Effectiveness of novel versustraditional anterior repositioning splints for anterior disc displacement with reduction of the temporomandibular joint

Effectiveness of novel versustraditional anterior repositioning splints for anterior disc displacement with reduction of the temporomandibular joint | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effectiveness of novel versus traditional anterior repositioning splints for anterior disc displacement with reduction of the temporomandibular joint Zhilei Liu, Antong Wu, Wenyi Cai, Jiaqian Fan, Yunyi Yuan, Yufu Lin, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7083956/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Anterior disc displacement with reduction (ADDwR) is a common subtype of temporomandibular disorders (TMD). Anterior repositioning splints (ARSs) serve as a key conservative treatment modality. This study aimed to compare the clinical efficacy of a novel Mono-Block splint (nMB) with that of a traditional Twin-Block splint (tTB) in the management of ADDwR. Methods A total of 118 patients with ADDwR were randomized to receive either an nMB or tTB splint. Clinical outcomes were assessed at baseline (T0) and 1 (T1), 3 (T3), and 6 months (T6). CBCT scans were obtained at T0 and T6, and patient satisfaction was evaluated at T6. Results Joint noise: The nMB group showed significantly greater improvement than the tTB group at T1 and T6. Joint pain: Greater symptom relief was observed in the nMB group at T3. 3. MMO: The nMB splint induced a significantly greater increase in MMO only at T1. Anterior disc displacement: CBCT evaluation revealed comparable outcomes between the two groups, with no significant differences in relative disc position. Patient satisfaction: The nMB splint achieved significantly higher ratings in general satisfaction, comfort, and stability, while no significant differences were noted in cleaning and retention. Conclusion The nMB splint demonstrated superior effectiveness in reducing joint noise and improving patient comfort compared to the tTB splint, while both splints exhibited similar efficacy in relieving joint pain and enhancing MMO. Although neither splint significantly improved disc reduction on CBCT, the nMB design offers a promising, patient-oriented approach for conservative treatment of ADDwR. Dentistry Temporomandibular joint disorders Anterior disc displacement with reduction Anterior repositioning splint CBCT Figures Figure 1 Figure 2 Figure 3 Figure 4 1. Introduction Temporomandibular disorder (TMD) is among the four most prevalent conditions affecting the oral and maxillofacial region. TMD encompasses a spectrum of functional impairments involving the temporomandibular joint (TMJ), masticatory muscles, and associated neural structures [ 1 , 2 ]. It predominantly affects adults between the ages of 20 and 40 and occurs more frequently in females [ 3 , 4 ]. Epidemiological studies estimate that approximately 10–15% of the adult population experience TMD symptoms [ 3 , 5 ]. The primary clinical manifestations of TMD include joint noise (e.g., clicking or popping), joint pain, and restricted mouth opening. Additional symptoms may involve masticatory muscle tenderness, difficulties with chewing or speaking, tinnitus, dizziness, and headaches. Among the various subtypes, anterior disc displacement with reduction (ADDwR) stands out as both highly prevalent and clinically significant [ 6 , 7 ]. Clinically, ADDwR is characterized by clicking sounds during mandibular movement. Typically, a loud click occurs during mouth opening, followed by a softer click upon closure—corresponding to disc recapture and subsequent displacement [ 8 ]. Magnetic resonance imaging (MRI) in these patients often shows anterior displacement of the articular disc in the closed-mouth position, with normal disc-condyle alignment re-established upon opening—a key diagnostic indicator of the “reduction” phenomenon [ 9 ]. In addition, cone beam computed tomography (CBCT) findings commonly reveal structural changes in patients with ADDwR, such as increased anterior joint space, decreased posterior joint space, and posterior positioning of the condyle within the glenoid fossa [ 10 , 11 ]. The management of ADDwR primarily emphasizes conservative, non-invasive treatment strategies, among which intraoral appliances—such as occlusal splints—play a pivotal role [ 12 , 13 ]. These appliances function to redistribute occlusal forces, correct discrepancies in the spatial relationship among the occlusion, masticatory muscles, condyle, and articular disc, and reduce excessive muscular activity. Through these mechanisms, they aim to progressively restore a stable disc-condyle relationship while minimizing further damage to the TMJ [ 14 ]. Among the various splint types, the anterior repositioning splint (ARS) has demonstrated particular efficacy in the treatment of ADDwR [ 13 ]. The ARS repositions the mandible anteriorly, thereby altering the distribution of joint space, promoting disc recapture, and alleviating hallmark symptoms such as joint clicking and masticatory muscle pain [ 14 – 16 ]. Despite the proven therapeutic benefits of ARS in the management of ADDwR, traditional ARS designs present certain limitations. For example, Twin-Block (TB) splints may fail to maintain consistent mandibular advancement during sleep, particularly in patients with mouth breathing habit [ 17 – 19 ]. In contrast, Mono-Block (MB) splints offer greater stability but are often bulky, resulting in significantly reduced comfort and patient compliance [ 20 ]. To address these issues, we developed a novel Mono-Block (nMB) splint. Although conceptually based on existing ARS principles, the clinical efficacy of this redesigned nMB splint in managing ADDwR has not yet been validated in a large-scale, controlled clinical trial. Therefore, this randomized controlled trial was conducted to compare the therapeutic efficacy of the nMB splint with that of the traditional TB (tTB) splint, which served as a positive control. Patients diagnosed with ADDwR were randomly allocated to either treatment groups. Treatment outcomes were assessed through multiple clinical parameters, including joint noise, maximum mouth opening (MMO), joint pain (via Visual Analog Scale, VAS), CBCT analysis, and patient satisfaction ratings (VAS). This study aimed to evaluate the clinical value of the nMB splint in the management of ADDwR and to provide insights into optimizing effective, patient-oriented strategies for the management of TMD and ADDwR. 2. Methods and materials 2.1 Participants Patients diagnosed with ADDwR at the Temporomandibular Joint Department of the Affiliated Stomatology Hospital of Guangzhou Medical University between December 2023 and December 2024 were considered for inclusion. All participants provided written informed consent prior to enrollment. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Affiliated Stomatology Hospital of Guangzhou Medical University (Ethics Approval Number: LCYJ20250618004). Inclusion criteria : a) Diagnosis of TMD based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD); b) MRI confirming ADDwR; c) Relatively complete dentition in both the maxillary and mandibular arches; d) Good compliance and willingness to adhere to treatment protocols and follow-up visits. Exclusion criteria : a) Moderately to severely limited mouth opening (maximum mouth opening < 20 mm); b) Significant tooth loss in either dental arch compromising splint fitting or retention; c) History of orthognathic surgery, prior TMD treatment, or maxillofacial trauma; d) Presence of severe congenital, systemic, or hereditary conditions, or psychological disorders affecting compliance; e) Loss to follow-up or voluntary withdrawal during the study period; f) Other exclusion factors as deemed appropriate by the investigators (Supplementary Fig. 1) . 2.2 Splint treatment protocol A total of 118 eligible patients were enrolled and randomly assigned to two groups: the nMB splint group (n = 59) and the tTB splint group (n = 59). The nMB splint is a one-piece ARS that covers the full dental arch (Supplementary Fig. 2A, B) . Before fabrication, dental impressions and occlusal registrations were obtained. Patients were instructed to perform repeated mandibular opening and closing movements to facilitate proprioceptive relaxation. Once joint noise was eliminated at MMO, the mandible was guided gently into the minimal protruded position that did not induce muscular fatigue or discomfort. This position was identified as the optimal therapeutic protrusion [ 21 ]. Intraoral scans and wax bite registrations were captured in this position using a digital intraoral scanner. All procedures were performed by the same experienced clinician to ensure standardization. The acquired records were submitted to the laboratory, where all splint was fabricated by a single dedicated technician to minimize inter-operator variability. For the tTB splint group (Supplementary Fig. 2C, D ), the same clinical and laboratory workflow was followed to ensure protocol consistency across both groups. 2.3 Clinical evaluations Clinical data were collected at four time points: baseline (T0), one-month(T1), three months (T3), and six months (T6) following splint delivery. All assessments were performed by the same experienced clinician following a standardized protocol outlined in our previous research [ 22 ]. a) Joint noise: Bilateral TMJ sounds were assessed by palpation. Patients were instructed to perform three repetitions of mandibular opening and closing, as well as anterior-posterior and lateral excursions. Any audible clicking, popping, or crepitus was recorded and classified as abnormal. B) Joint pain: Subjective pain intensity was evaluated using a 5-point (0–5) VAS, where 0 indicated no pain and 5 represented the most severe pain perceived. c) MMO: MMO was measured as the interincisal distance (in millimeters) between the upper and lower central incisors during pain-free maximal mouth opening. 