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Clinical study of two mandibular advancement devices in the treatment of Obstructive Sleep Apnea: a pilot randomized controlled trial

BMC Oral Health volume 24, Article number: 1492 (2024) Cite this article

Abstract

Objective

A preliminary clinical evaluation of the efficacy, comfort, and adverse reactions of two mandibular advancement devices (MADs) in the treatment of Obstructive Sleep Apnea (OSA).

Methods

Forty patients with mild-to-severe OSA were recruited and randomly divided into two groups. They were treated with Shark-fin or Silensor MAD, respectively. Treatment efficacy was evaluated by home sleep apnea tests, the snoring scale, Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI). A comfort scale questionnaire was applied. Cone beam computed tomography (CBCT), cephalometric radiography, and intraoral scanning were made before and after 3-month treatment to detect temporomandibular joints (TMJ), dental and skeletal changes. All data were assessed as normal distributed and analyzed by t test. The significance level was defined as α = 0.05.

Results

The effective rate, defined as a decrease in Respiratory Event Index (REI) to less than 5 events per hour or a decrease of more than 50%, was 70% in the Shark-fin MAD group and 50% in the Silensor MAD group. REI, lowest oxygen saturation and maximum apnea and hypoventilation time were significantly improved in Shark-fin MAD group (P < 0.01), and the proportion of non-rapid eye movement (REM) sleep stage 3 was higher than before use (P < 0.05), while only REI and lowest oxygen saturation were significantly improved in Silensor MAD group (P < 0.05). The loudness of snoring was significantly decreased after one day using Shark-fin MAD (P < 0.05), and further decreased after one month (P < 0.01). Conversely, Silensor MAD exhibited inferior efficacy in mitigating snoring compared to Shark-fin MAD. Upon wearing the Shark-fin MAD, ESS were significantly improved after one month and three months (P < 0.05), and PSQI improved after three months (P < 0.05). Additionally, the Shark-fin MAD group had a significantly better comfort score compared to the Silensor MAD group (P < 0.05). There was no significant difference in TMJ, dental and skeletal structures in the two groups before and after treatment (P > 0.05).

Conclusion

Both two MADs were effective in reducing REI and increasing lowest oxygen saturation on OSA patients, and Shark-fin MAD has better improvement effect and faster onset of action. In addition, Shark-fin MAD was superior to Silensor MAD in improving snoring loudness, daytime sleepiness, sleep quality and wearing comfort. There were no significant dental or skeletal changes, and no alterations in occlusion or temporomandibular joint function in the short term.

Trial registration

Clinical Trials.gov Registration ID ChiCTR2400086628. Registered 08/07/ 2024-Retrospectively registered, https://register.clinicaltrials.gov.

Peer Review reports

Introduction

Obstructive Sleep Apnea (OSA) is a prevalent sleep breathing disorder characterized by recurrent upper airway obstruction during sleep. Untreated OSA can lead to severe long-term consequences, including hypertension, stroke, and even life-threatening complications [1,2,3]. OSA typically arises from the relaxation of pharyngeal muscles and the collapse of airway soft tissue. The primary conservative treatment is Continuous Positive Airway Pressure (CPAP) [4]. However, CPAP comes with drawbacks, including poor tolerance and compliance, high cost, maintenance difficulties, and portability issues. Additionally, long-term use can cause adverse reactions, such as skin allergies, conjunctivitis, airway dryness, and pneumothorax [5, 6].

As an alternative to CPAP, oral appliances have gained recognition. Mandibular advancement devices (MADs) are commonly used among these appliances. Protracting the mandible causes the genioglossus and tongue to move forward, creating tension in the pharyngeal mucosa and the palatoglossus muscles. This reduces pressure on the soft palate and uvula, which in turn expands the diameter of the upper airway [7,8,9]. MADs are considered the first-line treatment for patients with mild to moderate OSA and those severe patients who cannot tolerate CPAP or surgical treatment [10].

MADs can be categorized into two types based on their ability to adjust the mandibular protrusion. Titratable MADs, which allow for varying degrees of mandibular advancement, have shown more significant improvements in Apnea-Hypopnea Index (AHI) and blood oxygen saturation than the non-titratable MADs [10]. One well-studied titratable MAD is the Silensor, composed of two separate splints made form the patient’s maxillary and mandibular tooth plaster models, connected by bars of different lengths to adjust the mandibular advancement distance [11]. The Silensor MAD have proven as an effectivement for OSA with a relatively low incidence of adverse reactions [12,13,14].

