Double-layer night molar oral pad and preparation method thereof

Abstract

The invention provides a double-layer night molar oral pad and a preparation method thereof, and belongs to the field of medical instruments. The invention provides a double-layer night molar oral pad which is composed of a hollow GC soft lining layer and a hollow PEEK hard layer, and the outer surface of the GC soft lining layer is in contact with the inner surface of the PEEK hard layer. The inner layer of the double-layer night molar oral pad adopts the flexible biocompatible material-GC soft lining to be attached to the dentition and soft tissue, so that the oppressive sensation and foreign body sensation are greatly relieved, the double-layer night molar oral pad is suitable for being worn for a long time, and the compliance of a patient is remarkably improved; the outer layer is made of high-strength and wear-resistant PEEK, has excellent occlusion wear resistance and structural stability, and is particularly suitable for long-term use of moderate and severe night molar patients.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a double-layer night bruxism mouth pad and a preparation method thereof. Background Art

[0002] Bruxism is a common oral disorder characterized by unconscious teeth grinding, clenching, or tapping during sleep. Left untreated, bruxism can lead to severe tooth wear, exposing dentin and causing dentin sensitivity and cracked teeth. This can severely impact tooth life and facial aesthetics, damage periodontal tissues, and cause temporomandibular joint disorders. Therefore, effective interventions are urgently needed to reduce tooth wear.

[0003] At present, mouth pads are the main intervention method for bruxism, which can relieve patients' symptoms by isolating the upper and lower teeth, dispersing the bite force and protecting the tooth tissue. Currently, the existing mouth pads are divided into hard mouth pads and soft mouth pads. Traditional hard mouth pads are widely used in the treatment of bruxism due to their high strength and wear resistance. However, there are significant shortcomings in the clinical application of hard mouth pads: their excessive rigidity may cause discomfort when wearing. In contrast, soft mouth pads (such as silicone rubber or thermoplastic materials) are favored by some patients because of their softness and comfort, but they have poor wear resistance and are prone to deformation or breakage, especially in patients with severe bruxism. They have a short service life and are difficult to maintain a stable occlusal relationship during long-term use, which limits their scope of clinical application. Summary of the Invention

[0004] The invention provides a double-layer night bruxism mouth pad and a preparation method thereof. The double-layer night bruxism mouth pad of the invention has good wear resistance and comfort.

[0005] The invention provides a double-layer night bruxism mouth pad, which consists of a hollow GC soft lining layer and a hollow PEEK hard layer. The outer surface of the GC soft lining layer is in contact with the inner surface of the PEEK hard layer.

[0006] Preferably, the thickness of the GC soft lining is 0.4-0.6 mm; the thickness of the double-layer night bruxism pad is 1-2 mm.

[0007] The present invention also provides a method for preparing the double-layer night bruxism mouth pad described in the above technical solution, comprising the following steps:

[0008] After using the LeafGauge method to determine that a certain space is separated in the posterior tooth area, the teeth are molded with silicone rubber to obtain a double-layer night molar mouth pad template, and the double-layer night molar mouth pad template is three-dimensionally scanned. Scan and get double night molars 3D scanning data of the mouth pad; the certain space is the space of the double-layer night molar mouth pad between;

[0009] Editing the inner surface of the 3D scan data to reserve space for the GC soft lining layer, thereby obtaining 3D processing data;

[0010] Processing the PEEK raw material according to the 3D processing data to obtain a PEEK hard layer;

[0011] The raw materials of the GC soft lining layer are poured into the interior of the PEEK hard layer and then bitten to obtain the GC soft lining layer.

[0012] Preferably, the reverse mold comprises:

[0013] The bite registration material was injected into the maxillary posterior teeth on both sides until the canine area. The number of bite plates required for a 1.0 mm separation was again placed between the upper and lower anterior teeth on both sides. The mandible was slid back and forth before closing the mouth. After the bite registration material hardened, the left and right bite registration materials were obtained.

[0014] When placing the bite record material on the left side, a resin ball was placed in the central fossa of the right mandibular first molar, centric occlusion was achieved, and the resin ball was cured. When placing the bite record material on the right side, a resin ball was placed in the central fossa of the left mandibular first molar, centric occlusion was achieved, and the resin ball was cured.