2.4 CBCT analysis The condyle–fossa relationship was evaluated using the method proposed by Kamelchuk [ 10 , 23 ]. Specifically, two horizontal lines (L1 and L2) were drawn parallel to the Frankfort horizontal (FH) plane: L1 was tangent to the roof of the glenoid fossa, and L2 tangent to the superior surface of the condyle. The perpendicular distance between L1 and L2 was recorded as the superior joint space (S). Tangents L3 and L4 were drawn along the anterior and posterior margins of condyle, passing through the tangent points of the superior margin of articular fossa. Plumb lines perpendicular to L3 and L4 indicated the anterior joint space (A) and the posterior joint space (P), respectively ( Fig. 1 ) . The Pullinger method [ 10 , 24 ] was used to assess condylar position in the articular fossa: A value of ln(P/A) 0.25 indicates that the condyle is in an anterior position; and a value of ln(P/A) between − 0.25 and + 0.25 indicates that the condyle is in an essentially neutral position. 2.5 Patient Satisfaction Ratings All patients evaluated the comfort and usability of the occlusal splints by rating their satisfaction across five aspects: general satisfaction, ease of cleaning, stability, retention, and comfort. Each parameter was assessed using a 5-point VAS [ 25 ] based on their subjective experience—where 0 indicated complete dissatisfaction and 5 indicated complete satisfaction. 2.6 Statistical Analysis Statistical analyses were performed using SPSS version 27.0 (IBM Corp., Armonk, NY, USA). The Shapiro-Wilk test was used to assess the normality of the quantitative data. Depending on data type and distribution, the following tests were applied to evaluate differences between the two groups at various time points: independent samples t -test, Mann-Whitney U test, Chi-square χ² test, Wilcoxon signed-rank test, and paired t -test. A p -value < 0.05 was considered statistically significant. 3. Results 3.1 Basic characteristics A total of 118 patients diagnosed with ADDwR were enrolled in this study. Among them, including 32 males (27.1%) and 86 females (72.9%) ( Fig. 2 A ). Participants ranged in age from 12 to 68 years. Based on the World Health Organization’s age classification [ 26 – 28 ], the largest proportion belonged to the early adulthood group (25–44 years), comprising 63 patients (53.4%), while the late adulthood group (≥ 60 years) included only 3 patients (2.5%). Following randomization, 59 patients were assigned to the nMB splint group and 59 to the tTB splint group. The nMB treatment group consisted of 17 males and 42 females ( Fig. 2 B ) . while the tTB treatment group included 15 males and 44 females ( Fig. 2 C ) . There was no significant difference in gender distribution between the two groups ( p = 0.679 ). Regarding age distribution, the nMB group comprised 8 adolescents, 15 in youth, 31 in early adulthood, 3 in middle adulthood, and 2 in late adulthood. The tTB group included 6 adolescents, 16 in youth, 32 in early adulthood, 4 in middle adulthood, and 1 in late adulthood. No statistically significant difference was found in age distribution between the groups ( p = 0.937 ). 3.1 Efficacy of joint noise reduction with nMB and tTB splint treatments At baseline (T0), joint noise was reported in 56 patients (94.9%) in the nMB splint group and 57 patients (96.6%) in the tTB splint group, with no significant difference between groups ( p = 1.000 ). Following treatment, the number of patients with joint noise in the nMB group decreased to 19 at one month (T1), 16 at three months (T3), and 10 at six months (T6), corresponding to improvement rates of 66.1%, 71.4%, and 82.1%, respectively (all p < 0.001 vs. baseline). In the tTB group, joint noise reduced to 30 at T1, 26 at T3, and remained at 26 at T6, with respective efficacy rates of 47.4%, 54.4%, and 54.4% (all p < 0.001 vs. baseline). Intergroup comparisons showed significantly greater reductions in joint noise in the nMB group at T1 ( p = 0.040 ) and T6 ( p = 0.001 ). At T3, the difference approached significance but did not reach statistical significance ( p = 0.055 ) ( Fig. 3 A ). 3.2 Efficacy in joint pain relief with nMB and tTB splint treatments Treatment efficacy in alleviating TMD-related joint pain was assessed using VAS scores. In the nMB splint treated group, VAS scores significantly decreased from 2.69 ± 1.83 at T0 to 1.32 ± 0.84 at T1, 0.71 ± 0.49 at T3, and 0.27 ± 0.49 at T6 ( all p < 0.001 ). Similarly, the tTB splint treatment showed significant pain reduction, with VAS scores declining from 2.71 ± 1.94 at T0 to 1.51 ± 0.92 at one month, 0.98 ± 0.57 at three month, and 0.41 ± 0.56 at six month (all p < 0.001 ). Between-group comparisons revealed no significant differences at T0 ( p = 0.884 ), T1 ( p = 0.195 ), or T6 ( p = 0.161 ). However, at T3, the nMB splint group exhibited significantly greater pain reduction compared to the tTB group ( p = 0.009 ) ( Fig. 3 B ). 3.3 Efficacy in improving limited mouth opening with nMB and tTB splint treatments Both the nMB and tTB splints significantly improved MMO in patients with ADDwR over the course of treatment. In the nMB group, MMO increased from 35.83 ± 6.31 mm at baseline to 39.51 ± 2.30 mm at T1, 41.26 ± 1.32 mm at T3, and 42.38 ± 1.42 mm at 6 months T6 (all p < 0.001 ). Similarly, in the tTB group, MMO improved from 35.56 ± 4.60 mm at T0 to 38.91 ± 3.02 mm at T1, 40.79 ± 1.58 mm at T3, and 41.99 ± 1.55 mm at T6 (all p < 0.001 ). Between-group comparisons showed significant differences at T0 ( p = 0.022 ) and T1 ( p = 0.035 ), with the nMB group demonstrating slightly better early outcomes. However, no significant differences were observed at T3 ( p = 0.083 ) or T6 ( p = 0.156 ) (Fig. 3 C ) . 3.5 CBCT imaging analysis of anterior disc displacement Anterior disc displacement was indirectly evaluated by measuring ln(P/A) values at baseline and 6 months post-treatment in both the nMB and tTB splint. In the nMB group, ln(P/A) increased slightly from − 0.45 ± 0.31 to − 0.38 ± 0.29 ( p = 0.737 ), while in the tTB group, it changed from − 0.54 ± 0.51 to − 0.56 ± 0.22 ( p = 0.601 ), indicating no significant intra-group differences. Similarly, inter-group comparisons at both time points showed no statistically significant differences ( T0: p = 0.300; T6: p = 0.231 ) ( Table 1 ) . Patients with ln(P/A) values < − 0.25 were classified as positive for anterior disc displacement [ 10 ]. We further calculated the positive rate of anterior disc displacement as the number of positive joints divided by the total number of joints. In the nMB group, the positive rate decreased from 75% at T0 to 56% at T6 ( p = 0.264 ), whereas no change was observed in the tTB group ( p = 1.000 ). Inter-group comparisons of positive rates at T0 and T6 also revealed no significant differences ( T0: p = 1.000; T6: p = 0.180 ) ( Table 2 ) . Table 1 CBCT images analyze of ln(P/A) at different time points nMB T0 vs. tTB T0 nMB T6 vs. tTB T6 nMB T0 vs. nMB T6 tTB T0 vs. tTB T6 ln(P/A) -0.45 ± 0.31 (-0.54 ± 0.51) -0.38 ± 0.29 (-0.56 ± 0.22) -0.45 ± 0.31 (-0.38 ± 0.29) -0.54 ± 0.51 (-0.56 ± 0.22) p 0.300 0.231 0.737 0.601 Pairwise comparisons between groups were conducted using the paired t-test, Wilcoxon signed-rank test, Mann–Whitney U test, and independent samples t-test, as appropriate based on data distribution and pairing. Table 2 Positive rate of anterior disc displacement at different time points nMB T0 vs. tTB T0 nMB T6 vs. tTB T6 nMB T0 vs. nMB T6 tTB T0 vs. tTB T6 Positive rate 75% (78%) 56% (78%) 75% (56%) 78% (78%) p 1.000 0.180 0.264 1.000 χ 2 test was performed to assess differences in positive rates between different time periods. 3.6 Satisfaction ratings To compare patient satisfaction between the nMB and tTB splint groups, five parameters were assessed using the VAS: general satisfaction, comfort, ease of cleaning, stability, and retention. In the nMB group, the mean scores were as follows: general satisfaction 3.83 ± 1.04, comfort 3.78 ± 1.00, cleaning 3.85 ± 0.89, stability 4.07 ± 1.16, and retention 3.22 ± 1.33. In the tTB group, the corresponding scores were 3.05 ± 1.02, 3.27 ± 1.03, 3.80 ± 0.92, 3.08 ± 0.87, and 2.88 ± 1.45. The nMB splint group showed significantly higher ratings in general satisfaction ( p < 0.001 ), comfort ( p = 0.005 ), and stability ( p < 0.001 ) compared to the tTB group. However, no significant differences were observed in ease of cleaning ( p = 0.771 ) or retention ( p = 0.195 ) ( Fig. 4 ) . 4. Discussion ARSs have been widely recognized as an effective conservative treatment for TMD [ 15 , 18 , 29 – 33 ]. This randomized controlled trial compared the therapeutic outcomes of the nMB splint with the tTB splint in managing ADDwR. Our findings indicate that the nMB splint offers superior clinical benefits in joint noise reduction and improved comfort, making it a promising conservative treatment option for ADDwR, despite showing similar outcomes in disc position reduction and pain relief. ARS therapy is a non-invasive, reversible intervention widely used in the management of TMD and ADDwR. Its therapeutic mechanism involves guiding the mandible into a minimal protruded position where joint noise is eliminated, thereby promoting relaxation of the masticatory muscles and reducing compressive forces on the posterior aspect of the TMJ. This decompression may enhance local vascular perfusion and facilitate the redistribution of intra-articular space, creating a biomechanically favorable environment for disc recapture. Consequently, ARS therapy supports the restoration of functional coordination among the condyle, articular disc, and joint fossa, thereby achieving therapeutic efficacy in patients with ADDwR [ 13 , 34 , 35 ]. The nMB splint developed in this study retains the core therapeutic functions of conventional ARS appliances while incorporating structural refinements designed to enhance clinical efficacy and improve patient comfort. Joint noise is a common symptom in patients with ADDwR [ 36 , 37 ], and may be associated with abnormalities in joint fluid dynamics, disc-condyle coordiation, or condylar morphology [ 38 , 39 ]. ARS have demonstrated clinical efficacy in alleviating joint noise symptoms [ 16 , 40 – 42 ]. In this study, the nMB group exhibited significantly greater improvement in joint noise relief compared to the tTB group at both the 1-month (T1: 66.1% vs. 47.4%) and 6-month (T6: 82.1% vs. 54.4%) follow-ups, although no significant difference was observed at 3 months (T3). Importantly, the overall therapeutic efficacy of the nMB