period of light radiation may last at least 1, 2, 5, 7, 10, 15, 20, 25, 30, 40, 50, or 60 seconds, 2, 3, 4 minutes, but less than 5, 4, 3, 2, or 1 minute, 50, 40, 30, 25, 20, 15, 10 or 5 seconds.

In another embodiment, the total duration may be at least 30, 40, 50, 60, 90, 120, 180 or 240 minutes, but less than 500, 480, 420, 360, 300, 240, 80, 120, 90, 60, 50, 40 minutes. In some applications, the tooth whitening composition and carrier may be intended for use overnight, such that a relatively long delay period (e.g., from about 360 minutes to about 480 minutes) occurs when the user sleeps.

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Thus, in various embodiments, the total duration may be at least 30, 40, 50, 60, 90, 120, 180 or 240 minutes, but less than 500, 480, 420, 360, 300, 240, 80, 120 90, 60, 50, 40 minutes; combined with a period of light radiation lasting at least 1, 2, 5, 7, 10, 15, 20, 25, 30, 40, 50, or 60 seconds, 2, 3, 4 minutes, but less than 5, 4, 3, 2, or 1 minute, 50, 40, 30, 25, 20, 15, 10 or 5 seconds; in addition, combined with a lag period of at least 1, 2, 5, 7, 10, 15, 20, 25, 30, 40, 50, or 60 minutes, but less than 480, 120, 90, 60, 50, 40, 30 , 25, 20, 15, 10, 5 or 2 minutes.

In addition, the teeth whitening process may comprise a third period or a second delay period which follows a period of light radiation in which the tooth whitening composition remains on the teeth without the use of light therapy before the composition is removed. This second delay period may, for example, last from about 1 minute to about 30 minutes.

In one exemplary method of teeth whitening, about thirty minutes of teeth whitening treatment includes approximately a twenty-five minute delay period and about a five-minute period of light radiation. In another example of tooth whitening, about thirty minutes of teeth whitening treatment includes approximately a twenty-and-a-half-minute delay period and a 30-second period of light radiation.

Other example diagrams (treatments) for teeth whitening are listed in Table 1 below:

<td>Period delays (Minutes)</td><td>Period radiation light (Minutes)</td><td>Together (Minutes)</td><td>Period Delays%</td>

<td>25</td><td>5</td><td>thirty</td><td>83.33</td>

<td>thirty</td><td>0.05</td><td>30.05</td><td>99.83</td>

<td>thirty</td><td>0.5</td><td>30.5</td><td>98,36</td>

<td>thirty</td><td>1</td><td>31</td><td>96.77</td>

<td>thirty</td><td>3</td><td>33</td><td>90.91</td>

<td>thirty</td><td>5</td><td>35</td><td>85.71</td>

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<td>60</td><td>0.05</td><td>60,05</td><td>99.92</td>

<td>60</td><td>0.5</td><td>60.5</td><td>99.17</td>

<td>60</td><td>5</td><td>65</td><td>92,31</td>

<td>120</td><td>0.5</td><td>120.5</td><td>99.59</td>

<td>120</td><td>5</td><td>125</td><td>96,00</td>

<td>360</td><td>0.5</td><td>360.5</td><td>99.86</td>

<td>360</td><td>5</td><td>365</td><td>98.63</td>

<td>480</td><td>0.5</td><td>480.5</td><td>99.90</td>

<td>480</td><td>5</td><td>485</td><td>98,97</td>

Table 1: Sample periods of delay and light radiation for teeth whitening treatment

The duration of the delay and the periods of light radiation for tooth whitening treatments can be selected depending on many factors. For example, a delay period may be selected to allow the oxidation process or bleaching agent sufficient time to obtain discolorations on the teeth to a degree below the outer surface of the teeth prior to the light activation of these discolorations. In one such embodiment, a delay period sufficient to absorb an effective amount of peroxide through the teeth is selected to delay application of the light radiation until the period in which the efficacy is increased. Because the use of light radiation directly activates discoloration on the teeth by a reinforced oxidation absorbing agent, the remains of the tooth whitening composition on the tooth surface (and any carriers of the tooth whitening composition) can be removed from the teeth at the end of the lag period and before the application of light radiation. In one such tooth bleaching process, the carrier and / or the tooth whitening composition may be provided with an opaque, translucent or matt material, and the tooth whitener and / or composition may be removed prior to the light treatment. The possibility of using opaque, translucent or matt materials can increase the number of types of materials that can be used in the carrier and whitening composition. In addition, in some applications, the use of opaque,

Sensitivities which could result from the combination of light radiation and an excessive amount of the tooth whitening composition on the teeth and soft tissues.

