Background

A dental restoration, or a dental filling, utilizes a restorative dental material used to improve function, integrity and morphology of missing or irregular tooth structure. For example, a dental restoration may be used to restore missing tooth structure due to congenital discrepancies, following external trauma, or as part of a restorative treatment for dental caries, or tooth decay.

Restorative dentistry often includes drilling decay from an infected tooth (commonly referred to as “preparing” the tooth) and then using simple tools and a high level of craftsmanship to isolate, retract, fill and contour the finished restoration. Quality isolation via a rubber dam is cumbersome and often skipped for less effective isolation via cotton rolls - increasing the risk of contamination which reduces longevity of the restoration. Retraction of soft and hard tissue includes manipulation of cords, wedges and matrix bands, and imperfect technique may result in contamination, difficulty in finishing and/or polishing in interproximal areas, and poorly adapted contacts.

While ‘bulk fill’ restorative materials and high intensity curing lights facilitate relatively fast filling of deep cavities (e.g., 4-5 mm), many restorations are completed in a single shade as practitioners may be uncertain of the correct layering protocol for multiple shades or types of restorative material. Last, with little geometrical guidance available on a prepared tooth, creation of the final filling level and surface geometry may include overfilling with restorative dental material, followed by an iterative process of grinding and checking tooth contact and biting function on an anesthetized patient. This process may be the most time consuming for dental restorations and errors here may result in tooth sensitivity and return visits for adjustment.

Commonly-assigned patent applications United States Patent Publ. No. 2018/0021113, titled “Dental Restoration Molding Techniques,” filed December 7, 2015, United States Patent Application Serial No. 16/061362, titled “One-Piece Dental Restoration Molds,” filed December 15, 2016, United States Patent Application Serial No. 16/061350, titled “Dental Restoration Molds,” filed December 15, 2016, WO 2018/022616 Publ. No., titled “Dental Restoration Molds,” filed July 25, 2017, and United States Patent Provisional Application Serial No. 62/560457, titled “Dental Restoration Molds,” filed September 19, 2017 all disclose dental restoration techniques incorporating the molding of dental restorative material directly on a tooth located within the mouth of a patient.

Summary

This disclosure relates to methods for dental restoration, custom tools used for dental restoration and techniques for producing custom tools for dental restoration In one example, the disclosure is directed to a custom tool for forming a dental restoration in a mouth of a patient. The custom tool includes a lingual mold body for a patient-specific, customized fit with the lingual side of at least one tooth of the patient, wherein the lingual mold body includes a restorative portion; and a tongue guard. In another example, the disclosure is directed to a different custom tool for forming a dental restoration in a mouth of a patient. This custom tool includes a facial mold body for a patient-specific, customized fit with the facial side of at least one tooth of the patient, wherein the facial mold body includes a restorative portion; and a tongue guard. In yet another example, the disclosure is directed to yet a different custom tool for forming a dental restoration in a mouth of a patient. This custom tool includes a mold body providing for a customized fit with at least one tooth of the patient, the mold body including a facial portion and further including a separate lingual portion, wherein the mold body is configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of the tooth; and a tongue guard.

In further examples, the disclosure is directed to methods of forming a dental restoration, and methods of designing a custom tool for forming a dental restoration of a tooth.

Brief Description of the Drawings

Figure 1 is a front view of an embodiment of a facial mold body that may be a part of a custom tool for forming a dental restoration;

Figure 2 is a back view of the facial mold body of Figure 1;

Figure 3 is bottom view of the facial mold body of Figure 1 ;

Figure 4 is a front view of an embodiment of a lingual mold body that may be a part of a custom tool for forming a dental restoration;

Figure 5 is a back view of the lingual mold body of Figure 4;

Figure 6 is bottom view of the lingual mold body of Figure 4;

Figure 7 is a front view of an embodiment of a tongue guard that may be a part of a custom tool for forming a dental restoration;

Figure 8 is a back view of an embodiment of the tongue guard of Figure 7;

Figure 9 is perspective view of the facial mold body of Figure 1, the lingual mold body of Figure 4, and the tongue guard of Figure 7 prior to interlocking them together;

Figures 10A and 10B are top views convenient for showing how the facial mold body of Figure 1 and the lingual mold body of Figure 4 may interlock together to form an embodiment of custom tool for forming a dental restoration;

Figure 11 is a perspective view of the custom tool of Figure 10B;

Figures 12A and 12B are a perspective and top view of the custom tool of Figure 11 in the mouth of a patient;

Figure 12C is a partial cross sectional view of an alternative embodiment of the custom tool in the mouth of the patient shown in Figures 12A and 12B.

Figures 13A-13D illustrate example steps for using the tool of Figure 9 to form a dental restoration in the mouth of the dental patient; Figure 14A illustrates another embodiment of a tongue guard that may be a part of a custom tool for forming a dental restoration;

Figure 14B illustrates yet another embodiment of a tongue guard that may be a part of a custom tool for forming a dental restoration;

The following embodiments are intended to be illustrative of the present disclosure and not limiting.

Detailed Description

Restorative dentistry may be used to add tooth structure to a patient’s dentition, e.g., to an existing tooth, in order to improve at least one of function, integrity, aesthetics, or morphology of missing or irregular tooth structure. For example, restorative dentistry can be an aesthetic treatment to improve appearance of teeth by, for example, altering their shape and/or optical properties (e.g., shape, translucency), which can be achieved using any suitable technique, such as by applying a veneer, managing position or contour of adjacent soft tissues, lessening or removing a gap (diastema) and/or resolving the appearance of malposition. As another example, restorative dentistry may be used to adjust the biting or chewing function of teeth to affect tooth function and/or other aspects of overall oral health such as temporomandibular joint (TMJ) disorders, periodontal involvement, gingival recession or as part of a larger plan to construct a healthy and stable oral environment.

In some cases, a dental restoration process includes drilling decay from an infected tooth or reshaping teeth by removing undesired tooth structure (e.g., which may be referred to as “preparing” the tooth) and then using tools and craftsmanship to manually isolate, retract, fill and contour the finished restoration.

Different techniques may be used to isolate the dental restoration site. Quality isolation of the dental restoration site via a rubber dam can be cumbersome and may be skipped for less effective isolation via cotton rolls, which may increase the risk of contamination, reduce longevity of the restoration, or both. Retraction of soft and hard tissue may include manipulation of cords, wedges and matrix bands. Imperfect retraction techniques may result in contamination, difficulty in achieving proper tooth contours and symmetry, finishing and/or polishing in interproximal areas, poorly adapted contacts, or any combination thereof.

While “bulk fill” restorative materials and high intensity curing lights may facilitate relatively fast filling of deep cavities (e.g., 4-5 mm), many restorations may be completed in a single shade as practitioners may be uncertain of the correct layering protocol for multiple shades or types of restorative material. Additionally, with little geometrical guidance available on a prepared tooth, creation of the final filling level and surface geometry may include overfilling with restorative dental material, followed by an iterative process of grinding and checking tooth proportions, symmetry, contact and biting function on an anesthetized patient. This process may be the most time consuming for dental restorations and errors here may result in compromised smile aesthetics, tooth sensitivity and return visits for adjustment. Although several patent applications and patents describe tools and methods for dental restorations, there remains a need for improved methods and tools to manage the patient’s tongue during dental restoration procedures so that the tongue does not interfere with the restoration process.

