DENTAL DEVICE AND METHODS OF FORMING SAME

Abstract

A customized dental device for placement over the natural teeth of a user is disclosed, as well as various methods for forming such a device. The method expands on conventional methods of forming a cast replica and model integrating retaining features into either the cast replica or a temporary model to help the device naturally and seamlessly hold to the teeth of the user in a customized manner. Alternative methods of formation through injection molding are disclosed. In different embodiments, the device may be used as a veneer to improve appearance of the user's natural teeth and/or as a weight control device by governing food intake.

Claims

1-32. (canceled)

33. A method of making a non-permanent dental device with improved retention capability on a user's set of teeth, comprising the steps of: preparing a cast replica from an original dental impression taken from the user; modifying the cast replica to create a temporary modified model by at least reducing one or more dimensions of the cast replica in one or more predetermined retention areas; forming a permanent model from the temporary modified model; and forming the dental device from the permanent model.

34. The method of claim 33 wherein modifying the cast replica further comprises defining buccal or palatal and lingual or labial gingival margins by creating a groove along said margins in the case replica.

35. The method of claim 33 further comprising the step of forming a pre-device from the permanent model, the pre-device having at least two tooth casings.

36. The method of claim 35 wherein the pre-device comprises a clip structure associated with each of the at least two tooth casings, each clip structure having an open-ended pincer arrangement.

37. The method of claim 36 further comprising the step of removing at least a portion of a simulated occlusal surface from the clip structure.

38. The method of claim 33 wherein modifying the cast replica further comprises adding approximately 15 mm of material to a form a pallette portion of the device between the predetermined retention areas designed to align with the palette of the user's mouth.

39. The method of claim 33 wherein the device is thermoformed, and wherein the cast replica is modified using wax.

40. The method of claim 33 wherein the device is injection molded, and wherein the device is made of acetyl resin.

41. The method of claim 36 further comprising the step of shaping the at least two tooth casings such that each clip partially will extend around a mesial surface of the user's tooth.

42. The method of claim 40 further comprising the step of creating a counter-replica mold using the temporary modified model.

43. The method of claim 38, wherein adding the material comprises the alternating steps of adding a powder polymer and adding a liquid monomer.

44. The method of claim 43 further comprising the step of placing the device in a heated pressure pot for 10-15 minutes for curing.

45. A customized dental device for placement over a user's natural teeth, the device comprising: at least two tooth casings corresponding to teeth on opposing sides of a user's mouth; retention features formed in predetermined retention areas that provide an interference fit to a user's molar teeth on opposing sides of the user's mouth without contacting the gingiva; a thickened pallette portion extending between the at least two tooth casings corresponding to the user's pallette; and a groove along gingival margins; wherein the device is formed using the steps of: preparing a cast replica from an original dental impression taken from the user; modifying the cast replica to create a temporary modified model; forming a permanent model from the temporary modified model; and forming the dental device from the permanent model.

46. The customized dental device of claim 45, further comprising a clip structure associated with each of the at least two tooth casings, each clip structure having an open-ended pincer arrangement.

47. The customized dental device of claim 45, wherein the device is thermoformed, and wherein the cast replica is modified using wax.

48. The customized dental device of claim 45, wherein the device is injection molded, and wherein the device is made of acetyl resin.

49. The customized dental device of claim 46, wherein each clip is formed to partially extend around a mesial surface of the user's corresponding teeth.

50. The customized dental device of claim 45, wherein the thickened pallette portion is formed by alternating steps of adding a powder polymer and adding a liquid monomer.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0056] For a better understanding of the invention, and to show how exemplary embodiments may be carried into effect, reference will now be made to the accompanying drawings in which:

[0057] FIG. 1 is a schematic view of a typical upper and lower jaw showing the teeth;

[0058] FIG. 2a is a front view of a cast made from an impression from a patient;

[0059] FIG. 2b is a front view of the cast of FIG. 2a that has been processed according to the method of the invention;

[0060] FIG. 3a is an underside view of the cast of FIG. 2a made from an impression from a patient;

[0061] FIG. 3b is an underside view of the cast of FIG. 3a that has been processed according to the method of the invention;

[0062] FIG. 4a is a front view of the unprocessed veneer form prepared from the processed cast of FIG. 2b;

[0063] FIG. 4b is an underside view of the unprocessed veneer form of FIG. 4a;

[0064] FIG. 4c is a front view of the unprocessed veneer cut from the veneer form of FIG. 4a;

