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U.S. Patent Aug. 10, i»3 sheet 2 of 2 5,234,342
1 2
both during and after treatment is reportedly less than SUSTAINED RELEASE METHOD FOR TREATING that associated with conventional in-office bleaching.
TEETH SURFACES Notwithstanding the foregoing advantages, there
remain some important disadvantages to home-use This application is a divisional of application Ser. No. 5 bleaching products and techniques. One important dis07/497,934, filed Mar. 22, 1990, now U.S. Pat. No. advantage is that the bleaching agent must be frequently 5,098,303. replaced during the day. Clinical test results indicate
nArvronnvn sa^'va dilution and swallowing of the bleaching
agent caused the volume of agent in the tray to diminish
1. The Field of the Invention 1° rapidly over time, thereby decreasing the amount of The present invention relates to sustained release active ingredient available for tooth bleaching. Test
dental compositions and methods for treating teeth results show that after one hour, less than one-half the
surfaces. More particularly, the present invention is original volume of bleaching agent was present. Thus,
directed to high viscosity sustained release dental com- existing bleaching agents should be replenished about
positions, such as tooth bleaching compositions, used in 15 every hour in order to be effective,
combination with a dental tray having reservoirs for Many patient's daytime schedules do not permit them
holding the dental composition located adjacent the to constantly replenish the bleaching agent. In addition,
teeth surfaces to be treated. even the suggestion of periodically replenishing the
2. The Prior Art bleaching agent during the night would not be favorVirtually all people desire white or whiter teeth. To 20 ably received by most patient's. Because of the inconve
achieve this goal, people either have veneers placed nience of constantly replacing the dental agent, patient over their teeth or have their teeth chemically bleached. compliance is difficult to maintain, and since patient In the past, patients who desired to have their teeth compliance determines the ultimate success of the treatbleached had to submit to conventional in-office bleach- ment, the need to constantly replace the dental bleaching techniques. This usually involved carefully placing ing agent is a major inconvenience which limits the a hydrogen peroxide solution (typically 30% H2O2) on success of the treatment.
the teeth, protecting the sensitive soft tissues with a Another disadvantage with current home-use bleachligated rubber dam, and applying heat or light to the ing compositions and techniques is that it often takes solution. Such treatments typically last 30 minutes to 1 3Q weeks to see an observable result. Although some have hour with from 4 to 10 appointments being necessary reported lightening of teeth in shorter periods of time, for a significant change. Only the labial surface of the in most cases the home-use bleaching treatment lasts 6-8 front teeth is treated. from 4 to 6 weeks. Under such circumstances, patients
Since its introduction in early 1989, there has been a often lose their enthusiasm for the procedure and often growing interest among the dental profession in home- j5 stop complying with the treatment regimen, use tooth bleaching products and methods. A current From the foregoing, it will be appreciated that what representative technique includes: (1) making an algi- is needed in the art are improved compositions and nate impression of the patient's teeth; (2) making a stone methods for treating tooth surfaces which facilitate cast of the impression; (3) vacuum forming a tray from patient compliance, so that the ultimate purpose of the the cast, usually from thin (0.020-0.030 inch) hard trans- ^ treatment is realized.
parent material, and trimming to exclude gingival cov- Additionally, it would be a significant advancement erage; (4) instructing the patient to (a) place 2-3 drops in the art to provide sustained release dental composiof a bleaching solution into each area of each tooth to be tions for treating tooth surfaces which do not need to be bleached, (b) place the tray in the mouth, (3) expecto- continuously replaced so that patient compliance is rate any excess bleaching solution, (4) change the 45 enhanced.
bleaching solution every 1 to 2.5 hours, and (5) remove It would be another significant advancement in the the tray during meals. A few recommend wearing the art to provide sustained release dental compositions for tray during the night. treating tooth surfaces which provide a more constant
The most commonly used dental bleaching agent is level of dental agent in contact with the teeth surfaces 10% carbamide peroxide ... also called 50 rather than periodic high and low levels of the dental urea hydrogen peroxide, hydrogen peroxide carbamide, agent in contact with the patient's teeth, and perhydrol-urea. Carbamide peroxide has been used It would be an additional advancement in the art to by dental clinicians since the 1960's as an oral antiseptic. provide sustained release dental compositions and methTooth bleaching was a side effect of extended contact ods for bleaching a patient's teeth which provide noticetime. Over the counter ("OTC") compositions of 10% 55 able lightening in a matter of days rather than weeks, carbamide peroxide are available as "Gly-Oxide" by Such sustained release dental compositions and methMarion Laboratories and "Proxigel" by Reed and Cam- ods for treating tooth surfaces are disclosed and claimed rick. herein.
Positive results using the foregoing technique have been reported. The effectiveness depends upon such 60 factors as type and intensity of stain, bleaching agent contact time on teeth, and amount of available active The present invention is directed to high viscosity ingredient in the bleaching agent. Because the time sustained release dental compositions, such as tooth commitment for the actual bleaching process takes bleaching or fluoride compositions, for treating tooth place outside the dental office, the cost for the proce- 65 surfaces. An improved dental tray having reservoirs for dure is substantially less than conventional in-office holding the dental composition adjacent the desired bleaching techniques. Moreover, patient discomfort tooth surfaces is preferably used in combination with associated with home-use tooth bleaching techniques the sustained release dental composition.
