Preparation mold and preparation method of gingival crevicular fluid sampling brush capable of rapidly sampling

Abstract

The invention discloses a preparation mold and a preparation method of a gingival crevicular fluid sampling brush capable of rapidly sampling. The preparation mold comprises a female mold and a male mold cover plate, brush hair fibers are placed in the female mold, the male mold cover plate is covered after the brush hair fibers are evenly and fully laid, the brush hair fibers are slightly pressed through the gravity of the cover plate, and then the tail ends of the fibers are glued; on the basis of mold preparation, sampling brushes of different specifications are prepared through quantification, trimming, gluing, drying and fixing and two-step screening, the structure preparation is simple, operation is easy, the liquid absorption rate is high, compared with periopaper, the speed is increased by two times, the discomfort of a patient can be relieved, and the working efficiency is improved.

Description

Technical Field

[0001] The invention relates to a stomatological instrument, in particular to a preparation mold of a gingival sulcus fluid sampling brush for rapid sampling and a preparation method thereof. Background Art

[0002] Periodontitis remains a worrying global problem. Studies conducted between 2011 and 2020 showed that the combined prevalence of dentate adults was 62%, the combined prevalence of moderate to severe periodontitis was 53.2%, and the combined prevalence of severe periodontitis was 23.6%. The International Classification Symposium on Periodontal and Peri-implant Diseases held in Chicago in 2017 proposed the concept of periodontitis grading and staging, and emphasized the significance of biomarkers for the grading and diagnosis of periodontitis. Compared with saliva, gingival crevicular fluid can better reflect the periodontal health status of a specific site. Therefore, it is of great significance to explore how to collect samples quickly, efficiently, and at low cost in clinical practice.

[0003] Currently reported gingival crevicular fluid sampling methods include gingival crevicular irrigation, capillary tube method and paper strip method. The gingival crevicular irrigation method cannot recover all the fluid, and GCF cannot be quantified. It is generally used in the maxilla, which currently limits its application to GCF. Although the capillary tube method can accurately quantify, the sampling time is long, and a single site can exceed 30 minutes. It is difficult to remove a complete sample from the tube. It is time-consuming and laborious to use clinically, and is not suitable for a large number of gingival crevicular fluid sampling needs. Currently, the most commonly used method in clinical practice is the paper strip method. Periopaper is the most widely used gingival crevicular fluid sampling method. It is easy to operate and can complete single-point sampling in only 30 seconds, but the elution process is time-consuming and complicated, and needs to be imported from abroad, which is expensive.

[0004] Defects and shortcomings of periopaper technology:

[0005] 1. The elution process is complicated. The time for standing, shaking and centrifuging after collection often exceeds 30 minutes and requires large equipment such as a 4°C centrifuge, which is time-consuming and labor-intensive.

[0006] 2. It is expensive. Customs duties need to be paid when purchasing. The cost of a single spot paper can be as high as 4-5 yuan.

[0007] 3. The front end width is greater than 2mm, which makes it difficult to take samples for patients with healthy periodontal health and shallow gingival pockets.

[0008] 4. Currently, the sampling time per unit point is 30 seconds, which is too long and leads to low sampling efficiency.

[0009] The patent application with publication number CN 116919471 A, "A gingival sulcular fluid collection brush and its preparation method", still has the problem of unclear guidance on clinical selection and affecting the liquid absorption rate. Summary of the invention

[0010] In order to overcome the shortcomings of the above-mentioned prior art, the present invention provides a preparation mold and a preparation method for a gingival sulcus fluid sampling brush for rapid sampling. Sampling brushes of different specifications are prepared by adjusting the number of fibers and the size of the mold, and the sampling brush of the best size is selected by size screening method and liquid absorption rate screening method. These two-step screening will lay the foundation for large-scale industrial preparation of sampling brushes, which will help reduce production costs. At the same time, the improvement of liquid absorption rate improves sampling efficiency, shortens sampling time, helps to alleviate patient discomfort, and improves scientific research efficiency.

[0011] In order to achieve the above purpose, the technical solution adopted by the present invention is:

[0012] A preparation mold for a gingival sulcus fluid sampling brush for rapid sampling includes a comb-tooth-shaped female mold 1 and a male mold cover plate 2 buckled on the female mold 1, wherein one end of the comb teeth 9 of the female mold 1 is a tip 7, and the other end is a tail 8; a plurality of bristle fibers 3 are evenly placed and spread inside the comb teeth 9 of the female mold 1, and the bristle fibers 3 are adhered with viscose 4.

[0013] The shape and size of the male mold cover plate 2 are adapted to the female mold 1 .

[0014] The width of the tip 7 of the female mold 1 is set to 0.5-1.5 mm.

[0015] The width of the tail end 8 of the female mold 1 is set to 1.5-2.5 mm.

[0016] The female mold 1 and the male mold cover plate 2 are made of acrylic plates or hard plastics.

[0017] The length of the comb teeth 9 of the female mold 1, that is, the length from the tip 7 to the tail 8, is 14-16 mm.