[0015] The silicone rubber is placed in the occlusal space between the upper and lower jaws, and is fully centered, retracted, protruded, and lateral occluded. After the silicone rubber hardens, it is removed and trimmed to obtain a silicone rubber template of the teeth.

[0016] The inner layer of the double-layer bruxism mouth pad of the present invention uses a flexible biocompatible material - GC soft lining to fit the dentition and soft tissue, greatly reducing the pressure and foreign body sensation, making it suitable for long-term wear and significantly improving patient compliance; the outer layer is made of high-strength, wear-resistant PEEK, which has excellent resistance to occlusal wear and structural stability, and is particularly suitable for long-term use by patients with moderate to severe bruxism.

[0017] The outer occlusal surface (PEEK hard layer) of the present invention is designed based on three-dimensional occlusal data modeling, forming a scientific contact area and guiding surface. This can effectively guide mandibular movement, relieve masseter muscle tension, reduce pressure on the temporomandibular joint, enhance treatment efficacy, and improve the uniform distribution of bite force, avoiding the stress concentration problem of hard mouth pads and significantly extending their service life. Therefore, the double-layer night bruxism mouth pad prepared by the present invention achieves an ideal balance between comfort and durability while ensuring therapeutic efficacy, providing an optimized solution for the long-term treatment of night bruxism.

[0018] The present invention adopts intraoral scanning + digital modeling + processing process to prepare double-layer night bruxism mouth pads, which realizes standardized personalized customization, short production cycle, high precision, good repeatability, and improves clinical work efficiency; does not rely on plaster models and manual mixing, avoids problems such as inaccurate occlusion and insufficient fit caused by human errors, improves patient experience and treatment safety; ensures that the soft and hard layers are firmly combined and not easy to delaminate or fall off, Ensure structural stability and lasting functionality during long-term use sex.

[0019] All patients' occlusal design data can be stored and traced, facilitating doctor follow-up, remote adjustment and efficacy tracking, and improving the informatization and intelligence level of oral medical services. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 Traditional soft mouth pads and digital soft lining materials / PEEK mouth pads;

[0021] Figure 2 This is a sleep monitoring chart;

[0022] Figure 3 This is a diagram to check the wear of the mouth pad;

[0023] Figure 4 2D and 3D images of the traditional soft mouth pad and the digital soft lining material / PEEK mouth pad during T-scan occlusal analysis;

[0024] Figure 5 This is the ratio chart of traditional soft mouth pads and digital soft lining material / PEEK mouth pads during rapid eye movement sleep;

[0025] Figure 6 The wear statistics of traditional soft mouth pads and digital soft lining material / PEEK mouth pads after 1, 2, and 3 months;

[0026] Figure 7 The following are the statistical charts of hygiene scores of traditional soft mouth pads and digital soft lining material / PEEK mouth pads at 1, 2, and 3 months. DETAILED DESCRIPTION

[0027] The invention provides a double-layer night bruxism mouth pad, which consists of a hollow GC soft lining layer and a hollow PEEK hard layer. The outer surface of the GC soft lining layer is in contact with the inner surface of the PEEK hard layer.

[0028] In the present invention, the thickness of the GC soft lining is preferably 0.4-0.6 mm; the thickness of the double-layer night bruxism pad is preferably 1-2 mm.

[0029] The present invention also provides a method for preparing the double-layer night bruxism mouth pad described in the above technical solution, comprising the following steps:

[0030] After using the LeafGauge method to determine that a certain space is separated in the posterior tooth area, a silicone rubber mold is formed on the teeth to obtain a double-layer night molar pad template. The double-layer night molar pad template is three-dimensionally scanned to obtain 3D scanning data of the double-layer night molar pad; the certain space is the space of the double-layer night molar pad;

[0031] Editing the inner surface of the 3D scan data to reserve space for the GC soft lining layer, thereby obtaining 3D processing data;

[0032] Processing the PEEK raw material according to the 3D processing data to obtain a PEEK hard layer;

[0033] The raw materials of the GC soft lining layer are poured into the interior of the PEEK hard layer and then bitten to obtain the GC soft lining layer.

