Background

[01] Related Applications

[02] The present application is a non-provisional of U.S. provisional application serial no. 62/850462, filed on May 20, 2019, which is incorporated herein by reference and to which priority is claimed pursuant to 35 USC 119,

120.

[03] Field of the Technology

[04] The invention relates to the field of orthodontics and in particular to use of orthodontic aligners, such as exemplified in CPC A61C 9/00, 3/00, 19/04; A61 B 1/04, 1/00, 1/32; G06K 9/62; and NQ4N 7/18.

[05] Description of the Prior Art

[06] The conventional method of how to monitor aligner treatment in the orthodontist's office is simply to visually examine how weli or closely the aligner fits with the patient's teeth. The position of the interior aligner surfaces relative to file tooth surfaces of various aligners in a series of aligners is observed by a trained orthodontist to assess progression with a series of aligners. Dental Monitoring SAS, Paris, France, has devised a holder for a smartphone that allows the patient to scan an image of their teeth and send to the practitioner's office for analysis by artificial intelligence to track progress with aligners.

[07] What is needed is means and method whereby the patient may be able to make him or herself or assist the orthodontist in remotely making an assessment of fit of the aligners.

[08] Brief Summary

[09] The illustrated embodiments of the invention are directed to a method of monitoring the degree of fit of an aligner among a series of aligners defining a corresponding series of tooth positions comprising the following steps. Patient does not have to send images of his or her teeth to a

practitioner, although that option is always available. Instead, the patient can self-assess visually the degree of fit and or use a color chart as described below. The material disposed into the aligner will appear darker and more opaque where the aligner fit is the poorest, and very light colored and translucent where the fit is better, and not be visible at ail where the fit is best

[10] The method includes the steps of selecting an aligner in the series of aligners whose fit to a patient's teeth are to be tested to determine its fit with the selected aligner; disposing a nontoxic plastic material into the selected aligner; setting the patient's teeth into the selected aligner containing the nontoxic plastic material; and determining the amount of material disposed onto the interior aligner’s surfaces by visual inspection by assessment of the materiaI disposed therein, a good fit being indicated by a minimum of material extruded onto almost all of the interior aligner surfaces, and a poor fit being indicated by an excess of material extruded onto one or more locations of the aligner interior surfaces

[11] In the preferred embodiment the step of disposing a nontoxic piastic material Into the aligner, the nontoxic plastic material is colored with the intensity of color being proportional to the thickness of the material and the step of determining the amount of material disposed onto the interior aligner’s surfaces by visual inspection by assessment of the material disposed therein comprising determining a good fit by a light color of the disposed material and determining a poor fit by a dark color of the disposed material

J12| The step of determining a good fit by a light color of the disposed material and determining a poor fit by a dark color of the disposed material comprises comparing observed color of the disposed material to a color chart to determine when the color is a light color indicative of a good fit or when the color is a dark color indicative of a poor fit and corresponding intensities of color therebetween corresponding to degrees of fit therebetween

[13] The step of setting the patient’s teeth into the selected aligner containing the nontoxic plastic material comprises improving the fit using cotton roils or chewies.

[14] The method further includes the steps of selecting a next aligner higher in the series of aligners whose fit to a patient's teeth are to be tested to determine whether it is appropriate to progress to use of the next aligner in the series; disposing a nontoxic plastic material into the selected next aligner; setting the patient’s teeth into the selected next aligner containing the nontoxic plastic material; and determining the amount of material disposed onto the interior next aligner’s surfaces by visual inspection by assessment of the material disposed therein, a good fit being indicated by a minimum of material extruded onto almost all of the Interior aligner surfaces, and a poor fit being indicated by an excess of materia! extruded onto one or more locations of the next aligner interior surfaces.

[15] The method further includes the step of comparing an assessment of fit between the selected aligner and selected next aligner to determ ine which is a better fit with the corresponding selected aligner and selected next aligner to determine appropriateness of progressing higher in the series of aligners.

