United States Patent
`
`119]
`
`[11] Patent Number:
`
`5,725,843
`
`USOOS725843A
`
`
`
` Fischer [451 Date of Patent: *Mar. 10, 1998
`
`
`
`[54] METHODS FOR BLEACHING TEETH
`SURFACES
`Inventor: Dan E. Fischer. Sandy. Utah
`
`[75]
`
`[73] Assignee: Ultradent Products, Inc.. South
`Jordan. Utah
`
`[*1
`
`Notice:
`
`The term of this patent shall not extend
`beyond the expiration date of Pat. Nos.
`5.234.342. 5.098.303 and 5.376.006.
`
`[2 1]
`
`[22]
`
`[53]
`
`Appl. No.: 722,549
`
`Filed:
`
`Sep. 27, 1996
`
`Related US. Application Data
`
`Continuation of Ser. No. 378,315. Jan. 25, 1995. which is a
`continuation of Ser. No. 99,247. In]. 28, 1993. abandoned,
`which is a continuation of Ser. No, 985,700, Dec. 2, 1993,
`abandoned, which is acontinuation of Ser. No. 718,210,11111.
`20, 1991, abandoned, which is a division of Ser. No.
`497,934. Mar. 22, 1990. abandoned.
`
`Int. Cl.6 ................................ A61K 7/16; A61C 5/00
`[51]
`[52] US. Cl. .............................. 424/49; 424/53; 514/900;
`514/944; 433/215
`[58] Field ofSearch .................................. 424/49. 52. 53.
`424/673; 252/315.01. 514; 514/900. 944;
`433/215
`
`[56]
`
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`Primary Examiner—Raj Bawa
`Attorney; Agent, or Firm—Workman Nydegger Seeley
`
`[57]
`
`ABSTRACT
`
`The present invention discloses high viscosity sustained
`release dental compositions. such as tooth bleaching or
`fluoride compositions. for treating tooth surfaces. For maxi—
`mum results. an improved dented tray having reservoirs for
`holding the dental composition adjacent the desired tooth
`surfaces is preferably used in combination with the sustained
`release dental composition. The sustained release dental
`compositions include a high carboxypolymethylene concen-
`tration which results in very high viscosity. The high level of
`carboxypolymethylene makes dilution of the dental compo-
`sitions from saliva diflicult and time consuming so that the
`compositions stay within the tray reservoirs. thereby pro-
`viding sustained release. The concentrated carboxypolym-
`ethylene adds a unique tackiness to the dental composition
`which helps retain and seal the soft tray material against the
`pafient’s teeth.
`
`14 Claims, 2 Drawing Sheets
`
`
`
`CLIO USA
`EXHIBIT 1005
`PAGE 000001
`
`PAGE 000001
`
`CLIO USA
`
`EXHIBIT 1005
`
`

`

`1,642,653
`1,691 ,785
`1 ,934,688
`2,257,709
`2,798,053
`2,835,628
`2,858,281
`2,923,692
`2,985,625
`3,060,935
`3,073,300
`3,234,942
`3,247,844
`3,379,193
`3,380,446
`3,385,291
`3,416,527
`3,448,738
`3,481,329
`3,499,844
`3,527,218
`3,527,219
`3,536,069
`3,624,909
`3,625,215
`3,657,413
`3,742,942
`3,844,286
`3,955,281
`3,969,499
`3,988,433
`3,998,945
`4,032,627
`4,044,762
`4,064,628
`4,138,814
`4,164,940
`4,173,219
`4,173,505
`4,239,818
`4,244,942
`4,251,507
`4,302,441
`4,376,628
`4,428,373
`4,431,631
`4,518,721
`4.522.805
`4,528,180
`4,537,778
`4,560,351
`4,568,536
`4,592,487
`4,592,488
`4,661 .070
`4,687,663
`4,696,757
`4,755,386
`4,770,634
`4,788,052
`4,812,308
`4,839,156
`4,839,157
`4,849,213
`4,895,721
`4,902,227
`4,939,284
`4,954,487
`4,968,251
`4,971,782
`
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`
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`
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`
`
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`
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`
`2132: gfrghash
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`
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`
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`
`4/1968 Martin ..