Recently, a new type of customized titratable MAD known as the Shark-fin MAD has been introduced in clinical practice. Unlike the Silensor MAD, the Shark-fin MAD is made from a soft, elastic material and features a Shark-fin-like protrusion in each of the mandibular canine regions, this design element is intended to provide specific functional benefits, improving the fit or stability of the device. It also features two resin-embedded metal screw stents on the maxillary posterior region, complete with a hole design and a handle for precise adjustment of mandibular forward extension, with a minimum accuracy of 0.25 mm. A preliminary self-control study of the Shark-fin MAD compared the AHI, lowest oxygen saturation, snore index, ESS score, snore VAS score, comfort value of all patients before and after treatment, which shown promising results for the shark-fin MAD in treating mild to moderate OSA without significant adverse effects [15].

Currently, there are few randomized controlled studies comparing different types of MAD. Considering the comfort of MADs can affect patient compliance and wearing time, subsequently affecting treatment outcomes [5, 16, 17], patient comfort while wearing both devices was also studied. The null hypothesis was that there is no difference in efficacy, adverse effects, and patient comfort between the two MADs. Therefore, the aim of this study was to evaluate the efficacy and adverse effects of two MADs, specifically the Shark-fin MAD and the Silensor MAD, in OSA treatment.

Materials and methods

Study design and patient population

This study recruited patients experiencing sleep snoring who sought treatment at the General Department, Stomatology Hospital of Zhejiang Chinese Medical University for treatment from January to November 2022. The inclusion criteria were as follows: (1) Age 18 years or older; (2) with no major systemic diseases; (3) with no severe active periodontal disease, temporomandibular joint disorder, or severe dentition defects, so as routine intraoral operation could be performed; (4) diagnosis of OSA through polysomnography (PSG) conducted at Zhejiang Province’s First Affiliated Hospital of the University School of Medicine or Run Run Shaw Hospital of Zhejiang University School of Medicine; (5) willingness to voluntarily accept mandibular advancement device treatment, return for scheduled appointments, and cooperate with relevant examinations and questionnaires. Patients were excluded from the study if they had poor general health, were unable to cooperate, had underlying pathological factors causing airway obstruction, or were single without a bed partner.

The sample size was calculated by using the following formula: \(\:\text{n}=2\times\bar{\text{p}}\bar{\text{q}}\times{\text{(}{\text{Z}}_{\alpha}+{\text{Z}}_{\beta}\text{)}}^{\text{2}}/{\text{(}{\text{P}}_{\text{1}}-{\text{P}}_{\text{2}}\text{)}}^{\text{2}}\), where \(\:{\text{P}}_{1}\) means a treatment effectiveness rate of 80% for Silensor MAD, which was provided by the manufacturer, \(\:{\text{P}}_{2}\) means a treatment effectiveness rate of 67% for Shark-fin MAD [15]. Besides, Zα is 0.05, Zβ is 0.09, \(\:\bar{p}\)and \(\:\bar{q}\) are calculated to 0.735 and 0.265. It was determined that 18 subjects were required in each group. A total of 40 subjects were finally included in this study, meeting the sample size requirements. This study was approved by the Institutional Review Board of the Affiliated Stomatological Hospital of Zhejiang University of Chinese Medicine (approval number: 330108002 − 202200002), and all patients signed informed consent forms. Study procedures flow diagram was shown in Fig. 1.

Fig. 1
figure 1

Flowchart of study procedure

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The severity of OSA can be classified based on the Apnea Hyponea Index (AHI), which represents the average number of apneas and hypopneas per hour of sleep [1, 18, 19]. According to the results of PSG monitoring, there were 14 mild cases (5 < AHI < 15), 17 moderate cases (15 < AHI < 30), and 9 severe cases (AHI > 30), in this study. All patients were single-blinded, and PSG monitors numbered all 40 eligible study subjects from 1 to 40 using a computer-generated random number table. Based on the parity of random numbers, 20 subjects with odd numbers were divided into Shark-fin MAD and the remaining 20 subjects into the Silensor MAD group. Difference in baseline characteristics between the two groups was analyzed by t test. The initial mandibular advancement was determined by gradually advancing the mandible to the same, comfortable position with the patient in the semi-supine posture [20]. This process was repeated three times to ensure consistency. The devices used in the study are shown in Fig. 2. There were no significant differences in disease severity between the two groups.