splint throughout the treatment period was. This benefit is likely attributable to the distinctive design features of the nMB splint, which allows for precise and stable mandibular advancement with a retention system that effectively maintains the therapeutic position. This design is particularly beneficial during sleep, when minimizing mandibular positional drift is critical for sustaining disc-condyle coordination. In contrast, the tTB splint relies on the occlusal inclines of separate maxillary and mandibular components. Such a mechanism may be more susceptible to displacement during nocturnal use, especially in patients with mouth breathing or muscular relaxation, thereby compromising the disc recapture consistency [ 17 – 19 ]. The sustained clinical benefit of the nMB splint in alleviating joint noise underscores its potential to more effectively reestablish a stable and functional disc-condyle relationship over the long term. ARS also contributed to patients' pain alleviation [ 43 , 44 ] by unloading TMJ structures, including retrodiscal tissue and masticatory muscles [ 45 – 47 ]. VAS scores indicated significant reductions in joint pain for both groups following treatment (nMB splint group: 2.69 ± 1.83 to 0.27 ± 0.49; tTB splint group: 2.71 ± 1.94 to 0.41 ± 0.56). Notably, the nMB splint group exhibited a significantly greater reduction in pain at 3 months, while no significant differences were observed between groups at 1 month or 6 months. This transient difference may be attributed to the distinct ways the two splint designs modulate masticatory muscle activity. By maintaining a stable mandibular advancement position, the nMB splint may more effectively reduce abnormal hyperactivity in the masseter and temporalis muscles, leading to more pronounced muscle relaxation at T3. In contrast, the tTB splint, which depends on dynamic occlusal contact between two separate components - maxillary and mandibular, may result in a delayed neuromuscular adaptation process and, consequently, a less pronounced intermediate-term analgesic effect [ 48 ]. Nonetheless, over the long term, both splints restored the functional balance between the joint and muscles, achieving comparable pain relief outcomes. Both groups exhibited significant increases in MMO following treatment (nMB splint group: 35.83 ± 6.31 mm to 42.38 ± 1.42 mm; tTB splint group: 35.56 ± 4.60 mm to 41.99 ± 1.55 mm). Throughout the treatment period, both splint designs demonstrated comparable efficacy in achieving favorable therapeutic outcomes. This suggests that both splints contribute to the relaxation of periarticular musculature and promote mandibular advancement, thereby increasing intra-articular space. As a result, the condyles may seat more centrally in the glenoid fossa, eliminating mechanical interference from the displaced disc during condylar translation, which ultimately facilitates the restoration of normal mandibular opening [ 14 , 49 ]. Previous studies have proposed that the mechanism of ARS involves “recapturing” of the disc by downward and forward movement of the condyle [ 14 ]. However, no significant changes were observed in the positive rate of anterior disc displacement following treatment with the nMB splint and the tTB splint. As noted by Chen [ 50 ], the stability of disc-condyle relationship often cannot be maintained upon ARS removal in the majority of patients, which may explain the limited improvement in anterior disc displacement rates in the present study. While demonstrating therapeutic efficacy comparable to the tTB splint, the nMB splint showed superior outcomes in terms of general satisfaction, ease of cleaning, and stability. This result aligns with our original intent behind this novel splint, which aimed to optimize patient compliance by improving usability. In conclusion, this study demonstrates that the nMB splint, as a novel ARS design, provides comparable improvements in mouth opening and joint pain relief to the tTB splint, while offering superior reduction in joint noise and enhanced patient comfort. These advantages are likely attributed to its stable, integrated structure. Although no significant improvement was observed in disc reduction rates, this finding concurs with previous research highlighting the transient nature of such changes. Overall, the nMB splint represents a promising innovation of ARS therapy and warrants further evaluation in larger-scale and imaging-supported clinical studies. 5. Conclusion The nMB splint demonstrated superior efficacy over the tTB splint in reducing joint noise and enhancing patient comfort, with higher patient-reported satisfaction in terms of comfort, retention and stability. Both splints showed comparable effectiveness in improving MMO, relieving joint pain, and restoring disc-condyle relationship. These findings suggest that the nMB splint is a promising, patient-oriented advancement in ARS therapy for the conservative management of ADDwR. Abbreviations ADDwR: Anterior Disc Displacement witht Reduction ARS: Anterior Repositioning Splints DC/TMD: Diagnostic Criteria for Temporomandibular Disorders MB: Mono-Block MMO: Maximum Mouth Opening TB: Twin-Block TMD: Temporomandibular Disorders TMJ: Temporomandibular Joint χ² test: Chi-square test Declarations Ethics approval The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Affiliated Stomatology Hospital of Guangzhou Medical University (Approval number: LCYJ20250618004). Consent for publication Not applicable. Availability of data and materials The corresponding author D.DS. Dr. W. Cao had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The data and material that support the findings of this study are available from the corresponding author upon reasonable request. Funding This research was funded by the National Key Research and Development Program of China (2023YFC2509200), the Research Capability Enhancement Program of Guangzhou Medical University (No. 2024SRP162), and the Medical Science and Technology Research Foundation of Guangdong Province (No. A2024532). Authors' contributions Z. Liu : Data collection, Writing–original draft, Formal analysis, Validation, Visualization; A. Wu : Data collection, Writing–original draft, Funding acquisition, Conceptualization, Methodology, Writing – review & editing; J. Fan : Validation, Methodology, Writing – review& editing; Y. Yuan: Writing – review & editing, Data collection, Methodology; Y. Lin: Data collection, Methodology; R. Zhang: Project administration, Data collection, Methodology; Q . Zhang Project administration, Supervision, Writing – review & editing; W. Cao : Funding acquisition, Conceptualization, Supervision, Project administration, Supervision, Writing – review & editing. Acknowledgements We would like to express our sincere gratitude to Mr. Liangming Zhang from the Department of Information Technology, School and Hospital of Stomatology, Guangzhou Medical University, Guangzhou, China, for his valuable assistance with data collection in this research. Conflict of Interest Statement The authors declare no competing interests. References Qamar Z, Alghamdi AMS, Haydarah NKB, Balateef AA, Alamoudi AA, Abumismar MA, Shivakumar S, Cicciù M, Minervini G (2023) Impact of temporomandibular disorders on oral health-related quality of life: A systematic review and meta-analysis. 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Cranio 41(5):432–439 Kamelchuk LS, Grace MG, Major PW (1996) Post-imaging temporomandibular joint space analysis. Cranio 14(1):23–29 Pullinger A, Hollender L (1986) Variation in condyle-fossa relationships according to different methods of evaluation in tomograms. Oral Surg Oral Med Oral Pathol 62(6):719–727 Kimoto S, Kimoto K, Kitamura A, Saita M, Iijima M, Kawai Y (2013) Effect of dentist's clinical experience on treatment satisfaction of a complete denture. J Oral Rehabil 40(12):940–947 Kowal P, Chatterji S, Naidoo N, Biritwum R, Fan W, Lopez Ridaura R, Maximova T, Arokiasamy P, Phaswana-Mafuya N, Williams S, Snodgrass JJ, Minicuci N, D'Este C, Peltzer K, Boerma JT (2012) Data resource profile: the World Health Organization Study on global AGEing and adult health (SAGE). Int J Epidemiol 41(6):1639–1649 Dick B, Ferguson BJ (2015) Health for the world's adolescents: a second chance in the second decade. J Adolesc Health 56(1):3–6 Beard JR, Officer AM, Cassels AK (2016) The World Report on Ageing and Health. Gerontologist 56 Suppl 2 S163–S166 Ma Z, Xie Q, Yang C, Zhang S, Shen Y, Abdelrehem A (2019) Can anterior repositioning splint effectively treat temporomandibular joint disc displacement? Sci Rep 9(1):534 Lee LM, Zhu YM, Yang R, Li SY, Liang X, Wang YM (2025) Early management of anterior disc displacement without reduction: Evaluating the effectiveness of modified arthroscopy discopexy with anterior disc repositioning splint. J Craniomaxillofac Surg 53(2):97–103 Guo YN, Cui SJ, Zhou YH, Wang XD (2021) An Overview of Anterior Repositioning Splint Therapy for Disc Displacement-related Temporomandibular Disorders. Curr Med Sci 41(3):626–634 Fang Z, Yao Y, Fan S, Jin L, Yang Y, Liu S (2024) Physical therapy and non-surgical manual disc reduction combined with anterior repositioning splint for acute disc displacement without reduction of the temporomandibular joint in adolescents. Clin Oral Investig 28(10):517 Conti PC, Miranda JE, Conti AC, Pegoraro LF, Araújo R, Cdos (2005) Partial time use of anterior repositioning splints in the management of TMJ pain and dysfunction: a one-year controlled study. J Appl Oral Sci 13(4):345–350 Yadav S, Karani JT (2011) The essentials of occlusal splint therapy. Int J Prosthet Dent 2(1):12–21 Lakshmi M, Kalekhan SM, Mehta R, Bhangdia M, Rathore K, Lalwani V (2016) Occlusal splint therapy in temporomandibular joint disorders: an update review. J Int Oral Health 8(5):639–645 Motoyoshi M, Ohya M, Hasegawa M, Namura S (1994) A study of temporomandibular joint sounds; Part 1. Relationship with articular disc displacements. J Nihon Univ Sch Dent 36(1):48–51 Elfving L, Helkimo M, Magnusson T (2002) Prevalence of different temporomandibular joint sounds, with emphasis on disc-displacement, in patients with temporomandibular disorders and controls. Swed Dent J 26(1):9–19 Manzione JV, Katzberg RW, Manzione TJ (1984) Internal derangements