Disposable multi-specification child fluorine-coated denture as well as preparation method and application thereof

Abstract

The invention belongs to the field of oral cavity health care, and particularly relates to a disposable multi-specification child fluorine-coated denture and a preparation method and application thereof.The disposable multi-specification child fluorine-coated denture comprises an upper denture body and a lower denture body which are used for maxillary teeth and mandibular teeth respectively, and the upper denture body and the lower denture body are of split structures which are separated from each other; each denture is provided with a U-shaped groove matched with the dentition form of a child, and a preset dosage of fluorine-containing coating agent is preloaded in each U-shaped groove; the upper denture and the lower denture are both made of flexible medical high polymer materials, and a peelable sealing film covers an opening of the U-shaped groove; the upper denture and the lower denture are designed into different specifications and models according to the dental arch sizes of children of different age groups, and the split type design is combined with a multi-specification system, so that the denture can better adapt to the oral cavity characteristics of children of different age groups, and the contact efficiency of a fluorine agent and a dental surface in the fluorine coating process is improved.

Description

Technical Field

[0001] This invention belongs to the field of oral health care, specifically relating to disposable multi-size children's fluoride varnish dental trays, their preparation methods, and their applications. Background Technology

[0002] Childhood dental caries is one of the major challenges to children's oral health worldwide, with a high incidence and wide impact. Fluoride application has proven to be an effective and cost-efficient method for preventing childhood caries. Currently, the main ways children obtain fluoride include fluoride varnish treatments at professional dental clinics, daily use of fluoride toothpaste, and fluoridation of community water supplies.

[0003] Existing fluoride varnish products for children are mostly in the form of toothpaste and mouthwash. These products have relatively low fluoride concentrations and it is difficult to ensure sufficient contact time, which affects their caries prevention effect. While fluoride varnish treatments at professional dental clinics are highly effective, they require professional operation and are costly, making regular fluoride varnish treatments difficult, especially for children in economically underdeveloped areas.

[0004] Therefore, there is an urgent need for a convenient, safe, economical fluoride varnish device for children that is suitable for home use, especially a fluoride varnish tray that can adapt to the oral development characteristics of children of different ages, in order to meet the actual needs of children's oral health care. Summary of the Invention

[0005] The purpose of this invention is to solve the problems existing in the prior art and to provide a disposable multi-size children's fluoride varnish dental tray, its preparation method and application. The dental tray is simple in design, safe to use and highly adaptable. It is especially suitable for operation by non-professionals in the home environment and provides children with effective fluoride varnish protection against tooth decay.

[0006] To achieve the above objectives, the technical solution provided by the present invention is as follows:

[0007] A disposable, multi-size fluoride varnish dental tray for children includes an upper tray and a lower tray for the upper and lower teeth respectively, which are separate, modular structures. Each tray has a U-shaped groove adapted to the morphology of a child's dentition, and the U-shaped groove is pre-filled with a predetermined dose of fluoride varnish. Both the upper and lower trays are made of flexible medical polymer material, and the opening of the U-shaped groove is covered with a peelable sealing film. The upper and lower trays are designed in different sizes according to the dental arch size of children of different ages.

[0008] Preferably, both the upper and lower dental trays have handles at their front ends. The handles are used for holding the trays when wearing and removing them, and to prevent the trays from slipping into the depths of the mouth.

[0009] In one embodiment of the present invention, the different sizes include size S for children aged 3 to 6, size M for children aged 7 to 9, and size L for children aged 10 to 12; wherein size S has an upper teething tray width of 36 mm and a lower teething tray width of 34 mm; size M has an upper teething tray width of 42 mm and a lower teething tray width of 40 mm; and size L has an upper teething tray width of 48 mm and a lower teething tray width of 45 mm.

[0010] Furthermore, the flexible medical polymer material is selected from medical silicone, thermoplastic elastomers or closed-cell foam plastics, and the material does not contain plasticizers or bisphenol A.

[0011] Preferably, the fluorinated coating agent is a fluorinated foam or fluorinated gel with an effective fluoride ion concentration of 0.1% to 2.0%, and the fluoride component of the fluorinated coating agent is selected from one or more of sodium fluoride, stannous fluoride or sodium monofluorophosphate, and an edible flavoring agent is added.