Fig. 2
figure 2

Photos of the two MADs used in this study. A–C show the Shark-fin MAD placed on the model and intraorally, The Shark-fin MAD has two outwardly extending parts in the shape of shark’s fin (shown in circle), and features a hole design and a handle (shown in rectangle) for precise adjustment of mandibular forward extension, with a minimum accuracy of 0.25 mm. D–F show the Silensor MAD placed on the model and intraorally. The Silensor MAD has a design improvement that includes curved bars for enhanced comfort and six pairs of bars of varying lengths, spaced 1 mm apart, allowing for flexible customization

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Efficacy evaluation

In this study, home sleep apnea tests (HSAT) was employed for sleep monitoring instead of PSG. HSAT uses ultra-wide-band (UWB) radar monitoring technique to detect chest movement caused by breathing and interpret radar echoes to capture whole-body motion. This allows for non-invasive monitoring of sleep apnea events. In addition, pulse oximetry is used to measure pulse oxygen saturation. The collected data, including the number of apnea and hypopnea events, as well as sleep duration, are analyzed using various detection algorithms [18]. The study by Bassam et al. demonstrates that HSAT exhibits comparable consistency to PSG in distinguishing between sleep and wakefulness states, and exhibits high accuracy in identifying sleep epochs [21]. Clinical research has shown that HSAT is as effective as PSG for diagnosing OSA [22]. However, HSAT is simpler, more comfortable, and more cost-effective in comparision with PSG [19]. Consequently, it is recommended for assessing oral appliance treatment efficacy [23]. All patients in this study underwent 3 overnight HSAT recordings. The initial monitoring served as a baseline recording before treatment, while the subsequent 2 occurred 1 month and 3 months after the use of MADs. For sleep breathing monitoring conducted by HSAT, it is recommended to use the Respiratory Event Index (REI), whose calculation method and evaluation criteria are consistent with the AHI [24]. Each recording measured the REI, lowest and average oxygen saturation, non-REM sleep stage 3, and maximum apnea and hypoventilation time.

The degree of daytime sleepiness and sleep quality was assessed using two self-administered questionnaires, the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) [10, 25]. All patients were required to complete these questionnaires both before wearing MADs and after wearing them for 1 and 3 months. The higher ESS indicated the higher degree of daytime sleepiness, and the greater PSQI indicated the poorer sleep quality. To evaluate the loudness of patients’ snoring, a standard 10-point Visual Analogue Scale was employed [10]. The scale ranged from 0 to 10, where a score of 0 signified no snoring and a score of 10 indicated that the bed partner felt compelled to leave the room due to the snoring. This assessment was conducted by the bed partner prior to the patient wearing MADs and at 1 day, 1 week, 1 month, and 3 months after starting to use MADs.

Comfort evaluation

Patients were instructed to complete a comfort scale questionnaire after wearing the MAD for 1 day, 1 week, 1 month, and 3 months [5]. The questionnaire involved assigning scores to 7 common discomfort reactions, such as a foreign body sensation affecting their ability to fall asleep, increased saliva secretion, dry mouth, tooth discomfort, muscle tenderness, temporomandibular joint discomfort or pain, and gum discomfort. A score of 0 indicated no discomfort, 1 represented mild discomfort, 2 reflected moderate discomfort, 3 signified noticeable but bearable discomfort, and 4 indicated that the discomfort was pronounced and unbearable.

Adverse reactions and side effects

In this study, dental and skeletal changes were identified as adverse reactions and side effects. All patients underwent Cone Beam CT (CBCT) with a field of view of 16 × 11 cm, Cephalometric radiography, and occlusion relationship recording using an iTero intraoral scanner (the default ratio was 0.05 ~ 0.75 mm) both before and after wearing the MADs for 3 months.