The tools described herein may include features designed to provide interferences between the two primary mold portions of the tool and certain engagement portions which interlock, which overall helps with preventing relative movement between the mold portions in multiple directions, helps with better clamping of the tool to the patient’s teeth and for sealing the two mold portions together. Such interferences are digitally designed into the custom mold is when it is designed and produced.

Traditional molds do not have digitally designed interferences. In order to interlock together or separate the two mold portions from each other, they may need to deform or bend. In addition, the tools described herein may eliminate the need for external tools, like ring clamps, and are instead self-contained and thus, quicker and simpler to install on a patient’s teeth. In addition, captive doors provide a reduction of individual parts that need to be assembled, and decreasing the likelihood of losing individual parts.

Lastly, the tools described herein may reduce flash and/or to allow increased control of the placement of restorative material compared to practitioners using more traditional skills and techniques.

In some examples, a tool described herein may be digitally designed. For example, a tool may be designed using a three-dimensional (3D) model of the patient’s tooth structure (e.g., obtained from an intraoral scan of all or part of the patient’s dentition or scanning of a conventional impression or model). The tool can be, for example, manufactured from the digital data using an additive technique, such as 3D printing, or a subtractive technique, such as CAD/CAM milling.

In some examples, the tool for a dental restoration may include a mold designed based on the 3D model of the patient’s tooth structure, and may include additional features to provide advantages over molds that are formed based simply on the 3D scan, a wax mold, or other molds based simply on the shape of the anatomy and/or desired tooth structure of the patient. The disclosed techniques may facilitate high quality dental restorations with improved quality, reduced flash, reduced time and/or skill requirements compared to conventional dental restoration techniques.

Example tools for a dental restoration are described in commonly-assigned patent applications United States Patent Publ. No. 2018/0021113, titled “Dental Restoration Molding Techniques,” fried December 7, 2015, United States Patent Application Serial No. 16/061362, titled “One-Piece Dental Restoration Molds,” fried December 15, 2016, United States Patent Application Serial No. 16/061350, titled “Dental Restoration Molds,” fried December 15, 2016, WO 2018/022616 Publ. No., titled “Dental Restoration Molds,” fried July 25, 2017, and United States Patent Provisional Application Serial No. 62/560457, titled “Dental Restoration Molds,” fried September 19, 2017, the entire contents of which are incorporated by reference.

While a dentist performs a dental restoration, she may ask the patient to relax their tongue or move it away from the area where the restoration is being performed. This is to avoid the tongue inadvertedly interfering with the restoration when it is performed. However, most patent’s tongues are constantly moving, and it can be difficult for a patient to relax. Even a momentary movement of the tongue onto a restoration site can transfer saliva which can then permanently compromise the performance of the restoration that is being constructed. The present invention includes a tongue guard, which helps stop the tongue from moving in the area where the tooth or teeth restoration is planned. The tongue guard prevents the tongue from moving past the front teeth longitudinally, such as from the lingual to facial direction, or prevents the tongue fully or partially moving laterally or vertically within the mouth of the patient. Different embodiments of the inventive tongue guard are described relative to Figures 7-14B below.

Figures 1, 2, and 3 illustrate an embodiment of a facial portion of the custom tool 10 of the present invention. Figures 4, 5, and 6 illustrate an embodiment of a lingual portion of the custom tool 10 of the present invention. Figures 7, 8, 14A, and 14B illustrate different embodiments of the tongue guard. Figures 9-13D illustrate how the facial portions, tongue guard, and lingual portion fit together to form a complete a custom tool 10 for forming a patient-specific dental restoration.

Figures 1-3 are views of the facial mold body 12 of custom tool 10 for forming a patient-specific dental restoration. The tool 10 includes a facial mold body 12, which may be configured to provide a personalized, unique, and customized fit with at least one tooth of a patient. For example, facial mold body 12 may be specifically designed to fit next to, mate with, and provide restorative structure to the at least one tooth. In the example shown in Figure 1, the facial mold body 12 includes a restorative portion 16 and an engagement portion 18. A practitioner uses the restorative portion 16 of the custom tool to restore at least one tooth in the mouth of the patient. In the illustrated embodiment, there are two engagement portions 18a, 18b positioned at opposite ends of the restorative portion 16, which is located between the engagement portions 18a, 18b. This is ideal, but not necessary. For example, the facial mold body 12 could include just one engagement portion 18 positioned adjacent the restorative portion 16. In tools having two engagement portions 18a, 18b, this provides two points of interlock between the lingual and facial mold bodies 12, 14.

The first engagement portion 18a and second engagement portion 18b both extend away from the restorative portion 16. In the illustrated embodiment, the engagement portions 18 extend at a generally right angle relative to the restorative portion 16. When compared to the patient’s mouth, which includes an occlusal plane shown generally by line A-A in Figure 2) the engagement portions 18 extend generally perpendicular to such occlusal plane.

The length of the engagement portions 18 extend some distance from the restorative portion 16 of the facial mold body 12. The length of the engagement portions may be customized and optimized for the individual patient. If the engagement portions are too long, they will stretch the patient’s jaw, making it uncomfortable for her. If the engagement portions are too short, the facial mold body 12 will disengage from the patient’s teeth. In one embodiment, the length of the engagement portions may be 1 mm to 5 cm in length. However, it may depend on where exactly the engagement portions are located in the patient’s mouth. They may be longer, if they are attached to the patient’s teeth near the front of the mouth, such as the incisors. They may be shorter, if they are attached to the back of the mouth, like the molars. Also, the patient’s overall opening distance between the upper and lower arches of teeth is a design consideration.

As illustrated in Figure 3, engagement portions 18 of the facial mold body 12 may include a variety of engagement surfaces configured to mate appropriately with the engagement surfaces on a lingual mold body 14. Engagement portions 18a, 18b of the facial mold body 12 may include a protrusion 20a, 20b respectively or some other mechanism known in the art for interlocking with the lingual mold body 14. In the illustrated embodiment, protrusion 20 includes a first engagement surface 24, a second engagement surface 26, and a third engagement surface 28. Protrusions 20a, 20b are sized and shaped to interlock or snap fit with the indentations 30a, 30b in the lingual mold body 14. Alternatively, engagement portions 18 of the facial mold body 12 could include a protrusion on one end and an indentation on the opposite end, and the lingual mold body 14 could include an indentation on one end and a protrusion on the opposite end, to allow the two bodies 12, 14 to interlock together. Various structures known in the art may be substituted for the protrusion 20 and indentations 30, so long as they assist in securely interlocking the facial mold body 12 to the lingual mold body 14. For example, dovetail vertical slides or button and snaps may also be used as interlocking features of the engagement portions.

The engagement portions 18a, 18b of the facial mold body 12 are structured to engage with or interlock with the engagement portions 31, 32, and 33 on the lingual mold body 14, as explained in more detail below in reference to Figures 9, 10A, and 10B.

In the illustrated embodiment, the restorative mold body 16 is sized and shaped to mate with the anterior teeth of a patient. The engagement portions 18 are sized and shaped be adjacent to the posterior teeth. However, in other embodiments (not illustrated), an engagement portion 18 could be adjacent the anterior teeth and the restorative portions 16 could be adjacent the posterior teeth.

In the example shown in Figure 2, the facial body 12 includes one or more apertures 34, which may each be configured to align with a portion of a facial surface of a respective tooth of the patient to be restored. In some examples, the portion is a majority of the facial surface of the tooth to be restored. For example, aperture 34 may be configured to align with a portion comprising a majority of a facial surface of one tooth and aperture 34 may be configured to align with a portion comprising a majority of a facial surface of another tooth. The surface of the tooth to be restored and aligned with the respective apertures 34 may, for example, be defined by existing tooth structure or by the dental restoration formed using the facial mold body 12 and lingual mold body 14.