[0065] FIG. 5a is a perspective side view of a processed veneer made from the unprocessed veneer of FIG. 4c;

[0066] FIG. 5b is a perspective upside-down side view of the processed veneer of FIG. 5a;

[0067] FIG. 6a is a front view of the processed veneer of FIG. 5a;

[0068] FIG. 6b is a front upside-down view of the processed veneer of FIG. 5a;

[0069] FIG. 7a is a front view of a patient cast without veneers;

[0070] FIG. 7b is a front view of a patient case with veneers;

[0071] FIG. 8a is an underside view of a processed veneer of FIG. 5a in place on the cast replica;

[0072] FIG. 8b is a bottom-up view of the processed veneer of FIG. 5a;

[0073] FIG. 9a is an underside view of a waxed-up duplicate replica that has been processed according to a different embodiment of the method of the invention; and

[0074] FIG. 9b is a bottom-up view of a processed veneer made from the duplicate replica of FIG. 9a.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0075] The method of making a non-permanent dental device (10, 100) with improved retention capability on a patient's set of teeth according to the invention, comprises the steps of: (a) preparing a cast replica (20) from an original dental impression taken from the patient; and (b) forming the dental device (10, 100) using the cast replica (20) as a model, wherein the method further comprises reducing one or more dimensions of the cast replica (20) in one or more predetermined retention areas (50).

[0076] As shown in FIGS. 5, 6, 8 and 9, the method of the present invention generally applies to making of a non-permanent dental device (10, 100) that covers up to the first ten teeth (including the incisors, canines, and pre-molars). If the most distal of the pre-molars (tooth 5) is missing, the dental device (10, 100) would only cover the first eight teeth (to tooth 4). In the instance where the pre-molars (teeth 4 and 5) are completely missing, the dental device (10, 100) would only cover the first six teeth (to tooth 3 on each side).

[0077] The conventional process for making a removable/non-permanent dental device (10, 100) which will fit over a patient's teeth comprises the following steps.

[0078] 1) A Dental Impression is Taken from a Patient (Not Shown). [0079] The impression is taken using a very precise impression material loaded into a bite tray, which is then applied to the patient's teeth and held there until set (usually 3-5 minutes depending upon the impression material used). It is usually very important that the impression is clear and accurate, preferably with no drag.

[0080] 2) Preparing a Cast Replica (20) of the Patient's Teeth. [0081] In accordance with conventional practice, this is done by pouring casting material into the impression and allowed to set. Once set, the cast is removed from the impression and trimmed of the excess material to create the cast replica (20). A cast replica (20) is shown in FIGS. 2a and 3a and comprises replica teeth (21), the replica gum (22), the peripheral palatal or lingual surface (23) and the gingival margins (24, 25).

[0082] 3) Modifying the Cast Replica (20) to Create a Temporary Modified Model (30). [0083] During this step, reconstruction work is performed on the cast replica (20) using wax to build up any teeth (as at 31) and fill in any cracks, chips, gaps and spaces (32). If there are teeth missing these are usually filled using preformed acrylic denture teeth (33). The wax is not be applied to the gingival margins (24, 25). The end of an Ash 5 is used to scrape along the replica buccal/palatal and lingual/labial gingival margins (24, 25) making the insertion as smooth as possible to distinguish the replica teeth (21) from replica gum (22) more clearly. If there is any drag on the cast replica (20) it is removed at this stage to form the temporary modified model (30).

[0084] 4) Forming a Permanent Model (Not Shown) from the Temporary Modified Model (30) [0085] A (second) impression (not shown) of the temporary modified model (30) is taken. This is done using an impression tray similar to the method in step 1, but instead performed upon the temporary modified model (30). The second impression is checked for imperfections and corrected accordingly. The permanent model is created from the second impression, by pouring casting material into the second impression and allowing to set. Once the impression material is set, the permanent model is removed from the second impression and trimmed of excess material.

[0086] 5) Forming the Pre-Device (40). [0087] This is done using the permanent model or, if there is no permanent model (usually because no reconstruction work is required) from the cast replica (20). The correct shade of device-forming material (41) is selected and laid over the cast replica (20)/permanent model and thermoformed using a Dreve or equivalent Pressure Former. The pre-device (40) comprises at least a number of tooth casings (45) that correspond to simulated teeth surrounded by excess material (46).