[0034] The present invention uses Leaf Gauge method to determine that a certain space is separated in the posterior tooth area, and then uses silicone rubber The teeth are molded to obtain a double-layer night molar pad template, and the double-layer night molar pad template is three-dimensionally scanned to obtain 3D scanning data of the double-layer night molar pad; the certain space is the space of the double-layer night molar pad.

[0035] In the present invention, the inverted mold preferably includes:

[0036] The bite registration material was injected into the maxillary posterior teeth on both sides until the canine area. The number of bite plates required for a 1.0 mm separation was again placed between the upper and lower anterior teeth on both sides. The mandible was slid back and forth before closing the mouth. After the bite registration material hardened, the left and right bite registration materials were obtained.

[0037] When placing the bite record material on the left side, a resin ball was placed in the central fossa of the right mandibular first molar, centric occlusion was achieved, and the resin ball was cured. When placing the bite record material on the right side, a resin ball was placed in the central fossa of the left mandibular first molar, centric occlusion was achieved, and the resin ball was cured.

[0038] The silicone rubber is placed in the occlusal space between the upper and lower jaws, and is fully centered, retracted, protruded, and lateral occluded. After the silicone rubber hardens, it is removed and trimmed to obtain a silicone rubber template of the teeth.

[0039] In the present invention, the instrument used for the 3D scanning is preferably a 3shape intraoral scanner.

[0040] In the present invention, the format of the 3D scanning data of the double-layer night molar pad is preferably STL format.

[0041] After obtaining the 3D scanning data of the double-layer night molar pad, the present invention edits the inner surface of the 3D scanning data, reserves space for the GC soft lining layer, and obtains 3D processing data.

[0042] In the present invention, the software used for editing is preferably T-Scan3 digital occlusal analysis system GeomagicWrap 2021 software.

[0043] After obtaining the 3D processing data, the present invention processes the PEEK raw material according to the 3D processing data to obtain the PEEK hard layer.

[0044] The present invention has no particular limitation on the processing, and methods well known to those skilled in the art can be used. Specifically, the 3D processing data is imported into CAD / CAM and then the PEEK raw material is precisely cut.

[0045] After the PEEK hard layer is obtained, the raw materials of the GC soft lining layer are poured into the PEEK hard layer and then interlocked to obtain the GC soft lining layer.

[0046] In the present invention, trimming is preferably performed after the biting to obtain the GC soft lining.

[0047] The double-layer night bruxism mouth pad and the preparation method thereof provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0048] This clinical trial was approved by the Ethics Committee of the School of Stomatology and Stomatological Hospital of Jilin University (SJDKQ2025041). This invention was conducted in the Stomatological Hospital of Jilin University. All of the participants have provided informed consent to participate in the present invention. Letter of intent.

[0049] Inclusion criteria:

[0050] (1) Patients with bruxism; (2) Aged ≥ 18 years; (3) Willing to accept two types of oral splint treatment; (4) Healthy periodontal, dental, and oral mucosal structures; (5) Possessing complete autonomy in behavior and expression.

[0051] Exclusion criteria:

[0052] (1) The presence of bruxism; (2) The lack of full autonomous behavioral and expressive abilities; (3) Severe malocclusion and other factors that may affect occlusion; (4) Sleep-related diseases such as obstructive sleep apnea syndrome.

[0053] Statistical methods:

[0054] Statistical analyzes were performed using SPSS22.0, with T-test to compare groups. Statistical significance was set at P<0.05.

[0055] The present invention selected 20 patients with bruxism, and prepared 20 pairs of digital soft lining material / PEEK mouth pads according to the method of Example 1, and prepared traditional soft mouth pads according to the method of Comparative Example 1.

[0056] The experimental group was the digital soft lining material / PEEK mouth pad group, and the control group was the traditional soft mouth pad group.