OnDemand 3D Dental was applied for measuring the anterior, superior, and posterior spaces of the bilateral temporomandibular joints on CBCT using the 45-degree angle bisector method, with the process repeated thrice for accuracy [26,27,28]. The measurement process is as follows, Through the horizontal line of the highest point of the condyle, the vertical line was made which obtained the superior joint space. Two lines with a 45-degree angle to the horizontal line were made through the most anterior and the most posterior point of the condyle, so the former obtained the anterior joint space, and the latter obtained the posterior joint space. The same method was used on the bilateral sides of temporomandibular joints. The SN line was used as a reference for skull base image overlay during cephalometric analysis. Relevant angles and distances were measured [29, 30].

Statistical analysis

Statistical analysis was performed using SPSS software (SPSS version 25.0, IBM, USA) on the data from different time points within the same group, as well as changes of the data between the two groups within the same time. All data were assessed as normal distributed and analyzed by t test. The significance level was defined as α = 0.05.

Results

In this study, the Shark-fin MAD group consisted of 7 mild, 7 moderate, and 6 severe patients, with an average age of 39.45 ± 10.84 years and a BMI of 26.07 ± 7.89 kg/m². The Silensor MAD group included 7 mild, 10 moderate, and 3 severe patients, with an average age of 34.40 ± 7.94 years and a BMI of 27.32 ± 3.52 kg/m². Difference of each index in both two groups before wearing had no statistical significance (P > 0.05).

Effective treatment is typically defined as a reduction in the REI to fewer than 5 events per hour or a reduction of more than 50% [31]. In this study, the efficiently individual quantity was 14 in the Shark-fin MAD group and 10 in the Silensor MAD group.

As shown in Fig. 3, patients in the Shark-fin MAD group exhibited a significant reduction in REI after 1-month treatment (P < 0.01) and the lowest oxygen saturation displayed significant improvement (P < 0.05) after one month of treatment. After 3-month treatment, the REI further decreased (P < 0.01), and the maximum apnea and hypoventilation time significantly decreased (P < 0.05), along with significant increases in the lowest oxygen saturation and non-REM sleep stage 3 (P < 0.01). In the Silensor MAD group, there were no significant differences in any parameters at one month treatment, but after 3-month treatment, REI significantly decreased (P < 0.05) and lowest oxygen saturation significantly increased (P < 0.05), while there were no statistically significant differences in non-REM sleep stage 3 and maximum apnea and hypoventilation time compared to pre-treatment levels (P > 0.05). The average oxygen saturation did not show significant statistical differences before and after treatment in either group (P > 0.05).

Fig. 3
figure 3

Comparison of the home sleep apnea tests outcome in patients with two kinds of MADs. Statistical differences are indicated by horizontal lines with an asterisk (* denotes P < 0.05, ** denotes P < 0.01)

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Compared with the pre-treatment, there was no statistically significant difference observed in various data between the two groups within the same time period (e.g., wearing MAD for 1 month or 3 months) (P > 0.05).

In the Shark-fin MAD group, snoring score decreased significantly after 1-day treatment (P < 0.05), and further decreased after 1-month treatment (P < 0.01). However, in the Silensor MAD group, snoring score did not decrease significantly until 1 month later (Fig. 4a). As shown in Fig. 4b and c, in Shark-fin MAD group, ESS and PSQI scores were significantly improved after 1-month and 3-month treatment (P < 0.05). However, in Silensor MAD group, there was no significant difference in ESS and PSQI scores before and after treatment (P > 0.05). Compared between two groups, there was no significant difference in snoring, ESS, and PSQI scores at the same time period (P > 0.05).

Fig. 4
figure 4

Comparison of Visual Analogue Scale for snoring, ESS Scale, PSQI Scale and Comfort Scale in patients with two kinds of MADs. Statistical differences are indicated by horizontal lines with an asterisk (* denotes P < 0.05, ** denotes P < 0.01)

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There was no significant difference in the comfort score of the Shark fin group compared to the first day of wearing for 1 week and 1 month (P > 0.05). However, the score significantly decreased after 3 months of wearing (P < 0.05). In contrast, the differences in the comfort scores of the Silensor MAD group at various follow-up points were not significant (P > 0.05). After 1 day and 3 months of wearing, the Shark-fin MAD group had lower comfort scores than the Silensor MAD group (P < 0.05), but at 1 week and 1 month after wearing, there was no significant difference between two groups (Fig. 4d).