[0088] 6) Shaping the Pre-Device (40) to Form the Device (10). [0089] Whilst the pre-device (40) is still in situ on the cast replica (20)/permanent model, an ultra-fine tip marker is used to: [0090] (a) draw (42) along the buccal/labial gingival margin (24), and [0091] (b) draw a straight line (43) 2 mm below the gingival margin (25) along the palatal/lingual part of the pre-device (40). [0092] The device (10) is then lifted off the cast replica (20)/permanent model. Using a pair of Quinby scissors or equivalent the device (10) is cut 1 mm below the drawn lines (42, 43). [0093] The device (10) comprises a number of connected tooth casings/simulated teeth (11).

[0094] 7) Adapting the Fit of the Device (10) to the Patient's Teeth. [0095] The temporary modified model (30) from step 3 is taken back to its original cast replica (20) state by removing all of the reconstruction wax material (31, 32) and acrylic teeth (33), typically by boiling off/steaming off all the wax. Any undercuts are blocked out and any preformed acrylic teeth that formed part of the temporary modified model (30) are placed in the correct place within the device (10). [0096] A filling material, usually a cold curing acrylic, is poured into the inside of the dental device (10) (e.g. inside the tooth casings (11)) and then the dental device (10) is quickly applied to the cast replica (20) and secured. It is important to remove any excess acrylic immediately and then the device (10) is placed in a warm Hydraflask until the acrylic is set. The adapted device (10) is then taken off the original cast replica (20).

[0097] 8) Finishing the Dental Device (10). [0098] The edges of the device (10) are smoothed and the surface is polished to give a comfortable fit.

Specific Method Steps According to a First Embodiment of the Present Invention

[0099] The method of the present invention improves on the conventional method by adapting certain method steps and adding new steps to produce a first type of device (10) as shown in FIGS. 5, 6, 7 and 8.

[0100] Step 1A Dental Impression is Taken from a Patient (Not Shown)

[0101] This step is the same as described in the conventional method.

[0102] Step 2Preparing a Cast Replica (20) of the Patient's Teeth

[0103] This step is the same as described in the conventional method.

[0104] Between Steps 2 and 3Reducing One or More Dimensions of the Prepared Cast Replica (20).

[0105] In the present invention, an additional method step is employed between steps 2 and 3 in which one or more dimensions of the prepared cast replica (20) are reduced.

[0106] In one specific embodiment of the present invention, this is achieved by shaving away 0.5 mm of cast material from the surface at predetermined areas (50) on the cast replica (20).

[0107] In a different embodiment of the present invention, the reduced dimension(s) is/are achieved by the addition of 0.5 mm impression material to the patient's impression (not shown) in step 1 at predetermined areas (not shown) that correspond to the predetermined areas (50) on the cast replica (20). This results in a cast replica (20) with reduced dimensions (by 0.5 mm) in the predetermined areas (50).

[0108] In either of the two embodiments, the predetermined areas (50) correspond to the lingual surface (on a lower/mandibular cast replica), or the palatal surface (on an upper/maxillary cast replica) of one or more teeth. As shown in FIG. 3b, in an exemplary embodiment, the predetermined area corresponds to the lingual surface (on a lower/mandibular cast replica), or the palatal surface (on an upper/maxillary cast replica) of the final tooth (tooth 5). In any event this adaptation will apply to the last available tooth, or the penultimate tooth.

[0109] With the addition of this method step, the resultant dental device (10) is slightly smaller and therefore, tighter around the patient's teeth at predetermined areas (18) on the device (10) that correspond to the predetermined areas (50) on the cast replica (20).

[0110] In use, due to the method steps employed, the whole device (10) is a snug fit against the contours of the patient's teeth, gingival margins and palatal/labial gum. However, due to the resiliently deformable characteristics of the material (41) used, when the device (10) is being fitted, the smaller predetermined areas (18) of the device (10) are able to flex and slide over the respective patient's teeth. The predetermined areas (18) click firmly into position over the patient's corresponding teeth to give a durable retentive fit. The device (10) therefore, provides greatly improved retention performance.

[0111] Step 3Modifying the Cast Replica (20) to Create a Temporary Modified Model (30)

[0112] This step is the same as described in the conventional method.

[0113] Step 4Forming the Permanent Model.

[0114] The best result to establish a permanent model has been found using a medium impression tray and Zhermacks Hydrogum 5 alginate. Once the impression is set, a debubbiliser is used prior to casting the permanent model therefrom.

[0115] Step 6Forming the Clip (60).