of the temporomandibular joint. I. Normal anatomy, physiology, and pathophysiology. Int J Periodontics Restor Dent 4(4):8–15 Motoyoshi M, Matsumoto Y, Ohnuma M, Arimoto M, Takahashi K, Namura S (1995) A study of temporomandibular joint sounds. Part 2. Acoustic characteristics of joint sounds. J Nihon Univ Sch Dent 37(1):47–54 Tecco S, Festa F, Salini V, Epifania E, D'Attilio M (2004) Treatment of joint pain and joint noises associated with a recent TMJ internal derangement: a comparison of an anterior repositioning splint, a full-arch maxillary stabilization splint, and an untreated control group. Cranio 22(3):209–219 Conti PC, dos Santos CN, Kogawa EM, de Castro AC, de Conti F (2006) Araujo Cdos, The treatment of painful temporomandibular joint clicking with oral splints: a randomized clinical trial. J Am Dent Assoc 137(8):1108–1114 Singh BP, Singh N, Jayaraman S, Kirubakaran R, Joseph S, Muthu MS, Jivnani H, Hua F (2024) Occlusal interventions for managing temporomandibular disorders. Cochrane Database Syst Rev 9(9) Cd012850. Haketa T, Kino K, Sugisaki M, Takaoka M, Ohta T (2010) Randomized clinical trial of treatment for TMJ disc displacement. J Dent Res 89(11):1259–1263 Schiffman EL, Velly AM, Look JO, Hodges JS, Swift JQ, Decker KL, Anderson QN, Templeton RB, Lenton PA, Kang W, Fricton JR (2014) Effects of four treatment strategies for temporomandibular joint closed lock. Int J Oral Maxillofac Surg 43(2) 217 – 26. Eberhard D, Bantleon HP, Steger W (2002) The efficacy of anterior repositioning splint therapy studied by magnetic resonance imaging. Eur J Orthod 24(4):343–352 Kuroda M, Otonari-Yamamoto M, Sano T, Fujikura M, Wakoh M (2015) Diagnosis of retrodiscal tissue in painful temporomandibular joint (TMJ) by fluid-attenuated inversion recovery (FLAIR) signal intensity. CRANIO® 33(4):272–276 Wieckiewicz M, Boening K, Wiland P, Shiau Y-Y, Paradowska-Stolarz A (2015) Reported concepts for the treatment modalities and pain management of temporomandibular disorders. J Headache Pain 16:1–12 Özköylü G, Saraç D, Sasany R, Umurca DG (2024) Comparison of monoblock and twinblock mandibular advancement devices in patiens with obstructive sleep apnea and temporomandibular disorder: effects on airway volume, polysomnography parameters, and sleepiness scale scores. BMC Oral Health 24(1):1026 Hersek N, Uzun G, Cindas A, Canay S, Kutsal YG (1998) Effect of anterior repositioning splints on the electromyographic activities of masseter and anterior temporalis muscles. Cranio 16(1):11–16 Chen HM, Liu MQ, Yap AU, Fu KY (2017) Physiological effects of anterior repositioning splint on temporomandibular joint disc displacement: a quantitative analysis. J Oral Rehabil 44(9):664–672 Additional Declarations The authors declare no competing interests. Supplementary Files floatimage5.jpeg Supplementary Figure 1. Flowchart of participant enrollment and follow-up. A total of 118 patients diagnosed with anterior disc displacement with reduction (ADDwR) were randomly assigned to two groups and received treatment with either the novel Mono-Block (nMB) splint or the traditional Twin-Block (tTB) splint. Assessments were conducted at baseline (T0), and at 1 month (T1), 3 months (T3), and 6 months (T6) following treatment. Evaluations included maximum mouth opening (MMO), joint noise, joint pain, cone beam computed tomography (CBCT), and patient satisfaction ratings. floatimage6.jpeg Supplementary Figure 2. Representative images of the novel Mono-Block (nMB) splint and the traditional Twin-Block (tTB) splint. (A–B) Lateral and occlusal views of the nMB splint. (C–D) Lateral and occlusal views of the tTB splint. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7083956","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":482967376,"identity":"8e23a962-6413-41be-b59d-7bb995b3069d","order_by":0,"name":"Zhilei Liu","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Zhilei","middleName":"","lastName":"Liu","suffix":""},{"id":482967377,"identity":"6e38ad9f-2ec8-435a-8fb7-cdab51649878","order_by":1,"name":"Antong Wu","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Antong","middleName":"","lastName":"Wu","suffix":""},{"id":482967378,"identity":"148b7941-6788-4567-a476-527095508e50","order_by":2,"name":"Wenyi Cai","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Wenyi","middleName":"","lastName":"Cai","suffix":""},{"id":482967379,"identity":"defd0297-19cf-4277-891a-19f96eb5056d","order_by":3,"name":"Jiaqian Fan","email":"","orcid":"","institution":"University of Manchester","correspondingAuthor":false,"prefix":"","firstName":"Jiaqian","middleName":"","lastName":"Fan","suffix":""},{"id":482967967,"identity":"bc28b037-260a-455f-85cf-70a32cc0e387","order_by":4,"name":"Yunyi Yuan","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Yunyi","middleName":"","lastName":"Yuan","suffix":""},{"id":482967968,"identity":"2eaa3be3-3a98-45a0-933a-baf94dc70a8a","order_by":5,"name":"Yufu Lin","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Yufu","middleName":"","lastName":"Lin","suffix":""},{"id":482967969,"identity":"8754f1d1-984b-4704-8cee-f4ae806236c9","order_by":6,"name":"Rong Zhang","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Rong","middleName":"","lastName":"Zhang","suffix":""},{"id":482967970,"identity":"02914344-ca36-4611-af10-2b4208d1a32f","order_by":7,"name":"Qinbin Zhang","email":"","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":false,"prefix":"","firstName":"Qinbin","middleName":"","lastName":"Zhang","suffix":""},{"id":482967971,"identity":"6478f433-a247-4379-a937-ec544cf3f22f","order_by":8,"name":"Wei Cao","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6ElEQVRIiWNgGAWjYDCCA3AW8wEGxgYwy4CQFqg6BrYEkrXwGBCnhe948/MHH/cwyPO393x++XPHtsQG9uZtEgw1d3BqkTxzzLBxxjMGwxlnzm6zkDxzO7GB51iZBMOxZzi1GNzIYWzmOcCQwHAjd5uBYRtQi0SOmQRjw2HCWuRv5DwzSARpkX9DpBYgg/nBQbAtPPi1gPwyc8YBCcONZ46ZMTa23TZu40krtkg4hlsLMMQefPhwwEZe7njz448/227L9rMf3njjQw1uLVAgASLYICSISCCkAQqYPxCpcBSMglEwCkYYAAAjjV4U6AUW7QAAAABJRU5ErkJggg==","orcid":"","institution":"Guangzhou medical university","correspondingAuthor":true,"prefix":"","firstName":"Wei","middleName":"","lastName":"Cao","suffix":""}],"badges":[],"createdAt":"2025-07-09 12:41:32","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-7083956/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7083956/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":86664415,"identity":"68ec69a6-8a5f-4984-b308-801fc648fbb4","added_by":"auto","created_at":"2025-07-14 10:54:43","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1330499,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCBCT measurement based on Kamelchuk’s method.\u003c/strong\u003e L1: Horizontal line parallel to the Frankfort Horizontal (FH) plane, tangent to the roof of the glenoid fossa. L2: Horizontal line parallel to the FH plane, tangent to the superior edge of the condyle. L3: Tangent line to the anterior surface of the condyle. L4: Tangent line to the posterior surface of the condyle. A: Anterior joint space. P: Posterior joint space. S: Superior joint space.\u003c/p\u003e","description":"","filename":"floatimage121.png","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/cd69329c8b7ed16496233fdd.png"},{"id":86664416,"identity":"a47d474f-e887-4c42-9db1-2e5ab1549599","added_by":"auto","created_at":"2025-07-14 10:54:43","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":175026,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDemographic characteristics of participants and group allocation. \u003c/strong\u003e(A) Age and gender distribution of all participants (n = 118). (B) Age and gender distribution of patients treated with the novel Mono-Block (nMB) splint (n = 59). (C) Age and gender distribution of patients treated with the traditional Twin-Block (tTB) splint (n = 59).\u003c/p\u003e","description":"","filename":"floatimage226.png","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/10decd3990d7f83bceb980ed.png"},{"id":86665330,"identity":"1340f7b1-1fd5-47a4-8489-c76005a3549b","added_by":"auto","created_at":"2025-07-14 11:02:43","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":139977,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparative efficacy of the novel Mono-Block (nMB) splint and the traditional Twin-Block (tTB) splint in the treatment of anterior disc displacement with reduction (ADDwR). \u003c/strong\u003e(A) Number of patients with joint noise at each time point in the nMB and tTB groups. (B) Visual Analog Scale (VAS) scores for joint pain in both groups at each time point. (C) Maximum mouth opening (MMO) values in both groups at 1 month (T1), 3 months (T3), and 6 months (T6) after treatment. * \u003cem\u003ep \u0026lt; 0.05\u003c/em\u003e, nMB group compared with tTB group; \u003cem\u003e## p \u0026lt; 0.001\u003c/em\u003e, compared to baseline within the nMB group; \u003cem\u003e$$ p \u0026lt; 0.001\u003c/em\u003e, compared to baseline within the tTB group; ns: not significant.\u003c/p\u003e","description":"","filename":"floatimage311.png","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/693c1a4fbeaee02d43b0321c.png"},{"id":86666928,"identity":"f516e227-8c1f-4d89-8966-126d8ed192d0","added_by":"auto","created_at":"2025-07-14 11:10:44","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":91453,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eVisual Analog Scale (VAS) assessment of patient satisfaction after 6 months (T6) of treatment. \u003c/strong\u003eSatisfaction ratings were compared between the novel Mono-Block (nMB) splint group and the traditional Twin-Block (tTB) splint group across five domains: overall satisfaction, ease of cleaning, comfort, stability, and retention. Data are presented as mean ± SD. \u003cem\u003e* p \u0026lt; 0.05, ** p \u0026lt; 0.001\u003c/em\u003e, nMB group compared with tTB group; ns: not significant.\u003c/p\u003e","description":"","filename":"floatimage410.png","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/71899872307727a2c61f9796.png"},{"id":86668183,"identity":"3eaa2cd2-e2d6-4033-9339-8c0fc180ffd2","added_by":"auto","created_at":"2025-07-14 11:18:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3065178,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/428e6523-e15d-4984-9c58-9ccc38a019aa.pdf"},{"id":86664421,"identity":"d27067e6-c654-48a7-8521-670b235e8486","added_by":"auto","created_at":"2025-07-14 10:54:43","extension":"jpeg","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":16207320,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSupplementary Figure 1. Flowchart of participant enrollment and follow-up.