[0012] This invention also provides a method for preparing the above-mentioned disposable multi-size fluoride varnish dental tray for children, comprising the following steps:

[0013] a. Based on the dental arch size data of children of different ages, design the U-shaped groove inner cavity structure and outer dimensions of the upper and lower dental trays;

[0014] b. Select flexible medical polymer materials and prepare the base structure of the upper and lower dental trays through injection molding process;

[0015] c. Precisely inject a predetermined amount of fluoride-containing coating agent into the U-shaped grooves of the upper and lower dental trays;

[0016] d. A peelable sealing film is heat-sealed onto the U-shaped groove openings of the upper and lower dental trays;

[0017] e. Place the prepared upper and lower dental trays into separate aluminum-plastic composite packaging bags and seal them.

[0018] In a preferred embodiment of the preparation method, for size S dental trays, the amount of fluoride coating agent injected into each U-shaped groove is 0.3 ml; for size M dental trays, the amount of fluoride coating agent injected into each U-shaped groove is 0.4 ml; and for size L dental trays, the amount of fluoride coating agent injected into each U-shaped groove is 0.5 ml.

[0019] Preferably, the temperature of the injection molding process is controlled at 160 to 200°C, the pressure is controlled at 10 to 20 MPa, and the molding time is 15 to 25 seconds.

[0020] In addition, the peelable sealing film is made of polyethylene composite aluminum foil material with a thickness of 0.03 to 0.08 mm; the aluminum-plastic composite packaging bag is made of polyester / aluminum / polyethylene three-layer composite material with a thickness of 0.10 to 0.15 mm.

[0021] This invention also provides the application of the above-mentioned disposable multi-size fluoride varnish dental tray for children in home settings for fluoride varnish treatment to prevent tooth decay in children. The method of use includes the following steps:

[0022] a. Select the appropriate size of upper and lower dental trays according to the child's age;

[0023] b. Tear open the aluminum-plastic composite packaging bag and remove the upper and lower dental trays;

[0024] c. Peel off the sealing film at the opening of the U-shaped groove of the upper and lower dental trays to expose the pre-installed fluoride coating inside;

[0025] d. Place the upper and lower dental trays into the child's mouth respectively, so that the U-shaped grooves fit the upper and lower dentition respectively;

[0026] e. Keep wearing the fluoride coating for 2 to 5 minutes to allow it to fully contact the tooth surface;

[0027] f. Remove the upper and lower dental trays, and instruct the child to gently spit out any excess fluoride coating and not to rinse or eat immediately.

[0028] g. Dispose of used upper and lower dental trays as medical waste.

[0029] The beneficial effects of this invention are:

[0030] 1. The combination of a split design and a multi-size system allows the dental tray to better adapt to the oral characteristics of children of different ages, improving the contact efficiency between the fluoride agent and the tooth surface during the fluoride varnishing process;

[0031] 2. Made of flexible medical materials, it balances comfort and safety, reduces irritation to oral soft tissues, and prevents the risk of accidental swallowing;

[0032] 3. The dental tray is pre-filled with a measured amount of fluoride and is sealed in packaging, ensuring the freshness and effectiveness of the fluoride, while simplifying the home use process and avoiding the risk of overdosing or underdosing;

[0033] 4. The disposable design avoids cross-infection issues, making it suitable for use in home hygiene environments;

[0034] 5. Through a well-designed fluoride concentration and contact time, it achieves a caries prevention effect comparable to that of professional fluoride varnish application at a clinic, providing an alternative for children who cannot make regular medical visits. Attached Figure Description

[0035] Figure 1 This is a top view of the upper dental tray of the present invention.

[0036] Figure 2 This is a top view of the lower dental tray of the present invention.

[0037] Figure 3 This is a schematic diagram of the wearing state of the dental tray of the present invention. Detailed Implementation

[0038] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0039] The disposable multi-size fluoride varnish dental tray of this invention mainly consists of two parts: an upper tray and a lower tray. These are separate designs that can fit the upper and lower jaws of a child respectively. (See reference...) Figure 1-3 As shown, both the upper and lower dental trays are U-shaped, conforming to the shape of the human dental arch, and have handles at the front for easy operation and to prevent accidental swallowing. The inner side of the tray has a U-shaped groove to accommodate the pre-applied fluoride coating and conform to the tooth surface. Based on the oral development characteristics of children at different ages, the dental trays of this invention are designed in three sizes: S (suitable for children aged 3-6), M (suitable for children aged 7-9), and L (suitable for children aged 10-12). In use, the upper and lower trays conform to the upper and lower dentition respectively, ensuring full contact between the fluoride coating and the tooth surface.

