Premixed gap sealant composition for rubber dams and method for its preparation and use

Abstract

This invention provides a premixed gap sealant composition for rubber dams, its preparation method, and its application. The composition comprises the following components: component a: a water-absorbing and swelling material; component b: a hydrophobic liquid carrier; and component c: a thickener. Components a and c account for 41%-72% of the total mass of the composition, and component b accounts for 28%-59% of the total mass of the composition. The hydrophobic liquid carrier includes one or more of dimethyl silicone oil, eugenol, dimethylsiloxane, polymethylsiloxane, silicone oil, and vegetable oil. This invention also provides a method for preparing the above composition and its application in the preparation of hydrophobic and water-resistant sealants. This composition effectively seals gaps around rubber dams and is resistant to liquid rinsing without leakage.

Description

Technical Field

[0001] This invention relates to a premixed gap sealant composition for rubber barriers, its preparation method and application, and relates to the field of medical materials technology. Background Technology

[0002] During dental treatment, a rubber dam is needed to prevent liquids (such as chemical solutions) from entering the patient's mouth and to maintain a relatively sterile surgical environment. The most basic requirement for placing a rubber dam is that it has good sealing properties and no leakage. This is especially important in root canal treatment, resin filling, and the bonding of posts and crowns.

[0003] Dentists encounter many unfavorable situations during root canal treatment. For example, after placing a rubber dam, if the sealing effect is not perfect, leakage often occurs during the use of irrigating solutions such as sodium hypochlorite into the patient's oral cavity, irritating the mucosa and throat, causing the patient to cough. A common cause is that after placing the rubber dam, the rubber blanket sometimes cannot fit tightly to all tooth surfaces, and there are still leakage areas and areas of incomplete sealing between the rubber dam and the tooth, or between the rubber dam clip and the tooth. This allows saliva or irrigating solutions used during treatment to leak into the surgical area or oral cavity through the gaps.

[0004] Incomplete sealing of the pores in the rubber dam after isolation is often caused by several reasons: ① The pores are much larger than the size of the tooth in the isolation area; ② Adjacent pores are too close together, causing the rubber dam to be pulled by the isolated tooth, resulting in the inability to seal the edges; ③ The pores in the rubber dam are broken; ④ The tooth in the isolation area has a large and deep groove in a certain place, etc. Figures 1a-1b As shown, where: Figure 1a The situation is due to the inability to close the lip edges, resulting in exposed soft tissue; Figure 1b The observed gaps are large, indicating poor sealing. Regardless of the cause, the best solution is to re-drill holes or use an edge sealant to seal the unsealed holes in the rubber barrier. Figures 1c-1d The situation shown is that the gaps are sealed with an edge sealant, but after sealing, the tension of the rubber barrier needs to be reduced, which will have a significant adverse effect on actual use.

[0005] Currently, clinicians lack a dedicated and effective fissure sealant. They often use other products such as gingival protectants, fluid resins, fissure sealants, cement, periodontal dressings, glass ionomer cement, or rubber impression materials as sealant materials. While these materials have unique uses and are suitable for different treatment procedures, they cannot meet the sealing requirements for rubber dams. Ideal rubber dam sealants should have good sealing effects, be easy to place and remove, not adhere to teeth, require no special curing methods, and be non-toxic and non-irritating. Gingival protectants, fluid resins, fissure sealants, cement, periodontal dressings, glass ionomer cement, or rubber impression materials do not fully meet these requirements. For example, cement, periodontal dressings, and glass ionomer cement require mixing, which is time-consuming; they are too adhesive and easily stick to gloves, teeth, and instrument surfaces, making them difficult to handle and remove. Rubber impression materials also have problems such as uncertain sealing effects and inconvenient handling.

[0006] Currently, overseas countries require every patient undergoing root canal treatment to use a gap sealant to seal the gaps around the rubber dam. Developing gap sealants with good water resistance, good sealing properties, simple operation, and easy cleaning has broad market value and application prospects. Summary of the Invention

[0007] To address the aforementioned technical problems, the present invention aims to provide a gap sealant composition that can effectively seal gaps around a rubber barrier and withstand liquid rinsing without leakage.

