SNORING AND OBSTRUCTIVE SLEEP APNEA PREVENTION DEVICE

Abstract

An oral appliance (OA) made as add-on optional feature in a denture of a user with or without implants to facilitate adjustable mandibular advancement assisting in partially or fully reducing snoring and thus ameliorating obstructive sleep apnea (OSA). The mandibular advancement is realized by deployment of pins in the denture set, and a set of straps that may have optional features such as recess, reinforcement, and the OA may be made of bio-compatible materials using several manufacturing approaches including 3D printing, molding, or milling. An optional additional process comprises of economical production of a similar or alternatively simpler, lighter secondary unit that may be offered to a patient ordering a primary denture, at a discounted price that may serve the purpose of cosmetic function as well as anti-snoring function.

Claims

1. A system for preventing or assisting in reducing condition of snoring or obstructive sleep apnea comprising of means to hold a pair of dentures inside human oral cavity for enabling mandibular advancement.

2. The system of claim 1, wherein at least one pair of two pins and a strap is deployed to enable holding of a mandibular part of a denture set in an advanced position relative to a maxillary part of the denture set.

3. The system of claim 2, wherein a set of straps of different lengths are deployed to vary the amount of mandibular advancement.

4. The system of claim 2 or 3, wherein the straps may have a slit or recess to allow relative movement between the mandibular and maxillary parts of the denture.

5. The system of claim 1, wherein denture set may be provided as denture without implants such as Removable Partial Dentures or Removable Full Dentures.

6. The system of claim 5, wherein retention of denture is enhanced by use of glue between denture and gum adequate to withstand mandibular advancement force.

7. The system of claim 1, wherein denture set may be provided as any of the Implant Supported Dentures, such as single tooth dental implant, multiple-tooth on implant-supported bridge, or multiple-tooth on implant-retained denture.

8. The system of claim 1, wherein one or more constituent parts are made of bio-compatible Nylon.

9. The system of claim 1, wherein at least one or more constituent parts are made by 3D printing or additive manufacturing process.

10. The system of claim 1, wherein all constituent parts are made by 3D printing or additive manufacturing process.

11. The system of claim 2 or 3, wherein the straps are made from blanking process.

12. The system of claim 2 or 3, wherein the straps are made of multi-layer hybrid construction wherein a stronger material such as Kevlar® cord is core to provide strength over which bio-compatible material such as Nylon-12 is coated allowing a combination of both strength as well as flexibility.

13. The system of claim 12, wherein the combination of strength and flexibility facilitates relative movement between the mandibular and maxillary parts of the denture set in multiple directions of 3D space, specifically forward-backward, upward-downward, leftward-rightward, or other possible intermediate directions.

14. A process for increased use of anti-snoring or obstructive sleep apnea reducing means of claim 1 by providing the steps obtain intra-oral information necessary and adequate for manufacture of denture; manufacture and provide primary denture set; suggest and offer a secondary denture set; follow through consent of user to deploy earlier obtained intra-oral information for manufacture of a secondary denture set; provide secondary denture set.

15. The process of claim 14, wherein a secondary denture set is provided at discounted price for cosmetic or anti-snoring or both purposes.

16. The process of claim 15, wherein the secondary denture set is made of different design compared to primary denture set satisficing only cosmetic or anti-snoring or both purposes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] FIG. 1A presents a photographic view of a typical conventional full denture set.

[0042] FIG. 1 shows an overall assembled view of an embodiment of the invention having a maxillary full denture, a mandibular full denture, the two connected by a pair of straps.

[0043] FIG. 1B presents a view of a typical strap connecting a maxillary denture, and a mandibular denture.

[0044] FIG. 1C shows a sectional view of the FIG. 1B.

[0045] FIG. 2A shows a representative set of straps of different lengths to enable different distances of mandibular advancement.

[0046] FIG. 2B, 2C, 2D show alternative embodiments of configurations of the straps and shapes of pin heads that enable advantages in ensuring securing and ease of change of straps.

[0047] FIG. 2E shows a sectional view of a typical multi-layer strap configuration with a stronger cord material reinforcing as core to enable improved durability with flexibility.

[0048] FIG. 3 shows a punch and die set for blanking process as an optional manufacturing process for straps to enable economy of scale.

[0049] FIG. 4 shows an overall assembled view of an embodiment of the invention having a typical ISD set comprising of a maxillary part, a mandibular part, and a pair of straps connecting the maxillary and mandibular parts to enable desired mandibular advancement.