[0040] Example 1: Preparation of Size S disposable fluoride varnish dental tray for children

[0041] This embodiment provides a method for preparing a size S fluoride varnish dental tray suitable for children aged 3-6 years.

[0042] First, based on oral anatomy data of children aged 3-6 years, a U-shaped groove structure with an upper dental tray width of 36 mm and a lower dental tray width of 34 mm was designed. Medical-grade silicone (purchased from Dow Corning, USA, model MDX4-4210) was selected as the material, which has excellent flexibility and biocompatibility and does not contain plasticizers or harmful components such as bisphenol A.

[0043] Silicone raw material is molded at 180℃ and 15MPa using an injection molding process, with the molding time controlled within 20 seconds, to obtain the basic upper and lower dental tray structures. The molded dental tray has moderate hardness (Shore hardness 40A) and good elasticity, which can conform to children's teeth and avoid irritating the soft tissues of the oral cavity.

[0044] Subsequently, 0.3 ml of fluoride foam (sodium fluoride, effective fluoride ion concentration 0.9%, with added strawberry flavoring) was precisely infused into the U-shaped grooves of the upper and lower dental trays. The infusion process was performed under sterile conditions, using a precision quantitative filling device (Optima GmbH, Germany, model MDL-100) to ensure accurate dosage.

[0045] Next, a 0.05 mm thick polyethylene composite aluminum foil sealing film (3M, model 1326) was heat-sealed at the opening of the U-shaped groove at a temperature of 140°C, a pressure of 0.8 MPa, and a time of 3 seconds.

[0046] Finally, the prepared upper and lower dental trays are placed in aluminum-plastic bags (0.12 mm thick) made of a three-layer composite material of polyester / aluminum / polyethylene, sealed in a nitrogen atmosphere, and clearly labeled with product information and instructions for use.

[0047] Example 2: Preparation of Size M disposable fluoride varnish dental tray for children

[0048] This embodiment provides a method for preparing a size M fluoride varnish dental tray suitable for children aged 7-9 years.

[0049] Based on oral data of children aged 7-9, a U-shaped structure with an upper dental tray width of 42 mm and a lower dental tray width of 40 mm was designed. Medical-grade thermoplastic elastomer (TPE, purchased from BASF, Germany, model Elastollan 1185A) was selected as the dental tray material. This material has good toughness and resilience and does not contain harmful components.

[0050] TPE material was injection molded at 190℃ and 18MPa for 18 seconds to obtain a denture base with appropriate elasticity. The molded denture has a Shore A hardness of 45A, which provides sufficient flexibility to conform to the teeth while maintaining good shape stability.

[0051] 0.4 ml of fluoride gel (a compound formula of sodium fluoride and sodium monofluorophosphate, with an effective fluoride ion concentration of 1.2% and added mint flavoring) was poured into the U-shaped grooves of the upper and lower dental trays respectively. The filling was performed using a fully automated quantitative filling system (Shikoku, Japan, model AFPP-200) to ensure a filling accuracy error of less than ±0.02 mm.

[0052] A 0.06 mm thick polyethylene composite aluminum foil sealing film (Toppan, Germany, model AF-60) was heat-sealed at the opening of the U-shaped groove at a temperature of 145°C, a pressure of 1.0 MPa, and a time of 3.5 seconds.

[0053] Finally, the completed upper and lower dental trays are placed in aluminum-plastic composite packaging bags with a thickness of 0.13 mm and sealed, and then sterilized (ethylene oxide sterilization, dosage of 600 mg / L, time of 4 hours).

[0054] Example 3: Preparation of Size L Disposable Fluoride Dental Tray for Children

[0055] This embodiment provides a method for preparing a size L fluoride varnish dental tray suitable for children aged 10-12 years.

[0056] Based on dental arch development data of children aged 10-12 years, the upper dental tray was designed with a width of 48 mm and the lower dental tray with a width of 45 mm. Medical-grade closed-cell foam (purchased from Rogers Corporation, USA, model PORON 4701-30) was selected as the material, which has excellent fit and comfort.

[0057] Closed-cell foam plastic is hot-pressed at 170℃ and 12MPa for 22 seconds. The resulting dental tray has a microporous structure, providing better fit and comfort, and has a Shore A hardness of 35A, making it suitable for extended wear.

[0058] 0.5 ml of fluorinated foam (stannous fluoride, effective fluoride ion concentration 1.5%, with added lemon flavoring) was poured into the U-shaped grooves of the upper and lower dental trays respectively. The filling process was carried out in a Class 100 cleanroom using a high-precision volumetric filling machine (Optima, Switzerland, model MDL-200G) to ensure accurate dosage.