In another example, the delay period may be selected to allow the bleaching agent to disperse or dissolve (e.g., via saliva) on the soft tissue surrounding the teeth being treated prior to any application of the light radiation. This can reduce the irritation of soft tissues that could result from the combination of light radiation and bleaching to soft tissues. In one such embodiment, a sufficient period for reducing peroxide concentration in soft tissue, below the concentration threshold, is selected to delay the use of light radiation until the period of reduced susceptibility to soft tissue irritation. For example, selected periods may be sufficient to reduce the concentration of peroxide (or other bleaching agent) to less than about 2% (by weight),

The duration of the light radiation period for tooth whitening treatments can be chosen to increase the whitening efficiency, while minimizing the sensitivity of teeth and soft tissue.

Clinical studies, as described in Example 1 below, showed a greater increase in luminance (AL *) and reduced yellowness (Ab *), compared to treatments performed without light enhancement, and the period of light radiation was extended in the final phase of the procedure. One common skill in the art is that additional tests can be performed using a larger range in time delays and light radiation in combination with any suitable tooth whitening composition to determine the appropriate delay period for the entire period and the corresponding period of light radiation in the over the entire period, to provide increased whitening efficiency, while minimizing the sensitivity of the teeth and soft tissue, as described herein.

While a minimum luminous intensity may be required to activate tooth discoloration for enhanced whitening, in accordance with one aspect of the present application, differences in light intensity above the required threshold may have a minor effect on whitening performance. research

Clinical EP 2 582 349, as described in Example 2 below, showed that when the light intensity is as low as about 41.5 mW / cm² (corresponding to the light emitted by LiteON Technology Corp. LED part # LTL1CHTBK5 BIN: QBOY 470 nm, which current intensity is about 10 mA), this causes a significant increase in luminance and reduced yellowness (compared with surgery without light amplification), increasing the intensity of light to about 134.7 mW / cm² (corresponding to the light emitted from the abovementioned Lite-ON Technology Corp. LED, which current intensity is around 50 mA) resulted in only marginal improvements in whitening efficiency. This suggests that low intensity (at least as low as about 41.5 mW / cm²) light is sufficient to activate tooth discoloration to an increased level of quantum energy, while increased intensity (at least as high as about 134.7 mW / cm)²) is insufficient to subject the teeth to discoloration to the next level of quantum energy for greater activation of these discolorations.

The effectiveness of treatments using low light radiation intensity can facilitate the home use of the enhanced teeth whitening process, because self-employed low-intensity light radiation will probably be safe for adult patients. For example, it is less likely that a low intensity of light radiation will lead to an increase in temperature on the teeth or in the mouth and that it will cause dryness in the mouth. The use of low-intensity light also reduces the risk of eye damage. The use of the procedure which is enhanced teeth whitening with low-intensity light at home can be further facilitated by the use of a teeth whitening composition and a carrier that provide controlled dosage of the bleaching agent, without having to isolate the surrounding soft tissue. Examples of suitable tooth whitening products include stripe whitening products, which are described in US Patent No. 6,949,240.

Accordingly, a household lightening whitening kit for home use can be provided as shown in Figures 1 - 3. The kit 10 may include a translucent strip 14 sized to cover one or more teeth 22, the strip comprising a layer 12 from a translucent tooth whitening composition

EP 2 582 349 located on the surface 28 of the strap 14. The kit 10 further comprises a portable light source 25 (e.g. a flashlight), adapted to emit light radiation with a maximum energy efficiency of about 10,000 miliarandels (mcd) or a maximum intensity of about 150 mW / cm², or other maximum energy output or intensity that is safe to use around the eyes and at the same time sufficient to activate discolorations on the teeth. The portable light source may be located on the other side of the tooth whitening composition carrier or directly on the teeth (e.g., when the carrier is removed prior to the operation which is light radiation). The portable light source can be kept at a suitable distance from the teeth, such as from about 0.5 cm to about 3 cm, and about 2 cm. The intensity of the light to which the teeth are exposed will depend on the distance of the light source to the teeth and the energy of the light source.