CBCT and cephalometric measurements revealed that after using MADs for three months, there were no significant differences in the bilateral joint spaces, teeth, and bone positions of all patients compared to their conditions before treatment (see Tables 1 and 2). Furthermore, the occlusal changes observed in all patients before and after treatment fell within the range of 0.05 to 0.2 mm.

Table 1 Joint space comparison outcomes
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Table 2 Cephalometric analysis outcomes
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Discussion

This prospective clinical study compared the treatment effect of Shark-fin MAD and Silensor MAD. The null hypothesis of the present study was partially rejected. Because statistically significant differences were found in efficacy and patient comfort between the two MADs.

This study found that after 1 and 3 months of wearing Shark-fin MAD, the REI decreased by 53.66% and 60.94% respectively, and the lowest oxygen saturation increased by 6.16% and 7.54% respectively. However, in the Silensor MAD group, these indicators did not significantly improve after one month treatment, but after three months, REI decreased by 47.08% and lowest oxygen saturation increased by 8.69%. After 3-months treatment, the Shark-Fin MAD group showed a 29.71% increase in non-REM sleep stage 3 and a 15.79% decrease in maximum apnea and hypoventilation time, while the Silensor MAD group showed no significant improvement in these indicators. These results indicated that Shark-Fin MAD has a better effect on improving sleep quality. Although MADs operated on the same mechanism, differences in their structures resulted in variations in efficacy [16].The Shark-fin MAD was more accurate than Silensor MAD in terms of the smallest unit of mandibular advancement. Silensor MAD was 1 mm per change of the bar, and the Shark-fin MAD was adjusted by turning around, for 0.25 mm per turn. Too much activation of the Silensor MAD may lead to decreased comfort, and patients may not adapt quickly and continue to wear it, resulting in a slow effect. In addition, the Shark-fin MAD was much softer than the Silensor MAD. The contact surface of Shark-fin MAD was located in the posterior tooth area, and its mandibular advancement device was positioned on the side, enhancing comfort and compliance [16], which were crucial factors for MAD functionality [12, 32].

Consistent with the results of home sleep apnea tests, the results of snoring scale, ESS scale and PSQI scale in this study all showed that Shark-fin MAD was more effective and faster than Silensor. The improvement in those efficacy may further motivate patients to continue wearing the MADs.

Short-term adverse effects caused by MADs generally include dental and muscle discomfort [33]. In this study, 67.5% of patients reported experiencing discomfort in their teeth lasting for more than half hour after removing the MAD in the morning. Some patients even found it affected their ability to eat breakfast, with a small number experiencing discomfort until noon. Additionally, 25% of patients noted more pronounced pain in the temporomandibular joint area compared with tooth discomfort. A biomechanical analysis suggested that mandibular advancement could increase activity in masticatory muscles, with pain occurrence linked to changes in muscle dynamics rather than increased stress on the joints [34]. Therefore, while MADs may cause pain symptoms, they do not necessarily damage mandibular function [35].

Regarding long-term MADs use, potential side effects include a decrease in overbite and overjet, changes in occlusal contact points, teeth movement, and changes in tooth inclination, such as backward inclination of maxillary incisors, forward inclination of mandibular incisors, inside tilting of mandibular molars, and outside tilting of maxillary molars [5, 15, 27, 36]. These side effects typically manifest after using MADs for 2 to 3 years [37]. However, due to the limited follow-up time in this study, no significant dental or skeletal changes, occlusal alterations, or temporomandibular joint changes were observed after wearing both MADs. It’s important to note that the potential harm of OSA often outweighs MAD side effects; thus, MADs may still be considered even in the presence of adverse reactions [33].

A limitation of this study is the short follow-up period. Three months of clinical follow-up can only provide a preliminary evaluation of the efficacy of the two MADs. Therefore, to fully understand the therapeutic effects of the two MADs on patients with different degrees of OSA, and to clarify whether they will cause adverse reactions and side effects, long-term follow-up studies are needed in the future.

According to this study, both MADs demonstrated good efficacy and safety in treating OSA patients. The Shark-fin MAD was found to improve sleep quality more effectively and quickly, reduce daytime sleepiness, and may also enhance the sleep quality of the bed partner.