[0059] A 0.08 mm thick polyethylene composite aluminum foil sealing film (Toyo Aluminum, Japan, model TL-80) was heat-sealed at the opening of the U-shaped groove at a heat sealing temperature of 150°C, a pressure of 1.2 MPa, and a time of 4 seconds.

[0060] Finally, the completed dental tray is placed in a high-barrier aluminum-plastic composite packaging bag with a thickness of 0.15 mm (Dainippon Printing, Japan, model DNP-150) and sealed in a nitrogen environment to ensure the long-term stability of the product.

[0061] Example 4: Preparation of a size S fluoride-coated dental tray with a low-concentration fluoride formulation

[0062] This embodiment provides a method for preparing a No. S fluoride-coated dental tray using a low-concentration fluoride formulation.

[0063] The base structure of the S-size dental tray was designed and prepared according to the method in Example 1, using medical-grade silicone material, but the fluoride coating agent was adjusted to a low-concentration formula: sodium fluoride foam with an effective fluoride ion concentration of 0.1% and an apple flavoring agent. 0.3 ml of the above-mentioned fluoride foam was poured into the U-shaped grooves of both the upper and lower dental trays.

[0064] The remaining preparation steps are the same as in Example 1, including heat-sealing the film and packaging in an aluminum-plastic bag. This low-concentration formulation is suitable for children in areas with enamel hypoplasia or a high risk of fluorosis.

[0065] Example 5: Preparation of L-size fluoride varnished dental tray with high-concentration fluoride formulation

[0066] This embodiment provides a method for preparing a size L fluoride-coated dental tray using a high-concentration fluoride formulation.

[0067] The substrate structure of the L-size dental tray was designed and prepared according to the method of Example 3, but the fluoride coating agent was adjusted to a high-concentration formulation: a composite gel of sodium fluoride and stannous fluoride, with an effective fluoride ion concentration of 2.0%, and an orange flavoring agent was added. 0.5 ml of the above-mentioned fluoride gel was poured into the U-shaped grooves of the upper and lower dental trays respectively.

[0068] The remaining preparation steps are the same as in Example 3. This high-concentration formula is suitable for intensive protection in children at high risk of tooth decay and should be used under strict supervision by a guardian.

[0069] Example 6: Preparation of M-size fluoride-coated dental trays with multi-layer structure

[0070] This embodiment provides a method for preparing a size M fluoride-coated dental tray with a multi-layer structure design.

[0071] Based on the M-size dental tray design of Example 2, a double-layer structure is adopted: the outer layer is medical-grade silicone (Shore hardness 30A), and the inner layer is thermoplastic elastomer (Shore hardness 50A). This double-layer structure gives the dental tray both good external flexibility and sufficient internal support strength.

[0072] The double-layer structure is achieved through two-color injection molding technology. First, the inner TPE material is injection molded at 175℃ and 14MPa for 15 seconds. Then, the outer silicone material is injection molded in the same mold at 160℃ and 12MPa for 20 seconds.

[0073] 0.4 ml of fluoride foam (sodium monofluorophosphate, effective fluoride ion concentration 1.0%, with added grape flavoring) was poured into the U-shaped groove of the completed multi-layered dental tray. The remaining preparation steps were the same as in Example 2.

[0074] Comparative Example 1: One-piece design children's fluoride dental tray

[0075] This comparative example uses a traditional one-piece design to manufacture children's fluoride varnish dental trays, with the upper and lower trays connected as one unit at the back.

[0076] Medical-grade silicone was used for injection molding under the same conditions, but the mold was designed as a one-piece structure. Fluorinated foam (sodium fluoride, effective fluoride ion concentration 0.9%) with the same formulation and dosage was poured into the U-shaped groove. The remaining preparation steps were the same as in Example 1.

[0077] Comparative Example 2: Children's dental trays without pre-filled fluoride

[0078] This comparative example prepares a children's dental tray without pre-filled fluoride, using the same M-size dental tray design and materials as in Example 2, but without pre-filled fluoride coating in the U-shaped groove, and is used only as a regular dental tray.

[0079] Comparative Example 3: Single-size children's fluoride dental tray

[0080] This comparative study presents a single-size (universal size) children's fluoride varnish dental tray, with an upper tray width of 45 mm and a lower tray width of 42 mm, designed to cover all children aged 3-12 years.