[0050] FIG. 5 shows the schematic diagram for an optional additional production and business process offering a secondary discounted priced unit to a patient ordering a primary denture generating add-on revenue.

DETAILED DESCRIPTION OF THE INVENTION

[0051] An overall illustration of a conventional full denture set is presented in a photographic view of a typical set in FIG. 1A. The set is well known in the art as upper or maxillary denture and lower or mandibular denture. Each denture has a denture base, a denture flange, denture borders and denture teeth.

[0052] FIG. 1 illustrates a configuration of mandibular and maxillary dentures in relation with the lower and upper jaws of a user respectively, pointing out the locations of different anatomical parts of interest in view of the disclosed inventive aspects for fixation of straps to realize mandibular advancement to mitigate snoring or OSA. The jaws of user are shown in an open state to be able to view the internal parts of oral cavity of the user. The lower jaw has lower gum (also called gingiva) part 10 placed over a bone structure 11 in the mandible. The bone structure extends to the back as a Temporomandibular Joint (TMJ) 15 comprising of parts known in the art as condyle 12, fossa 13, and disc 14. The mandibular denture 20 is placed over the lower gum 10 in a reasonably tight but comfortable fit and remains retained during day-to-day activities of the user such as speaking, chewing, etc. In a standard denture that does not use any implants to secure the denture to the mandible, the shape and fit between the mandible and the mandibular denture serve the purpose of retention.

[0053] The user is generally provided with options for increased levels of retention, for example, by inserting or applying between denture 20 and gum 10 bio-compatible human use safe glue materials claiming several characteristics such as being Zinc free, impervious to water, providing soft cushion, quality seal from food particles, ooze-control, use of natural ingredients like gum wax, beneficial herbs, and vitamins. Several glue products are available, for example, Effergrip® denture adhesive cream (manufacturer: Prestige Consumer Healthcare, Irvington, N.Y.; Source: Amazon® USA), Fixodent® Ultra Max Hold Dental Adhesive (Procter & Gamble®, Cincinnati, Ohio, USA), SECURE® Sensitive Adhesive (Cutting Edge International, LLC, Los Angeles, Calif., USA), Instant Smile™ Secure Fit Adhesive (Billy Bob Products Inc., Hardin, Ill., USA), Super Poligrip® Denture and Partials Adhesive Cream (Glaxo Smith Kline, Philadelphia, Pa., USA), Corega® Denture Adhesive Cream (Glaxo Smith Kline, Bulgaria, Source: Amazon®, USA), Y-Kelin Denture Adhesive Cream (Anhui Greenland Biotech Co. Ltd., Bengbu, Anhui, China), DenSureFit® Lower Denture Reline Kit (OTC Dental Inc., Vancouver, Wash., USA), and from many other manufacturers or sources.

[0054] The use of glue between denture and gum is found to achieve good average retention force in compliance with reported research, for example, in the range of 16.66±7.32 lbs for milled denture bases and in the range of 12.19±6.15 lbs for the conventional heat polymerized denture bases (AlHelal, Abdulaziz Abdullah, “Comparison of Retention between Milled and Conventional Denture Bases: A Clinical Study” (2016), Loma Linda University Electronic Theses, Dissertations & Projects, 323). Our experimental tests have shown that 3D printed dentures provide better or at least comparable retention force relative to milled denture bases. We have found that this retention force is adequate to withstand the mandibular advancement force reported in the art as approximately 1 to 1.2 Newtons per millimeter of mandibular advancement (for example, 1.18 Newtons per millimeters as per J Cohen-Levy, B PeteIle, J Pinguet, E Limerat, B Fleury, Sleep Breath, 2013 May; 17(2):781-9. doi: 10.1007/s11325-012-0765-4. Epub 2012 Sep. 11).

[0055] The mandibular denture 20 comprises of an exterior wall or flange 21, an exterior ridge or border 22, and an interior ridge or border 23. A cavity known in the art as trough is formed between the exterior and interior walls that fits over the lower gum 10. A set of teeth 25 that substitute natural teeth known in the art with nomenclature (starting from back or TMJ side, a set of teeth—one on left and one on right sides) Second Molar, First Molar, Second Premolar, First Premolar, Canine or Cuspid, Lateral Incisor, and Central Incisor (front most teeth set) are embedded symmetrically in the mandibular denture in a U-shaped configuration. This is considering the prevailing trend of not having Third Molar or Wisdom teeth at the back most location, like the natural teeth set where their extraction is recommended by dentist profession, resulting in a total fourteen teeth in the mandibular denture.