Conclusion

In terms of home sleep apnea tests, both two MADs were effective in reducing REI and increasing lowest oxygen saturation, with Shark-fin MAD showing superior efficacy and faster onset compared to Silensor MAD. Additionally, only Shark-fin MAD effectively improved non-REM sleep stage 3, as well as reduced maximum apnea and hypoventilation time. In addition, Shark-fin MAD was superior to Silensor MAD in improving snoring loudness, daytime sleepiness, sleep quality and wearing comfort. There were no significant dental or skeletal changes and no change in occlusion or temporomandibular joint either after wearing MADs for short term. However, the treatment of MADs is a dynamic process, and the follow-up work is an important part. The frequency of follow-up visits should be increased in the initial stage of treatment, the causes of discomfort caused by MADs should be addressed in time, and patients should be encouraged to insist on wearing it.

Data availability

Data is provided within the manuscript or supplementary information files.

Abbreviations

MAD:

Mandibular Advancement Device

OSA:

Obstructive Sleep Apnea

ESS:

Epworth Sleepiness Scale

PSQI:

Pittsburgh Sleep Quality Index

CBCT:

Cone Beam Computed Tomography

REM:

Rapid Eye Movement

TMJ:

Temporomandibular Joints

CPAP:

Continuous Positive Airway Pressure

AHI:

Apnea Hyponea Index

REI:

Respiratory Event Index

PSG:

Polysomnography

HSTA:

Home Sleep Apnea Tests

References

  1. Patel SR. Obstructive sleep apnea. Ann Intern Med. 2019;171(11):ITC81–96.

    Article  PubMed  Google Scholar 

  2. Su XF, Liu L, Li JH, Qian XS, Han JM. Research progress of obstructive sleep apnea-related stroke. Chin J Geriatr Heart Brain Vessel Dis. 2021;23(09):1006–8.

    Google Scholar 

  3. Xia F, Sawan M. Clinical and Research Solutions to manage obstructive sleep apnea: a review. Sensors. 2021;21(5):1784.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Gottlieb DJ, Punjabi NM. Diagnosis and management of obstructive sleep apnea: a review. JAMA. 2020;323(14):1389–400.

    Article  PubMed  Google Scholar 

  5. Xu TT, You DM, Chen X. Non-surgical treatment of obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2018;275(2):335–46.

    Article  Google Scholar 

  6. Wu CL. Effect observation and nursing of non-invasive ventilator in the treatment of obstructive apnea syndrome. Proc Clin Med. 2011;20(11):865–8.

    Google Scholar 

  7. Wojda M, Kostrzewa-Janicka J, Śliwiński P, Bieleń P, Jurkowski P, Wojda R, et al. Mandibular Advancement Devices in Obstructive Sleep Apnea patients intolerant to continuous positive airway pressure treatment. Adv Exp Med Biol. 2019;1150:35–42.

    Article  CAS  PubMed  Google Scholar 

  8. Dieltjens M, Vanderveken O. Oral appliances in obstructive sleep apnea. Healthc (Basel). 2019;7(4):141.

    Google Scholar 

  9. Heiser C, Edenharter G, Bas M, Wirth M, Hofauer B. Palatoglossus coupling in selective upper airway stimulation. Laryngoscope. 2017;127(10):E378–83.

    Article  PubMed  Google Scholar 

  10. Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, et al. Clinical practice Guideline for the treatment of obstructive sleep apnea and snoring with oral Appliance Therapy: an update for 2015. J Clin Sleep Med. 2015;11(7):773–827.

    Article  PubMed  PubMed Central  Google Scholar 

  11. ZhouLX ZGR, Qian YF. Research progress in the oral appliances therapy for obstructive sleep apnea syndrome. Chin J Practical Stomatol. 2016;9(11):693–7.

    Google Scholar 

  12. Henke KG, Frantz DE, Kuna ST. An oral elastic mandibular advancement device for obstructive sleep apnea. Am J Respir Crit Care Med. 2000;161(2 Pt 1):420–5.

    Article  CAS  PubMed  Google Scholar 

  13. Tan YK, L’Estrange PR, Luo YM, Smith C, Grant HR, Simonds AK, et al. Mandibular advancement splints and continuous positive airway pressure in patients with obstructive sleep apnoea: a randomized cross-over trial. Eur J Orthod. 2002;24(3):239–49.