\u003c/strong\u003e A total of 118 patients diagnosed with anterior disc displacement with reduction (ADDwR) were randomly assigned to two groups and received treatment with either the novel Mono-Block (nMB) splint or the traditional Twin-Block (tTB) splint. Assessments were conducted at baseline (T0), and at 1 month (T1), 3 months (T3), and 6 months (T6) following treatment. Evaluations included maximum mouth opening (MMO), joint noise, joint pain, cone beam computed tomography (CBCT), and patient satisfaction ratings.\u003c/p\u003e","description":"","filename":"floatimage5.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/9477d24b4e035c8c73f6f21d.jpeg"},{"id":86664420,"identity":"dac877a5-b896-430e-9fb4-1c2d1dcb121c","added_by":"auto","created_at":"2025-07-14 10:54:43","extension":"jpeg","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":5737612,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSupplementary Figure 2. Representative images of the novel Mono-Block (nMB) splint and the traditional Twin-Block (tTB) splint. \u003c/strong\u003e(A–B) Lateral and occlusal views of the nMB splint.\u003cstrong\u003e \u003c/strong\u003e(C–D) Lateral and occlusal views of the tTB splint.\u003c/p\u003e","description":"","filename":"floatimage6.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7083956/v1/b7d3f29da094669902744c71.jpeg"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eEffectiveness of novel \u003c/strong\u003e\u003cem\u003e\u003cstrong\u003eversus\u003c/strong\u003e\u003c/em\u003e\u003cstrong\u003etraditional anterior repositioning splints for anterior disc displacement with reduction of the temporomandibular joint\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eTemporomandibular disorder (TMD) is among the four most prevalent conditions affecting the oral and maxillofacial region. TMD encompasses a spectrum of functional impairments involving the temporomandibular joint (TMJ), masticatory muscles, and associated neural structures [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. It predominantly affects adults between the ages of 20 and 40 and occurs more frequently in females [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Epidemiological studies estimate that approximately 10\u0026ndash;15% of the adult population experience TMD symptoms [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe primary clinical manifestations of TMD include joint noise (e.g., clicking or popping), joint pain, and restricted mouth opening. Additional symptoms may involve masticatory muscle tenderness, difficulties with chewing or speaking, tinnitus, dizziness, and headaches. Among the various subtypes, anterior disc displacement with reduction (ADDwR) stands out as both highly prevalent and clinically significant [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eClinically, ADDwR is characterized by clicking sounds during mandibular movement. Typically, a loud click occurs during mouth opening, followed by a softer click upon closure\u0026mdash;corresponding to disc recapture and subsequent displacement [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Magnetic resonance imaging (MRI) in these patients often shows anterior displacement of the articular disc in the closed-mouth position, with normal disc-condyle alignment re-established upon opening\u0026mdash;a key diagnostic indicator of the \u0026ldquo;reduction\u0026rdquo; phenomenon [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. In addition, cone beam computed tomography (CBCT) findings commonly reveal structural changes in patients with ADDwR, such as increased anterior joint space, decreased posterior joint space, and posterior positioning of the condyle within the glenoid fossa [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe management of ADDwR primarily emphasizes conservative, non-invasive treatment strategies, among which intraoral appliances\u0026mdash;such as occlusal splints\u0026mdash;play a pivotal role [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. These appliances function to redistribute occlusal forces, correct discrepancies in the spatial relationship among the occlusion, masticatory muscles, condyle, and articular disc, and reduce excessive muscular activity. Through these mechanisms, they aim to progressively restore a stable disc-condyle relationship while minimizing further damage to the TMJ [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Among the various splint types, the anterior repositioning splint (ARS) has demonstrated particular efficacy in the treatment of ADDwR [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The ARS repositions the mandible anteriorly, thereby altering the distribution of joint space, promoting disc recapture, and alleviating hallmark symptoms such as joint clicking and masticatory muscle pain [\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDespite the proven therapeutic benefits of ARS in the management of ADDwR, traditional ARS designs present certain limitations. For example, Twin-Block (TB) splints may fail to maintain consistent mandibular advancement during sleep, particularly in patients with mouth breathing habit [\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. In contrast, Mono-Block (MB) splints offer greater stability but are often bulky, resulting in significantly reduced comfort and patient compliance [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. To address these issues, we developed a novel Mono-Block (nMB) splint. Although conceptually based on existing ARS principles, the clinical efficacy of this redesigned nMB splint in managing ADDwR has not yet been validated in a large-scale, controlled clinical trial.\u003c/p\u003e\u003cp\u003eTherefore, this randomized controlled trial was conducted to compare the therapeutic efficacy of the nMB splint with that of the traditional TB (tTB) splint, which served as a positive control. Patients diagnosed with ADDwR were randomly allocated to either treatment groups. Treatment outcomes were assessed through multiple clinical parameters, including joint noise, maximum mouth opening (MMO), joint pain (via Visual Analog Scale, VAS), CBCT analysis, and patient satisfaction ratings (VAS). This study aimed to evaluate the clinical value of the nMB splint in the management of ADDwR and to provide insights into optimizing effective, patient-oriented strategies for the management of TMD and ADDwR.\u003c/p\u003e"},{"header":"2. Methods and materials","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Participants\u003c/h2\u003e\u003cp\u003ePatients diagnosed with ADDwR at the Temporomandibular Joint Department of the Affiliated Stomatology Hospital of Guangzhou Medical University between December 2023 and December 2024 were considered for inclusion. All participants provided written informed consent prior to enrollment. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Affiliated Stomatology Hospital of Guangzhou Medical University (Ethics Approval Number: LCYJ20250618004). \u003cb\u003eInclusion criteria\u003c/b\u003e: a) Diagnosis of TMD based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD); b) MRI confirming ADDwR; c) Relatively complete dentition in both the maxillary and mandibular arches; d) Good compliance and willingness to adhere to treatment protocols and follow-up visits. \u003cb\u003eExclusion criteria\u003c/b\u003e: a) Moderately to severely limited mouth opening (maximum mouth opening\u0026thinsp;\u0026lt;\u0026thinsp;20 mm); b) Significant tooth loss in either dental arch compromising splint fitting or retention; c) History of orthognathic surgery, prior TMD treatment, or maxillofacial trauma; d) Presence of severe congenital, systemic, or hereditary conditions, or psychological disorders affecting compliance; e) Loss to follow-up or voluntary withdrawal during the study period; f) Other exclusion factors as deemed appropriate by the investigators \u003cb\u003e(Supplementary Fig.\u0026nbsp;1)\u003c/b\u003e.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Splint treatment protocol\u003c/h2\u003e\u003cp\u003eA total of 118 eligible patients were enrolled and randomly assigned to two groups: the nMB splint group (n\u0026thinsp;=\u0026thinsp;59) and the tTB splint group (n\u0026thinsp;=\u0026thinsp;59). The nMB splint is a one-piece ARS that covers the full dental arch \u003cb\u003e(Supplementary Fig.\u0026nbsp;2A, B)\u003c/b\u003e. Before fabrication, dental impressions and occlusal registrations were obtained. Patients were instructed to perform repeated mandibular opening and closing movements to facilitate proprioceptive relaxation. Once joint noise was eliminated at MMO, the mandible was guided gently into the minimal protruded position that did not induce muscular fatigue or discomfort. This position was identified as the optimal therapeutic protrusion [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Intraoral scans and wax bite registrations were captured in this position using a digital intraoral scanner.\u003c/p\u003e\u003cp\u003eAll procedures were performed by the same experienced clinician to ensure standardization. The acquired records were submitted to the laboratory, where all splint was fabricated by a single dedicated technician to minimize inter-operator variability. For the tTB splint group \u003cb\u003e(Supplementary Fig.\u0026nbsp;2C, D\u003c/b\u003e), the same clinical and laboratory workflow was followed to ensure protocol consistency across both groups.