[0116] During shaping of the device (10), a clip (60) is formed from the last replica/simulated teeth/tooth casings on both sides of the device (10). Each clip (60) is integrally moulded as part of the device (10) and is therefore attached to an adjacent support structure (19) on the device (10). The support structure (19) will depend upon the individual patient's teeth and how many teeth the device (10) is being made to cover. The support structure (19) will usually comprise an adjacent simulated/replica tooth formed as part of the device (10), or an adjacent tooth cover. The support structure (19) may comprise a simulated tooth, or veneer (tooth casing (11)) for an adjacent tooth.

[0117] Each clip (60) is shaped to encase the lingual/palatal surface and the buccal/facial surface of the respective tooth. Therefore, each clip (60) is cut from the pre-device (40) to define two side walls (61, 62) to provide a lingual/palatal wall (61) and a buccal/facial wall (62) respectively. During cutting, care is taken to ensure that the side walls (61, 62) curve around to encompass the available portions of the mesial and distal walls of the tooth casings (11).

[0118] The lingual/palatal side wall (61) on each clip comprises the predetermined area (18).

[0119] During moulding, it may be that openings (63, 64) are automatically provided at either end of the walls (61, 62), although, cutting of the device (10) may be required to free the distal end of the clip (60).

[0120] Each clip (60) may be left with a simulated occlusal surface or wall. However, in a preferred embodiment, each clip (60) is freed of the replica occlusal surface to leave an open top side.

[0121] With this configuration, the clips (60) are provided with a greater degree of flexibility to facilitate fitting, but allow for the improved retention performance.

[0122] Step 8Finishing the Device

[0123] It is important to ensure that the finished device (10) is comfortable to wear for long periods of time. Therefore, the following steps are performed: [0124] a) a Queenie point or Rubber polisher is used to smooth and shape all edges. [0125] b) a white lisko (fine) is lightly moved over the edges. [0126] c) a scalpel is used to cut any excess material off. [0127] d) a fine diamond disc is used to lightly separate each tooth individually. [0128] e) an orange lisko (ultra-fine) is used over all edges.

[0129] Additional Step

[0130] In another embodiment of the present invention, replica occlusal surfaces (not shown) that cover the patient's pre-molar teeth are provided on the device (10) as part of the process.

[0131] Prior to the finishing step 8, the replica occlusal surfaces are cut away using a tungsten carbide bur to provide openings (16, 17) in the device (10). Accordingly, the patient's occlusal surfaces are uncovered when the device (10) is worn, and so there is no inhibition to chewing.

Specific Method Steps According to a Second Embodiment of the Present Invention

[0132] The method of the present invention improves on the conventional method by adapting certain method steps and adding new steps to produce a second type of device (100) as shown in FIG. 9b-c.

[0133] Step 1A Dental Impression is Taken from a Patient (Not Shown)

[0134] This step is the same as described in the conventional method.

[0135] Step 2Preparing a Cast Replica (20) of the Patient's Teeth

[0136] This step is the same as described in the conventional method. The casting material is chosen specifically to be suitable for use with acetyl resin.

[0137] Between Steps 2 and 3Reducing One or More Dimensions of the Prepared Cast Replica (20).

[0138] As discussed in relation to the first embodiment of the invention, in the present embodiment, an additional method step is employed between steps 2 and 3 in which one or more dimensions of the prepared cast replica (20) are reduced.

[0139] Step 3Modifying the Cast Replica (20)

[0140] Modification of the cast replica (20) comprises defining the buccal/palatal and lingual/labial gingival margins with the Ash 5 scrape as before. However, no reconstruction work is performed at this stage.

[0141] Step 3Modifying the Cast Replica (20) to Create a Temporary Modified Model (90)

[0142] In this step, as shown in FIG. 9a, the cast replica (20) is waxed up by applying wax (91) to create a temporary modified model (90). The wax (91) is intended to model a desired aesthetic, such as the smile of a famous person, or a perfect smile. Therefore, the application of the wax (91) is accurately performed on the model (90) to reflect the shape, size and configuration of the final device (100).

[0143] Step 4Forming the Permanent Model.

[0144] This step is adapted considerably to prepare for an injection moulding process using an injection moulding machine. The end result is a permanent injection mould.

[0145] Using a two part dental flask that is applicable to a particular injection moulding machine, the temporary modified model (90) is sunk into one half of the flask. The flask is then closed on the temporary modified model (90). The flask is filled with plaster and left to set.

[0146] Once set, the flask is opened and the wax is boiled away from the temporary modified model (90) to revert back to the cast replica (20), which remains embedded in the flask.