[0057] Example 1

[0058] The LeafGauge method was used (1. Any number of bite plates were placed on the midline of the patient's anterior teeth, parallel to the lingual plane of the maxillary central incisor; 2. The patient was asked to occlude the posterior teeth until the lower anterior teeth contacted the lower surface of the bite plate; 3. The number of bite plates was gradually increased as needed until the posterior teeth were elevated by 1 mm when the patient bit the bite plate; 4. The LeafGauge bite plates were removed, and the volunteer was asked not to close his mouth to eliminate the influence of tooth contact proprioceptors; 5. The silicone rubber bite record material was injected into the posterior teeth on both sides of the volunteer's maxilla until the canine area, and the same number of bite plates were placed again between the volunteer's upper and lower anterior teeth, and the patient was asked to slide the mandible back and forth before closing the mouth; 6. After the bite record material hardened, the bite record was removed and the letters "L" and "R" were written on the side of the bite record. Mark the upper and lower and left and right sides of the occlusal record respectively; 7. When placing the left occlusal record, place a resin ball in the central fossa of the right mandibular first molar, ask the patient to occlude centrally, and solidify the resin ball. When placing the right occlusal record, place a resin ball in the central fossa of the left mandibular first molar, ask the patient to occlude centrally, and solidify the resin ball; 8. Place the silicone rubber in the occlusal space between the upper and lower jaws, ask the patient to perform sufficient centric, posterior, protrusive and lateral occlusion, take it out after hardening the silicone rubber, trim the shape to form a mouth pad template) so that the posterior teeth are separated by 1.0mm (as a restoration space for the mouth pad), and then use the 3shape intraoral scanner to perform a three-dimensional scan of the silicone rubber mouth pad template, obtain the STL format data and import it into the T-Scan3 digital occlusal analysis system Geomagic Wrap 2021 software, and use the surface editing function to eliminate the 0.5mm thickness of the contact surface with the maxillary dentition to reserve space. soft Lining material space. After data optimization (using the surface editing function to eliminate the 0.5mm contact surface with the maxillary dentition) The thickness (thickness reserved for the soft lining material) was then exported as a cutting file. This file was imported into CAD / CAM, and the PEEK was precisely cut to complete the digital fabrication of the mouth pad. The GC soft lining material was poured onto the contact surface of the mouth pad with the maxillary dentition, and then occluded. After curing for 3 minutes, the excess soft lining material was removed to obtain the digital soft lining material / PEEK mouth pad.

[0059] Comparative Example 1

[0060] Impressions of the patient's upper and lower jaws are taken and cast into plaster models. A release agent is then evenly applied to the working area of the plaster model. A preheated PET-G film is placed on the clamping frame of a vacuum laminator and heated to a softening temperature of 180-200°C. Vacuum suction is immediately activated to ensure the film adheres tightly to the model's dentition. After cooling, the pressed film is removed, excess material removed, and the edges polished to create a traditional soft mouth pad.

[0061] Figure 1 For traditional soft mouth pads and digital soft lining materials / PEEK mouth pads: Figure 1 Middle (a) is a traditional soft mouth pad; Figure 1 Middle (b) shows a traditional soft mouth pad worn in the mouth; Figure 1 Middle (c) is a digital soft lining material / PEEK mouth pad; Figure 1 Middle (d) shows the digital soft lining material / PEEK cushion worn in the mouth.

[0062] T-scan occlusal contact detection

[0063] Occlusal contact testing was performed using the T-Scan8 digital occlusal analysis system (TeKscan, USA). All patients maintained the same upright sitting position, relaxed, and looking straight ahead. A support fork and 3M conductive film matching the patient's jaw arch were selected and connected to the handle. The T-Scan8 software was opened, and a new patient profile was created. The conductive film was placed in the mouth parallel to the occlusal plane, with the tip of the support fork aligned with the midline and lightly contacting the mesial incisal angle of the upper central incisor. Sensitivity was calibrated and tested at the same sensitivity. Each patient underwent three bite tests, each time occluding to the interdigital position and then separating. Patients were instructed to bite firmly on the conductive film during the test.

[0064] Figure 4 2D and 3D images of the traditional soft mouth pad and the digital soft lining material / PEEK mouth pad during T-scan occlusal analysis: Figure 4 (a) is a 2D diagram of the traditional soft mouth pad occlusal analysis; Figure 4 Middle (b) is the 3D diagram of the soft bite analysis of comparative example 1; Figure 4 Middle (c) is the 2D image of the digital soft lining material / PEEK mouth pad occlusal analysis; Figure 4 (d) is a 3D image of the digital soft lining material / PEEK mouth pad occlusal analysis.