[0008] To achieve the above objectives, the present invention provides a premixed gap sealant composition for rubber barriers, wherein the composition comprises the following components:

[0009] Component a: Water-absorbing and swelling material;

[0010] Component b: Hydrophobic liquid carrier;

[0011] Component c: Thickener;

[0012] The contents of components a and c account for 41%-72% of the total mass of the composition, the contents of component b account for 28%-59% of the total mass of the composition, and the sum of the mass percentages of all components is 100%.

[0013] The hydrophobic liquid carrier includes one or more of the following: dimethyl silicone oil, eugenol, dimethylsiloxane, polymethylsiloxane, silicone oil, and vegetable oil.

[0014] According to a specific embodiment of the present invention, preferably, the water-absorbing and swelling material includes one or more of bentonite, diatomite, porous clay, etc.

[0015] According to a specific embodiment of the present invention, preferably, the bentonite includes one or a combination of two or more of sodium-based bentonite, calcium-based bentonite, hydrogen-based bentonite (activated clay), organo-bentonite, modified bentonite, bentonite ore, and montmorillonite. The present invention uses bentonite as a water-absorbing and swelling material in the rubber dam gap sealant composition, which has significant advantages; on the one hand, it can absorb water and swell, providing a good sealing effect; on the other hand, it can effectively adsorb patient blood, bacteria, etc. In the prior art, a small amount of bentonite is mixed with other cement materials, hydrophilic liquids, etc., and used as a root canal sealant. Its sealing effect is due to the relatively closed space within the root canal, where there is no large amount of water flushing. If such root canal sealants, or bentonite alone combined with thickeners, are placed around the rubber dam clamp, they are easily washed away by water from a water gun during dental treatment due to rapid water absorption and swelling, or cracks after solidification, thus failing to provide an effective water-blocking seal; therefore, they are not suitable for use in rubber dam gap sealing. The premixed rubber dam gap sealant composition provided by this invention, by employing a hydrophobic liquid carrier, is well-suited to the specific characteristics of rubber dam gaps requiring frequent rinsing with water and liquid agents. It maintains a good sealing effect while preventing it from being washed away by water, ensuring a good and continuous sealing effect during use. Furthermore, it is easy to use, effectively solving difficulties encountered by dentists in treatment and improving the treatment outcome of affected teeth. After use, the premixed rubber dam gap sealant composition of this invention exhibits good water resistance, does not solidify, and is easy to remove.

[0016] According to a specific embodiment of the present invention, preferably, the thickener includes one or a combination of two or more of the following: sodium alginate, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, sodium hydroxypropyl cellulose, calcium alginate, guar gum, xanthan gum, CL plant gum, starch, etc.

[0017] According to a specific embodiment of the present invention, preferably, the content of component a accounts for 30%-60% of the total mass of the composition.

[0018] According to a specific embodiment of the present invention, preferably, the content of component c accounts for 5%-42% of the total mass of the composition.

[0019] According to a specific embodiment of the present invention, preferably, the composition comprises the following components based on the total mass of the composition: component a: 30%-60%, component b: 28%-59%, component c: 5%-42%;

[0020] Among them, component a is one or more of sodium-based bentonite, calcium-based bentonite, organic bentonite, modified bentonite, diatomite, and hydrogen-based bentonite.

[0021] Component b is one or more of the following: dimethyl silicone oil, eugenol, dimethylsiloxane, polymethylsiloxane, silicone oil, etc.

[0022] Component c is one or more of the following: carboxymethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, xanthan gum, hydroxypropyl methylcellulose, etc.

[0023] The present invention also provides a method for preparing the above-mentioned premixed gap sealant composition for rubber barriers, comprising the following steps:

[0024] Components a and c are stirred and mixed to obtain a premixture;

[0025] Component b is stirred and mixed evenly, then added to the premix and stirred to homogenize, to obtain the premixed gap sealant composition for rubber barriers.

[0026] The present invention also provides the application of the above-mentioned premixed rubber barrier gap sealant composition in the preparation of hydrophobic and water-resistant sealants.