[0056] Analogous to the mandibular denture 20, the maxillary denture 30 comprises of an exterior wall or flange 31, an exterior ridge or border 32, and an interior ridge or border 33. A cavity known in the art as trough is formed between the exterior and interior walls that fits over the upper gum 16. Generally, an impression of upper palate of user's oral cavity is obtained to provide a bridge between the left and right sides of interior walls in the maxillary denture. This bridge part known as Palate 34 generally is in close contact with the user's upper palate helping in improved retention of the maxillary denture. The maxillary denture 30 is placed over the upper gum 16 in a reasonably tight but comfortable fit and remains retained during day-to-day activities of the user such as speaking, chewing, etc. In a standard denture that does not use any implants to secure the denture to the maxilla, the shape and fit between the maxilla and the maxillary denture along with palatal contact serve the purpose of retention. The user is generally provided with options for increased levels of retention, for example, by inserting or applying between denture 30 and gum 16 bio-compatible human use safe glue materials claiming several characteristics as mentioned earlier in the context of mandibular denture. A set of teeth 35 that substitute natural teeth known in the art with nomenclature (starting from back or TMJ side, a set of teeth—one on left and one on right sides) Second Molar, First Molar, Second Premolar, First Premolar, Canine or Cuspid, Lateral Incisor, and Central Incisor (front most teeth set) are embedded symmetrically in the maxillary denture in a U-shaped configuration. This is considering the prevailing trend of not having Third Molar or Wisdom teeth at the back most location, like the natural teeth set where their extraction is recommended by dentist profession, resulting in a total fourteen teeth in the maxillary denture.

[0057] A location 51 on the user's right-side wall 31 of the maxillary denture 30, and location 52 on the user's right-side wall 21 of the mandibular denture 20 exemplify the locations of connection of pins 45 illustrated in FIG. 1B and FIG. 1C. Similarly, a location 55 on the user's left-side wall of the maxillary denture 30, and location 56 on the user's left-side wall of the mandibular denture 20 exemplify the locations of connection of pins 45 illustrated in FIG. 1B and FIG. 1C. The pins may be integrated structurally with respective denture body while manufacturing the same by molding, milling, 3D printing or additive manufacturing or other fabrication methods. Alternatively, other approaches also may be deployed such as affixing the pins into the denture bodies by adhesion, fitting into receptor holes, or by screwing into receptor threaded holes by having matching threads in the pins, or a combination of such approaches. FIG. 1B illustrates a view of a strap 40 assembled with the dentures using the pins 45 as viewed from the front of the walls of the dentures.

[0058] FIG. 1C illustrates a sectional view of the assembly shown in FIG. 1B wherein the strap 40 is retained or fixed on the maxillary denture 30 and mandibular denture 20 using a pair of pins 45 that have pin heads 46. The pins and pin heads are not sectioned in the section A-A view shown in FIG. 1C. The pin heads 46 may be an integral part of the pins 45 in an embodiment of the invention. The pin heads 46 may be attached to the pins 45 in another optional embodiment of the invention by means such as threads, snap fit, and other methods. The shapes of the pins and the pin heads are shown as circular cylindrical in the embodiment illustrated in the FIGS. 1B and 1C, however, those skilled in the art may appreciate that there are several other conceivable shapes possible, and all such shapes are included in the spirit of this invention. The gainful deployment of a few of those shapes are illustrated in FIG. 2D and described in the following paragraphs.

[0059] FIG. 2A illustrates a set of 4 different lengths of strap 40. The set of different lengths enables customization of the amount of mandibular advancement that may work most effectively for a particular user. Typically, the relative positions of pins 45 fixed on the mandibular denture 20 and maxillary denture 30 is such that use of shortest strap results in maximum mandibular advancement, whereas the use of longest strap results in minimum mandibular advancement. Different strap lengths may be tried between these to optimise the amount of mandibular advancement best suited for a particular user considering factors such as clearance of airway passage, and comfort of use including reduction or management of side effects such as temporomandibular joint (TMJ) pain. Optionally and preferably, the configuration of a strap 40 illustrated in the Figures has a relatively thicker boss area surrounding the pin hole to provide better strength and thus resistance to tear due to the mandibular advancement force reported in the art as approximately 1 to 1.2 Newtons per millimeter of mandibular advancement (for example, 1.18 Newtons per millimeters as per J Cohen-Levy, B PeteIle, J Pinguet, E Limerat, B Fleury, Sleep Breath, 2013 May; 17(2):781-9. doi: 10.1007/s11325-012-0765-4. Epub 2012 Sep. 11, as quoted earlier). Those skilled in the art may appreciate that there may be other number of straps in a set ranging from 2 to 10 or more or even a single strap optimised a priori before handing over to a user, and all such possibilities are within the scope and spirit of this invention disclosure.