[0081] Medical-grade TPE material was injection molded under the same conditions as in Example 2, with 0.45 ml of fluorinated gel (sodium fluoride, effective fluoride ion concentration 1.0%) poured into the U-shaped groove. The remaining preparation steps were the same as in Example 2.

[0082] To evaluate the actual effectiveness of the dental tray of this invention, we designed the following test experiment:

[0083] Experiment 1: Fluoride Coverage Test on Tooth Surface

[0084] This experiment aims to test the effectiveness of different denture designs in covering the tooth surface with fluoride.

[0085] Test Method: Fluoride-containing coatings were labeled with fluorescent dyes, and the coverage of dentures was tested on plaster models simulating the dentition of children of different ages. After irradiation with ultraviolet light, the tooth surface coverage was calculated using image analysis software. Each denture type was tested 10 times, and the average value was taken.

[0086] Test results:

[0087] Table 1: Results of Fluoride Coverage Test on Tooth Surface (Unit: %)

[0088] Test sample Anterior tooth coverage Posterior tooth coverage Overall average coverage Example 1 (S-type split design) 93.4 88.7 91.2 Example 2 (M-type split type) 94.6 90.2 92.5 Example 3 (L-size split type) 95.1 91.8 93.6 Example 6 (Multi-layer structure) 96.5 93.2 95 Comparative Example 1 (Conjoined) 87.2 76.5 82.4 Comparative Example 3 (Single Specification) 89.3 72.8 81.6

[0089] Results Analysis: The split-type multi-size dental tray of the present invention significantly outperforms the one-piece and single-size designs in terms of tooth surface coverage. Among them, the multi-layer structure dental tray (Example 6) performed best, with a coverage of 95.0%. This is mainly attributed to the fact that the split design can better adapt to the anatomical differences between the upper and lower jaws, while the targeted design of different sizes ensures the best fit for children of the corresponding age groups.

[0090] Experiment 2: Comfort and Safety Testing of Dental Tray Materials

[0091] Testing Methods: Thirty volunteer children aged 3-12 years were recruited (with approval from the ethics committee and parental consent), and the comfort of different dental trays was tested in three age groups. The tests included a wearing experience rating (1-10 points, with higher scores indicating greater comfort), any discomfort, and material safety testing (oral mucosal irritation test and cytotoxicity test).

[0092] Test results:

[0093] Table 2: Test Results of Comfort and Safety of Dental Tray Materials

[0094] Test sample Comfort rating (1-10) Discomfort reporting rate (%) Oral mucosal irritation index Cytotoxicity level Example 1 (Medical-grade silicone) 8.7 3.3 0.2 0 Example 2 (TPE) 8.2 6.7 0.3 0 Example 3 (Closed-cell foam) 9.1 0 0.1 0 Example 6 (Multi-layer structure) 9.3 0 0.1 0 Comparative Example 1 (Conjoined) 6.5 23.3 0.3 0

[0095] Results Analysis: The split-type dental tray of this invention, especially the one using closed-cell foam material and a multi-layer structure design, achieved a significantly higher comfort score than the one-piece design. All tested materials had an oral mucosal irritation index <0.5 (no irritation) and cytotoxicity level 0 (no toxicity), meeting medical device safety standards.

[0096] Experiment 3: Fluoride Release Kinetics and Enamel Resorption Test

[0097] Test methods: Using an in vitro artificial saliva circulation system and extracted human tooth specimens, the fluoride release and fluoride absorption of different dental trays were tested at time points of 2, 3, 5, and 10 minutes. Fluoride concentration was measured using an ion-selective electrode, and the fluoride content of the enamel surface was determined by electron probe microscopy.

[0098] Test results:

[0099] Table 3: Fluoride Release Kinetics and Enamel Resorption Test Results

[0100] Test sample 2-minute release rate (%) 3-minute release rate (%) 5-minute release rate (%) 10-minute release rate (%) Increased fluoride content in tooth enamel (ppm) Example 1 (0.9% Fluorine) 65.3 82.7 95.4 99.7 1280 Example 4 (0.1% fluorine) 72.1 88.5 97.8 99.9 520 Example 5 (2.0% Fluorine) 58.9 76.4 92.1 98.5 2350 Comparative Example 2 (without pre-filled fluorine) - - - - 15*

[0101] *Comparative Example 2: Test was conducted by applying commercially available fluoride toothpaste before use.