[0147] Step 5Forming the Pre-Device

[0148] The flask is once again closed and the injection process is performed. The injection mould is left to set and cool before de-flasking takes place.

[0149] Step 6Shaping the Pre-Device (40) to Form the Device (10).

[0150] Since the device (100) was injection moulded using the cast replica (20) of the patient's teeth, the external configuration of the device (100) is already shaped and so no further significant shaping is necessary.

[0151] Step 7Adapting the Fit of the Device (100) to the Patient's Teeth

[0152] Since the device (100) was injection moulded using the cast replica (20) of the patient's teeth, the internal configuration of the device (100) is already adapted to the patient's teeth and so no further adaptation is necessary.

[0153] Step 8Finishing the Device (100).

[0154] It is important to ensure that the finished device (10) is comfortable to wear for long periods of time and aesthetically accurate. Therefore, the following steps are performed: [0155] a) the device (100) is de-flasked carefully. [0156] b) the device (100) is eased onto the original cast replica (20). [0157] c) a white lisko (fine) is lightly moved over the edges. [0158] d) a scalpel is used to cut any excess material off. [0159] e) a fine diamond disc is used to lightly separate each tooth individually. [0160] f) an orange lisko (ultra-fine) is used over all edges. [0161] g) The device (100) is polished to a high sheen.

[0162] The above method provides a preferred device (100) with exceptional aesthetic characteristics, durability and retention performance.

[0163] During injection moulding of the device (100), a clip (600) is formed from the last replica/simulated teeth/tooth casings on both sides of the device (100). Each clip (600) is integrally moulded as part of the device (100) and is therefore attached to an adjacent support structure (190) on the device (100). The support structure (190) will depend upon the individual patient's teeth and how many teeth the device (100) is being made to cover. The support structure (190) will usually comprise an adjacent simulated/replica tooth formed as part of the device (100), or an adjacent tooth cover. The support structure (190) may comprise a simulated tooth, or veneer (tooth casing (110)) for an adjacent tooth.

[0164] Each clip (600) is shaped to encase the lingual/palatal surface and the buccal/facial surface of the respective tooth. Therefore, each clip (600) is moulded to define two side walls (610, 620) to provide a lingual/palatal wall (610) and a buccal/facial wall (620) respectively. During cutting, care is taken to ensure that the side walls (610, 620) curve around to encompass the available portions of the mesial and distal walls of the tooth casings (110). The lingual/palatal side wall (610) on each clip comprises the predetermined area (180).

[0165] During moulding, openings (630, 640) are automatically provided at either end of the walls (610, 620), although, cutting of the device (100) may be required to free the distal end of the clip (600). Each clip (600) is freed of the replica occlusal surface to leave an open top side. With this configuration, the clips (600) are provided with a greater degree of flexibility to facilitate fitting, but allow for the improved retention performance.

[0166] The device (100) is made from crystallized acetyl resin, which is very durable and has a slight flexibility. The flexibility allows the device (100) to flex over the heights and contours of the existing teeth and snap back onto the gingival third of the teeth. A device (100) formed from this resin is expected to last about 3 to 5 years and possibly longer with proper care.

[0167] During the method, the carving (in step 3) of the labial/palatal wall of the last tooth enhance the clip (600) function. This is helpful in cases where there are multiple missing teeth, since the device (100) can surround the abutment tooth/teeth circumferentially, utilizing not only the buccal and lingual aspects of the teeth, but also the mesial and distal aspects, and obtain almost the same retention performance.

[0168] Specific Devices Made According to the Present Invention

[0169] The present invention provides a non-permanent dental device (10, 100) with improved retention capability on a patient's set of teeth, comprising one or more reduced internal dimensions to produce a tighter fit on the patient's teeth at predetermined retention points or areas (18, 180).

[0170] The predetermined retention points or areas (18, 180) provide a tighter fit. The location of the areas (18, 180) are tailored to the individual patient depending upon the teeth that are available, but as shown in FIGS. 5-8 and in most circumstances, the areas (18, 180) correspond to the lingual surface (on a lower/mandibular cast replica), or the palatal surface (on an upper/maxillary cast replica) of the most distal pre-molar (tooth 5) on each side of the mouth.

[0171] The reduced dimension(s) of the device (10, 100) are smaller than the outer dimensions of the corresponding patient's dimensions at the predetermined areas (18, 180) by approximately 0.5 mm and the device (10, 100) is formed from a resiliently deformable/flexible material.