[0060] FIG. 2B illustrates a set of 4 different lengths of another optional configuration of strap 40 wherein there is a slot. The set of different lengths enables customization of the amount of mandibular advancement that may work most effectively for a particular user. Typically, the relative positions of pins 45 fixed on the mandibular denture 20 and maxillary denture 30 is such that use of shortest strap results in maximum mandibular advancement, whereas the use of longest strap results in minimum mandibular advancement. Different strap lengths may be tried between these to optimise the amount of mandibular advancement best suited for a particular user considering factors such as clearance of airway passage, and comfort of use including reduction or management of side effects such as temporomandibular joint (TMJ) pain. Optionally and preferably, the configuration of a strap 40 illustrated in this Figure has a slot recess connecting the pin holes to provide sliding between the pin and the slot thus better flexibility of movement between maxillary and mandibular jaws in forward-backward, upward-downward, and lateral (leftward-rightward) directions. Those skilled in the art may appreciate that there may be other number of straps in a set ranging from 2 to 10 or more or even a single strap optimised a priori before handing over to a user, and all such possibilities are within the scope and spirit of this invention disclosure.

[0061] Optionally, and in addition to the configurations described so far, FIG. 2C illustrates a circular, elliptical, and a rectangular portion of increased sized recess or slot portion at the middle portion of the strap. This larger recess in the slot of strap is intended to allow a circular, elliptical or rectangular head 46 of pin 45 to come out of the strap facilitating ease of change of strap. This configuration of the invention is incorporated to ameliorate the problem of unwanted disengagement between pin and strap when the pin hole or slot connecting the pin holes is kept too large to facilitate the ease of change of strap. By providing a larger recess only at the middle part, the disengagement during use inside mouth of the user is avoided. As the strap is required to be changed only outside the mouth of user, the maxillary and mandibular dentures can be freely moved to a relative position such that a pin can access the wider recess at the middle of a strap to facilitate removal of strap from pin. The figure shows increase in outer width of the strap to retain strength of the strap at the middle portion.

[0062] FIG. 2D illustrates the different shapes of pin heads 46, viz. circular, elliptical and rectangular cross-sections, as can be seen in end view-P, whereas, the pin is generally circular cross section in most cases.

[0063] An optional but additional configuration of the strap has a stronger reinforcement cord embedded inside a relatively weaker strap material to solve a problem that was encountered during trials, namely tearing off or severance of the strap. This is of particular relevance and advantage of this disclosure where the strap is made of flexible material, for example, made of one of the acceptable bio-compatible elastomers (Saliterman, Steven S., “Introductory Medical Device Prototyping: Medical Device Polymers”, Presentation, Dept. of Biomedical Engineering, University of Minnesota, USA); whereas the reinforcement cord may be made of a stronger material such as Kevlar® (DuPont®, headquartered at Wilmington, Del., USA, manufactured by Advanced Fibre Systems, VA, USA). FIG. 2E (not to scale, only indicative representation) shows a sectional view of a typical multi-layer strap configuration with a stronger cord material reinforcing as core to enable improved durability with flexibility. The circular cross section of the reinforcing cord 41 can be seen embedded inside the strap cross-section. The combination of both strength as well as flexibility allows the relative movement between the mandibular and maxillary parts of the denture in multiple directions of 3D space, viz. forward-backward, upward-downward, leftward-rightward. The multi-layer construction may be achieved by several alternative manufacturing means such as molding, 3D printing, or other methods that may be available in the state-of-the-art, gainfully deployed for this application.