[0027] According to a specific embodiment of the present invention, preferably, the hydrophobic and water-resistant sealant is a hydrophobic and water-resistant sealant used in dentistry, orthopedics, or orthopedic surgery. After proper placement of the rubber dam, clinicians can use the premixed rubber dam gap sealant composition provided by the present invention to create a hydrophobic and water-resistant sealant that effectively seals gaps, prevents leakage, reduces patient discomfort, surgical site contamination, and ease of operation.

[0028] The premixed rubber dam gap sealant composition of the present invention uses bentonite and other water-absorbing and swelling materials as the main phase, with the addition of at least one hydrophobic liquid carrier and at least one thickener. It utilizes the excellent water absorption and swelling properties of bentonite and other materials, the adhesive properties of the hydrophobic liquid carrier, and the good biocompatibility of both, resulting in a rubber dam gap sealant material with excellent injectability and non-solidification. This material maintains a fluid state under sealing conditions. When filled between a rubber dam and the rubber dam clamp, or between teeth, it effectively repels water upon contact with water, better blocking water penetration. It can be used in areas requiring water resistance and sealing of gaps between the tooth and the rubber dam, including dental procedures (root canal treatment, dental restoration, etc.), better solving the leakage problem encountered by dentists when using rubber dams. It can also be used for other medical applications requiring hydrophobicity and water resistance.

[0029] Compared with the prior art, the advantages of the present invention are:

[0030] (1) Compared with fluid resins, pit and fissure sealants, root canal filling agents, etc., the premixed dental gap sealing composition of the present invention does not require light curing, is easy for doctors to operate, and is not easy to open the gap.

[0031] (2) Compared with cement, glass ionomer, etc., the premixed dental gap sealant of the present invention has the following advantages: (A) better hydrophobic and water-resistant properties; (B) does not solidify and is easy to clean after use. Attached Figure Description

[0032] Figures 1a-1d This article discusses the current problems and solutions encountered in the use of rubber barriers.

[0033] Figure 2a A photograph of the premixed rubber barrier gap-sealing composition obtained in Example 1.

[0034] Figure 2b Photographs showing the sealing effect of the premixed rubber barrier gap-sealing composition obtained in Example 1.

[0035] Figure 2c Photographs showing the sealing effect of the premixed rubber barrier gap-sealing composition obtained in Comparative Example 1.

[0036] Figures 3a-3h The figure shows the experimental results of a practical application experiment using the premixed rubber barrier gap-sealing composition of Example 1. Detailed Implementation

[0037] In order to provide a clearer understanding of the technical features, objectives and beneficial effects of the present invention, the technical solution of the present invention will now be described in detail below, but it should not be construed as limiting the scope of implementation of the present invention.

[0038] Example 1

[0039] This embodiment provides a premixed gap-sealing composition for rubber barriers, the preparation process of which is as follows:

[0040] (1) Weigh out each raw material:

[0041] Component a: 40 grams of sodium bentonite;

[0042] Component b: 35 grams of dimethyl silicone oil;

[0043] Component c: 25 grams of carboxymethyl cellulose;

[0044] The total weight of the above components is 100 grams.

[0045] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0046] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully mix into a paste, and obtain the premixed dental gap sealing composition.

[0047] The composition remains in a fluid state under sealed conditions. Extruded samples are placed in a dental conveyor with a height of 10 cm and 4 cm above it. An indigo aqueous solution (6 cm above the top) is added on top. After 1 hour and 4 hours, the penetration height of the indigo solution is observed. The results are 0.1 mm (1 hour) and 0.5 mm (4 hours), showing good sealing and water-blocking effects. When filled into the gaps between rubber barriers and rubber barrier clamps and between extracted teeth, the paste cannot be washed away with water. After 4 hours, no leakage is observed under the rubber barrier.

[0048] A photograph of the premixed gap-sealing composition for rubber barriers obtained in Example 1 is shown below. Figure 2a As shown.

[0049] The water-blocking effect test photos of the premixed rubber barrier gap-sealing composition obtained in Example 1 are shown below. Figure 2b As shown.

[0050] Example 2

[0051] This embodiment provides a premixed gap-sealing composition for rubber barriers, the preparation process of which is as follows:

[0052] (1) Weigh out each raw material:

[0053] Component a: 30 grams of calcium-based bentonite;

[0054] Component b: 22g clove oil, 37g polymethylsiloxane;

[0055] Component c: 11 grams of sodium alginate;

[0056] The total weight of the above components is 100 grams.