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`
`191/1969 Warm-1.1: -
`-- 08/66
`3,1970 K‘bbf" 5‘ ”1*
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`32313 235"“ ------
`””29
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`' 42452
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`12/1977 Weitzman
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`2/1979 Weitzman
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`
`
`
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`8“979 Quillby
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`$313 £3356:.......
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`.. 424/31
`
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`
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`
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`
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`Declaration of P. Michael Clinard. Civil Action No. 91—1406
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`
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`2:95CV 0163W (D. Utah).
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`2:95CV 0163 W (D. Utah).
`Trial Testimony of Garold S. Yost (Rebuttle). Civil Action
`No. 2:95CV 0163W (D. Utah).
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`Action No. 2:95CV 0163W (D. Utah).
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`No. 2:95CV 0163W (D. Utah).
`Trial Exhibits. Civil Action No. 2:95CV 0163W (D. Utah).
`
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`Mar. 10, 1998
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`1
`METHODS FOR BLEACHING TEETH
`SURFACES
`
`RELATED APPLICATIONS
`
`This application is a continuation of application Ser. No.
`08/378315. filed Jan. 25. 1995.
`in the name of Dan E.
`Fischer. D.D.S.. for “AN'I'ICARIOGENIC AND ANTIMI-
`CROBIAL DENTAL COMPOSITIONS AND METHODS
`FOR TREATING TEETH SURFACES". which is a file
`wrapper continuation of application Ser. No. 08/099247.
`filed Jul. 28. 1993. for “SUSTAINED RELEASE DENTAL
`COMPOSITIONS AND METHODS FOR TREATING
`TEETH SURFACES” (abandoned). which is a file wrapper
`continuation of application Ser. No. 07/985 .700. filed Dec.
`2. 1992. (abandoned). which is a file wrapper continuation
`of US. application Ser. No. 07/718210. filed Jun. 20. 1991.
`(abandoned). which is a divisional of US. application Ser.
`No. 07/497 .934. filed Mar. 22. 1990. (abandoned).
`BACKGROUND
`
`1. The Field of the Invention
`
`The present invention relates to sustained release dental
`compositions and methods for treating teeth surfaces. More
`particularly. the present invention is directed to high viscos-
`ity sustained release dental compositions. such as tooth
`bleaching compositions. used in combination with a dental
`tray having reservoirs for holding the dental composition
`located adjacent the teeth surfaces to be treated.
`2. The Relevant Technology
`Virtually all people desire white or whiter teeth. To
`achieve this goal. people either have veneers placed over
`their teeth or have their teeth chemically bleached. In the
`past. patients who desired to have their teeth bleached had
`to submit to conventional in-officc bleaching techniques.
`This usually involved carefully placing a hydrogen peroxide
`solution (typically 30% H202) on the teeth. protecting the
`sensitive soft tissues with a ligated rubber dam. and applying
`heat or light to the solution. Such treatments typically last 30
`minutes to 1 hour with from 4 to 10 appointments being
`necessary for a significant change. Only the labial surface of
`the 6—8 front teeth is treated.
`
`Since its introduction in early 1989. there has been a
`growing interest among the dental profession in home-use
`tooth bleaching products and methods. A current represen—
`tative technique includes: (1) making an alginate impression
`of the patient’s teeth; (2) making a stone cast of the
`impression; (3) vacuum forming a tray from the cast. usually
`from thin (0020—0030 inch) hard transparent material. and
`trimming to exclude gingival coverage; (4) instructing the
`patient to (a) place 2—3 drops of a bleaching solution into
`each area of each tooth to be bleached. (b) place the tray in
`the mouth. (c) expectorate any excess bleaching solution. (d)
`change the bleaching solution every 1 to 2.5 hours. and (e)
`remove the tray during meals. A few recommend wearing
`the tray during the night.
