Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial (original) (raw)
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Effects of a mandibular repositioner on obstructive sleep apnea
American Journal of Orthodontics and Dentofacial Orthopedics, 2000
The purpose of this study was to investigate the effects of a mandibular repositioner on airway, sleep, and respiratory variables in patients with obstructive sleep apnea. Twenty-two patients selected for this study were confirmed with a diagnosis of obstructive sleep apnea based on initial nocturnal polysomnography. The patients were fitted with a mandibular repositioner designed to hold the mandible anteroinferiorly. Six months later, an outcome polysomnographic study was undertaken for each patient with the appliance in place. Lateral cephalometric radiographs in the upright position were also obtained before and after 6 months of treatment. The respiratory disturbance index decreased in 21 of the 22 patients with the appliance in place. The mean respiratory disturbance index of the 22 patients decreased significantly from 40.3 to 11.7 events per hour (P <.01). Some 59.1% of subjects were considered a treatment success with follow-up respiratory disturbance index < 10 events per hour. The mean minimum blood oxygen saturation level during sleep also improved significantly from 73.4% to 81.3% (P <. 01). The mandibular repositioner was constructed to position the mandible at 75% of the maximal mandibular advancement and with a 7 mm opening between the upper and lower incisors, and no aberrant effect on temporomandibular joint was noted. The retropalatal airway space increased and the cross-sectional area of the soft palate and the vertical distance of the hyoid bone to the mandibular plane decreased significantly. The tongue posture became significantly flatter. A significant linear correlation was found between the reduction in apnea index and specific craniofacial skeletal structures (length of anterior cranial base, mandibular plane angle, and upper to lower facial height ratios, P <.05). Subjects with a smaller reduction in apnea index tended to have shorter anterior cranial bases, steeper mandibular planes, and smaller upper to lower facial height ratios. We conclude that a mandibular repositioner may be an effective treatment alternative for obstructive sleep apnea and that a reduction in the frequency of apneic episodes is mainly attributed to the effects of the appliance on oropharyngeal structures.
[Treatment of obstructive sleep apnea with a mandibular repositioning appliance]
[Osaka Daigaku shigaku zasshi] The journal of Osaka University Dental Society, 1990
A patient with obstructive sleep apnea has been treated by means of a mandibular repositioning appliance made of silicone rubber. The patient is a male and 54 years old with a slim body and complained a excessive daytime sleepiness and unsatisfied sleep. A lateral head plate revealed retruded mandible and narrow A-P diameter in the lower part of oropharynx. Moderate frequency of apnea was found in the initial all-night polysomnographic recording. The mandible has been brought forward by 5 mm and downward by 11 mm, which enlarges the diameter of oropharynx anterio-posteriorly by 2-3 mm. Since the appliance has been inserted during bed-time, the daytime sleepiness and unsatisfied sleep has been eliminated. The second polysomnographic recording revealed significant increment of deep NREM sleep and REM sleep and decrement of arousal during sleep after insertion of the appliance. It is indicated, therefore, that the application of the mandibular repositioning appliance is one of the effe...
Sleep Medicine, 2008
To assess the efficacy and compliance of a traction-based mandibular repositioning device (MRD) for treatment of moderate to severe obstructive sleep apnea syndrome (OSAS) under a patient-driven protocol in a routine outpatient care setting. Forty patients, 10 severe and 30 moderate OSAS sufferers (apnea-hypopnea index [AHI] &amp;gt;30 and between 15 and 30, respectively), were enrolled by four sleep centers. Nocturnal polygraphy, quality of life, and quality of sleep questionnaires were used to measure the effect of treatment after 45 days. Thirty-five patients completed the study. Frequency of respiratory events, daytime sleepiness, snoring, patient assessment of sleep quality, specific short-form multipurpose health survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) improved significantly with the MRD. Sixty percent of patients were &amp;quot;responders&amp;quot; (&amp;gt;50% decrease in AHI); 46% of patients were &amp;quot;full responders&amp;quot; (&amp;gt;50% decrease and AHI &amp;lt;10). Observance of treatment was high; 80% of patients wore the MRD every night. Side effects and patient complaints were minor and transitory. No serious side effects or cases of pathology aggravation were reported. Efficacy on respiratory and somnolence parameters of this innovative traction-based MRD was validated under a simple protocol of care with response rates similar to those published in the literature. This study shows consistent significant improvement by the MRD in quality of life and quality of sleep parameters across several tests. Treatment with the MRD under a simple, patient-driven protocol of care with control of efficacy by nocturnal polygraphy is appropriate in routine outpatient practice for moderate OSAS patients.