BRIEF SUMMARY AND OBJECTS OF THE
INVENTION
3 4
One currently preferred sustained release dental com- ment time of the day since less mouth activity "pumps"
position includes a dental bleaching agent, such as carb- material from the tray.
amide peroxide. The concentration of dental bleaching It is, therefore, an object of the present invention to agent may vary depending upon its reactivity. For carb- provide improved compositions and methods for treatamide peroxide, for example, the currently preferred 5 ing tooth surfaces which facilitate patient compliance, concentration range is from about 3% to about 20%, so that the ultimate purpose of the treatment is realized, with a range from about 4% to about 15% being most Another important object of the present invention is preferred. to provide sustained release dental compositions for
The dental bleaching agent is preferably included in a treating tooth surfaces which do not need to be continuhigh viscosity matrix material to form the sustained 10 ously replaced so that patient compliance is enhanced, release dental composition. Suitable matrix materials Yet another significant object of the present invenare preferably safe for oral use, do not readily dissolve tion >st0 provide sustained release dental compositions in saliva, and do not react with the dental bleaching for treating tooth surfaces which provide a more conagent. One currently preferred high viscosity matrix «tant level of dental agent in contact with the teeth material is a supersaturated carboxypolymethylene 15 surfaces rather than periodic high and low levels of the composition. A quantity of base is preferably added to dentaI a«ent TM with *>» patient's teeth thereby the carboxypolymethylene composition to adjust the providing noticeable lightening of a patient's teeth in a PH to within about 5.0 to about 7.0. mater ofteys rather than weeks.
The sustained release bleaching agents within the A important object of the present invention is
scope of the present invention have such a high viscos- 20 t0 Pr.0Vlde ■? TMFrov?1 de,ntal tray ^vmg built m res
ity that positive pressure is needed to dispense them, *!r holdm8 **** compositions for treating
gravity iVnot sufficient. Unlike existing low-viscosity ^n surfaces which enhance the effectiveness of the
bleaching agents, the sustained release bleaching agents den^ treatment and patient comfort.
cannot te dispensed drop-wise from a bottle. A syrtoge, „ . ^ aod.1?*« ... ""J J"*""* °f pmT
., „ K r . ., ... J ?■ 25 invention will become more fully apparent from the
squeezable tube, or other smnlar positive pres ure dis- ^ ^ Qf J £Pleamed b {he
penang device must be used to dispense the bleaching Qf {he mvention,
compositions within the scope of the present mvention. r
An improved dental tray having reservoirs for hold- BRIEF DESCRIPTION OF THE DRAWINGS
ing the dental composition adjacent the desired tooth 3Q FIG j js a pe^^ ^ of a stone ^ of a
surfaces is preferably used in combination with the tient>s teeth with a ri^d ^ lied t0^_
sustained release dental composition. The general pro- lected teeth surfaces
cess for preparing dental trays is known in the art. For FIG 2 is a ^^0^ view of the stone ^ of FIG
example, an alginate impression which registers all teeth j with a denta] tfay formed from the cast ^ trimmed
surfaces plus gingival margin is madeand a stone cast is 35 according t0 the teachings of the present invention,
promptly made of the impression. The reservoirs are FIG 3 ^ a cross_sectjonai view taken along line 3—3
prepared by building a layer of rigid material on the Qf pjQ. 2.
stone cast on specific teeth surfaces to be treated. A FIG 4 k a ... view taken along line 4—4
dental tray is then vacuum formed from the modified 0f Fig. 2. cast using conventional techniques. Once formed, the
tray is preferably trimmed barely shy of the gingival DETAILED DESCRIPTION OF THE margin on both buccal and lingual surfaces. The result- PREFERRED EMBODIMENTS ing tray provides a perfect fit of the patient's teeth with As summarized above, the present invention is generreservoirs or spaces located where the rigid material ... related to high viscosity sustained release dental was placed on the stone cast. 45 compositions, such as tooth bleaching or fluoride comThe reservoirs may also be creatively built into trays positions, for treating tooth surfaces. An improved dento provide additional bleaching agent to specific teeth ^ tray having reservoirs for holding the dental compoor teeth surfaces which need more whitening than oth- sition adjacent the desired tooth surfaces is preferably ers. It has also been found that patients may experience used in combination with the sustained release dental less tooth discomfort from tray pressures when using a 50 composition.
tray with built in reservoirs. One currently preferred sustained release dental com
Before commencing a home-use teeth bleaching position includes a dental bleaching agent, such as carb
treatment, it is recommended that the patient's teeth be amide peroxide. The concentration of dental bleaching
clean and that there be no restorations with leaky mar- agent may vary depending upon its reactivity. For carb
gins or exposed dentin. If there are large areas of ex- 55 amide peroxide, for example, the currently preferred
posed dentin or if restorations are inadequate, patients concentration range is from about 3% to about 20%,
can develop mild to moderately severe pain. with a range from about 4% to about 15% being most
The amount of whitening obtained during tooth preferred. In the case of hydrogen peroxide, which is
bleaching is dependent upon (1) the length of time each more reactive than carbamide peroxide, the currently
day the tray is worn; (2) the number of days the tray is 60 preferred concentration range is from about 2% to
worn; and (3) the susceptibility of the teeth to the about 10%.
bleaching agent. For maximum whitening, an acceler- The dental bleaching agent is preferably included in a
ated treatment time of approximately 18-20 hours per high viscosity matrix material to form the sustained
day is recommended. The treatment schedule may be release dental composition. Suitable matrix materials
tailored to each patient's lifestyle or response to the 65 are preferably safe for oral use, do not readily dissolve
treatment, but will usually include at least treatment in saliva, and do not react with or inactivate the dental
during the patient's sleep. It has been found that treat- bleaching agent. One currently preferred high viscosity
ment during sleep is the most productive single treat- matrix material is a concentrated carboxypolymethy
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