    Article  CAS  PubMed  Google Scholar 

  14. Nakano H, Mishima K, Matsushita A, Suga H, Matsumura M, Mano T, et al. Efficacy of the Silensor for treating obstructive sleep apnea syndrome. Oral Maxillofac Surg. 2013;17(2):105–8.

    Article  PubMed  Google Scholar 

  15. Pang F, Lu YT, Tan Y, Liu J, Deng WM, Lin MM, et al. Efficacy of the customized adjustable oral appliance in the treatment of mild and moderate obstructive sleep apnea hypopnea syndrome. Chin Arch Otolaryngol Head Neck Surg. 2021;28(08):506–9.

    Google Scholar 

  16. Manetta IP, Ettlin D, Sanz PM, Rocha I, Meira E, Cruz M. Mandibular advancement devices in obstructive sleep apnea: an updated review. Sleep Sci. 2022;15(Spec 2):398–405.

    PubMed  PubMed Central  Google Scholar 

  17. Zeng JP, Li HY, Yang XJ, Liao JH. Effect of doctor-patient communication on the compliance of patients with obstructive sleep apnea and hypopnea syndrome to the treatment with snore-prevention equipment. J Guangdong Med Coll. 2015;33(04):422–4.

    Google Scholar 

  18. Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, et al. Clinical practice guideline for diagnostic testing for adult obstructive sleep apnea: an American academy of sleep medicine clinical practice guideline. J Clin Sleep Med. 2017;13(3):479–504.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Wei Y, Fu CP, Shen YY, Li SQ, Zhang XQ. Interpretation of clinical guidelines for diagnosis of adult obstructive sleep apnea in 2017 by American Academy of Sleep Medicine. World Clin Drugs. 2020;41(04):242–6.

    Google Scholar 

  20. Zhou J, Li DH, Zhu PF, Yi CY, Chang L, Zhang Y, et al. Effect of mandibular advancement device on the stomatognathic system in patients with mild-to-moderate obstructive sleep apnoea-hypopnoea syndrome. J Oral Rehabil. 2020;47(7):889–901.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Chakar B, Senny F, Cambron L, Poirrier AL, Bruwier A, Baharloo F, et al. Validation of mandibular movements’ analysis to measure sleep in adults with sleep complaints by comparison with actigraphy and polysomnography. Sleep Sci. 2022;15(3):318–25.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Zancanella E, do Prado LF, de Carvalho LB, Machado Júnior AJ, Crespo AN, do Prado GF. Home sleep apnea testing: an accuracy study. Sleep Breath. 2022;26(01):117–23.

    Article  PubMed  Google Scholar 

  23. Xu SF, Zhu M. Application and research progress on home sleep apnea monitoring in diagnosis of obstructive sleep apnea. Chin J Clin Med. 2019;26(03):503–7.

    Google Scholar 

  24. Mieno Y, Hayashi M, Hirochi M, Ikeda A, Kako H, Ina T, et al. Availability of home sleep apnea test equipment LS-140 on a comparison with Polysomnography. Fujita Med J. 2022;8(1):17–24.

    PubMed  Google Scholar 

  25. Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: a systematic review and meta-analysis. Sleep Med Rev. 2016;25:52–73.

    Article  PubMed  Google Scholar 

  26. Zhang ZK, ZhaoFY, Sun GX. X-ray analysis of 100 sides of temporomandibular joint in normal adults. Nati Med J Chin. 1975;55:130–2.

    Google Scholar 

  27. Kamelchuk LS, Grace MG, Major PW. Post-imaging temporomandibular joint space analysis. Cranio. 1996;14(1):23–9.

    Article  CAS  PubMed  Google Scholar 

  28. Wu GX, Liu PP, Liu J, Guo J. Subjective symptoms and temporomandibular joint space evaluation in subjects wearing orthodontic vacuum-formed retainers. Stomatology. 2017;37(06):537–40.

    Google Scholar 

  29. Niu SQ, Hou FC, Zhang QQ, Zang YJ. Study on the changes of soft and hard tissue before and after early treatment of ClassIIskeletal malocclusion with twin-block appliance. Shanghai Kouqiang Yixue. 2021;30(1):81–4.