International Archives of Otorhinolaryngology, 2014
Introduction Obstructive sleep apnea syndrome affects up to 4% of middle-aged men and 2% of adult women. It is associated with obesity. Objective The objective of this article is to review the literature to determine which factors best correlate with treatment success in patients with obstructive sleep apnea syndrome treated with a mandibular repositioning appliance. Data Synthesis A search was performed of the PubMed, Cochrane, Lilacs, Scielo, and Web of Science databases of articles published from January 1988 to January 2012. Two review authors independently collected data and assessed trial quality. Sixty-nine articles were selected from PubMed and 1 from Cochrane library. Of these, 42 were excluded based on the title and abstract, and 27 were retrieved for complete reading. A total of 13 articles and 1 systematic review were considered eligible for further review and inclusion in this study: 6 studies evaluated anthropomorphic and physiologic factors, 3 articles addressed cephalometric and anatomic factors, and 4 studies evaluated variables related to mandibular repositioning appliance design and activation. All the studies evaluated had low to moderate methodologic quality and were not able to support evidence on prediction of treatment success. Conclusion Based on this systematic review on obstructive sleep apnea syndrome treatment, it remains unclear which predictive factors can be used with confidence to select patients suitable for treatment with a mandibular repositioning appliance.
The use of a mandibular repositioning device for obstructive sleep apnea
European Archives of Oto-Rhino-Laryngology, 2014
The objective of this study was to verify the effect of a mandibular repositioning device (MRD) on polysomnographic parameters and on the mean electromyographic activity of the masseter and temporal muscles in individuals with obstructive sleep apnea syndrome (OSAS). This is a prospective cohort study conducted at multidisciplinary OSAS center in a tertiary referral center. Nineteen individuals with mild or moderate OSAS associated with Mallampati 3-4 were treated with an MRD during sleep. The subjects underwent diurnal electromyography (EM) and nocturnal polysomnography (PSG) examinations both prior and after initial treatment (3 months with MRD for PSG and 6 and 12 months of treatment for EM). The examinations performed at different times were compared. Comparison of the initial and final polysomnography examination revealed a significant mean reduction of apnea-hypopnea index (AHI) from 13.8 to 7.8. The successful treatment rate with the MRD was 52.6 %, and the improved treatment rate was 68.4 %. Patients with lower pre-treatment AHI presented higher rates of cure. There was no statistically significant change in electromyography examination among different times. The MRD reduced the apnea-hypopnea index in individuals with enlarged base of tongue and mild and moderate OSAS without damaging the function of the masseter and temporal muscles as determined by electromyography.
Indian Journal of Sleep Medicine, 2016
Introduction: Medical dental sleep appliance (MDSA) is an adjustable mandibular advancement device (MAD) recommended for treatment of snoring and obstructive sleep apnea (OSA). There are very few studies on Indian population which evaluate the therapeutic efficacy of mandibular advancement devices in the management of OSA. Materials and Methods: A prospective clinical study was carried out. Twenty polysomnography diagnosed OSA patients fulfilling the inclusion and exclusion criteria were treated with MDSA and changes in pre and post-treatment sleep parameters (apneahypopnea index (AHI) and epworth sleepliness scale (ESS)) were recorded. Results: Mean differences in pre-(T 1 = 30.7 ± 5.0) and posttreatment (T 2 = 17.2 ± 3.9) AHI values and ESS pre-treatment (T 1 = 17.2 ± 0.6) and post-treatment (T 2 = 10.9 ± 0.9) were highly statistically significant (p < 0.001). Clinically the maximum improvement was observed in mild and moderate OSA cases. Although significant clinical improvement was also observed in severe OSA cases, the post-treatment AHI and ESS were still high. Conclusion: MDSA is a non-invasive, low risk and cost-effective treatment option for patients suffering from mild and moderate obstructive sleep apnea and also in cases of severe OSA who are not comfortable with CPAP or not willing for surgery.