[0064] Mass production of straps deploying economy of manufacture scale may be an optional yet another additional method deployed as an alternative to a stronger reinforced strap configuration. FIG. 3 illustrates a perspective view of configuration of a typical punch set showing the contours of the end faces of the punches 310 and 320 that may be deployed for progressive 2-step blanking process, each using a different punch and die set (dies are not shown in the figure) as an optional manufacturing process for straps (for example, the third shape out of the shape options illustrated in FIG. 2C) to enable economy of scale, wherein a large number of inexpensive spare straps may be provided instead of stronger and costlier straps. It can be appreciated by those skilled in the art that a punch-die set comprises of closely slidably fitting cavity in a die that receives a correspondingly shaped protrusion known as punch, the relative impact between die and punch piercing the part of a sheet material of interest placed between a punch and a die. In the illustrated case, the pierced part produced by the first set of punch-die interaction will produce an interim part as blank, while the second set of punch and die interaction will produce a useful intended strap part and a scrap or waste part corresponding to the shape of slot or recess in the strap. We have found that bio-compatible versions of materials such as Kapton® (DuPont®, headquartered at Wilmington, Del., USA) available readily in sheet form are suitable raw material for such blanking process.

[0065] While the figures and description in this disclosure has presented in detail full maxillary and mandibular dentures, we have developed several additional and optional embodiments that are covered by the scope and spirit of the overall invention. For example, an embodiment of the invention has a typical RPD set comprising of a maxillary part, a mandibular part, an embrasure clasp, a pair of multiple circlet clasps, and a pair of straps connecting the maxillary and mandibular parts to enable desired mandibular advancement. Clasps are means to secure partial dentures with the help of surviving natural teeth in a person's jaws. The terminology of different types of clasps are well known in the denture related art, but to our knowledge not gainfully deployed or used in oral appliances for obstructive sleep apnea or anti-snoring devices. We have experienced and found the forces that can be withstood by unique designs and arrangements of different types of retainers/clasp assemblies, without glue, to have enough retention force to withstand mandibular advancement force that is in fact quite small. This is found to be valid for several clasp designs, for example, Circumferential (Circle or Akers) clasp, Ring clasp, Embrasure (Double Akers) Clasp, “C” clasp (Hair-pin or Reverse action), etc.

[0066] Another optional variant of the embodiment described above is the one wherein an improvised embrasure clasp is deployed to enable facilitation of resting the tongue of wearer constraining it so that it does not slide backwards contributing to airway blockage.

[0067] In yet another optional and additional variant of the embodiment discussed so far, a combination of multiple improvised clasps is deployed to enable facilitation of adjustable mandibular advancement with or without the need for straps.

[0068] Furthermore, in another optional variant of the embodiment presented above, a combination of multiple improvised clasps is deployed to enable facilitation of adjustable mandibular advancement without the need for straps, additionally providing for resting the tongue of wearer constraining it so that it does not slide backwards contributing to airway blockage.

[0069] Furthermore, another optional embodiment of the invention has a typical ISD set comprising of a maxillary part, a mandibular part, and a pair of straps connecting the maxillary and mandibular parts to enable desired mandibular advancement. FIG. 4 illustrates typical locations of implant pins 810 on the mandible's lower gum 10 over bone structure 11, and implant pins 820 on the upper gum 16 of maxilla that are used to retain the denture on the wearer's jaws, essentially serving the purpose of retention of denture without the use of adhesive. The dentures possess mating holes that slidably and snugly receive corresponding implant pins to form good connection and thus retention of dentures over the gums. These dentures are found to have higher retention force capacity compared to adhesive based retention, thus can very easily overcome the mandibular advancement forces. Those skilled in the art can appreciate that the number of implants and their locations depend on several factors such as jawbone density, jawbone loss, bone grafting, etc.; and thus although 2 to 4 implants per jaw are typical, there may be more implants necessary in some cases, for example, 12 to 16 dental implants have been found necessary in some cases. For the purpose of withstanding the mandibular advancement force of approximately 1 to 1.2 Newtons per millimeter of mandibular advancement, considering that the advancement required is generally within 5 millimeters, these numbers of implants are adequate. Generally, the number of implants needed for the dual purpose of general denture retention for chewing and for mandibular advancement is found to be same or close to the number of implants needed for single conventional purpose of denture retention only for chewing.

[0070] Furthermore, in another optional but additional variant of the embodiment described above, an improvised embrasure clasp is deployed to enable facilitation of resting the tongue of wearer constraining it so that it does not slide backwards contributing to airway blockage.

[0071] Furthermore, in yet another optional but additional variant of the embodiment described above, a combination of multiple improvised clasps is deployed to enable facilitation of adjustable mandibular advancement with or without the need for straps.

[0072] Furthermore, in yet another optional but additional variant of the embodiment described above, a combination of multiple improvised clasps is deployed to enable facilitation of adjustable mandibular advancement without the need for straps, additionally providing for resting the tongue of wearer constraining it so that it does not slide backwards contributing to airway blockage.