[0065] Depend on Figure 4It can be seen that there are significant differences in the occlusal force distribution characteristics between the traditional soft mouth pad and the digital soft lining material / PEEK mouth pad. The traditional soft mouth pad shows a significant occlusal force concentration phenomenon. Its occlusal contact is mainly distributed in the anterior and posterior teeth areas, and the occlusal force value in this area is relatively large, while the occlusal force in the premolar area is significantly reduced, showing a "dumbbell-shaped" distribution characteristic. In contrast, the occlusal contact points of the control sample 1 mouth pad are distributed in the entire dentition. The distribution is more even, and each functional area (front teeth, premolars, molars) The bite force difference is small, and the overall The peak bite force is lower than that of traditional mouth pads.

[0066] Sleep quality assessment

[0067] The O2 Ring blood oxygen ring was used to dynamically monitor the sleep characteristics of patients with bruxism after wearing the oral pad. The sleep data of 4 days at night were collected every month before the treatment and 1, 2, and 3 months after wearing the oral pad. The multi-channel physiological sensor built into the O2 Ring automatically recorded the duration and proportion of rapid eye movement (REM) in the sleep cycle, and analyzed the impact of the oral pad intervention on sleep structure (such as Figure 2 This longitudinal observational design provides objective data support for the timeliness of the oral pad in regulating sleep rhythm through continuous monitoring with wearable devices.

[0068] Figure 2 This is a sleep monitoring chart.

[0069] Figure 5 This is a chart showing the rapid eye movement (REM) sleep period ratios for traditional soft mouthpads and digital soft lining material / PEEK mouthpads: red represents the REM sleep period ratio when no mouthpad is worn; blue represents the REM sleep period ratio when using a traditional soft mouthpad; and green represents the REM sleep period ratio when using a digital soft lining material / PEEK mouthpad.

[0070] Depend on Figure 5 In the early stages of treatment, without a mouthpiece, patients' REM sleep accounted for 19.10% ± 1.52%. During the intervention phase, REM sleep decreased to 18.60% ± 2.09% with a traditional soft mouthpiece and 18.60% ± 1.76% with a digital soft lining / PEEK mouthpiece.

[0071] Statistical analysis showed that the proportion of REM sleep showed a slight downward trend compared with the baseline level after intervention with both mouth pads, but this change did not reach the statistically significant level (p>0.05).

[0072] Mouth pad wear

[0073] A high-precision semi-ruler (0.01 mm accuracy) was used to quantitatively assess the wear of the mouthpiece after 1, 2, and 3 months of clinical use. The thickness of the mouthpiece was measured at the functional cusp of the first molar and the canine cusp. Cumulative wear was calculated by comparing the difference between the initial wear baseline thickness and the thickness at each time point. To visualize the wear distribution, heatmap visualization was used to present the wear data at different time points.

[0074] Figure 3 This is the inspection diagram of the mouth pad wear: Figure 3 (a) is the measurement of the thickness of the mouth pad using a dental semi-ruler; Figure 3 Middle (b) is a probing test to see if the oral pad is worn through.

[0075] Figure 6 The wear statistics of traditional soft mouth pads and digital soft lining material / PEEK mouth pads after 1, 2, and 3 months: Figure 6 (a) is the wear heat map of the traditional soft mouth pad; Figure 6 Middle (b) is the digital wear heat map of soft lining material / PEEK mouth pad; Figure 6 Middle (c) shows the wear of traditional soft mouth pads and digital soft lining material / PEEK mouth pads in the first month; Figure 6 Middle (d) shows the wear of traditional soft mouth pads and digital soft lining material / PEEK mouth pads in the second month; Figure 6 (e) in the middle is a traditional soft mouth pad and a digital soft lining material / PEEK Wear of oral pads in the third month.