The portable light source may optionally include a timer to indicate the start or stop of the delay period and / or the period of light radiation and may be configured to limit the emission of light radiation for the final period. In another embodiment, the tooth whitening composition carrier may be provided with a portable light source (e.g., one or more LEDs) disposed on or in the carrier such that the light may be directed to the teeth by a given carrier. In one such example, the medium may also include a time circuit that delays the lighting of the portable light source for a predetermined delay period and illuminates the teeth for a predetermined period of light radiation.

The light source used for the procedure, which is the whitening of teeth with enhanced light, can be selected to provide light radiation at a wavelength that is best absorbed by discolorations on the teeth. The light radiation may be selected to be at the wavelengths corresponding to the color of light at the opposite pole as the color of the discoloration, as determined for example in the 1976 CIE LAB color space (see figure 4). By using the color of the light at the opposite pole, the absorption of light by discoloration can be increased or strengthened. For example, yellow discolorations (as they are commonly found on the teeth may be bleached), can better absorb blue light (about 380 - 520 nm). As such, the source of light

EP 2 582 349 may be selected to provide light radiation with a wavelength from about 400 nm to about 520 nm, or about 440 nm to about 490 nm, or an average wavelength of about 440 nm, or about 450 nm, or about 460 nm, or about 470 nm, or about 480 nm, or about 490 nm. As another example, green discolorations can be better absorbed by red light, such as, for example, light at a wavelength of about 600 nm to about 780 nm. As such, a light source for use in whitening green discolorations may be selected to provide light radiation with a wavelength of about 600 nm to about 780 nm, or about 680 nm to about 720 nm, or an average wavelength of about 680 nm, or about 690 nm, or about 700 nm, or about 710 nm, or about 720 nm.

Additionally or alternatively, the tooth whitening composition or carrier (e.g., cap or strip) may be configured to obscure, filter or otherwise block the undesirable intensity and frequency of the light, thereby adjusting the light radiation from the light source that reaches the discoloration. on the teeth in the desired intensity and wavelength ranges. For example, the carrier of the tooth whitening composition may be provided in a translucent material selected to block about 30% light, or up to about 50% light, or up to about 70% light. As another example, the carrier of the tooth whitening composition may be provided in a translucent material selected to block light having a wavelength longer than about 780 nm or longer than about 700 nm,

Many different tooth whitening compositions and methods of application can be used in combination with the radiation light treatment described above. For example, peroxide based whitening compositions may be provided with various peroxide concentrations. Other additives may be included in the composition, including, for example, photosensitizing agents, gelling agents, humectants, pH adjusting agents, stabilizers, desensitizing agents and accelerating agents or bleach activators. The composition may be provided in the form of a viscous liquid, paste, gel, solution or any other state or phase that may be applied to the teeth. In addition, the tooth whitening composition may be applied directly to the teeth, or it may be included in the overlay

In the case of a tooth or a flexible material, it is configured so that it can be applied to the tooth surfaces for whitening. Examples of such tooth whitening compositions and methods of use are described in US Patent No. 6,949,240 and US Application No. 2003/0152528.

Several factors may be considered in the choice of the right composition and method of use, including, for example, whitening efficacy, soft tissue tolerance, peroxide concentration, and the amount of bleaching composition.

In general, in toothless bleaching applications, as the concentration of peroxide increases, the whitening efficiency increases as shown by the upward slope of the efficacy curves in the graph of Fig. 5, described in more detail in U.S. Patent No. 6,949,240. In addition, the soft tissue tolerance decreases with increasing peroxide concentration, as shown by the downward slope of the tolerance curves on the graph of Figure 5. Considering this set of curves, it should be noted that it is possible to maintain acceptable soft tissue tolerance, while increasing the tolerance. whitening efficacy by increasing the concentration of peroxide to a relatively high level when the amount of the composition is appropriately reduced. In other words, it is possible to increase the concentration of the peroxide-containing active agent in order to achieve better bleaching efficiency, while maintaining acceptable soft tissue tolerance, without the use of artificial protections by the appropriate selection of the amount of the composition. This relationship can also be characterized by the parameter which is the density of peroxide, which is the ratio of the amount of active peroxide or the dose of peroxide (mg) to the surface (cm²) a thin layer that is applied to the surfaces of the teeth and adjacent to the oral soft tissue. This surface may be other than an &amp; quot; exposed surface &amp; quot; and / or &amp; quot; unprotected surface &amp; quot; as discussed in US Patent No. 6,949,240.