Journal of Sleep Disorders & Therapy, 2015
Background: Oral appliances have emerged as an important alternative in treating patients with mild-moderate obstructive sleep apnea (OSA). They are effective, simple to use and well tolerated by the patient compared to other therapeutic solutions, such as continuous positive airway pressure (CPAP) or surgery of the upper airways. Aim: The aim of this preliminary study was to assess the effectiveness of a new mandibular advancement device, the BestMAD, in the treatment of OSA patients. Materials and methods: We selected 10 patients, 9 males and 1 female, with an average age of 51.5 years, affected by OSA, with a BMI (Body Mass Index) value ≤25 kg/m2. All patients used the BestMAD for at least 6 months. A control polysomnography was repeated after 6 months and a questionnaire was administered to assess the side effects eventually felt by the patient. Results: After treatment with BestMAD, a statistically significant improvement was found in AHI (p=0.0051), RDI (p=0.0051) and ESS (p=0.0049). With regard to adherence to the treatment, 8 patients claimed to have used the BestMAD for the entire duration of nocturnal rest, while the remaining 2 only for a few hours at night. Conclusions: BestMAD is a comfortable device which has proved effective in improving the polysomnographic parameters.
European Respiratory Journal, 2016
INTRODUCTION: ORCADES, a national prospective multicentre cohort study is evaluating the long-term benefits of a custom-made MRD in OSA patients noncompliant with Continuous Positive Airway Pressure (CPAP). AIMS AND METHODS: 379 OSA pts fitted with a custom-made titratable MRD (ResMed, Narval™) are evaluated over 5 years for evolution of respiratory and sleep data, symptoms, quality of life, compliance and side effects. Interim data of systematic polygraphy/polysomnography and dental sleep assessment at 2 years minimum FU are presented here. RESULTS: 73% of patients treated with MRD were kept in the study at 2 years FU. 16% stopped prematurely MRD for either side effect (8%) or lack of efficacy (8%), and 11% withdrew the study or returned to CPAP therapy. AHI decreased globally under MRD therapy from 28±14/h (median [Q1; Q3]: 26 [18; 37]) at baseline to 12±12/h (median [Q1; Q3]: 8 [4; 16]) at 2-year FU. An AHI In severe OSA patients (AHI>30), AHI was reduced from 41±11 (median [Q1; Q3]: 37 [32; 47]) at baseline to 18±15 (median [Q1; Q3]: 14 [8; 23]) at 2-year FU. Moreover, a decrease in baseline AHI by ≥50% + post-treatment AHI Compared to previous 3 month-FU evaluation, MRD efficacy and compliance (6.7h/night, 6.6 days/week) were kept at similar level in the 3 OSA severity groups. CONCLUSION: Effectiveness of custom-made Narval MRD in noncompliant CPAP patients is satisfactorily maintained at long-term FU irrespective of initial OSA severity.
European Archives of Oto-Rhino-Laryngology, 2018
Purpose This study aimed to determine the effectiveness of a mandibular advancement device in a sample of obstructive sleep apnea syndrome patients by the evaluation of respiratory and neurophysiologic parameters and clinical symptoms. Second, the influence of certain predictor factors related with the patient and the intraoral device, were considered in the final response with this treatment option. Methods Forty-one patients constituted the final sample. Outcomes were measured using polysomnography, Epworth sleepiness scale and an analogue visual snoring scale, before treatment and once the device was properly titrated. Results Mean apnea-hypopnea index decreased from 22.5 ± 16.8 to 9.1 ± 11.6 (p ≤ 0.05), influencing only gender and Fujita index as predictor factors. The oxygen saturation, arousal index, percentages of sleep stages and sleep efficiency significantly improved with the mandibular advancement device (MAD) placement. The snoring index improved in absolute terms in 6.1 units and the excessive daytime sleepiness was reduced from 12.2 ± 4.7 to 8.5 ± 3.8 (p ≤ 0.00). Conclusions The successful treatment rate with the MAD was 65.8%. The placement and posterior regulation of the intraoral appliance efficiently reduced the apnea-hypopnea index, improved the sleep quality and the clinical symptomatology associated. Obstructive sleep apnea syndrome is a highly prevalent disease. and dentists should be aware of the benefits enhanced by this prosthetic device, considered the first treatment option by certain physicians.