[0076] Depend on Figure 6 It can be seen that the cumulative wear of the oral pad group in comparative example 1 at 1, 2 and 3 months was 0.22±0.07mm, 0.48±0.13mm and 0.83±0.16mm, respectively, showing a linear trend of significant increase with time; while the wear of the digital soft lining material / PEEK oral pad group during the same period was only 0.04±0.02mm, 0.11±0.04mm and 0.17±0.04mm, and the wear rate was significantly lower than that of the soft group (p<0.01).

[0077] Oral pad hygiene assessment

[0078] The oral hygiene of the two groups of patients (experimental and control) was systematically evaluated. The hygiene of the two oral pads was scored as follows: 1 (plaque present inside the pad); 2 (plaque present on both the inner and outer surfaces); and 3 (substantial calculus deposits visible on both the inner and outer surfaces). Changes in these scores were recorded during treatment in both groups through regular clinical examinations. The Mann-Whitney U test was used to analyze the oral pad hygiene scores in the two groups to assess plaque adhesion on the different oral pad materials. All assessments were performed by the same calibrated examiner to ensure consistency in the scoring criteria.

[0079] Figure 7 The following are the hygiene score statistics of traditional soft mouth pads and digital soft lining material / PEEK mouth pads after 1, 2, and 3 months: Figure 7 Middle (a) is the oral pad hygiene score at 1 month; Figure 7 Middle (b) is the oral pad hygiene score at 2 months; Figure 7 Middle (c) is the oral pad hygiene score at 3 months.

[0080] Depend on Figure 7 The hygiene scores for the traditional soft mouthguard group at 1, 2, and 3 months were 0.7±0.57, 0.9±0.64, and 1.2±0.62, respectively, while those for the digital soft lining / PEEK mouthguard group were 0.6±0.59, 0.85±0.51, and 1.1±0.55, respectively. The Mann-Whitney U test revealed no statistically significant difference in hygiene scores between the two groups (p>0.05).

[0081] Patient satisfaction survey

[0082] A multidimensional satisfaction survey was conducted in both groups using a visual analog scale (VAS, 0-10). The evaluation criteria included comfort (0: extreme discomfort, 10: no discomfort), aesthetics (0: completely unacceptable, 10: very satisfactory), and retention stability (0: continuous loss, 10: completely stable). Patients completed the scale independently after one month of oral pad wear to avoid interference from clinical staff. Data were compared between groups using independent t-tests, and non-normally distributed data were analyzed using the Mann-Whitney U test.

[0083] The results of clinical satisfaction using the visual analogue scale (VAS) are shown in Table 1 .

[0084] Table 1 Patient satisfaction scores of the two groups of oral pads

[0085] Group Comfort Aesthetics retention Traditional soft mouth pad 7.40±1.07 9.35±0.67 8.30±0.98 Digital soft lining material / PEEK mouth pad 7.09±1.38 7.60±0.88 8.50±0.83 P-value P＝0.38 P＜0.01 P＝0.55

[0086] As shown in Table 1, the traditional soft mouthguard group scored 7.40 ± 1.07 points for comfort, slightly higher than the 7.09 ± 1.38 points for the digital soft lining / PEEK mouthguard group, but the difference between the two groups was not statistically significant (P = 0.38). In the aesthetic evaluation, the traditional soft mouthguard received a significantly higher score (P < 0.01), which may be related to its better translucency and edge adaptability. In terms of retention stability, the two groups performed comparable (P = 0.55), indicating that both mouthguards provide reliable clinical retention.

[0087] Summarize

[0088] Oral pads are a clinically important treatment for bruxism, but due to the limitations of both hard and soft oral pads, the combination of high-molecular-weight PEEK materials and digital technology offers a new therapeutic approach. This study compared the clinical efficacy of a digital soft-hard dual-layer digital soft lining material / PEEK oral pad with traditional soft oral pads in various aspects, exploring their clinical application value.