In one embodiment of United States Patent Specification No. 6,949,240, the peroxide density is less than about 1.3 mg peroxide / cm², an acceptable compromise between soft tissue tolerance and bleaching efficacy may be used

EP 2 582 349 peroxide concentrations greater than at least about 7.5%. While very high concentrations of peroxide can be used unexpectedly, it is generally desirable to use a peroxide at concentrations less than 60%, and it is even more desirable that the peroxide density is less than about 1.3 mg / cm² for teeth whitening applications, because soft tissue tolerance is acceptable. This controlled peroxide density may also limit the sensitivity of teeth and soft tissue in treatments using light-strengthened peroxide as described herein.

In other embodiments, the peroxide density is less than about 1.2 mg / cm²or less than about 1.1 mg / cm²or less than about 1 mg / cm², or less than about 0.75 mg / cm², or less than about 0.5 mg / cm² and / or more than about 0.01 mg / cm², or more than about 0.1 mg / cm²or more than about 0.25 mg / cm²or more than about 0.5 mg / cm² in combination with a peroxide concentration greater than about 10%, or greater than about 12%, or greater than about 16%, and / or less than about 20%. The peroxide-containing active agent can be any form that will release the peroxide by dissolving or hydration. All concentrations of peroxide active agents mentioned herein for hydrogen peroxide and the corresponding conversions must be made for other particle releasing peroxides, such as carbamide peroxide, calcium peroxide and sodium percarbonate, etc. Some other peroxide containing peroxide agents suitable for use in the present invention include calcium peroxide, carbamide peroxide, sodium percarbonate, benzoyl peroxide, and mixtures thereof.

The total amount of tooth whitening composition that is delivered to the oral cavity may vary depending on the size of the strip of material 12 and the concentration of the peroxide-containing active agent. Generally, more than about 0.0002 gram of tooth whitening composition is provided in the present invention or more than about 0.005 g, or more than about 0.01 g, or more than about 0.015 g, or more than about 0.02 g, or greater than about 0.025 g, or more than about 0.05 g, or more than about 0.075 g, or more than about 0.1 g, or more than about 0.15 g, or more than about 0.2 g, and / or less than about 0.3 g, or less than

About 0.2 g, or less than about 0.15 g, or less than about 0.1 g, or less than about 0.05 g, or less than about 0.025 g, or less than about 0.001 g .

The amount of tooth whitening composition may be greater than about

0.0005 g / cm²or greater than about 0.001 g / cm²or greater than about 0.002 g / cm², 5 or greater than about 0.0025 g / cm²or greater than about 0.005 g / cm² or greater than about 0.0075 g / cm²or greater than about 0.01 g / cm²or greater than about 0.015 g / cm², and / or less than about 0.03 g / cm², or less than about

0.02 g / cm², or less than about 0.015 g / cm², or less than about 0.01 g / cm², or less than about 0.005 g / cm², or less than about 0.001 g / cm².

As already mentioned above, the tooth whitening composition contains the peroxide-containing active agent and is provided in the form of a thin film 12 on the strip of material 14. In order to achieve the above-described amounts of the composition at higher peroxide concentrations, a thin layer 12 of the tooth whitening composition is used in The oral cavity may have a thickness of less than 0.3 mm, or less than 0.2 mm, or less than about 0.15 mm, or less than 0.1 mm, or less than about 0.06 mm, or less than about 0.03 mm, or less than about 0.001 mm and / or greater than about 0.0002 mm, or more than about 0.004 mm, or more than about 0.008 mm, or more than about 0.016 mm, or greater than about 0.018 mm, or greater than about 0.02 mm, or greater than about 0.1 mm, or greater than about 0.15 mm.These measurements are made by measuring from the surface 28 (Figure 1) from the strip of material 14 and above through a thin layer 12 of the tooth whitening composition.