[0057] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0058] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully mix into a paste, and obtain the premixed dental gap sealing composition.

[0059] The composition was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 10 cm and 4 cm. An indigo aqueous solution (6 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 0.5 mm (1 hour) and 2 mm (4 hours), showing good sealing and water-blocking effects.

[0060] Example 3

[0061] This embodiment provides a premixed gap-sealing composition for rubber barriers, the preparation process of which is as follows:

[0062] (1) Weigh out each raw material:

[0063] Component a: 60 grams of organic bentonite;

[0064] Component b: 28 grams of silicone oil;

[0065] Component c: 12 grams of xanthan gum;

[0066] The total weight of the above components is 100 grams.

[0067] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0068] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully mix into a paste, and obtain the premixed dental gap sealing composition.

[0069] The composition was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 10 cm and a height of 4 cm. An indigo aqueous solution (6 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 0.3 mm (1 hour) and 1.0 mm (4 hours), showing good sealing and water-blocking effects.

[0070] Example 4

[0071] This embodiment provides a premixed gap-sealing composition for rubber barriers, the preparation process of which is as follows:

[0072] (1) Weigh out each raw material:

[0073] Component a: 30 grams of calcareous bentonite;

[0074] Component b: 28 grams of silicone oil;

[0075] Component c: 42 grams of carboxymethyl cellulose;

[0076] The total weight of the above components is 100 grams.

[0077] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0078] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully mix into a paste, and obtain the premixed dental gap sealing composition.

[0079] The composition was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 10 cm and 4 cm. An indigo aqueous solution (6 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 0.1 mm (1 hour) and 0.3 mm (4 hours), showing good sealing and water-blocking effects.

[0080] Example 5

[0081] This embodiment provides a premixed gap-sealing composition for rubber barriers, the preparation process of which is as follows:

[0082] (1) Weigh out each raw material:

[0083] Component a: 50 grams of diatomaceous earth;

[0084] Component b: 20g polymethylsiloxane, 25g silicone oil;

[0085] Component c: 5 grams of hydroxypropyl methylcellulose;

[0086] The total weight of the above components is 100 grams.

[0087] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0088] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully mix into a paste, and obtain the premixed dental gap sealing composition.

[0089] The composition was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 10 cm and a height of 4 cm. An indigo aqueous solution (6 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 0.4 mm (1 hour) and 1.9 mm (4 hours), showing good sealing and water-blocking effects.

[0090] Example 6

[0091] This embodiment provides a premixed gap-sealing composition for rubber barriers, the preparation process of which is as follows:

[0092] (1) Weigh out each raw material:

[0093] Component a: 54 grams of activated clay;

[0094] Component b: 36 grams of dimethylsiloxane;

[0095] Component c: 10 grams of carboxymethyl cellulose;

[0096] The total weight of the above components is 100 grams.

[0097] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0098] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully mix into a paste, and obtain the premixed dental gap sealing composition.

[0099] The composition was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 10 cm and 4 cm. An indigo aqueous solution (6 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 0.5 mm (1 hour) and 1.7 mm (4 hours), showing good sealing and water-blocking effects.

[0100] Comparative Example 1

[0101] This comparative example provides a gap-sealing composition, the preparation process of which is as follows:

[0102] (1) Weigh out each raw material:

[0103] Component a: 40 grams of sodium bentonite;

[0104] Component b: 20g polyethylene glycol, 15g propylene glycol;

[0105] Component c: 25 grams of carboxymethyl cellulose;

[0106] The total weight of the above components is 100 grams.

[0107] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0108] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully blend into a paste and obtain the gap sealing composition.

[0109] The material was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 7 cm and a height of 3 cm. An indigo aqueous solution (4 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 3 mm (1 hour) and 11 mm (4 hours), indicating poor sealing and water-blocking effects.

[0110] The water-blocking effect test photos of the gap-sealing composition obtained in this comparative example are shown below. Figure 2c As shown.