[0089] The magnitude and distribution of bite force are crucial for the treatment of bruxism. The results of the T-Scan digital occlusal analysis system show that there are significant differences in the occlusal contact characteristics between traditional soft mouth pads and digital soft-hard double-layer digital soft lining materials / PEEK mouth pads. The traditional soft mouth pads have a concentrated occlusal force phenomenon, especially in the anterior and posterior areas, and the occlusal force in the premolar area is significantly reduced, showing a typical "dumbbell-shaped" distribution. The T-Scan image of the digital soft-hard double-layer digital soft lining material / PEEK mouth pad shows uniform occlusal contact and a low overall peak occlusal force. The soft mouth pad adopts compression molding processing technology, which cannot fully conform to the patient's occlusal relationship. The thermal expansion coefficient of PET-G is 6.5×10 -5 / K, its large thermal expansion coefficient causes it to deform to a certain extent after cooling, thus forming a "dumbbell-shaped" distribution when biting. This is consistent with the invention results of Seifollah Gholampour. During the intraoral shaping process of the digital double-layer mouth pad silicone rubber template, the patient performed sufficient centration, retraction, protrusion and lateral movements, and the mouth pad processed according to the template achieved uniform occlusal contact with the opposing teeth. In addition, when the teeth bite on the digital soft lining material / PEEK mouth pad with a harder outer layer, the tactile discrimination of the teeth from the periodontal mechanoreceptors will activate the self-protection mode. From the perspective of the neural regulation mechanism, the mechanical stimulation is transmitted through the trigeminal midbrain nucleus-thalamus-cerebral cortex pathway, triggering the inhibitory regulation of the gamma motor neurons, forming a precise negative feedback loop, thereby reducing the peak bite force.

[0090] Healthy sleep is the guarantee for the normal and stable physiological functions of the body. In modern sleep inventions, many scholars use the term "sleep architecture" to describe the various stages of sleep and their interrelationships. Rapid Eye Movement (REM) is a stage in sleep architecture, usually accompanied by rapid eye movements, higher brain activity and the generation of dreams. Sufficient REM sleep is usually the key to high-quality sleep. Part of it helps restore body and brain functions and maintain mood The present invention can achieve emotional stability and clear cognition.Dynamic monitoring of REM sleep revealed that the proportion of REM sleep decreased after wearing both the traditional soft mouth pad and the digital soft-hard double-layer mouth pad, but the decrease did not reach statistical significance (p>0.05). This result indicates that wearing a mouth pad does not affect the patient's sleep quality. This is mainly attributed to the biomechanical adaptability brought about by its unique soft lining buffer layer design. Its 0.5mm thick elastic soft lining can effectively disperse the occlusal pressure and reduce the local stress peak. In addition, during the plasticization process of the digital soft lining material / PEEK mouth pad silicone rubber template, the patient's mandible undergoes sufficient centration, protrusion, retraction, and lateral movement. After the double-layer mouth pad made according to this template is placed in the patient's mouth, when the mandibular natural teeth come into contact with the PEEK surface of the double-layer mouth pad, there is no premature contact or oral interference over a large range, which greatly improves the patient's comfort. The semi-digital design combines the advantages of clinical occlusal records and digital design. By precisely controlling the gap design, it ensures the adaptive soft lining cushioning between the mouth pad and the maxillary dentition, and ensures the physiological freedom of mandibular functional movement, thereby achieving a high degree of adaptability between the restoration and the patient's dynamic occlusal function.

[0091] Wear is an important indicator for evaluating the durability of oral pads. The present invention found that the cumulative wear of soft oral pads gradually increased over 1, 2, and 3 months, and the wear rate was relatively fast, while the wear rate of double-layer oral pads was significantly lower than that of soft oral pads. The higher wear rate of soft oral pads is partly due to the insufficient wear resistance of the PET-G material and partly due to the high oral forces exerted by teeth grinding during sleep, as determined by the T-Scan bite force analysis results of the present invention. These two factors contribute to the rapid wear of traditional soft oral pads. In contrast, the excellent wear resistance and reduced oral forces of PEEK material result in less wear of double-layer oral pads. Double-layer oral pads can maintain good morphological and functional stability over extended use, making them suitable for long-term wear.

[0092] The present invention conducted a three-month longitudinal evaluation of the hygiene of two oral pads. Although the changes in hygiene scores for the two groups of oral pads at each time point did not reach statistical significance (p>0.05), the scoring data indicate that the hygiene of the soft oral pad was relatively poor, and gradually deteriorated during follow-up. This may be related to the surface properties of the PET-G material, which readily absorbs plaque and bacteria, thereby increasing the oral bacterial burden. In contrast, the PEEK surface of the double-layer oral pad is smooth and less susceptible to bacterial adhesion, ensuring better cleanliness and reducing the occurrence of oral hygiene problems.