Each of the apertures 34 has a suitable configuration (e.g., shape and/or size) for introducing restorative material into a mold cavity defined by an interior surface 42 of door 40 and the interior mold surface 64 of the lingual mold body 14 (shown in Figure 4) to cover the portion of the surface of the tooth to be restored, where both interior surfaces 42, 64 are surfaces facing the tooth or teeth to be restored. When door 40 is mated with a respective aperture 34, the surface 42 of the door 40 and the tooth structure of a patient may help shape the restorative material that is placed in the mold cavity, e.g., in order to define the surface of the tooth to be restored.

In some embodiments, the shape of one or more of apertures 34 may be designed to substantially match the shape of the tooth and/or the portion of the tooth to be restored. For example, apertures 34 may be substantially noncircular. In other examples, however, the shape of one or more apertures 34 may be circular.

Apertures 34 may be sized to be larger than a tip of a dental capsule or a syringe tip that is used to introduce restorative dental material into the mold cavity defined by mold bodies 12, 14. Apertures 34 may be sufficiently large to allow placement and flow of restorative material to cover the portion of the surface of the tooth being restored. Additionally, or alternatively, apertures 34 may be sufficiently large to allow movement of the tip of the capsule or syringe tip within aperture 34.

The facial mold body 12 may have individual doors 40 sized to closely fit with corresponding apertures 34. Some of the doors 40 may be attached to the facial mold body 12 as illustrated with a hinge 48 and hinge pin 46 at one end, and an attachment mechanism 44 at the other end. The attachment mechanism 44 in this case is a clip 44 which is designed to clip over or snap onto an engagement surface on the facial mold body 12. As such, the hinge 48 and hinge pin 46 are adjacent the occlusal surfaces of the patient’s teeth or located proximate an incisal edge of a tooth or teeth to be restored and the clip 44 and engagement surface are adjacent the gingiva of the patient’s teeth. This arrangement is convenient for the clip to snap over the occlusal surfaces or incisal edge of the patient’s teeth, spaced away from their tongue. However, in other embodiments not illustrated, their relative positions may be reversed, with the clip 44 and engagement surface adjacent the incisal or occlusal surfaces of the patient’s teeth and hinge 48 and hinge pin 46 adjacent the gingiva.

Additionally, some of the doors 40 may be attached to the facial mold body 12 as illustrated using a two-part hinge, having a first portion 56 and a second portion 58, and hinge pin 46 at one end, and an attachment mechanism 44 at the opposite end. The attachment mechanism 44 in this case is a clip 44 which is designed to clip over or snap onto an engagement surface on the facial mold body 12. The first portion of the hinge has a smaller diameter than the second portion of the hinge 58. The two-part hinge is convenient for lifting away and pulling the door 40 away from the aperture 34, when the second portion 58 is used. The two-part hinge is convenient for tightly inserting the door 40 into the aperture 34. The hinge pin 46 may move between the smaller diameter first portion and the larger diameter second portion of the hinge 58, as illustrated in Figures 12A- 13C.

In the illustrated embodiment, the door body 40 and facial mold body 14 are mechanically connected to each other by using a hinge 48 and hinge pin 46. This configuration helps maintain proper alignment between the door body 40 and corresponding aperture 34 during use of custom tool 10. However, door body 40 and facial mold body 14 may be connected via a snap hinge, a living hinge, a barrel hinge, a pin joint hinge, or any other suitable type of hinge. Door hinge 48 and hinge pin 46 may be formed separate from the door body 40 and/or facial mold body 14, or door hinge 48 and hinge pin 46 may be formed as an integral part of door body 40 and/or facial mold body 14.

The facial mold body 12 may include a first alignment member 52, which assists in properly aligning the facial and lingual mold bodies 12, 14 and tongue guard 100 before interlocking them together. In the illustrated embodiment, the first alignment member 52 is a post that is sized to fit with the second alignment member 54 in the lingual mold body 14, shown as a slot 55 in Figures 4-6. The facial mold body 12 and lingual mold body 14 may be configured to combine with at least one tooth of the patient to define a mold cavity encompassing at least a portion of desired tooth structure of the tooth or teeth to be restored. For example, in the illustrated example, the facial mold body 12 and lingual mold body 14 may combine with teeth of the patient to define a mold cavity encompassing at least a portion of desired tooth structure for each of the teeth with facial portions aligning with apertures 34. In some examples, the dental restoration may include a dental veneer restoration on the tooth or teeth to be restored, and the apertures 34 may allow a practitioner to have better control over the placement of restorative material in the mold cavity than a traditional mold. For example, the apertures 34, which align with a majority of a surface of a lingual or facial surface of a tooth may allow a practitioner to have better control over the final appearance of that surface, including the final surface texture, shading, and layering of the restorative materials.

Although not numbered, door body 40 could include a vent. A vent may be configured to allow excess restorative material to flow out of a mold cavity, which may be removed prior to curing (e.g., with a scalar instrument), providing for easier removal of flash. Alternatively, or in addition, a vent may be configured to allow air to flow out of the mold cavity.

The facial mold body 12 may include a custom gingival surface 36 that is generally contoured to match the patient’s individual gingiva, but not engaging such gingiva. This allows excess restoration material to be cleanly removed. The facial mold body 12 may also include a customized facial rib 38 to provide overall strength to the facial mold body.

Custom tool 10 may include a lingual mold body 14, which may also be configured to provide a personalized, unique, and customized fit with the at least one tooth of the patient. Figures 4, 5, and 6 illustrate views of one embodiment of the lingual mold body 14. Facial mold body 12 and lingual mold body 16 may be configured to combine with the at least one tooth of the patient to form the mold cavity. For example, facial mold body 12 and lingual mold body 14 may be configured to mate with one another and/or to be attached to the at least one tooth to form the mold cavity. In some examples, lingual mold body 14 is separable from and engageable with the facial mold body 12, while maintaining the integrity of the respective mold bodies, through use of their engagement portions 18, 19. The lingual mold body 14 may also include a custom gingival surface.

In the example shown in Figures 4-6, the lingual mold body 14 includes a restorative portion 17 and an engagement portion 19. A dental practitioner uses the restorative portion 17 of the custom tool 10 to restore at least one tooth in the mouth of the patient. In the illustrated embodiment, there are two engagement portions 19a, 19b positioned at opposite ends of the restorative portion 17, which is located between the engagement portions 19a, 19b. This is ideal, but not necessary. For example, the lingual mold body 14 could include just one engagement portion 19 positioned adjacent the restorative portion 17. In tools having two engagement portions 19a, 19b, this provides two points of interlock between the lingual and facial mold bodies 12, 14.

Lingual mold body 14 includes first engagement portion 19a and second engagement portions 19b. The engagement portions 19a, 19b of the lingual mold body 16 are structured to engage with or interlock with the engagement portions 18a, 18b on the facial mold body 12, as explained in more detail below in reference to Figures 9- 11.

The first engagement portion 19a and second engagement portion 19b both extend away from the restorative portion. In the illustrated embodiment, the engagement portions 19 extend at a generally right angle relative to the restorative portion 17. When compared to the patient’s mouth, which includes an occlusal plane illustrated as reference line B-B shown in Figure 5), the engagement portions 19 extend generally perpendicular to the occlusal plane.