[0111] Comparative Example 2

[0112] This comparative example provides a gap-sealing composition, the preparation process of which is as follows:

[0113] (1) Weigh out each raw material:

[0114] Component a: 30 grams of calcium-based bentonite;

[0115] Component b: 59 g of propylene glycol;

[0116] Component c: 11 grams of sodium alginate;

[0117] The total weight of the above components is 100 grams.

[0118] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0119] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully blend into a paste and obtain the gap sealing composition.

[0120] The material was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 7 cm and a height of 3 cm. An indigo aqueous solution (4 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 10 mm (1 hour) and 25 mm (4 hours), indicating poor sealing and water-blocking effects.

[0121] Comparative Example 3

[0122] This comparative example provides a gap-sealing composition, the preparation process of which is as follows:

[0123] (1) Weigh out each raw material:

[0124] Component a: 60 grams of organic bentonite;

[0125] Component b: 28 g of propylene glycol;

[0126] Component c: 12 grams of xanthan gum;

[0127] The total weight of the above components is 100 grams.

[0128] (2) Components a and c from step (1) are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix.

[0129] (3) Place component b in a mixer and stir for 5 minutes until homogeneous. Then add the premixed mixture from step (2) to component b, stir and homogenize for 15 minutes to fully blend into a paste and obtain the gap sealing composition.

[0130] The material was kept in a fluid state under sealed conditions. The extruded sample was placed in a dental conveyor with a height of 7 cm and a height of 3 cm. An indigo aqueous solution (4 cm high) was added on top. After 1 hour and 4 hours, the penetration height of the indigo solution was observed. The results were 2 mm (1 hour) and 8 mm (4 hours), indicating poor sealing and water-blocking effects.

[0131] Experimental Example

[0132] Practical application experiments were conducted using the premixed rubber barrier gap-sealing composition provided in Example 1, as detailed below:

[0133] 1. In the initial state, there are certain gaps around the rubber barrier, such as... Figure 3a As shown;

[0134] 2. Apply the premixed rubber barrier gap-sealing composition provided in Example 1, such as... Figure 3b As shown;

[0135] 3. Rinse with water using a syringe; its water-blocking effect is as follows: Figure 3c As shown;

[0136] 4. Using a larger flow of tap water for rinsing will improve the water-blocking effect. Figure 3d and Figure 3e As shown; by Figure 3e It can be seen that even under high-flow tap water rinsing, the premixed rubber barrier gap-sealing composition does not solidify and has a good water-blocking effect.

[0137] 5. Check the back, such as Figure 3f As shown, the premixed rubber barrier gap-sealing composition effectively seals gaps, preventing water leakage and providing good water resistance.

[0138] 6. Rinse with high-pressure water, commonly used in dental treatment; the effect is as follows: Figure 3g As shown, the premixed rubber barrier gap-sealing composition can be rinsed clean without leaving any residue; by Figure 3h As can be seen, after rinsing, there is no residue, and the previous cavities are revealed again.

[0139] The experiment shows that the premixed gap-sealing composition for rubber dams of the present invention can effectively seal the gaps and voids at the edge of the rubber dam without leakage. Moreover, it does not solidify under the flushing of water of normal intensity and can maintain a good water-blocking effect. Under the flushing of dental high-pressure water, it can be rinsed clean without leaving any residue.

Claims

1. A premixed gap sealant composition for rubber barriers, wherein, The composition contains the following components: Component a: 30 grams of calcareous bentonite; Component b: 28 grams of silicone oil; Component c: 42 grams of carboxymethyl cellulose; The total weight of the above ingredients is 100 grams; The preparation process of the premixed gap sealant composition for rubber barriers is as follows: Components a and c are placed into a mixer in sequence and stirred at 35 rpm for 15 minutes to obtain a premix. Place component b in a mixer and mix for 5 minutes until homogeneous. Then add the premix to component b and mix homogenize for 15 minutes to fully form a paste, thus obtaining a premixed dental gap-sealing composition.

2. The use of the premixed rubber barrier gap sealant composition of claim 1 in the preparation of a hydrophobic and water-resistant sealant, wherein, The hydrophobic and water-blocking sealant is a dental hydrophobic and water-blocking sealant.

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