The dose of peroxide, which is the total amount of peroxide-containing active agent in the thin layer of the tooth whitening composition, which is used in the oral cavity is less than about 100 mg, or less than about 95 mg, or less than about 85 mg, or less than about 80 mg, or less than about 40 mg, or less than about 20 mg, or less than about 15 mg, or less than about 12 mg, or less than about 10 mg, or less than about 5 mg, or less than about 1 mg and / or greater than about 0.1 mg, or greater than about 0.3 mg, or greater than about 0.6 mg, or greater than about 1 mg, or greater than about 1.5 mg, or greater than about 2 mg, or greater than about 10 mg.

If desired, the thin layer 12 of the tooth whitening composition may be either a homogenous, homogeneous and continuous coating, or the thin layer 12 may be non-uniform, discontinuous and / or non-uniform. On

For example, the thin layer 12 may be a laminate or separated layers of individual components, an amorphous mixture of ingredients, separate strips or points of different components, or a combination of these structures.

The tooth whitening composition of the present invention can be provided in the form of a viscous liquid, paste, gel, solution or any other suitable phase or condition. The tooth whitening composition may be provided in the form of a gel with a viscosity of about 200 to above 1,000,000 cP at low shear rates (about one second^-1). In another embodiment, the viscosity is from about 100,000 to about 800,000 cP, or from about

150000 to around 700,000 cP. In yet another embodiment, the viscosity is from about 300,000 to 700,000 cP.

As is known in the art, the tooth whitening composition further comprises a limit of elasticity. The elastic limit is the magnitude of the force present on the material before the material starts to move. The elastic limit must be high enough for the tooth whitening composition to be able to form a thin layer, and to be able to counteract the disturbances caused by the production, handling and storage processes. The elasticity limit of the tooth whitening composition is from about 2 Pa to about 3000 Pa, preferably from about 20 Pa to about 2000 Pa, more preferably from about 200 Pa to about 1500 Pa, and most preferably from about 200 Pa to about 400 Pa.

Additional components of the tooth whitening composition may include, but are not limited to, water, gelling agents, humectants, pH adjusting agents, stabilizers, desensitizing agents and accelerating agents or bleach activators. In addition to the above materials, a number of other materials can be added to the substance. Additional materials include, but are not limited to, flavoring agents, sweetening agents such as saccharin, xylitol, matting agents, colorants and chelates, such as ethylenediaminetetraacetic acid. These additional ingredients may also be used in place of the compounds described above. The use of such additives and additional materials is described in more detail in U.S. Patent No. 6,949,240.

Example 1

In a randomized, parallel, splitmouth clinical trial on thirty-five adult adults with shade

EP 2 582 349 A2 + teeth according to Vita Shade, who have not undergone tooth whitening treatments in the past two years and have not shown tooth sensitivity. Study participants are randomly assigned to one of six sequences that determine which procedure and on which side of the oral cavity they will receive. Each of the subjects uses 10% hydrogen peroxide in the form of a commercial whitening strip (CREST WHITESTRIPS PREMIUM) on their teeth (in the jaw) once a day, for 30 minutes, for seven days. One of the side incisors is subjected to a treatment LED light source (Lite-ON Technology Corporation, 720 South Hillview Drive, Milpitas, CA 95035, part # LTL1CHTBK5 BIN: QBOY 470 nm), with an intensity around

134.7 mW / cm² (with a current of about 50 mA supplied to the LEDs) and an average wavelength of 468 nm for 3, 30 or 300 seconds at the end of the 30 minute belt wear in accordance with the randomization schedule. Another of the lateral incisors is subjected to surgery without light enhancement to establish a control measurement. Digital images are collected at the initial screening stage, on the fourth day of therapy ("Day 4") and on the day after the end of treatment ("Day 8").

The treated groups are balanced in terms of demography and initial color of the tooth. Each treatment (including controlled therapies "only with strips") leads to a significant (p &lt;0.02) reduction of the b * and L * color parameters in relation to the initial values ​​at each visit during the test. A 300-second treatment with light results in a significantly higher yellowness reduction (Ab *), increased luminance (Ab *) and color change (AE) compared to the corresponding control measurement, as shown in Table 2 below, with a 97% increase in luminance and 69% more reduction in yellowness on day 8.