As illustrated in Figure 5, engagement portions 19 of the lingual mold body 12 may include a variety of engagement surfaces configured to mate appropriately with the engagement surfaces 24, 26, 28 on the facial mold body 14. Engagement portions 19a, 19b of the lingual mold body 14 may include an indentation 30a, 30b respectively or some other mechanism known in the art for interlocking with the facial mold body 12. In the illustrated embodiment, indentation 30 includes a first engagement surface 31, a second engagement surface 32, and a third engagement surface 33. Indentations 30a, 30b are sized and shaped to interlock or snap fit with the protrusions 20a, 20b in the facial mold body 12. Various structures known in the art may be substituted for the indentations 30 and protrusion 20, so long as they assist in securely interlocking the lingual mold body 14 to the facial mold body 12.

In the illustrated embodiment, the restorative mold body 17 is sized and shaped to be mate with the anterior teeth of a patient. The engagement portions 19 are sized and shaped to be adjacent the posterior teeth. However, in other embodiments (not illustrated), an engagement portion 19 could be adjacent the anterior teeth and the restorative portion 17 mate with the posterior teeth.

The lingual body 14 includes mold surfaces 64 sized to create appropriate mold cavity or cavities with the inner surface 42 of the door 40 (shown in Figures 1-3) and/or in combination with the tooth structure of a patient to help shape the restorative material that is placed in the mold cavity or cavities in order to define the surface of the tooth or teeth to be restored.

The lingual mold body 14 may include a custom lingual rib 39 to provide additional clamping or mating to the individual patient’s mouth.

The lingual mold body 14 may include a second alignment member 54 sized and shaped to fit with the first alignment member 52. In the illustrated embodiment, the second alignment member 54 may be mesial alignment receptor. Specifically, the second alignment member may be a portion 55 sized to receive the posts 5 on the facial mold body 12. Figures 7 and 8 illustrate an embodiment of the tongue guard 100 useful with the facial body 12 and lingual body 14. The tongue guard 100 may be most useful for use with dental restorations on the mandibular arch (the lower arch) of a patient because the mandible arch contains the tongue in the same relative space. The tongue guard may come in a variety of shapes and sizes. The guard 100 serves to assist in containing the patient’s tongue to avoid the tongue involuntarily or accidentally interfering with operations by the dentist during the restoration. The guard may also provide some comfort to the patient by limiting, reducing tongue muscle strain and fatigue experienced during the procedure. Other embodiments of the tongue guard are illustrated in Figures 14A and 14B.

Unlike the facial and lingual bodies 12, 14, the tongue guard could be either designed to be customized and unique for the individual patient, or could come in standard designs and shapes useful for most patient’s mouths. If it is designed in a noncustomized manner, such as useful for multiple patients’ mouths, then the tongue guard 100 would have standard mating fixtures to secure it to the lingual mold body 14. Such mating fixtures are known in the art, and two options are described in more detail below.

The tongue guard 100 includes a first side 102 and a second side 104, which is opposite the first side 102. The first side 102 includes an external surface, facing outwardly of the patient’s mouth. The second side 104 includes an internal surface, facing inwardly of the patient’s mouth and the patient’s tongue 150 will contact the internal surface. For instance, the tongue 150 may rest against the interior surface 104 of the tongue guard, as shown in Figures 12A and 12B.

At the bottom of the tongue guard 100 is a rib 108 which is useful for connecting the tongue guard 100 to the lingual mold body 14. The rib 108 snap fits between the rib 39 and the second alignment member 54 of the lingual mold body 14. The rib 108 of the tongue guard 100 is also designed to align longitudinally with the rib 39 of the lingual mold body 14. In an alternative embodiment illustrated in Figure 12C, the rib 108 of the tongue guard 100 may be integrally formed with the rib 39 of the lingual mold body 12. For instance, the two portion, the lingual mode body 12 and tongue guard 100 may be integrally formed together into one-piece, as illustrated in Figure 12C. For example, the tongue guard can be united to the lingual mold body in a 3D design environment via aligning, scaling and Boolean operations and then physically formed via 3D printing.

In the embodiment illustrated, the tongue guard 100 mates or connects with the lingual mold body 14, and then the lingual mold body 14 mates or connects with the facial mold body 12. However, other embodiments are envisioned where the tongue guard 100 may instead connect directly to the facial mold body 12. For this embodiment, the connection may be designed over the occlusal or incisal surfaces of the teeth.

The tongue guard 100 may include optional apertures 106 cut through the first and second sides 102, 104. Apertures 106 are designed to aid in moisture and fluid management. For instance, they allow the tongue to be exposed to air in help with drying, so as to not to interfere with the dental restoration process. Additionally, apertures 106 provide the patient airflow access for breathing or reducing potential for tongue suction. The apertures 106 also provide a means of introducing flex tuning of the tongue guard 100, potentially for patient comfort. The apertures 106 are also likely necessary for case frame design and three dimensional printing support, as they allow passage of support spars from the case frame to key support areas of the lingual mold body 14. However, this is more of a manufacturing consideration and not an end use functional consideration.

The apertures 106 could come a variety of shapes and sizes. The apertures in Figures 7 and 8 show two different shaped apertures 106a, 106b. Aperture 106a is sized and shape to connect with the first alignment member 52 and second alignment member 54.

Figures 9, 10A, 10B, 11, 12A, 12B, and 12C are useful for illustrating how the facial mold body 12, tongue guard 100, and lingual mold body 14 are assembled together and around the teeth 72, gums 90, tongue 150 of a patient to form a custom tool 10. One of the major benefits of this design is that once assembled, movement between the facial mold body, tongue guard, and the lingual mold body is restricted in multiple directions and multiple rotations. As a result, practitioners are able to create more accurate restorations for their patients. Although illustrated as three separate pieces, the lingual mold body 14 and the tongue guard may be integrally formed into one-piece.

With Figures 10A and 10B as a point of reference, a practitioner may first place the lingual mold body 14 and tongue guard 100 together by connecting the two portions together. In the illustrated embodiment, the two portions 14, 100 may interlock by placing the rib 108 of the tongue guard in alignment with the rib 39 of the lingual bold body and snapping the rib 108 in between the rib 39 and the second alignment member 54. In addition, the two portions 14, 100 may interlock by placing the second alignment member 54 into the aperture 106a. Then, the practitioner may place the interlocked tongue guard 100 and lingual mold body 14 behind the patient’s teeth, with the second alignment member 54 centered adjacent the occlusal surfaces of the patient’s teeth. In some situations, clinicians many perform certain steps of the procedure at this point, such as preparing tooth structure, drying, applying adhesive, opaquer, etc. to the teeth that are isolated by the lingual matrix and tongue guard. Next, the practitioner may place the facial mold body 12 over the front of the teeth and align the first alignment member 52, the post, to fit into the second alignment member 54, the notch. However, in other embodiments, mold bodies 12, 14 and guard 100 could include indicia or alignment features (e.g., visual indicators, other forms of mechanical mating features, keyholes, notches, and the like) to help a practitioner properly align and easily engage facial mold body 12, tongue guard 100, and lingual mold body 16 with one another.