[0018] A method for preparing a gingival sulcus fluid sampling brush for rapid sampling, the specific steps are as follows:

[0019] Step 1, quantification and trimming: count the corresponding number of fibers, align one end of the fiber and trim the other end to make it flush, place the fiber in the comb teeth 9 of the female mold 1 after trimming, ensure that one end of each fiber touches the tip 7 of the female mold 1, and the other end of the fiber is ≥2.5mm longer than the tail end 8 of the comb teeth, then gently cover the male mold cover plate 2, use the weight of the male mold cover plate 2 to lightly press the fiber, so that the fiber is evenly distributed in the mold;

[0020] Step 2, glue: For the fibers exposed outside the tail end 8 of the comb teeth of the female mold 1, glue is evenly applied along the width of the fiber section to cover the tail end of each fiber to ensure that all fibers are fully bonded;

[0021] Step 3, drying and fixing: After gluing, dry the mold with the sampling brush at 55-60℃ for 1-1.5h and take it out. When the tip of the solidified glue block is clamped with tweezers, if the bristles do not spread out, it means that the drying is good;

[0022] Step 4: Based on the individual differences of the sampled persons and the liquid absorption rate of the sampling brushes, the sampling brushes of different specifications are screened in two steps:

[0023] Initial screening: Based on the commonly used periodontal probe diameter of 0.4-0.6 mm, sampling brushes with a tip width and tip thickness of 0.4-0.6 mm were selected;

[0024] Screen again, and select the sampling brush with the fastest liquid absorption rate per unit time from the sampling brushes after the initial screening.

[0025] Compared with the prior art, the beneficial effects of the present invention are:

[0026] By preparing trapezoidal female molds and male mold cover plates 2 with different top and bottom widths, different numbers of bristles are placed in the female mold, covered with the male mold cover plate 2, and the bristles are flattened by the self-weight of the male mold cover plate 2, and then part of the adhesive is exposed for hand-holding. This preparation method is simple and convenient, and the finished bristles have good shape and excellent repeatability.

[0027] The length, width and number of fibers of the sampling brush mold were used to preliminarily select parameters that combine clinical applicability and high efficiency in liquid absorption. The clinical unit point sampling requirement can be met in 15 seconds, which is 2 times faster than that of periopaper.

[0028] This invention lays a good foundation for the large-scale industrial production of sampling brushes, which is conducive to reducing production costs and solving the "bottleneck" problem. In addition, the present invention greatly improves the clinical sampling efficiency, helps to reduce patient discomfort and improve work efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 (a) is a diagram of the sampling brush preparation model. Figure 1 (b) is a female mold 1, Figure 1 (c) is a schematic diagram of the male mold cover plate 2.

[0030] Figure 2 This is the change trend of the liquid absorption rate of three specifications of sampling brushes over time.

[0031] Figure 3 This is a calorimetric analysis of liquid aspiration by three specifications of sampling brushes at different times.

[0032] Figure 4 (a) is the recovery rate of IL-1β protein, Figure 4 (b) is the recovery rate of TNF-α protein, Figure 4(c) is the recovery rate of three MMP-8 proteins. DETAILED DESCRIPTION

[0033] The present invention will be further described in detail below with reference to the accompanying drawings

[0034] A preparation mold for a gingival sulcus fluid sampling brush for rapid sampling includes a comb-tooth-shaped female mold 1 and a male mold cover plate 2 buckled on the female mold 1, wherein one end of the comb teeth 9 of the female mold 1 is a tip 7, and the other end is a tail 8; a plurality of bristle fibers 3 are evenly placed and spread inside the comb teeth 9 of the female mold 1, and the bristle fibers 3 are adhered with viscose 4.

[0035] The shape and size of the male mold cover plate 2 are adapted to the female mold 1 .

[0036] The width of the tip 7 of the female mold 1 is set to 0.5-1.5 mm.

[0037] The width of the tail end 8 of the female mold 1 is set to 1.5-2.5 mm.

[0038] The female mold 1 and the male mold cover plate 2 are made of acrylic plates or hard plastics.

[0039] The comb teeth length of the female mold 1, that is, the length from the tip 7 to the tail 8, is 15 mm.

[0040] A method for preparing a gingival sulcus fluid sampling brush for rapid sampling, the specific steps are as follows:

[0041] Step 1, quantification and trimming: count the corresponding number of fibers, align one end of the fiber and trim the other end to make it flush, and after trimming, place the fiber in the comb teeth 9 of the female mold 1, ensuring that one end of each fiber touches the tip 7 of the female mold 1, and the other end of the fiber is 3 mm longer than the tail end 8 of the comb teeth, and then gently cover the male mold cover plate 2, and use the self-weight of the male mold cover plate 2 to lightly press the fiber so that the fiber is evenly distributed in the mold;