<td>Therapy</td><td>Delta L *</td><td>Delta a *</td><td>Delta b *</td><td>Delta E *</td>

<td>Light</td><td>1.68</td><td>-0.54</td><td>-1.81</td><td>2.54</td>

<td>Without light</td><td>0.85</td><td>-0.47</td><td>-1.07</td><td>1.72</td>

<td>% difference</td><td>97%</td><td>15%</td><td>69%</td><td>48%</td>

<td>p value</td><td>0.047</td><td>0.46</td><td>0,002</td><td>0.031</td>

Table 2: Day 8 - Effectiveness of teeth whitening by means of light radiation

EP 2 582 349

30-second treatment with light also causes a much greater reduction in yellowness compared to the appropriate control, with a 27% greater reduction in yellowness on day 8. All treatments are well tolerated, study participants did not stop the therapy due to toothache or oral irritation.

The end of therapy (Day 8) results from the Ab * value for all three treatments, which are presented in Table 3 below:

<td>Therapy</td><td>The adjusted average change from the initial values</td><td>Change resulting from a control sample based on adjusted average</td>

<td>3s light + strap</td><td>-0.89</td><td>0.22</td>

<td>30 s lights + strap</td><td>-1.50</td><td>-0.28</td>

<td>300 s light + strap</td><td>-1.66</td><td>-0.82</td>

Table 3: Day 8 - Reduce yellowing with different amounts of light radiation

The relationship between the exposure time and the change in the Ab * value resulting from the control measurement based on the corrected averages is shown in the graph shown in Fig. 6.

Example II

In a randomized, parallel, splitmouth clinical trial of thirty-five adults with the shade of A2 + teeth according to Vita Shade, who have not undergone tooth whitening over the past two years and have not shown tooth sensitivity. Study participants are randomly assigned to one of six sequences that determine which procedure and on which side of the oral cavity they will receive. Each of the subjects uses 10% hydrogen peroxide in the form of a commercial whitening strip (CREST WHITESTRIPS PREMIUM) on their teeth (in the jaw) once a day, for 30 minutes, for ten days. One of the side incisors is subjected to light radiation with an average wavelength of 468 nm and an intensity of approximately 41.5 mW / cm²around

108 mW / cm², or about 134.7 mW / cm² (corresponding to the light emitted from LTL1CHTBK5 BIN: QBOY 470 nm LED, described above, when in contact with the whitening strip and the current is approximately 10 mA, 25 mA to 50 mA respectively) for five minutes, at the end of the 30 minute belt wear. Different

EP 2 582 349 from the side incisors is subjected to surgery without light enhancement to establish a control measurement. Digital images are collected at the initial screening stage, on the fourth day of therapy ("Day 4"), on the eighth day of therapy ("Day 8") and on the day after the end of treatment ("Day 11").

The treated groups are balanced in terms of demography and initial color of the tooth. Each treatment (including controlled therapies with "only strips") leads to a significant (p &lt;0.04) reduction in yellowness (b *) already on Day 4, and increased brightness (L *) on day 11 of the study. All treatments with enhanced light using peroxide in the form of strips show significantly (p &lt;0.0001) a greater reduction in yellowness (Ab *) in relation to the corresponding control samples at each visit during the test. The AL * parameters do not differ significantly between treated groups. There were no significant differences between light treatments with values ​​of 41.5 mW / cm², 108 mW / cm² and 134.7 mW / cm².

All treatments were well tolerated, only two out of thirty-five subjects reported teeth sensitivity and two reported oral irritation.

The end of therapy (Day 11) results from the Ab * values, which are shown in Table 4 below:

<td>Therapy</td><td>The adjusted average change from the initial values</td><td>Change resulting from a control sample based on adjusted averages</td>

<td>10 mA light + strap</td><td>1.96</td><td>-1.07</td>

<td>25 mA light + strap</td><td>-2.55</td><td>-1.11</td>

<td>50 mA light + strap</td><td>-2.41</td><td>-1.19</td>

Table 4: Day 11 - Reduction of yellowness with different intensity of light radiation

Differences in yellowing reduction (Ab *) between treatments using differentiated enhanced light and control sample (only peroxide-containing stripes) measurements at the end of therapy, expressed as a percentage, are shown in the graph shown in Figure 7.

Dimensions and sizes disclosed here should not be taken as strictly limited to the numerical values ​​quoted in this description. However, unless otherwise specified, each dimension is meant to mean both

And a functionally equivalent range around this value. For example, the dimension defined as "40 mm" is to mean "about 40 mm".

EP 2 582 349