[0102] Results Analysis: Tests showed that the fluoride coating in the dental tray of this invention can release more than 80% of the effective fluoride within 3-5 minutes, and significantly increase the fluoride content on the enamel surface. Formulations with concentrations of 0.9% and 2.0% increased the fluoride content of enamel by 1280 ppm and 2350 ppm, respectively, reaching an effective level for caries prevention (literature reports that increases of more than 500 ppm have a significant caries-preventing effect). In contrast, Comparative Example 2, using ordinary toothpaste, only increased the fluoride content of enamel by 15 ppm, with a negligible effect.

[0103] Experiment 4: Adaptability Tests for Different Age Groups

[0104] Testing Method: Ninety children of different ages were recruited (30 children aged 3-6, 30 children aged 7-9, and 30 children aged 10-12). They were randomly assigned to use either the multi-size dental trays of this invention or a single-size dental tray. The fit of the dental trays was evaluated by a professional dentist (out of 5, with 5 being the best), and the number of times the trays slipped off during use was recorded.

[0105] Test results:

[0106] Table 4: Results of Adaptability Tests for Different Age Groups

[0107] age group Sample type Fit rating (1-5) Slippage event incidence (%) 3-6 years old S size split type 4.7 3.3 3-6 years old Single specification 2.1 43.3 7-9 years old M-size split type 4.8 0 7-9 years old Single specification 3.2 16.7 10-12 years old L-size split type 4.9 0 10-12 years old Single specification 4 6.7

[0108] Results Analysis: The test results clearly demonstrate that the multi-size design of the dental tray of this invention exhibits significantly better fit than the single-size dental tray in children of all ages. Particularly in the 3-6 year age group, the slippage rate of the single-size dental tray was as high as 43.3%, while that of the S-size split dental tray was only 3.3%. This verifies the significant contribution of the multi-size design of this invention to improving the adaptability and safety of dental trays in the oral cavity of children of different ages.

[0109] The technical advantages of this invention's disposable multi-size children's fluoride varnish dental tray mainly stem from the following scientific principles and mechanisms:

[0110] 1. The principle of adapting the split structure to oral anatomy:

[0111] This invention employs a separate upper and lower dental tray design, scientifically solving the key defects of traditional one-piece dental trays. From an oral anatomy perspective, there are significant differences in the morphology of the human maxillary and mandibular dental arches: the maxillary dental arch is elliptical, while the mandibular dental arch is parabolic and typically narrower than the maxillary arch. This difference changes with growth and development from the primary dentition stage to the mixed dentition stage. The separate design allows the upper and lower trays to be optimized according to their respective anatomical characteristics, ensuring optimal fit.

[0112] Experimental data shows that the split design increases tooth surface coverage by approximately 10-13 percentage points (compared to the one-piece design), an improvement that directly affects the effectiveness of fluoride varnish. The anti-caries mechanism of fluoride varnish mainly includes: ① fluoride ions react with hydroxyapatite in tooth enamel to form fluorapatite, increasing acid resistance; ② inhibiting oral bacterial metabolism; ③ promoting enamel remineralization. These effects all depend on sufficient contact between the fluoride and the tooth surface; therefore, higher coverage means better anti-caries effect.

[0113] 2. Synergy between multi-size systems and the characteristics of children's oral development:

[0114] This invention designs three sizes of dental trays (S, M, and L) based on the developmental patterns of children's oral cavity. This design is based on extensive oral measurement data of children and takes into account the following developmental characteristics:

[0115] 3-6 years old (S size): Mainly in the primary dentition stage, the dental arch is small and the front teeth are relatively closely spaced.

[0116] 7-9 years old (M size): In the early stage of mixed dentition, the dental arch begins to expand.

[0117] 10-12 years old (L size): Late stage of mixed dentition, permanent teeth gradually erupt, and the dental arch approaches adult size.

[0118] Each size of dental tray is precisely matched to the dental arch development characteristics of children in the corresponding age group, solving the problem of a "one-size-fits-all" approach with a single size. Experimental results showed that in the 3-6 year old group, the fit score of the size S dental tray (4.7 points) was significantly higher than that of the standard size tray (2.1 points), and the slippage rate was significantly reduced (3.3% vs 43.3%). This precise matching not only improved the effectiveness of fluoride varnish application but also significantly reduced the risks associated with its use.