[0093] In terms of patient satisfaction, the traditional soft mouth pad scored significantly higher than the double-layer mouth pad in terms of aesthetics, which may be related to the translucent nature of the soft mouth pad. In terms of comfort, the traditional soft mouth pad group scored slightly higher, but the difference between the two groups was not statistically significant. The soft lining of the double-layer mouth pad effectively improved the comfort of the traditional hard mouth pad. In terms of retention stability, both groups of mouth pads showed good retention effects, with no significant difference. This result shows that the double-layer mouth pad is slightly inferior to the soft mouth pad in terms of comfort and aesthetics, but In terms of retention stability, both can provide effective treatment support.

[0094] in conclusion

[0095] This study compared the clinical effectiveness of a digital soft-hard double-layer digital soft lining material / PEEK mouth pad with a traditional soft mouth pad in the treatment of bruxism. The results showed that the digital soft lining material / PEEK mouth pad significantly outperformed the traditional soft mouth pad in terms of occlusal stability and wear resistance, particularly exhibiting a lower wear rate (p < 0.01). Although there were no significant differences between the two mouth pads in terms of comfort and retention stability (p > 0.05), the traditional soft mouth pad scored significantly higher in terms of aesthetics (p < 0.01). Regarding sleep quality improvement, neither treatment significantly increased the proportion of REM sleep, indicating a limited impact on sleep architecture. Regarding oral hygiene, the difference between the two treatments did not reach statistical significance (p > 0.05). Overall, the digital soft-hard double-layer digital soft lining material / PEEK mouth pad had significant advantages in durability and occlusion, making it suitable for long-term treatment, while the traditional soft mouth pad had greater advantages in terms of aesthetics and initial comfort.

[0096] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A double-layer night bruxism mouth pad, characterized in that: The hollow GC soft lining layer is composed of a hollow GC soft lining layer and a hollow PEEK hard layer. The outer surface of the GC soft lining layer is in contact with the inner surface of the PEEK hard layer.

2. The double-layer night bruxism pad according to claim 1, characterized in that: The thickness of the GC soft lining is 0.4-0.6 mm; the thickness of the double-layer night bruxism pad is 1-2 mm.

3. The method for preparing the double-layer nighttime teeth grinding mouth pad according to claim 1 or 2, characterized in that: The following steps are involved: After using the LeafGauge method to determine that a certain space is separated in the posterior tooth area, a silicone rubber mold is formed on the teeth to obtain a double-layer night molar pad template. The double-layer night molar pad template is three-dimensionally scanned to obtain 3D scanning data of the double-layer night molar pad; the certain space is the space of the double-layer night molar pad; Editing the inner surface of the 3D scan data to reserve space for the GC soft lining layer, thereby obtaining 3D processing data; Processing the PEEK raw material according to the 3D processing data to obtain a PEEK hard layer; The raw materials of the GC soft lining layer are poured into the interior of the PEEK hard layer and then bitten to obtain the GC soft lining layer.

4. The preparation method according to claim 3, characterized in that The inverted mold comprises: The bite registration material was injected into the maxillary posterior teeth on both sides until the canine area. The number of bite plates required for a 1.0 mm separation was again placed between the upper and lower anterior teeth on both sides. The mandible was slid back and forth before closing the mouth. After the bite registration material hardened, the left and right bite registration materials were obtained. When placing the bite record material on the left side, a resin ball was placed in the central fossa of the right mandibular first molar, centric occlusion was achieved, and the resin ball was cured. When placing the bite record material on the right side, a resin ball was placed in the central fossa of the left mandibular first molar, centric occlusion was achieved, and the resin ball was cured. The silicone rubber is placed in the occlusal space between the upper and lower jaws, and is fully centered, retracted, protruded, and lateral occluded. After the silicone rubber hardens, it is removed and trimmed to obtain a silicone rubber template of the teeth.

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