[0172] Each of the predetermined areas (18, 180) forms part of a clip (60, 600) that is shaped to encase the lingual/palatal surface and the buccal/facial surface of the respective tooth. Therefore, each clip (60, 600) defines two side walls (61/610, 62/620) to provide a lingual/palatal wall (61, 610) and a buccal/facial wall (62, 620) respectively. Each of the side walls (61/610, 62/620) curves around to encompass the available mesial and distal surfaces of the respective tooth.

[0173] The lingual/palatal side wall (61, 610) on each clip comprises the predetermined area (18, 180).

[0174] During moulding, it may be that openings (63/630, 64/640) are automatically provided at either end of the walls (61/610, 62/620), although cutting of the device (10, 100) may be required to free the distal end of the clip (60, 600) and provide the opening (64, 640).

[0175] Each clip (60, 600) may be left with a simulated occlusal surface or wall. However, in a preferred embodiment, each clip (60, 600) is freed of the replica occlusal surface to leave an open top side.

[0176] The replica occlusal surfaces are cut away to provide openings (16/160, 17/170) in the device (10,100). With this arrangement, mastication is greatly improved when the dental device is in place.

[0177] The dental device (10, 100) comprises a natural abutment with the patient's gingival margin.

[0178] Veneers

[0179] In one embodiment of the invention as shown in FIGS. 5-8, the device (10, 100) is a non-permanent set of veneers comprising a plurality of simulated teeth (tooth casings) or veneers (11, 110), a peripheral palatal or lingual surface (13, 130), and clips (60, 600) comprising the predetermined areas (18, 180). The material corresponding to the simulated teeth (11, 110), the palatal or lingual surface (13, 130), the clips (60, 600) and the predetermined areas (18, 180) is approximately 1 mm in thickness.

[0180] The result is a non-permanent dental veneer device (10, 100) with improved retention capability on a patient's set of teeth comprising one or more simulated teeth/tooth casings (11, 110).

[0181] Anti-Obesity/Slimming Device

[0182] In another embodiment of the present invention the device (10, 100) is a non-permanent dental anti-obesity/slimming device comprising a palatal surface portion that covers a significant portion of the patient's palate, and also comprising the clips (60, 600) comprising the predetermined areas (18, 180) as before. The material corresponding to the clips (60, 600) and the predetermined areas (18, 180) is approximately 1 mm in thickness, although the palette is increased up to approximately 15 mm in thickness.

[0183] The increase in the palette thickness is achieved using the Salt and Pepper method (alternating application of a monomer (liquid) and a polymer (powder) in the following steps (to be completed in a timescale of 3-4 minutes to avoid porous acrylic): [0184] 1. Apply a small amount of separator to a lingual side of the palette on the device (10, 100) with a separator brush and spread it evenly; [0185] 2. Secure wires into place on the buccal side of the device (10, 100) with wax, using a #7 wax spatula. [0186] 3. Hold the device (10, 100) model slightly tilted toward the side acrylic resin will be applied and apply a thin layer of polymer (powder). [0187] 4. Powder along the lingual tooth surfaces of the device (10, 100) to the middle of the palette. [0188] 5. Apply several drops of monomer (liquid) until the polymer has been absorbed by monomer. [0189] 6. Repeat steps 3-5 using thin layers of monomer/polymer until the palette is approximately 3-4 mm thick. [0190] 7. Spray a very light film of polymer on the palette so that the acrylic will not run down the vault of the palate. [0191] 8. Turn the device over and repeat steps 3-7 until the other side of the palette is also approximately 3-4 mm thick. [0192] 9. Place the device (10, 100) in a heated pressure pot with 20 pounds of air pressure for 10-15 minutes to allow the acrylic to cure.

[0193] The method and the devices made according to the invention provide improved retention performance when compared with devices made according to other methods. The whole device (10, 100) provides a snug fit against the contours of the patient's teeth, gingival margins and palatal/labial gum. However, due to the resiliently deformable characteristics of the material (41) used, when the device (10, 100) is being fitted, the clips (60, 600) comprising the predetermined areas (18, 180) of the device (10, 100) are able to flex and slide over the respective patient's teeth. The clips (60, 600) click firmly into position over the patient's corresponding teeth and deliver a tighter fit due to the reduced dimensions provided by the altered predetermined areas (18, 180) to give a durable retentive fit. The device (10, 100) therefore, provides greatly improved retention performance.

[0194] Although a few preferred embodiments have been shown and described, it will be appreciated by those skilled in the art that various changes and modifications might be made without departing from the scope of the invention, as defined in the appended claims.