The facial and lingual mold bodies 12, 14 are preferably made of somewhat flexible and elastic materials to bend them at certain radiuses to successfully interlock them together, as illustrated in Figures 10A and 10B. A practitioner will interlock the mold bodies 12, 14 together by placing the protrusions 20a, 20b into the corresponding indentations 30a, 30b. The release tabs 22a, 22b may optionally be used to help fit protrusions 20a, 20b into the indentations 30a, 30b. Custom tools can be made from the full range of 3D printed materials, molded polymeric material or CAD/CAM shaped polymeric materials having certain desired strength, flexibility, translucency, or color. For example, the mold material can be polymeric material that may be transparent, translucent, or opaque. In some embodiments, clear or substantially transparent polymeric material that may include, for example, one or more of amorphous thermoplastic polymers, semi-crystalline thermoplastic polymers and transparent thermoplastic polymers chosen from polycarbonate, thermoplastic polyurethane, acrylic, polysulfone, polyprolylene, polypropylene/ethylene copolymer, cyclic olefin polymer/copolymer, poly-4-methyl-l-pentene or polyester/polycarbonate copolymer, styrenic polymeric materials, polyamide, polymethylpentene, polyetheretherketone and combinations thereof. In another embodiment, the mold may be chosen from clear or substantially transparent semi -crystalline thermoplastic, crystalline thermoplastics and composites, such as polyamide, polyethylene terephthalate. polybutylene terephthalate, polyester/polycarbonate copolymer, polyolefin, cyclic olefin polymer, styrenic copolymer, polyetherimide, polyetheretherketone, polyethersulfone, polytrimethylene terephthalate, and mixtures and combinations thereof. In some embodiments, the mold is a polymeric material chosen from polyethylene terephthalate, polyethylene terephthalate glycol, poly cyclohexylenedimethylene terephthalate glycol, and mixtures and combinations thereof. The custom tool may be formed as well from a wide range of thermoset polymers including acrylics, methacrylates, urethanes, epoxies, silicones and rubbers.

The custom tool 10 is designed to ensure a relatively tight fit between the mold bodies 12, 14 to help reduce or eliminate the flash that occurs along the edge where the two mate together. Any flash that does occur may be very thin along the incisal edge and may be relatively easily removed with a dental instrument. By providing a relatively tight fit along the incisal edge or another edge of mold bodies 12,14, this may help excess restorative material preferentially flow toward a vent, if included(where flash may be relatively easily seen and removed during finishing of the restoration.

Figure 10B is convenient for describing the clamping force that can be generated between the facial mold body 12 and the lingual mold body 14. The facial mold body 12 has a certain arch length C- C and the lingual mold body 14 has a certain arch length D-D. When the custom tool 10 is made, the geometry of the facial and/or lingual mold bodies 12, 14 is altered. For instance, the arch length C-C of the facial mold body 12 may be shortened, while the arch length D-D of the lingual mold body is maintained, and this configuration creates a clamping force between the two mold bodes 12, 14 when they are assembled. As mentioned above, the arch of the rib 108 of the tongue guard 100 will be designed to align with the arch of the rib 39 of the lingual body 14. In addition to the relative designs of the facial and lingual mold bodies arches, the mold bodies 12, 14 are sufficiently strong so as not to break or buckle, and the protrusion 20 and the indentation 30 can be interlocked without creating undue pressure in the mouth of the patient. Clamping forces can also be generated by slightly reducing the radius of curvature of the facial mold body 12, while maintaining the radius of curvature of the lingual mold body 14. Certain angles illustrate the latching surface relative to the arch tangent.

The degree of clamping force between the facial mold body 12 and the lingual mold body 14 should be tailored to balance the security of the installed tool 10 around the patient’s teeth and tongue, and sealing it against the teeth with ease of installation into and removal from the patient’s mouth. The degree of clamping force can be increased by increasing the stiffness of the mold bodies 12, 14 via materials, geometry the amount of shortening of the facial mold body 12, and/or reduction of the radius of curvature of the facial mold body 12. Modifications to the mold bodies 12, 14 can be applied across the mold bodies, for instance by applying an appropriate shrinkage factor, or they can be applied locally to various regions of the mold bodies and/or latching mechanism between the two. Latch securement and ease of engagement and removal can be tailored by adjusting the latching angle, length of the latching surfaces (engagement surface) 31 32, 33 and topography of the surfaces 24, 26, 28 to obtain the best balance of performance. Tools such as finite element modeling can be used to predict the appropriate parameters for a given custom tool based on test results of previously tested cases. Machine learning can be applied to improve prediction capability over time, including feedback on clinical performance from practitioners. Digital design and manufacturing, such as 3D printing or CNC machining, is particularly helpful in creating custom tool molds with active clamping forces.

Figure 11 illustrates the custom tool 10 assembled outside of the mouth of the patient. Figures 12A, 12B, and 12C illustrate the custom dental restorative tool 10 clamped appropriately around the patient’s teeth 72 in the mouth 70 of the patient and illustrates how the tongue guard 100 inhibits the tongue 150 from interfering with the planned restoration. The tongue 150 is contacting with the second surface 104 of the tongue guard 100. The benefits of the tongue guard are described above. As illustrated, the first engagement portions 18a, 19a of the facial and lingual mold bodies 12, 14 are interlocked together within the mouth, offset from the occlusal surfaces of the premolars and extending the direction of the patient’s tongue 150. Similarly, the second engagement portions 18b, 19b of the facial and lingual mold bodies 12, 14 are interlocked. The lingual mold body 14, tongue guard 100, and facial mold body 12 are all designed and shaped to sit in the patient’s mouth 70 comfortably due to their custom shape. In the illustrated embodiment, the patient is having four teeth restored.

Figure 12C illustrates an alternative embodiment of the tongue guard 100 and lingual mold body 14, where they are integrally formed together at their respective ribs 108, 39. This embodiment has certain advantages in that the dentist only then needs to interlock the respective engagement portions 18, 19 of the facial mold body 12 and lingual mold body 14 together and to not worry about the tongue portion 100 somehow disengaging from the lingual mold body 14.

Figures 13A-13D are convenient for illustrating the method steps for using the custom tool 10 of the present invention after the custom tool is properly applied in the patient’s mouth 70. Figure 13A illustrates some of the doors 40 opened to allow access to the teeth 72a, 72b to be restored, which are illustrated as broken. Figure 13B illustrates restorative material 80 applied to the teeth to be restored. Figures 13C illustrates custom tool 10 with doors closed during the curing of the restorative material 80 within the custom tool 10. Figure 13D illustrates the teeth 72 of the patient’s mouth 70 restored.

In some examples, apertures 34 of tool 10 may allow the practitioner to apply the restorative material 80 directly to the tooth to be restored. However, in other examples, the practitioner may apply the restorative material 80 to the tooth to be restored or to mold body 12, 14 before applying mold bodies 12, 14 over the teeth 72 of the patient. The practitioner may fill the mold cavity defined by mold bodies 12, 14 and the teeth around which the mold bodies 12, 14 are positioned with restorative material 80 by introducing the restorative material 80 through one or more of apertures 34 and into the mold cavity (Figure 13B). In some examples, the practitioner may use various tools to place the restorative material into the mold cavity. In some examples, restorative material 80 may be placed in the mold cavity through multiple apertures 34. The tongue guard 100 keeps the tongue 150 in place out of the way of the restoration process, so it does not accidently interfere with the restorative material 80.

One preferable dental restorative material is Filtek™ Supreme Universal A2™, commercially available from 3M Company based in St. Paul, Minnesota. After at least some restorative material 80 is introduced into the mold cavity, the practitioner may then close the door bodies 40 within the corresponding apertures 34 (Figure 13C). The inner surfaces 42 of door bodies 40 and the mold surfaces 64 may be used to shape one or more layers of restorative material 80 on the facial, incisal, occlusal, interproximal, or lingual surface of the tooth 72, to compress restorative material 80 within the mold cavity, or any combination thereof.