[0073] Additionally, but optionally, a universal version of the invention utilizing a compliant clasp approach is also invented that may be worn over either denture or natural teeth due to its lightweight and ease of attachment-detachment configuration to facilitate anti-snoring provisions.

[0074] Furthermore, in yet another optional but additional variant of the embodiment described above, another universal version of the invention utilizes a compliant clasp approach enabling stepless mandibular adjustment that may be worn over either denture or natural teeth due to its lightweight and ease of attachment-detachment configuration to facilitate anti-snoring provisions.

[0075] Furthermore, yet another optional but additional universal version of the invention utilizes a compliant clasp approach that may also be elastic enabling stepless mandibular adjustment with spring characteristic that may be worn over either denture or natural teeth due to its lightweight and ease of attachment-detachment configuration to facilitate anti-snoring provisions with enhanced comfort for the wearer allowing jaw movement.

[0076] Furthermore, yet another optional but additional universal version of the invention utilizes a reactive latch mechanism that realizes a mandibular advancement only after the user has gone on sleep causing excessive relaxation of the mandible relative to the maxilla, to facilitate anti-snoring provisions with enhanced comfort for the wearer allowing natural or moderate relaxed jaw positions during onset of sleep.

[0077] FIG. 5 illustrates the schematic diagram for an optional additional inventive process 1500 comprising of economical production of a secondary unit that may be offered to a patient ordering a primary partial or full, removable or permanent denture; at a discounted price that may serve the purpose of cosmetic function as well as anti-snoring function. This also illustrates gainful deployment of a business process promoting sale of primary denture, and/or add-on revenue generation through sale of secondary denture. This innovative process obtains intra-oral information 1510 that may involve use of either conventional mold material usage such as impression material and allied equipment for capturing the configurations of user's mandibular gum and maxillary gum or adjacent teeth in addition to the gums in the case of removable partial dentures (RPDs). Alternately, heat, chemically, or catalytically moldable materials may be used to obtain the impression. Optionally, other alternatives such as scanning of user's gum or teeth using imaging devices or scan of mold may be resorted to. This information 1520 is necessary and adequate for manufacture of partial or full, removable or permanent denture, and may be gainfully used or deployed for manufacturing either a primary denture 1540 and/or a secondary denture 1590. The manufacturing process 1530 may include Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) comprising of different options such as 3D printing, forming, thermo-forming such as injection molding, or milling.

[0078] While delivering the primary denture ordered by the user, or before the ordering process, or during the ordering process, or subsequently, an optional sleep study 1550 may be offered to the user. The sleep study may comprise of any of the different levels of sleep studies (Level 1, Level 2, Level 3, Level 4) either at a sleep lab or at home. With or without this optional sleep study, the user of denture may be offered a secondary denture at a discounted price. This offer process step 1560 involves suggestion and counselling 1570 about the advantages of a secondary set of dentures to be worn at night during sleep time that may be either an exact duplicate of the primary denture, or alternatively and preferably; a simpler, lighter, version with provisions such as increased exposure of gums to air as the purpose of this secondary denture is not chewing of food. While serving cosmetic purposes avoiding any embarrassing situations where the user may be exposed to known or new acquaintances by getting caught off-guard without any denture, the secondary denture also serves the important purpose as an anti-snoring device. Even if the user is not aware or not formally diagnosed for sleep disorders knowingly or un-knowingly, the secondary denture serves an important function of prevention is better than cure motto 1580. Once the user is convinced of the advantages of acquiring a secondary denture at discounted price, the necessary information 1520 for production that was available earlier for primary denture production may be advantageously re-used for manufacture process 1530 to produce the secondary denture 1590. While sleep study 1550 is just optional, in case the same is preferred by a user, furthermore optionally, related additional appliances such as a variety of biosensors 1551, sleep application 1552, and a kit 1553 comprising of one or more of a sleep mask, ear plugs, cleaning kit, bite re-positioner, jaw position measuring tool, and chewing gum may be offered and deployed for the sleep study. The biosensors 1551 deployed may be one or more biosensors configured to measure one or more sleep parameters, wherein the one or more sleep parameters are selected from heart rate, breathing rate, head movement, body movement, bite force, body temperature, blood glucose levels, actigraphy, oximetry, apnea hypopnea index (AHI), peripheral arterial tone (PAT), cardiac data, chest expansion, respiratory air flow, sleeping position, patient compliance and snoring.