`The most commonly used dental bleaching agent is 10%
`carbamide peroxide (CO(NH2)2H202). also called urea
`hydrogen peroxide. hydrogen peroxide carbamide. and
`perhydrol—urea. Carbamide peroxide has been used by dental
`clinicians since the 1960’s as an oral antiseptic. Tooth
`bleaching was a side effect of extended contact time. Over
`the counter (“OTC") compositions of 10% carbamide per—
`oxide are available as “Gly—Oxide" by Marion Laboratories
`and “Proxigel” by Reed and Carnrick.
`Positive results using the foregoing technique have been
`reported. The elfectiveness depends upon such factors as
`
`5 .725.843
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`type and intensity of stain. bleaching agent contact time on
`teeth. and amount of available active ingredient
`in the
`bleaching agent. Because the time commitment for the
`actual bleaching process takes place outside the dental
`office. the cost for the procedure is substantially less than
`conventional
`in-otfice bleaching techniques. Moreover.
`patient discomfort associated with home-u se tooth bleaching
`techniques both during and after treatment is reportedly less
`than that associated with conventional in-oflice bleaching.
`Notwithstanding the foregoing advantages. there remain
`some important disadvantages to home-use bleaching prod—
`ucts and techniques. One important disadvantage is that the
`bleaching agent must be frequently replaced during the day.
`Clinical test results indicate that saliva dilution and swal-
`lowing of the bleaching agent caused the volume of agent in
`the tray to diminish rapidly over time. thereby decreasing the
`amount of active ingredient available for tooth bleaching.
`Test results show that after one hour. less than one—half the
`original volume of bleaching agent was present. Thus.
`existing bleaching agents should be replenished about every
`hour in order to be effective.
`
`Many patient’s daytime schedules do not permit them to
`constantly replenish the bleaching agent. In addition. even
`the suggestion of periodically replenishing the bleaching
`agent during the night would not be favorably received by
`most patients. Because of the inconvenience of constantly
`replacing the dental agent. patient compliance is difficult to
`maintain. and since patient compliance determines the ulti—
`mate success of the treatment. the need to constantly replace
`the dental bleaching agent is a major inconvenience which
`limits the success of the treatment.
`
`Another disadvantage with cm’rent home-use bleaching
`compositions and techniques is that it often takes weeks to
`see an observable result. Although some have reported
`lightening of teeth in shorter periods of time. in most cases
`the home-use bleaching treatment lasts from 4 to 6 weeks.
`Under such circumstances. patients often lose their enthu-
`siasm for the procedure and often stop complying with the
`treatment regimen.
`From the foregoing. it will be appreciated that what is
`needed in the art are improved compositions and methods
`for treating tooth surfaces which facilitate patient
`compliance. so that the ultimate purpose of the treatment is
`realized.
`
`Additionally. it would be a significant advancement in the
`art to provide sustained release dental compositions for
`treating tooth surfaces which do not need to be continuously
`replaced so that patient compliance is enhanced.
`It would be another significant advancement in the art to
`provide sustained release dental compositions for treating
`tooth surfaces which provide a more constant level of dental
`agent in contact with the teeth surfaces rather than periodic
`high and low levels of the dental agent in contact with the
`patient’s teeth.
`It would be an additional advancement in the art to
`provide sustained release dental compositions and methods
`for bleaching a patient’s teeth which provide noticeable
`lightening in a matter of days rather than weeks.
`Such sustained release dental compositions and methods
`for treating tooth surfaces are disclosed and claimed herein.
`
`BRIEF SUMMARY AND OBJECTS OF THE
`INVENTION
`
`The present invention is directed to high viscosity sus-
`tained release dental compositions. such as tooth bleaching
`
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`10
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`20
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`or fluoride c