In some examples, the practitioner may cure the restorative material 80, while the door bodies 40 are closed into the apertures 34 of the facial mold body 12. For example, if the restorative material is light curable, the practitioner may expose the restorative material to the curing light (e.g., a blue light) through one or both of the mold bodies 12, 14, which may be formed of a material transparent to the curing light. The practitioner may remove the facial mold body 12 and the lingual mold body 14 from the teeth 72, which now have restored structure 72c, 72d defined by the restorative material, as illustrated in Figure 13D. Removing the mold bodies 12, 14 from the mouth 70 may include separating the facial mold body 12 from the lingual mold body 14 and tongue guard 100, which may include, for example, disengaging one or more of the first engagement portions 18a, 19a of the mold bodies 12, 16 from the second engagement portions 19a, 19b of the mold bodies 12, 16. In some example, the one or more of the door bodies 40 may leave “witness marks” on the lingual or facial surface of the tooth, but such marks may be relatively easily removable because they are relatively thin. In some examples, the practitioner may finish the teeth, which now include restored dental structure defined by the restorative material, such as by polishing, to remove flash or other undesired surface imperfections.

In some examples, the practitioner may place a release film on at least a portion of a surface 42 of the door 40 before placing the door 40 within its respective aperture 34. The release film may reduce the likelihood of trapping air within the mold cavity during stamping of the restorative material 80 with the door and/or may facilitate release of restorative material 40 from the surface 42 of the door 40.

In addition to, or instead of, the release film, in some examples, the practitioner may apply a coating on at least a portion of a surface 42 of the door 40 and/or the door body before placing the door 40 within the respective aperture 34. The coating may reduce the likelihood of trapping air within the mold cavity during stamping of the restorative material with the door and/or may facilitate release of restorative material from the surface of the door. Release coatings may also be applied to any of the mold components during the manufacturing process.

The introduction of the restorative material 80 into mold cavity may have enough force to separate parts of mold bodies 12, 14 from each other, thereby providing less of an engagement between facial mold body 12 and lingual mold body 14 and/or less of a customized fit with one or more teeth. However, the engagement portions 18, 19 help mold bodies 12, 14 self-align with each other and stay firmly fixed relatively to each other.

Figures 14A and 14B illustrate other embodiments of the tongue guard 100a and 100b. Tongue guard 100a and 100b both include a series of parallel grooves 105 on the second 104 which provide capillary fluid transport mechanism for the patient’s salvia, and help prevent saliva build up. The grooves 105 may also aid in patient comfort in doing so. . There could be multiple additional embodiments of capillary grooves, arrays of holes, pattemed/non-pattemed structures, etc. that could provide similar functions for fluid management. It should be noted that these additional functional textures, capillaries, features, etc. could also be applied to the first side surface 104 of the tongue guard 100a, 100b. The grooves 105 could alternatively be channels or used for porting away any unwanted fluids.

In Figures 14A and 14B, the internal groves or channeling 105 leads to a port or fitting sized to accept commonly available vacuum tubing (with vacuum used) in a dental operatory. For this case, this embodiment includes saliva intake ports 112. They are used for fluid/saliva management when active vacuum source (not illustrated) is connected and applied to ports 112. Alternatively, positive pressure “air” or other gas could be connected to a port 110 to provide a purging effect through the channeling 105, possibly with a corresponding outlet array directing the air/gas flow to a target area and/or air suction into another areas. Such strategies can be useful in managing both fluid and air flow during the procedure to minimize contamination of restoration surfaces and operatory room environments by saliva, blood, anesthetic gases, respiratory gases, respiratory droplets, etc.

In another embodiment the internal channeling 105 could be where the channeling is arranged to provide thermal transport, either “warming” or “cooling” functions, when a temperature controlled fluid (i.e. water) is ported to the internal channeling. The channeling trajectory, section, and/or density design could be customized to a patient’s anatomy or be specific to the given treatment of that patient. For instance, one patient might prefer heat or cooling on one side of the mouth and/or tongue or more vacuum or purge on one side or region of the mouth versus the other regions. Such customizations could be asymmetric or concentrated to suit the needs and comfort of the individual patient.

The custom molds of the present invention are advantageous of those of the prior art. As one example U.S. Patent No. 8,366,445 (Vuillemot) shows in Figures 4- 5 alignment features to register the buccal and lingual mold portions. The alignment features are placed on the interfacial surface between the buccal and lingual molds. They may be toleranced to provide some frictional resistance to secure the assembled molds. This has the several disadvantages over the spaced part engaging portions that interlocks. For example, the retentive features as shown in Vuillemot complicate the seating and curing of the mold. To create space for the retentive features, the mold interface area must be expanding, resulting in a more bulky design. If frictional forces are used to secure the mold, then these same frictional forces must be overcome to seat the mold and it is difficult to know when the mold halves are completely seated. Molds that are not completely seated will lead to flash as the composite flows into the gap during use. The retentive features on the mating surface result in bonding of the composite to the mold during the curing process and make removal of the molds extremely difficult.

In contrast, the interlocking engaging portions of the present invention, are not placed along the interface, rather they are separately located away from the interfacial surface. This provides several advantages. The interface between the lingual and facial molds is not expanded or complicated by fine alignment features, rather it is smooth, easy to seat closed, and easy to verify that it is seated. There is a smooth interfacial surface to minimize retention forces of any flash cured at the interface. The present latching mechanism (interlocking engaging portion) is physically separated from the areas where flash may be expressed during filling. The present latching mechanism interlocking engaging portion) is separately activated from the seating and releasing of the facial and lingual molds by easy-to-grasp tabs. Lastly, the present latching mechanism (interlocking engaging portion) can be configured to provide a designed interference between facial and lingual molds such that a residual seating pressure exists when the engagement portions are interlocked, even when the facial and lingual molds are closed. This seating pressure helps to keep the custom tool remain securely shut even under the pressure of composite filling.

Custom tools as described herein may be formed based on a digital model of the teeth and mouth of an individual patient, which can be produced an intra-oral 3D scan, such as a multi-channel scanner. In one particular example, the custom tools may be digitally designed using CAD software, such as solid modeling software based on the digital model. Custom tool was designed to fit over the tooth or teeth to be restored teeth (the restorative portion) and a portion of the neighboring teeth (the engagement portions). Subsequently, the tooth structure of teeth may be digitally subtracted from a mold block. Alternatively, an inverse of the tooth structure may be inverted within software to define the mold block. Engagement portions may be located in regions which correspond to regions of the teeth where they will extend from.

Within the digital model, the mold block design may be segmented into two sections (facial mold body and lingual mold body) to facilitate eventual assembly of the tool components on the teeth, with specific geometric interferences selected related to the arch lengths to provide desired the clamping forces, as discussed above. Within the digital model, engagement portions with certain interlocking geometries are designed, selecting overall heights of the engagement portions based where the engagement portions are placed within the patient’s mouth, as discussed in more detail above.

The following embodiments are intended to be illustrative of the present disclosure and not limiting. Exemplary Embodiments

Embodiment 1 is a custom tool for forming a dental restoration in a mouth of a patient, the custom tool comprising: a lingual mold body for a patient-specific, customized fit with the lingual side of at least one tooth of the patient, wherein the lingual mold body includes a restorative portion; and a tongue guard.