[16] The method further Includes the step of making an impression, a photograph or image of the lack of fit between the teeth and the selected aligner and the step of determining the amount of material disposed onto the interior aligner’s surfaces by visual inspection or assessing a photograph or image of the filled aligner by assessment of the materia! disposed therein, includes assessing the photograph, image or three dimensional shape of the impression. Taking a photo or image of the material residing in the gaps caused by the poor fit increases the ability to see these areas, measures the degree of poor fitting, and aids the observer or At in documenting the lack of fit and degree of lack of fit.

[173 The scope of the invention also extends to a composition of matter for monitoring the degree of fit of an aligner among a series of aligners defining a corresponding series of tooth positions comprising a nontoxic colored plastic material for disposition into a selected aligner which is pressure moldabie at room temperature to the patient’s teeth into the selected aligner and which is removable from the selected aligner from the patient's teeth without substantial adherence to the teeth, the nontoxic colored plastic material being translucent so that the amount of material disposed onto the interior aligners surfaces indicates by visual inspection of the material disposed therein of the degree of fit of the aligner to the tooth positions, a good fit being indicated by a minimum of materia! extruded onto almost all of the interior aligner surfaces and by a light color, and a poor fit being indicated by an excess of material extruded onto one or more locations of the aligner interior surfaces and a dark color.

[18] In one embodiment the nontoxic colored plastic material comprises a food stuff with a pudding consistency.

[19] While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any way by the construction of “means” or“steps" limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 112 are to be accorded full statutory equivalents under 35 USC 112. The disclosure can be better visualized by turning now to the following drawings wherein like elements are referenced by like numerals. [20] Brief Description of the Drawings

[21] Fig, i is a depiction of an aiigner set on the Sower teeth, which shows virtually no color indicated by the lack of shading in the diagram in any gaps between the aligner and teeth and hence is indicative of an excel lent fit to the aligner,

[22] Fig, 2 is a depiction of an aligner set on the upper teeth, which shows only a small amount of color indicated by shading in gaps between the aligner and teeth, which is indicative of a good fit to the aiigner,

£23] Fig. 3 is a depiction of an aligner set on the upper teeth, which shows an appreciable amount of color indicated by shading in gaps between the aligner and teeth, which is indicative of a poor fit to the aligner.

[24] Fig. 4 is a depiction of an aiigner set on tine upper teeth with the last aligner employed in a series for comparison with the fit shown by the next aligner up in the series.

[25] Fig, 5 is a schematic diagram where an impression of the quality of the fit between teeth of a patient and an aligner is made by using the aiigner as mold or tray for the impression made between the aligner and teeth.

[26] The disclosure and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the embodiments defined in the claims. It is expressly understood that the embodiments as defined by the claims may be broader than the illustrated embodiments described below. [27] Detailed Description of the Preferred Embodiments

[28] A series of aligners are prepared with a corresponding series or progression of tooth positions intended to be orthodontics! iy created by the aligner series. What is disclosed below is a method to monitor in an

orthodontist's office or for patient self-monitoring of the aligner fit, and whether if it is appropriate to move to the next aligner in a series.

[29] A nontoxic liquid or viscous material (e.g. a food product that has a color, a colored liquid or a pudding consistency) is poured or injected into a tooth aligner, When the aligner is inserted into the mouth and fitted to the teeth, it visibly shows areas where the teeth are "seating” well into the aligner and areas where it is not "seating” or tracking well. The quality of the fit is indicated by the amount of materia! present between the teeth and the aligner interior surfaces, which is indicated by the visible intensity or degree of color of the material between the teeth and the aligner,

[30] As shown in Fig. 1 an aligner 10 set on the lower teeth 12, which shows virtually no color in any gaps between the aligner 10 and teeth 12 and hence is indicative of an excellent fit to the aligner.

[31] As shown in Fig. 2 a light color or only a small amount of materia! is extruded between the tooth surfaces of teeth 14 and the aligner 10 in areas 16, which indicates a good fit and the appropriateness of moving up in the aligner series to the next defined tooth positions. Biting down on cotton roils or "chewies" to apply a distributed force in areas 16 may be used to atempt to adjust or improve the fit of aligner 10 to teeth 14.