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Clinical evaluations\u003c/h2\u003e\u003cp\u003eClinical data were collected at four time points: baseline (T0), one-month(T1), three months (T3), and six months (T6) following splint delivery. All assessments were performed by the same experienced clinician following a standardized protocol outlined in our previous research [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. a) Joint noise: Bilateral TMJ sounds were assessed by palpation. Patients were instructed to perform three repetitions of mandibular opening and closing, as well as anterior-posterior and lateral excursions. Any audible clicking, popping, or crepitus was recorded and classified as abnormal. B) Joint pain: Subjective pain intensity was evaluated using a 5-point (0\u0026ndash;5) VAS, where 0 indicated no pain and 5 represented the most severe pain perceived. c) MMO: MMO was measured as the interincisal distance (in millimeters) between the upper and lower central incisors during pain-free maximal mouth opening.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 CBCT analysis\u003c/h2\u003e\u003cp\u003eThe condyle\u0026ndash;fossa relationship was evaluated using the method proposed by Kamelchuk [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Specifically, two horizontal lines (L1 and L2) were drawn parallel to the Frankfort horizontal (FH) plane: L1 was tangent to the roof of the glenoid fossa, and L2 tangent to the superior surface of the condyle. The perpendicular distance between L1 and L2 was recorded as the superior joint space (S). Tangents L3 and L4 were drawn along the anterior and posterior margins of condyle, passing through the tangent points of the superior margin of articular fossa. Plumb lines perpendicular to L3 and L4 indicated the anterior joint space (A) and the posterior joint space (P), respectively \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. The Pullinger method [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] was used to assess condylar position in the articular fossa: A value of ln(P/A)\u0026thinsp;\u0026lt;\u0026thinsp;\u0026minus;\u0026thinsp;0.25 indicates that the condyle is in a posterior position; ln(P/A)\u0026thinsp;\u0026gt;\u0026thinsp;0.25 indicates that the condyle is in an anterior position; and a value of ln(P/A) between \u0026minus;\u0026thinsp;0.25 and +\u0026thinsp;0.25 indicates that the condyle is in an essentially neutral position.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Patient Satisfaction Ratings\u003c/h2\u003e\u003cp\u003eAll patients evaluated the comfort and usability of the occlusal splints by rating their satisfaction across five aspects: general satisfaction, ease of cleaning, stability, retention, and comfort. Each parameter was assessed using a 5-point VAS [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] based on their subjective experience\u0026mdash;where 0 indicated complete dissatisfaction and 5 indicated complete satisfaction.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003e2.6 Statistical Analysis\u003c/h2\u003e\u003cp\u003eStatistical analyses were performed using SPSS version 27.0 (IBM Corp., Armonk, NY, USA). The Shapiro-Wilk test was used to assess the normality of the quantitative data. Depending on data type and distribution, the following tests were applied to evaluate differences between the two groups at various time points: independent samples \u003cem\u003et\u003c/em\u003e-test, Mann-Whitney \u003cem\u003eU\u003c/em\u003e test, Chi-square \u003cem\u003eχ\u0026sup2;\u003c/em\u003e test, Wilcoxon signed-rank test, and paired \u003cem\u003et\u003c/em\u003e-test. A \u003cem\u003ep\u003c/em\u003e-value\u0026thinsp;\u003cem\u003e\u0026lt;\u0026thinsp;0.05\u003c/em\u003e was considered statistically significant.\u003c/p\u003e\u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Basic characteristics\u003c/h2\u003e\u003cp\u003eA total of 118 patients diagnosed with ADDwR were enrolled in this study. Among them, including 32 males (27.1%) and 86 females (72.9%) \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA\u003cb\u003e).\u003c/b\u003e Participants ranged in age from 12 to 68 years. Based on the World Health Organization\u0026rsquo;s age classification [\u003cspan additionalcitationids=\"CR27\" citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e], the largest proportion belonged to the early adulthood group (25\u0026ndash;44 years), comprising 63 patients (53.4%), while the late adulthood group (\u0026ge;\u0026thinsp;60 years) included only 3 patients (2.5%). Following randomization, 59 patients were assigned to the nMB splint group and 59 to the tTB splint group. The nMB treatment group consisted of 17 males and 42 females \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eB\u003cb\u003e)\u003c/b\u003e. while the tTB treatment group included 15 males and 44 females \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eC\u003cb\u003e)\u003c/b\u003e. There was no significant difference in gender distribution between the two groups (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.679\u003c/em\u003e). Regarding age distribution, the nMB group comprised 8 adolescents, 15 in youth, 31 in early adulthood, 3 in middle adulthood, and 2 in late adulthood. The tTB group included 6 adolescents, 16 in youth, 32 in early adulthood, 4 in middle adulthood, and 1 in late adulthood. No statistically significant difference was found in age distribution between the groups (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.937\u003c/em\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Efficacy of joint noise reduction with nMB and tTB splint treatments\u003c/h2\u003e\u003cp\u003eAt baseline (T0), joint noise was reported in 56 patients (94.9%) in the nMB splint group and 57 patients (96.6%) in the tTB splint group, with no significant difference between groups (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;1.000\u003c/em\u003e). Following treatment, the number of patients with joint noise in the nMB group decreased to 19 at one month (T1), 16 at three months (T3), and 10 at six months (T6), corresponding to improvement rates of 66.1%, 71.4%, and 82.1%, respectively (all \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001 vs.\u003c/em\u003e baseline). In the tTB group, joint noise reduced to 30 at T1, 26 at T3, and remained at 26 at T6, with respective efficacy rates of 47.4%, 54.4%, and 54.4% (all \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001 vs.\u003c/em\u003e baseline). Intergroup comparisons showed significantly greater reductions in joint noise in the nMB group at T1 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.040\u003c/em\u003e) and T6 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.001\u003c/em\u003e). At T3, the difference approached significance but did not reach statistical significance (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.055\u003c/em\u003e) \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eA\u003cb\u003e).\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Efficacy in joint pain relief with nMB and tTB splint treatments\u003c/h2\u003e\u003cp\u003eTreatment efficacy in alleviating TMD-related joint pain was assessed using VAS scores. In the nMB splint treated group, VAS scores significantly decreased from 2.69\u0026thinsp;\u0026plusmn;\u0026thinsp;1.83 at T0 to 1.32\u0026thinsp;\u0026plusmn;\u0026thinsp;0.84 at T1, 0.71\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49 at T3, and 0.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49 at T6 \u003cem\u003e(\u003c/em\u003eall \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e). Similarly, the tTB splint treatment showed significant pain reduction, with VAS scores declining from 2.71\u0026thinsp;\u0026plusmn;\u0026thinsp;1.94 at T0 to 1.51\u0026thinsp;\u0026plusmn;\u0026thinsp;0.92 at one month, 0.98\u0026thinsp;\u0026plusmn;\u0026thinsp;0.57 at three month, and 0.41\u0026thinsp;\u0026plusmn;\u0026thinsp;0.56 at six month (all \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e). Between-group comparisons revealed no significant differences at T0 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.884\u003c/em\u003e), T1 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.195\u003c/em\u003e), or T6 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.161\u003c/em\u003e). However, at T3, the nMB splint group exhibited significantly greater pain reduction compared to the tTB group (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.009\u003c/em\u003e) \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eB\u003cb\u003e).\u003c/b\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Efficacy in improving limited mouth opening with nMB and tTB splint treatments\u003c/h2\u003e\u003cp\u003eBoth the nMB and tTB splints significantly improved MMO in patients with ADDwR over the course of treatment. In the nMB group, MMO increased from 35.83\u0026thinsp;\u0026plusmn;\u0026thinsp;6.31 mm at baseline to 39.51\u0026thinsp;\u0026plusmn;\u0026thinsp;2.30 mm at T1, 41.26\u0026thinsp;\u0026plusmn;\u0026thinsp;1.32 mm at T3, and 42.38\u0026thinsp;\u0026plusmn;\u0026thinsp;1.42 mm at 6 months T6 (all \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e). Similarly, in the tTB group, MMO improved from 35.56\u0026thinsp;\u0026plusmn;\u0026thinsp;4.60 mm at T0 to 38.91\u0026thinsp;\u0026plusmn;\u0026thinsp;3.02 mm at T1, 40.79\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58 mm at T3, and 41.99\u0026thinsp;\u0026plusmn;\u0026thinsp;1.55 mm at T6 (all \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e). Between-group comparisons showed significant differences at T0 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.022\u003c/em\u003e) and T1 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.035\u003c/em\u003e), with the nMB group demonstrating slightly better early outcomes. However, no significant differences were observed at T3 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.083\u003c/em\u003e) or T6 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.156\u003c/em\u003e) (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eC\u003cb\u003e)\u003c/b\u003e.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003e3.5 CBCT imaging analysis of anterior disc displacement\u003c/h2\u003e\u003cp\u003eAnterior disc displacement was indirectly evaluated by measuring ln(P/A) values at baseline and 6 months post-treatment in both the nMB and tTB splint. In the nMB group, ln(P/A) increased slightly from \u0026minus;\u0026thinsp;0.45\u0026thinsp;\u0026plusmn;\u0026thinsp;0.31 to \u0026minus;\u0026thinsp;0.38\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.737\u003c/em\u003e), while in the tTB group, it changed from \u0026minus;\u0026thinsp;0.54\u0026thinsp;\u0026plusmn;\u0026thinsp;0.51 to \u0026minus;\u0026thinsp;0.