Embodiment 2 is the custom tool of Embodiment 1, further including a facial mold body for a patient-specific, customized fit with the facial side of at least one tooth of the patient.

Embodiment 3 is the custom tool of Embodiment 2, wherein the facial mold body includes a restorative portion and a first engagement portion extending away from the restorative portion,

Embodiment 4 is the custom tool of Embodiment 2, wherein the facial mold body and lingual mold body are configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of the at least one tooth to be restored.

Embodiment 5 is the custom tool of Embodiment 1, wherein the lingual mold body includes a first engagement portion; wherein the first engagement portion interlocks with the teeth of the patient.

Embodiment 6 is the custom tool of Embodiment 1, wherein the lingual mold body includes a first engagement portion extending away from the restorative portion,

Embodiment 7 is the custom tool of Embodiments 5 and 6, wherein the first engagement portion of the facial mold body interlocks with the first engagement portion of the lingual mold body.

Embodiment 8 is the custom tool of Embodiment 7, wherein the interlocked portions are configured to provide a clamping force between the facial body and lingual body.

Embodiment 9 is the custom tool of Embodiment 7, wherein the mouth of the patient includes an occlusal plane, and wherein the first engagement portion of the facial mold body and the first engagement portion of the lingual mold body extend generally perpendicular to the occlusal plane.

Embodiment 10 is the custom tool of Embodiments 5 and 6. The custom tool of claims 5 and 6, wherein the facial mold body includes a second engagement portion extending away from the restorative portion, and wherein the lingual mold body includes a second engagement portion extending away from the restorative portion; and wherein the second portion of the facial mold body interlocks with the second portion of the lingual mold body.

Embodiment 11 is the custom tool of Embodiment 10, wherein the first engagement portions are proximate the posterior teeth of the patient and the second engagement portions are proximate the posterior teeth of the patient, and the restoration portions of the facial mold body and lingual mold body mate with the anterior teeth.

Embodiment 12 is the custom tool of Embodiment 10, wherein the mouth of the patient includes an occlusal plane, wherein the first engagement portion and second engagement portion of the facial mold body extend generally perpendicular to the occlusal plane, and wherein the first engagement portion and second engagement portion of the lingual mold body extend generally perpendicular to the occlusal plane. Embodiment 13 is the custom tool of Embodiment 1, wherein the tongue guard extends generally perpendicular to the direction of the occlusal plane.

Embodiment 14 is the custom tool of Embodiment 1, wherein the tongue guard comprises one or more apertures.

Embodiment 15 is the custom tool of Embodiment 1, wherein the tongue guard comprises a vacuum port.

Embodiment 16 is the custom tool of Embodiment 15, wherein a vacuum source is connected through the vacuum port.

Embodiment 17 is the custom tool of Embodiment 1, wherein the tongue guard further comprises a saliva intake wherein the saliva intake is located adjacent the patient’s salivary ducts under the tongue.

Embodiment 18 is the custom tool of Embodiment 1, further including a first mesial alignment member on the facial mold body and a second mesial alignment member on the lingual mold body.

Embodiment 19 is the custom tool of Embodiment 1, wherein the first engagement portion of the facial mold body includes a protrusion and wherein the first engagement portion of the lingual mold body includes an indentation, wherein the protrusion of the facial mold body interlocks with the indentation of the lingual mold body adjacent to an occlusal plane of a patient’s mouth.

Embodiment 20 is the custom tool of Embodiment 1, wherein the first engagement portion of the lingual mold body includes a protrusion and wherein the first engagement portion of the facial mold body includes an indentation, wherein the protrusion of the lingual mold body interlocks with the indentation of the facial mold body adjacent to an occlusal surface of a patient’s tooth.

Embodiment 21 is the custom tool of Embodiment 1, wherein the facial mold body has a customized fit with the facial side of multiple teeth of the patient

Embodiment 22 is the custom tool of Embodiment 1, wherein the lingual mold body has a customized fit with the lingual side of multiple teeth of the patient.

Embodiment 23 is the custom tool of Embodiment 1, further including at least one aperture aligned with a portion of a surface of a tooth to be restored and at least one door having an inner surface forming a portion of a mold cavity encompassing missing tooth structure of the tooth to be restored, wherein the door mates with the aperture.

Embodiment 24 is a custom tool for forming a dental restoration in a mouth of a patient, the custom tool comprising: a facial mold body for a patient-specific, customized fit with the facial side of at least one tooth of the patient, wherein the facial mold body includes a restorative portion; and a tongue guard.

Embodiment 25 is a custom tool of Embodiment 24, further including a lingual mold body for a patient-specific, customized fit with the lingual side of at least one tooth of the patient.

Embodiment 26 is a custom tool of Embodiment 25, wherein the facial mold body includes a restorative portion and a first engagement portion extending away from the restorative portion, Embodiment 27 is a custom tool of Embodiment 25, wherein the facial mold body and lingual mold body are configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of the at least one tooth to be restored.

Embodiment 28 is a custom tool of Embodiment 24, wherein the lingual mold body includes a first engagement portion, wherein the first engagement portion interlocks with the teeth of the patient.

Embodiment 29 is a custom tool of Embodiment 24, wherein the lingual mold body includes a first engagement portion extending away from the restorative portion,

Embodiment 30 is a custom tool of Embodiments 28 and 29, wherein the first engagement portion of the facial mold body interlocks with the first engagement portion of the lingual mold body.

Embodiment 231 is a custom tool of Embodiment 30, wherein the interlocked portions are configured to provide a clamping force between the facial body and lingual body.

Embodiment 32 is a custom tool of Embodiment 30, wherein the mouth of the patient includes an occlusal plane, and wherein the first engagement portion of the facial mold body and the first engagement portion of the lingual mold body extend generally perpendicular to the occlusal plane.

Embodiment 33 is a custom tool of Embodiments 28 and 29, wherein the facial mold body includes a second engagement portion extending away from the restorative portion, and wherein the lingual mold body includes a second engagement portion extending away from the restorative portion; and wherein the second portion of the facial mold body interlocks with the second portion of the lingual mold body.

Embodiment 34 is a custom tool of Embodiment 33, wherein the first engagement portions are proximate the posterior teeth of the patient and the second engagement portions are proximate the posterior teeth of the patient, and the restoration portions of the facial mold body and lingual mold body mate with the anterior teeth.

Embodiment 35 is a custom tool of Embodiment 33, wherein the mouth of the patient includes an occlusal plane, wherein the first engagement portion and second engagement portion of the facial mold body extend generally perpendicular to the occlusal plane, and wherein the first engagement portion and second engagement portion of the lingual mold body extend generally perpendicular to the occlusal plane.

Embodiment 36 is a custom tool of Embodiment 24, wherein the tongue guard extends generally perpendicular to the direction of the occlusal plane.

Embodiment 37 is a custom tool of Embodiment 24, wherein the tongue guard comprises one or more apertures.

Embodiment 38 is a custom tool of Embodiment 24, wherein the tongue guard comprises a vacuum port.

Embodiment 39 is a custom tool of Embodiment 38, wherein a vacuum source is connected through the vacuum port.

Embodiment 40 is a custom tool of Embodiment 24, wherein the tongue guard further comprises a saliva intake wherein the saliva intake is located adjacent the patient’s salivary ducts under the tongue. Embodiment 41 is a custom tool of Embodiment 24, further including a first mesial alignment member on the facial mold body and a second mesial alignment member on the lingual mold body.