[32] As shown in Fig. 3 a dark color or a large amount of material allowed or extruded between the surfaces of teeth 14 and the surfaces of aligner 10 indicates a poor fit and the inappropriateness of moving up in the aligner series to the next defined tooth positions. Again the use of cotton rolls or chewies to readjust the fit of aligner 10 to teeth 14 is then made. If there is no improvement of fit, then the patient may be urged to report the same to his or her orthodontist's office for consultation and assistance.

[33] The depiction of Fig. 3 may, for example, be a step wherein the patient has moved up the series of aligners to test if the next aligner 10 in the series presents a better fit. Thus, in Fig. 4 the patient has inserted the last aligner 10 in the series to determine If a better fit is achieved than seen with the next aligner 10 in the series as shown in Fig, 3. If a return to the last aligner 10 in the series after adjustment using cotton roils or chewies as shown in Fig. 4 does not indicate a beter fit than seen in the fit of the next aligner 10 in the series as shown in Fig, 3, then the patient is directed to his or her orthodontist's office for consultation and assistance.

[34] While the dentist/orthodontist or their staff is trained and experienced in assessing the color differences and locations with respect to aligner fit, it Is harder for a patient to assess aligner fit, and the color paterns are also difficult to pick it up in photos, even those taken with specialized self- monitoring imaging systems designed for this purpose, which are now being marketed for the orthodontic market. While at home or in the office, the colored material is placed in an aligner 10, or for example used with every 5th aligner, to see if there is more than a thin line of the material at the edges of the teeth 12, 14. If it is more than in seen in comparison to sample images which are provided to the patient, the patient does not move to the next aligner and devices, such as chewies or cotton rolls, are employed to help seat the aligners better.

[35] The test can be used as often as the patient .likes, lust prior to moving up in the series to the next aligner, it is best to determine if they should change to the next aligner or extend the wearing of the present aligner, perhaps using devices, such as chewies or cotton rolls, to help the aligner seat better. Every 5th aligner may be too long of an interval. Most aligners are changed weekly, although most direct-to-consumer or in-house made aligners are worn for two weeks, more if just worn in the evening.

[36] As diagram maticaiiy shown in Fig. 5 nontoxic material could a iso be similar to that used for making dental impressions. The patient seats the aligner 10 on the teeth, lakes a "seifie" of their teeth, and checks the fit. The

impression 18 of the degree of fit can then just be pulled out of the tray or aligner 10 as a three dimensional impression 18 of the degree of misalignment or Sack of fit, since it has no adhesive properties. Some material may get stuck between spaces in the teeth, this would have to be removed by the patient or staff if in the office with a brush or pick. The patient, if seif- monitoring may take a picture of the impression 18 showing the degree and locations of misfit with a!igner 10 after it is removed to send to the treating practitioner to assess how well the aligner is fitting, assuming that a good intact impression 18 is formed and does not get stuck to the teeth.

[37] The patient may also evaluate the fit with comparison to a color chart (not shown). The chart could be used at, for example, the edge of the front teeth 12, 14. If the materia! is "thick ^" , indicating a poor fit, the color would be darker as defined by the color chart, as compared to where the material is "thinned out" where the tray or aligner is fitting well, where the material's color would be lighter, more transparent or translucent as defined by the color chart. The patient is then able to rate the fit themselves mom precisely based on assessments interpreted with use of the coior chart. The color chart could include information keyed to specified color intensities, such as "wear current aligner for another week and retest", or "use chewies (or something you bite on) every 4 hours to seat aligner better, retest in X number of days."

[38] The patient, if selfmonitoring, could also take a picture of the aligner in the mouth or, after they removed the aligner, send the photo to the treating doctor. Alternatively, an app for a smartphone would sample for the color and evaluate the color, or assess the color image over tefedentistry apps, FaceTime, Duo, and the like.

[39] Many alterations and modifications may be made by those having ordinary skii! in the art without departing from the spirit and scope of the embodiments. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following embodiments and its various embodiments.

[40] Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the embodiments includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the

embodiments is expticitty contemplated as within the scope of the embodiments.

[41] The words used in this specification to describe the various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to alt possible meanings supported by the specification and by the word itself.

[42] The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements In a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed

combination may be directed to a subcombination or variation of a

subcombination.

[43] Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. [44] The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionally equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the embodiments.