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.601\u003c/em\u003e), indicating no significant intra-group differences. Similarly, inter-group comparisons at both time points showed no statistically significant differences (\u003cem\u003eT0: p\u0026thinsp;=\u0026thinsp;0.300; T6: p\u0026thinsp;=\u0026thinsp;0.231\u003c/em\u003e) \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. Patients with ln(P/A) values \u0026lt; \u0026minus;\u0026thinsp;0.25 were classified as positive for anterior disc displacement [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. We further calculated the positive rate of anterior disc displacement as the number of positive joints divided by the total number of joints. In the nMB group, the positive rate decreased from 75% at T0 to 56% at T6 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.264\u003c/em\u003e), whereas no change was observed in the tTB group (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;1.000\u003c/em\u003e). Inter-group comparisons of positive rates at T0 and T6 also revealed no significant differences (\u003cem\u003eT0: p\u0026thinsp;=\u0026thinsp;1.000; T6: p\u0026thinsp;=\u0026thinsp;0.180\u003c/em\u003e) \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCBCT images analyze of ln(P/A) at different time points\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003enMB T0\u003cem\u003evs.\u003c/em\u003e tTB T0\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003enMB T6 \u003cem\u003evs.\u003c/em\u003e tTB T6\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003enMB T0\u003cem\u003evs.\u003c/em\u003e nMB T6\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003etTB T0\u003cem\u003evs.\u003c/em\u003e tTB T6\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eln(P/A)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-0.45\u0026thinsp;\u0026plusmn;\u0026thinsp;0.31\u003c/p\u003e\u003cp\u003e(-0.54\u0026thinsp;\u0026plusmn;\u0026thinsp;0.51)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-0.38\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29\u003c/p\u003e\u003cp\u003e(-0.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-0.45\u0026thinsp;\u0026plusmn;\u0026thinsp;0.31\u003c/p\u003e\u003cp\u003e(-0.38\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-0.54\u0026thinsp;\u0026plusmn;\u0026thinsp;0.51\u003c/p\u003e\u003cp\u003e(-0.56\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.300\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.231\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.737\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.601\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003ePairwise comparisons between groups were conducted using the paired t-test, Wilcoxon signed-rank test, Mann\u0026ndash;Whitney U test, and independent samples t-test, as appropriate based on data distribution and pairing.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePositive rate of anterior disc displacement at different time points\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003enMB T0 \u003cem\u003evs.\u003c/em\u003e tTB T0\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003enMB T6 \u003cem\u003evs.\u003c/em\u003e tTB T6\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003enMB T0 \u003cem\u003evs.\u003c/em\u003e nMB T6\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003etTB T0\u003cem\u003evs.\u003c/em\u003e tTB T6\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePositive rate\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e75% (78%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e56% (78%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e75% (56%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e78% (78%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ep\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.000\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.180\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.264\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.000\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eχ\u003csup\u003e2\u003c/sup\u003e test was performed to assess differences in positive rates between different time periods.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003e3.6 Satisfaction ratings\u003c/h2\u003e\u003cp\u003eTo compare patient satisfaction between the nMB and tTB splint groups, five parameters were assessed using the VAS: general satisfaction, comfort, ease of cleaning, stability, and retention. In the nMB group, the mean scores were as follows: general satisfaction 3.83\u0026thinsp;\u0026plusmn;\u0026thinsp;1.04, comfort 3.78\u0026thinsp;\u0026plusmn;\u0026thinsp;1.00, cleaning 3.85\u0026thinsp;\u0026plusmn;\u0026thinsp;0.89, stability 4.07\u0026thinsp;\u0026plusmn;\u0026thinsp;1.16, and retention 3.22\u0026thinsp;\u0026plusmn;\u0026thinsp;1.33. In the tTB group, the corresponding scores were 3.05\u0026thinsp;\u0026plusmn;\u0026thinsp;1.02, 3.27\u0026thinsp;\u0026plusmn;\u0026thinsp;1.03, 3.80\u0026thinsp;\u0026plusmn;\u0026thinsp;0.92, 3.08\u0026thinsp;\u0026plusmn;\u0026thinsp;0.87, and 2.88\u0026thinsp;\u0026plusmn;\u0026thinsp;1.45. The nMB splint group showed significantly higher ratings in general satisfaction (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e), comfort (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.005\u003c/em\u003e), and stability (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e) compared to the tTB group. However, no significant differences were observed in ease of cleaning (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.771\u003c/em\u003e) or retention (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.195\u003c/em\u003e) \u003cb\u003e(\u003c/b\u003eFig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eARSs have been widely recognized as an effective conservative treatment for TMD [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan additionalcitationids=\"CR30 CR31 CR32\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. This randomized controlled trial compared the therapeutic outcomes of the nMB splint with the tTB splint in managing ADDwR. Our findings indicate that the nMB splint offers superior clinical benefits in joint noise reduction and improved comfort, making it a promising conservative treatment option for ADDwR, despite showing similar outcomes in disc position reduction and pain relief.\u003c/p\u003e\u003cp\u003eARS therapy is a non-invasive, reversible intervention widely used in the management of TMD and ADDwR. Its therapeutic mechanism involves guiding the mandible into a minimal protruded position where joint noise is eliminated, thereby promoting relaxation of the masticatory muscles and reducing compressive forces on the posterior aspect of the TMJ. This decompression may enhance local vascular perfusion and facilitate the redistribution of intra-articular space, creating a biomechanically favorable environment for disc recapture. Consequently, ARS therapy supports the restoration of functional coordination among the condyle, articular disc, and joint fossa, thereby achieving therapeutic efficacy in patients with ADDwR [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. The nMB splint developed in this study retains the core therapeutic functions of conventional ARS appliances while incorporating structural refinements designed to enhance clinical efficacy and improve patient comfort.\u003c/p\u003e\u003cp\u003eJoint noise is a common symptom in patients with ADDwR [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e], and may be associated with abnormalities in joint fluid dynamics, disc-condyle coordiation, or condylar morphology [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. ARS have demonstrated clinical efficacy in alleviating joint noise symptoms [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan additionalcitationids=\"CR41\" citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. In this study, the nMB group exhibited significantly greater improvement in joint noise relief compared to the tTB group at both the 1-month (T1: 66.1% \u003cem\u003evs.\u003c/em\u003e 47.4%) and 6-month (T6: 82.1% \u003cem\u003evs.\u003c/em\u003e 54.4%) follow-ups, although no significant difference was observed at 3 months (T3). Importantly, the overall therapeutic efficacy of the nMB splint throughout the treatment period was. This benefit is likely attributable to the distinctive design features of the nMB splint, which allows for precise and stable mandibular advancement with a retention system that effectively maintains the therapeutic position. This design is particularly beneficial during sleep, when minimizing mandibular positional drift is critical for sustaining disc-condyle coordination. In contrast, the tTB splint relies on the occlusal inclines of separate maxillary and mandibular components. Such a mechanism may be more susceptible to displacement during nocturnal use, especially in patients with mouth breathing or muscular relaxation, thereby compromising the disc recapture consistency [\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The sustained clinical benefit of the nMB splint in alleviating joint noise underscores its potential to more effectively reestablish a stable and functional disc-condyle relationship over the long term.\u003c/p\u003e\u003cp\u003eARS also contributed to patients' pain alleviation [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e] by unloading TMJ structures, including retrodiscal tissue and masticatory muscles [\u003cspan additionalcitationids=\"CR46\" citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]. VAS scores indicated significant reductions in joint pain for both groups following treatment (nMB splint group: 2.69\u0026thinsp;\u0026plusmn;\u0026thinsp;1.83 to 0.27\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49; tTB splint group: 2.71\u0026thinsp;\u0026plusmn;\u0026thinsp;1.94 to 0.41\u0026thinsp;\u0026plusmn;\u0026thinsp;0.56). Notably, the nMB splint group exhibited a significantly greater reduction in pain at 3 months, while no significant differences were observed between groups at 1 month or 6 months. This transient difference may be attributed to the distinct ways the two splint designs modulate masticatory muscle activity. By maintaining a stable mandibular advancement position, the nMB splint may more effectively reduce abnormal hyperactivity in the masseter and temporalis muscles, leading to more pronounced muscle relaxation at T3. In contrast, the tTB splint, which depends on dynamic occlusal contact between two separate components - maxillary and mandibular, may result in a delayed neuromuscular adaptation process and, consequently, a less pronounced intermediate-term analgesic effect [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. Nonetheless, over the long term, both splints restored the functional balance between the joint and muscles, achieving comparable pain relief outcomes.