[0119] 3. Materials Science and Biocompatibility Principles:

[0120] The flexible medical polymer materials (medical silicone, TPE, closed-cell foam) selected in this invention have specific physicochemical properties, forming a good interaction with the oral environment:

[0121] Medical-grade silicone: Its molecular structure contains a -Si-O-Si- main chain and organic side groups, exhibiting excellent biocompatibility and stability;

[0122] TPE (Thermoplastic Elastomer): It combines the processability of thermoplastic plastics with the elasticity of elastomers, and physical cross-linking is formed between molecular chain segments;

[0123] Closed-cell foam: Contains an independent bubble structure inside, providing better compressibility and resilience;

[0124] These materials share the common characteristics of an appropriate hardness range (Shore 30A-50A) and good elastic modulus, enabling the dental tray to maintain shape stability while adapting to subtle differences in tooth alignment within the oral cavity. The material selection also takes into account factors such as pH variations (pH 5.6-7.6), temperature (approximately 37°C), and humidity in the oral environment to ensure that deformation or material degradation does not occur during use.

[0125] 4. Fluoride release kinetics and enamel interaction mechanism:

[0126] The pre-packaged fluorinated coating formulation of this invention is designed with fluoride release kinetics in mind. Experimental data show that the fluorinated coating releases 76.4%-97.8% of the effective fluoride within 3-5 minutes. This time window ensures both sufficient therapeutic effect and suitability for children's tolerance.

[0127] From a molecular level perspective, fluoride ions (F-) are related to hydroxyapatite [Ca], the main component of tooth enamel. 10 [(PO4)6(OH)2] undergoes an ion exchange reaction, where some OH- ions are replaced by F- ions to form fluorapatite [Ca] 10 (PO4)6F2]. Solubility product of fluorapatite (Ksp=10) -60 The value is much lower than that of hydroxyapatite (Ksp=10). -59 This significantly enhances the enamel's resistance to acid. The pre-filled fluoride design of this invention (concentration 0.1%-2.0%) ensures a sufficient fluoride ion concentration gradient to promote this reaction.

[0128] 5. Packaging technology and product stability principles:

[0129] The aluminum-plastic composite packaging system employed in this invention utilizes barrier theory from materials science. The polyethylene composite aluminum foil sealing film and the aluminum-plastic composite packaging bag form a dual barrier system, effectively preventing the penetration of moisture, oxygen, and light, and avoiding the oxidation, volatilization, or degradation of fluorinated coatings. The aluminum layer provides near-perfect gas barrier properties (oxygen permeability <0.01 cm³ / m²·24h·bar), while the polyester and polyethylene layers provide mechanical strength and heat-sealing performance.

[0130] This packaging design allows the product to maintain its shelf life of at least 18 months at room temperature (25±2℃), greatly improving the product's practicality and economy.

[0131] Based on the comprehensive test results and analysis, the optimal implementation of the present invention is the multi-layered M-size fluoride-coated dental tray described in Example 6, with the following specific features:

[0132] 1. Separate design, upper teething bracket width 42 mm, lower teething bracket width 40 mm, suitable for children aged 7-9 years;

[0133] 2. Double-layer structure: The outer layer is medical-grade silicone (Shore hardness 30A), and the inner layer is thermoplastic elastomer (Shore hardness 50A);

[0134] 3. The fluorinated coating agent is sodium monofluorophosphate foam with an effective fluoride ion concentration of 1.0% and added grape flavoring;

[0135] 4. Each dental tray has a U-shaped groove pre-filled with 0.4 ml of fluoride foam;

[0136] 5. Double sealing with polyethylene composite aluminum foil sealing film (0.06 mm thick) and aluminum-plastic composite packaging bag (0.13 mm thick).

[0137] This solution achieves the best balance in terms of tooth surface coverage (95.0%), comfort score (9.3 points), safety, and ease of use, demonstrating the core technical advantages of this invention.

[0138] This invention, the "Disposable Multi-Size Children's Fluoride Dental Tray," offers a safe, effective, and convenient new option for children's oral care at home through its innovative design, including a modular structure, a multi-size system, medical-grade materials, pre-filled fluoride, and sealed packaging. Compared to existing technologies, this invention achieves breakthroughs in the following aspects:

[0139] 1. Through its modular design and multi-size system, the oral fit of the dental tray and the efficiency of fluoride application are significantly improved;

[0140] 2. Through careful selection of materials and structural design, the product's comfort, safety, and functionality are all taken into account;

[0141] 3. The pre-filled metered fluoride solution and sealed packaging design simplify the home use process and ensure the effectiveness of fluoride coating;

[0142] 4. The disposable design solves the problems of hygiene and cross-infection, making it suitable for use in non-professional environments.