Embodiment 42 is a custom tool of Embodiment 24, wherein the first engagement portion of the facial mold body includes a protrusion and wherein the first engagement portion of the lingual mold body includes an indentation, wherein the protrusion of the facial mold body interlocks with the indentation of the lingual mold body adjacent to an occlusal plane of a patient’s mouth.

Embodiment 43 is a custom tool of Embodiment 24, 24, wherein the first engagement portion of the lingual mold body includes a protrusion and wherein the first engagement portion of the facial mold body includes an indentation, wherein the protrusion of the lingual mold body interlocks with the indentation of the facial mold body adjacent to an occlusal surface of a patient’s tooth.

Embodiment 44 is a custom tool of Embodiment 24, wherein the facial mold body has a customized fit with the facial side of multiple teeth of the patient

Embodiment 44 is a custom tool of Embodiment 24, wherein the lingual mold body has a customized fit with the lingual side of multiple teeth of the patient.

Embodiment 46 is a custom tool of Embodiment 24, further including at least one aperture aligned with a portion of a surface of a tooth to be restored and at least one door having an inner surface forming a portion of a mold cavity encompassing missing tooth structure of the tooth to be restored, wherein the door mates with the aperture.

Embodiment 47 is a custom tool for forming a dental restoration in a mouth of a patient, the custom tool comprising: a mold body providing for a customized fit with at least one tooth of the patient, the mold body including a facial portion and further including a separate lingual portion, wherein the mold body is configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of the tooth; and a tongue guard.

Embodiment 48 is a custom tool of Embodiment 47, wherein the facial portion is separable from and engageable with the lingual portion.

Embodiment 49 is a custom tool of Embodiment 47, wherein the facial portion includes a facial surface corresponding with a facial surface of the tooth.

Embodiment 50 is a custom tool of Embodiment 47, wherein the lingual portion including a lingual surface corresponding with a lingual surface of the tooth.

Embodiment 51 is a custom tool of Embodiment 47, wherein the custom tool forms a proximal surface corresponding with a proximal surface of a first adjacent tooth.

Embodiment 52 is a custom tool of Embodiment 51, wherein the facial portion forms the proximal surface, wherein the proximal surface corresponds with a proximal surface of the first adjacent tooth.

Embodiment 53 is a custom tool of Embodiment 51, wherein the lingual portion forms the proximal surface, wherein the proximal surface corresponds with a second adjacent tooth. Embodiment 54 is a custom tool of Embodiment 47, further including an occlusal portion including an occlusal surface, wherein the occlusal surface corresponds with an occlusal surface of the tooth.

Embodiment 55 is a custom tool of Embodiment 54, wherein the facial portion, lingual portion, and occlusal portion are all customized to fit around a tooth receiving a restoration.

Embodiment 56 is a custom tool of Embodiment 54, further including a tooth receiving the restoration in the patient’s mouth.

Embodiment 57 is a custom tool of Embodiment 47, wherein the facial portion and the lingual portion are based on three-dimensional scan data of the mouth of the patient.

Embodiment 58 is a custom tool of Embodiment 47, wherein the facial portion and the lingual portion are manufactured by three-dimensional printing.

Embodiment 59 is a custom tool of Embodiments 49 and 50, wherein the facial surface and the lingual surface together form an inner surface corresponding to the tooth’s outer surface prior to restoration.

Embodiment 60 is a custom tool of Embodiment 47, wherein the facial mold body and lingual mold body are configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of the at least one tooth to be restored.

Embodiment 61 is a custom tool of Embodiment 60, further comprising a dental restorative material located within the mold cavity.

Embodiment 52 is a custom tool of Embodiment 47, wherein the facial mold body includes a restorative portion and a first engagement portion extending away from the restorative portion,

Embodiment 63 is a custom tool of Embodiment 62, wherein the lingual mold body includes a restorative portion and a first engagement portion extending away from the restorative portion,

Embodiment 64 is a custom tool of Embodiment 63, wherein the first engagement portion of the facial mold body interlocks with the first engagement portion of the lingual mold body.

Embodiment 65 is a custom tool of Embodiment 63, wherein the mouth of the patient includes an occlusal plane, and wherein the first engagement portion of the facial mold body and the first engagement portion of the lingual mold body extend generally perpendicular to the occlusal plane.

Embodiment 66 is a custom tool of Embodiment 47, wherein the tongue guard extends generally perpendicular to the direction of the occlusal plane.

Embodiment 67 is a custom tool of Embodiment 47, wherein the tongue guard comprises one or more apertures.

Embodiment 68 is a custom tool of Embodiment 47, wherein the tongue guard comprises a vacuum port.

Embodiment 69 is a custom tool of Embodiment 67, wherein a vacuum source is connected through the vacuum port. Embodiment 70 is a custom tool of Embodiment 47, wherein the tongue guard further comprises a saliva intake wherein the saliva intake is located adjacent the patient’s salivary ducts under the tongue.

Embodiment 71 is a method of forming a dental restoration, the method comprising: positioning a patient-specific a facial mold body adjacent at least one tooth to be restored of a patient, wherein the facial mold body has a customized fit with the facial side of at least one tooth of the patient; positioning a patient-specific lingual mold body and a tongue guard adjacent the least one tooth to be restored, wherein the lingual mold body has customized fit with the lingual side of the tooth of the patient; interlocking the facial mold body with the lingual mold body to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of at least one tooth to be restored; introducing restorative material into the mold cavity; curing the restorative material; and removing the facial mold body, lingual mold body, and tongue guard from the at least one tooth.

Embodiment 72 is a method of Embodiment 71, wherein the facial mold body includes a restorative portion and a first engagement portion extending away from the restorative portion; wherein the lingual mold body includes a restorative portion and a first engagement portion extending away from the restorative portion; wherein the method further includes interlocking the first engagement portion of the facial mold body with the first engagement portion of the lingual mold body to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of at least one tooth to be restored;

Embodiment 73 is a method of Embodiment 72, wherein the introducing step occurs before the interlocking step.

Embodiment 74 is a method of designing a custom tool for forming a dental restoration of a tooth, the method comprising: receiving, by one or more processors, three-dimensional scan data of a supragingival tooth structure of a patient; designing, by the one or more processors, a custom tool for forming the dental restoration of the tooth based on the three-dimensional scan data of the supragingival tooth structure of the patient, and the desired tooth structure of the at least one tooth to be restored of the patient, wherein the tool comprises a facial mold body for a patient-specific, patient-specific, customized fit with the facial side of at least one tooth of the patient, wherein the facial mold body includes a restorative portion and a first engagement portion extending away from the restorative portion; a lingual mold body for a patient-specific, customized fit with the lingual side of the tooth of the patient, wherein the lingual mold body includes a restorative portion and a first engagement portion extending away from the restorative portion; and a tongue guard; wherein the first engagement portion of the facial mold body interlocks with the first engagement portion of the lingual mold body; and wherein the facial mold body and lingual mold body are configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of at least one tooth to be restored.

Embodiment 75 is a method of Embodiment 74, wherein the facial mold body, lingual mold body and tongue guard are manufactured by three-dimensional printing. Embodiment 76 is a method of Embodiment 74, wherein facial mold body, lingual mold body and tongue guard are manufactured by CAD/CAM milling processes.

Embodiment 77 is a method of Embodiment 74, further including receiving, by one or more processors, information relating to a subgingival tooth structure of the patient.