[0042] Step 2, glue: For the fibers exposed outside the comb teeth tail end of the female mold 1, apply glue evenly along the width of the fiber section, covering the tail end of each fiber to ensure that all fibers are fully bonded; take AB glue as an example: follow the instructions to extrude AB glue (1:1) onto a glass or plastic flat plate, mix with a fine needle or fine gun tip for 45 seconds, and after the mixed glue no longer draws, apply the glue evenly along the width of the fiber section (after curing, it will become glue 4). Note that the glue must cover all fibers to ensure that all fibers can be fully bonded;

[0043] Step 3, drying and fixing: After gluing, dry the mold with the sampling brush at 55°C for 1 hour and then take it out. When the tip of the solidified glue block is clamped with tweezers, if the bristles do not spread out, it means that the drying is good and it can be used for hand-held;

[0044] Step 4: According to the individual differences of the sampled persons and the liquid absorption rate of the sampling brushes, the sampling brushes of different specifications were screened by two-step method, see Figure 2 , Figure 3 :

[0045] Preliminary screening, based on the commonly used periodontal probe diameter of 0.5mm, three specifications of sampling brushes with tip width and tip thickness of 0.5mm were selected, that is, tip width mm / tail width mm / number of fibers were 0.5mm / 2.5mm / 40, 0.5mm / 1.5mm / 20, and 0.5mm / 2.5mm / 20 respectively;

[0046] Screen again, and select the sampling brush with the fastest liquid absorption rate per unit time after the initial screening. Figure 2 , Figure 3 As shown in the figure, in the periodontal pocket model test, the sampling brush with tip width (mm) / tail width (mm) / number of fibers (roots) of 0.5mm / 2.5mm / 40 completed 2u of liquid sampling within 15s, and its sampling rate was significantly higher than that of the other two groups. From the results of protein recovery after sampling, the recovery rates of IL-1β and TNF-α proteins using the 0.5 / 2.5 / 40 sampling brush were higher than those of Periopaper, and the difference was statistically significant. There was no statistical difference in the recovery rates of MMP-8 between the two sampling methods ( Figure 4 ). In summary, the sampling brush with a specification of 0.5mm / 2.5mm / 40 pieces has the feasibility of clinical application and large-scale production. In addition, the present invention provides a research basis for further modification to improve the liquid absorption rate and protein recovery. As the optimal application.

[0047] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A mold for preparing a gingival sulcus fluid sampling brush for rapid sampling, comprising a comb-shaped female mold (1) and a male mold cover plate (2) buckled on the female mold (1), characterized in that: One end of the comb teeth (9) of the female mold (1) is a tip end (7), and the other end is a tail end (8); a plurality of brush fibers (3) are evenly placed inside the comb teeth (9) of the female mold (1), and the brush fibers (3) are adhered with viscose (4).

2. The mold for preparing a rapid sampling gingival crevicular fluid sampling brush according to claim 1, characterized in that: The shape and size of the male mold cover plate (2) are adapted to those of the female mold (1).

3. The mold for preparing a rapid sampling gingival crevicular fluid sampling brush according to claim 1, characterized in that: The width of the tip (7) of the female mold (1) is set to 0.5-1.5 mm.

4. The mold for preparing a rapid sampling gingival crevicular fluid sampling brush according to claim 1, characterized in that: The width of the tail end (8) of the female mold (1) is set to 1.5-2.5 mm.

5. The mold for preparing a rapid sampling gingival crevicular fluid sampling brush according to claim 1, characterized in that: The female mold (1) and the male mold cover plate (2) are made of acrylic plates or hard plastics.

6. The mold for preparing a rapid sampling gingival crevicular fluid sampling brush according to claim 1, characterized in that: The length of the comb teeth (9) of the female mold (1), i.e. the length from the tip (7) to the tail (8), is 14-16 mm.

7. A method for preparing a gingival crevicular fluid sampling brush for rapid sampling, the specific steps are as follows: Step 1, quantification and trimming: count the corresponding number of fibers, align one end of the fibers and trim the other end to be flush, and after trimming, place the fibers in the comb teeth (9) of the female mold (1), ensuring that one end of each fiber touches the tip (7) of the female mold (1), and the other end of the fiber is ≥2.5 mm longer than the tail end (8) of the comb teeth, and then gently cover the male mold cover plate (2), and use the weight of the male mold cover plate (2) to lightly press the fibers so that the fibers are evenly distributed in the mold; Step 2, glue: For the fibers exposed outside the tail end (8) of the comb teeth of the female mold (1), glue is evenly applied along the width of the fiber section, covering the tail end of each fiber to ensure that all fibers are fully bonded; Step 3, drying and fixing: After gluing, dry the mold with the sampling brush at 55-60℃ for 1-1.5h and take it out. When the tip of the solidified glue block is clamped with tweezers, if the bristles do not spread out, it means that the drying is good; Step 4: Based on the individual differences of the sampled persons and the liquid absorption rate of the sampling brushes, the sampling brushes of different specifications are screened in two steps: Initial screening: Based on the commonly used periodontal probe diameter of 0.4-0.6 mm, sampling brushes with a tip width and tip thickness of 0.4-0.6 mm were selected; Screen again, and select the sampling brush with the fastest liquid absorption rate per unit time from the sampling brushes after the initial screening.

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