[0143] These innovations are not only technologically advanced, but also have significant social value, providing effective means of caries prevention for children who cannot regularly receive professional dental services, and promoting the universalization of oral health.

Claims

1. A disposable multi-size fluoride dental tray for children, characterized in that, The device includes an upper dental tray and a lower dental tray for the upper and lower teeth, respectively, which are separate, modular structures. Each tray has a U-shaped groove adapted to the morphology of a child's dental arch, and the U-shaped groove is pre-filled with a predetermined dose of fluoride coating. Both the upper and lower dental trays are made of flexible medical polymer material, and the opening of the U-shaped groove is covered with a peelable sealing film. The upper and lower dental trays are designed in different sizes and models according to the dental arch size of children of different ages.

2. The disposable multi-size fluoride varnish dental tray for children according to claim 1, characterized in that, Both the upper and lower dental trays have handles at their front ends. The handles are used for holding the trays when wearing and removing them, and to prevent the trays from slipping into the depths of the mouth.

3. The disposable multi-size fluoride varnish dental tray for children according to claim 1, characterized in that, The different sizes include size S for children aged 3 to 6, size M for children aged 7 to 9, and size L for children aged 10 to 12. Size S has an upper teething tray width of 36 mm and a lower teething tray width of 34 mm; size M has an upper teething tray width of 42 mm and a lower teething tray width of 40 mm; and size L has an upper teething tray width of 48 mm and a lower teething tray width of 45 mm.

4. The disposable multi-size fluoride varnish dental tray for children according to claim 1, characterized in that, The flexible medical polymer material is selected from medical silicone, thermoplastic elastomers, or closed-cell foam plastics.

5. The disposable multi-size fluoride varnish dental tray for children according to claim 1, characterized in that, The fluorinated coating agent is a fluorinated foam or fluorinated gel with an effective fluoride ion concentration of 0.1% to 2.0%. The fluoride component of the fluorinated coating agent is selected from one or more of sodium fluoride, stannous fluoride or sodium monofluorophosphate, and an edible flavoring agent is added.

6. The method for preparing the disposable multi-size fluoride varnish dental tray for children according to any one of claims 1 to 5, characterized in that, Includes the following steps: a. Based on the dental arch size data of children of different ages, design the U-shaped groove inner cavity structure and outer dimensions of the upper and lower dental trays; b. Select flexible medical polymer materials and prepare the base structure of the upper and lower dental trays through injection molding process; c. Precisely inject a predetermined amount of fluoride-containing coating agent into the U-shaped grooves of the upper and lower dental trays; d. A peelable sealing film is heat-sealed onto the U-shaped groove openings of the upper and lower dental trays; e. Place the prepared upper and lower dental trays into separate aluminum-plastic composite packaging bags and seal them.

7. The preparation method according to claim 6, characterized in that, In step c, for size S dental trays, the amount of fluoride coating injected into each U-shaped groove is 0.3 ml; for size M dental trays, the amount of fluoride coating injected into each U-shaped groove is 0.4 ml; and for size L dental trays, the amount of fluoride coating injected into each U-shaped groove is 0.5 ml.

8. The preparation method according to claim 6, characterized in that, In step b, the temperature of the injection molding process is controlled at 160 to 200°C, the pressure is controlled at 10 to 20 MPa, and the molding time is 15 to 25 seconds.

9. The preparation method according to claim 6, characterized in that, The peelable sealing film is made of polyethylene composite aluminum foil material with a thickness of 0.03 to 0.08 mm; the aluminum-plastic composite packaging bag is made of polyester / aluminum / polyethylene three-layer composite material with a thickness of 0.10 to 0.15 mm.

10. The application of the disposable multi-size fluoride varnish dental tray for children according to any one of claims 1 to 5 in home-based fluoride varnish treatment for preventing tooth decay in children, characterized in that... The usage method includes the following steps: a. Select the appropriate size of upper and lower dental trays according to the child's age; b. Tear open the aluminum-plastic composite packaging bag and remove the upper and lower dental trays; c. Peel off the sealing film at the opening of the U-shaped groove of the upper and lower dental trays to expose the pre-installed fluoride coating inside; d. Place the upper and lower dental trays into the child's mouth respectively, so that the U-shaped grooves fit the upper and lower dentition respectively; e. Keep wearing the fluoride coating for 2 to 5 minutes to allow it to fully contact the tooth surface; f. Remove the upper and lower dental trays, and instruct the child to gently spit out any excess fluoride coating and not to rinse or eat immediately. g. Dispose of used upper and lower dental trays as medical waste.

Images