    PubMed  Google Scholar 

  30. Wang XY, Gong X, Yu Z, Gao XM, Zhao Y. Follow-up study of dental and skeletal changes in patients with obstructive sleep apnea and hypopnea syndrome with long-term treatment with the Silensor appliance. Am J Orthod Dentofac Orthop. 2015;147(5):559–65.

    Article  Google Scholar 

  31. Du LN, Guo J. Volume change of upper airway induced by mandibular advancement device in patients with obstructive sleep apnea hypopnea syndrome and analysis of relevant factors. Chin J Orthod. 2010;3(03):5.

    Google Scholar 

  32. Zhao DC, He H. Clinical study of patients’ sleep and respiration after the appliance of the improved activator treats OSAS. J Clin Stomatology. 2004;20(08):480–2.

    Google Scholar 

  33. Faber J, Faber C, Faber AP. Obstructive sleep apnea in adults. Dent Press J Orthod. 2019;24(3):99–109.

    Article  Google Scholar 

  34. Heidsieck DSP, Koolstra JH, de Ruiter MHT, Hoekema A, de Lange J. Biomechanical effects of a mandibular advancement device on the temporomandibular joint. J Craniomaxillofac Surg. 2018;46(2):288–92.

    Article  PubMed  Google Scholar 

  35. Li HH, Li YH, Fang F. Effect of oral orthopaedic devices on temporomandibular joint function in patients with obstructive sleep apnea hypopnea syndrome. J CliPulm Med. 2019;24(02):271–4.

    CAS  Google Scholar 

  36. Alessandri-Bonetti G, D’Antò V, Stipa C, Rongo R, Incerti-Parenti S, Michelotti A. Dentoskeletal effects of oral appliance wear in obstructive sleep apnoea and snoring patients. Eur J Orthod. 2017;39(5):482–8.

    PubMed  Google Scholar 

  37. Liu X, Lu H, Hao SY. Interpretation of the 2015 the American Sleep Medicine Association and the American Academy of Dental Sleep Medicine Association clinical practice guidelines for the treatment of obstructive sleep apnea and snoring with oral appliances. World Clin Drugs. 2020;41(09):690–3.

    Google Scholar 

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Acknowledgements

The author gratefully acknowledges all the doctors for their participation in this study.

Funding

This work was supported by project of Zhejiang Chinese Medical University (Grant No. 352219A00605).

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Author notes

  1. Liang Yu and Ruohui Mao contributed equally to this work and share first authorship.

Authors and Affiliations

  1. School/Hospital of Stomatology, Zhejiang Chinese Medical University, Hangzhou, China

    Liang Yu, Ruohui Mao, Jing Zhao, Nengjie Lin, Zhe Sun & Yuanna Zheng

  2. Department of Stomatology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China

    Liang Yu

  3. Hangzhou Aizhe Health Management Limited Company Citizens Home Dental Clinic, Hangzhou, China

    Chaoyuan Zhang

  4. Ningbo Dental Hospital/Ningbo Oral Health Research Institute, Ningbo, China

    Yuanna Zheng

Authors
  1. Liang Yu
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Contributions

YZ, NL, ZS and JZ conceived the idea, designed and organized the survey. CZ contributed to data collection; LY and RM analyzed the data and led the writing. JZ and YZ revised the manuscript. LY and RM are co-first authors of the manuscript. Both of the two authors have made equally significant contributions to the work and share equal responsibility and accountability for it. All authors reviewed and approved the final version of the paper.

Corresponding author

Correspondence to Yuanna Zheng.

Ethics declarations

Ethics approval and consent to participant

This randomized controlled trial was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Stomatology Hospital of Zhejiang Chinese Medical University (330108002 − 202200002). Before participating in this clinical trial, all patients were required to sign the informed consent statement. Only if they agreed, the clinical trial would be completed. This study adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

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Yu, L., Mao, R., Zhang, C. et al. Clinical study of two mandibular advancement devices in the treatment of Obstructive Sleep Apnea: a pilot randomized controlled trial. BMC Oral Health 24, 1492 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12903-024-05289-0

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12903-024-05289-0

Keywords

BMC Oral Health

ISSN: 1472-6831

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