\u003c/p\u003e\u003cp\u003eBoth groups exhibited significant increases in MMO following treatment (nMB splint group: 35.83\u0026thinsp;\u0026plusmn;\u0026thinsp;6.31 mm to 42.38\u0026thinsp;\u0026plusmn;\u0026thinsp;1.42 mm; tTB splint group: 35.56\u0026thinsp;\u0026plusmn;\u0026thinsp;4.60 mm to 41.99\u0026thinsp;\u0026plusmn;\u0026thinsp;1.55 mm). Throughout the treatment period, both splint designs demonstrated comparable efficacy in achieving favorable therapeutic outcomes. This suggests that both splints contribute to the relaxation of periarticular musculature and promote mandibular advancement, thereby increasing intra-articular space. As a result, the condyles may seat more centrally in the glenoid fossa, eliminating mechanical interference from the displaced disc during condylar translation, which ultimately facilitates the restoration of normal mandibular opening [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e].\u003c/p\u003e\u003cp\u003ePrevious studies have proposed that the mechanism of ARS involves \u0026ldquo;recapturing\u0026rdquo; of the disc by downward and forward movement of the condyle [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. However, no significant changes were observed in the positive rate of anterior disc displacement following treatment with the nMB splint and the tTB splint. As noted by Chen [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e], the stability of disc-condyle relationship often cannot be maintained upon ARS removal in the majority of patients, which may explain the limited improvement in anterior disc displacement rates in the present study.\u003c/p\u003e\u003cp\u003eWhile demonstrating therapeutic efficacy comparable to the tTB splint, the nMB splint showed superior outcomes in terms of general satisfaction, ease of cleaning, and stability. This result aligns with our original intent behind this novel splint, which aimed to optimize patient compliance by improving usability.\u003c/p\u003e\u003cp\u003eIn conclusion, this study demonstrates that the nMB splint, as a novel ARS design, provides comparable improvements in mouth opening and joint pain relief to the tTB splint, while offering superior reduction in joint noise and enhanced patient comfort. These advantages are likely attributed to its stable, integrated structure. Although no significant improvement was observed in disc reduction rates, this finding concurs with previous research highlighting the transient nature of such changes. Overall, the nMB splint represents a promising innovation of ARS therapy and warrants further evaluation in larger-scale and imaging-supported clinical studies.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eThe nMB splint demonstrated superior efficacy over the tTB splint in reducing joint noise and enhancing patient comfort, with higher patient-reported satisfaction in terms of comfort, retention and stability. Both splints showed comparable effectiveness in improving MMO, relieving joint pain, and restoring disc-condyle relationship. These findings suggest that the nMB splint is a promising, patient-oriented advancement in ARS therapy for the conservative management of ADDwR.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eADDwR: Anterior Disc Displacement witht Reduction\u003c/p\u003e\n\u003cp\u003eARS: Anterior Repositioning Splints\u003c/p\u003e\n\u003cp\u003eDC/TMD: Diagnostic Criteria for Temporomandibular Disorders\u003c/p\u003e\n\u003cp\u003eMB: Mono-Block\u003c/p\u003e\n\u003cp\u003eMMO: Maximum Mouth Opening\u003c/p\u003e\n\u003cp\u003eTB: Twin-Block\u003c/p\u003e\n\u003cp\u003eTMD: Temporomandibular Disorders\u003c/p\u003e\n\u003cp\u003eTMJ: Temporomandibular Joint\u003c/p\u003e\n\u003cp\u003e\u0026chi;\u0026sup2; test: Chi-square test\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Affiliated Stomatology Hospital of Guangzhou Medical University (Approval number: LCYJ20250618004).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe corresponding author \u003cstrong\u003e\u003cem\u003eD.DS. Dr. W. Cao\u003c/em\u003e\u003c/strong\u003e had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The data and material that support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research was funded by the National Key Research and Development Program of China (2023YFC2509200), the Research Capability Enhancement Program of Guangzhou Medical University (No. 2024SRP162), and the Medical Science and Technology Research Foundation of Guangdong Province (No. A2024532).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eZ. Liu\u003c/em\u003e\u003c/strong\u003e: Data collection, Writing\u0026ndash;original draft, Formal analysis, Validation, Visualization; \u003cstrong\u003e\u003cem\u003eA. Wu\u003c/em\u003e\u003c/strong\u003e: Data collection, Writing\u0026ndash;original draft, Funding acquisition, Conceptualization, Methodology, Writing \u0026ndash; review \u0026amp; editing; \u003cstrong\u003e\u003cem\u003eJ. Fan\u003c/em\u003e\u003c/strong\u003e: Validation, Methodology, Writing \u0026ndash; review\u0026amp; editing; \u003cstrong\u003e\u003cem\u003eY. Yuan:\u003c/em\u003e\u003c/strong\u003e Writing \u0026ndash; review \u0026amp; editing, Data collection, Methodology; \u003cstrong\u003e\u003cem\u003eY. Lin:\u003c/em\u003e\u003c/strong\u003e Data collection, Methodology; \u003cstrong\u003e\u003cem\u003eR. Zhang:\u003c/em\u003e\u003c/strong\u003e Project administration, Data collection, Methodology; \u003cstrong\u003eQ\u003cem\u003e. Zhang\u003c/em\u003e\u003c/strong\u003e Project administration, Supervision, Writing \u0026ndash; review \u0026amp; editing; \u003cstrong\u003e\u003cem\u003eW. Cao\u003c/em\u003e\u003c/strong\u003e: Funding acquisition, Conceptualization, Supervision, Project administration, Supervision, Writing \u0026ndash; review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to express our sincere gratitude to Mr. Liangming Zhang from the Department of Information Technology, School and Hospital of Stomatology, Guangzhou Medical University, Guangzhou, China, for his valuable assistance with data collection in this research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eQamar Z, Alghamdi AMS, Haydarah NKB, Balateef AA, Alamoudi AA, Abumismar MA, Shivakumar S, Cicci\u0026ugrave; M, Minervini G (2023) Impact of temporomandibular disorders on oral health-related quality of life: A systematic review and meta-analysis. 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J Oral Rehabil 44(9):664\u0026ndash;672\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Guangzhou Medical University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Temporomandibular joint disorders, Anterior disc displacement with reduction, Anterior repositioning splint, CBCT","lastPublishedDoi":"10.21203/rs.3.rs-7083956/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7083956/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eAnterior disc displacement with reduction (ADDwR) is a common subtype of temporomandibular disorders (TMD). Anterior repositioning splints (ARSs) serve as a key conservative treatment modality. This study aimed to compare the clinical efficacy of a novel Mono-Block splint (nMB) with that of a traditional Twin-Block splint (tTB) in the management of ADDwR.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA total of 118 patients with ADDwR were randomized to receive either an nMB or tTB splint. Clinical outcomes were assessed at baseline (T0) and 1 (T1), 3 (T3), and 6 months (T6). CBCT scans were obtained at T0 and T6, and patient satisfaction was evaluated at T6.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eJoint noise: The nMB group showed significantly greater improvement than the tTB group at T1 and T6. Joint pain: Greater symptom relief was observed in the nMB group at T3. \u003cb\u003e3.\u003c/b\u003e MMO: The nMB splint induced a significantly greater increase in MMO only at T1. Anterior disc displacement: CBCT evaluation revealed comparable outcomes between the two groups, with no significant differences in relative disc position. Patient satisfaction: The nMB splint achieved significantly higher ratings in general satisfaction, comfort, and stability, while no significant differences were noted in cleaning and retention.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThe nMB splint demonstrated superior effectiveness in reducing joint noise and improving patient comfort compared to the tTB splint, while both splints exhibited similar efficacy in relieving joint pain and enhancing MMO. Although neither splint significantly improved disc reduction on CBCT, the nMB design offers a promising, patient-oriented approach for conservative treatment of ADDwR.\u003c/p\u003e","manuscriptTitle":"Effectiveness of novel versustraditional anterior repositioning splints for anterior disc displacement with reduction of the temporomandibular joint","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-14 10:54:38","doi":"10.21203/rs.3.rs-7083956/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"08414b6b-db9e-4a46-b926-00bb33d505dd","owner":[],"postedDate":"July 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":51282200,"name":"Dentistry"}],"tags":[],"updatedAt":"2025-07-14T10:54:39+00:00","versionOfRecord":[],"versionCreatedAt":"2025-07-14 10:54:38","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7083956","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7083956","identity":"rs-7083956","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}