Oral appliances.pdf

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Chapter 16

Oral appliancesJ.A. Fleetham* and F.R. Almeida#

SummaryOral appliances are commonly used for the treatment of snoringand obstructive sleep apnoea–hypopnoea (OSAH). Oralappliances increase the size of the upper airway. Mandibularadvancement splints (MAS) are the most widely used type oforal appliance. There is increasing evidence that MAS improvesleepiness, blood pressure and indices of sleep-disorderedbreathing. Continuous positive airway pressure (CPAP) ismore effective than MAS in improving sleepiness, health statusand indices of sleep-disordered breathing. CPAP remains theprimary treatment for severe OSAH. Current guidelinesrecommend oral appliances as a primary treatment for patientswith mild-to-moderate OSAH. Oral appliances are the bestalternative treatment for patients with OSAH who are unwillingor unable to comply with CPAP therapy. Oral appliance therapymay also be indicated as an adjuvant to CPAP when the patientis away from home or electrical power. Oral appliance therapyshould be supervised by both medical and dental specialists.MAS should not be recommended for patients with majorperiodontal disease. Follow-up sleep monitoring is needed toverify the efficacy of oral appliance therapy. Patients treatedwith oral appliances require long-term medical and dentalfollow-up care.

Keywords: Mandibular advancement device, mandibularadvancement splint, obstructive sleep apnoea-hypopneoa, oralappliance, tongue retaining device, snoring

*Dept of Medicine, Faculty ofMedicine and#Oral health Sciences, Faculty ofDentistry, UBC, Vancouver, BC,Canada.

Correspondence: J.A. Fleetham, TheLung Centre, 7th Floor, 2775 LaurelStreet, Vancouver, BC V5Z 1M9,Canada, Email [email protected]

Eur Respir Mon 2010. 50, 267–285.Printed in UK – all rights reserved.Copyright ERS 2010.European Respiratory Monograph;ISSN: 1025-448x.DOI: 10.1183/1025448x.00025209

Obstructive sleep apnoea–hypopnoea (OSAH) is a common syndrome that is characterised byrecurrent episodes of partial or complete upper airway obstruction during sleep. Currently,

the primary treatment for OSAH is nasal continuous positive airway pressure (CPAP). However,some patients are unable to tolerate and comply with CPAP on a long-term basis. Oral appliancesare now widely used for the treatment of snoring and mild-to-moderate OSAH, both as primarytherapy and as an alternative for patients who are unwilling or unable to tolerate CPAP. Oralappliances are a simple, reversible, quiet, and cost-effective therapy for selected patients withOSAH. However, oral appliances as therapy for OSAH remain underutilised. There are a variety ofsynonyms for oral appliances. In addition to oral, they may be called intraoral, dental ormandibular; instead of appliance, they may be called a device, splint or prosthesis. Oral appliancescan be divided into two major types: 1) those that reposition the mandible and the attachedtongue, the mandibular advancement splints (MAS) or mandibular advancement device (MAD),

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and 2) those that hold the tongue forward, the tongue retaining devices (TRD). Prior to treatmentwith any oral appliance, a complete assessment by an experienced physician, within the field, isimportant. Having concluded that treatment with an oral appliance is indicated, the physicianprovides the dentist, who should be knowledgeable in sleep medicine and have skills and experiencein oral appliance therapy, with a written referral and a copy of the sleep diagnostic report. Oralappliances improve OSAH because of an increase in upper airway size, the provision of a stableanterior position of the mandible, advancement of the tongue or soft palate, and possibly by achange in genioglossus muscle activity. Oral appliance therapy for OSAH is a long-termcommitment, so it is important that the appliance must be comfortable for the patient. Finally, as isthe case with CPAP, oral appliances can only be used to treat OSAH in cooperative patients who aremotivated to wear the oral appliance during sleep on a regular and consistent basis every night.

This chapter provides an update to previous recent reviews [1–3] and summarises the recentrecommendations from both the Cochrane Collaboration [4] and the American Academy of SleepMedicine [5]. It provides an overview of the effectiveness of treatment, the predictors of treatmentsuccess, adherence and the potential adverse effects associated with this treatment. It also outlinesa detailed clinical protocol and titration sequence for MAS, since this clinical procedure is oftennot well understood by practitioners new to the field. This chapter only focuses on the use of oralappliances in the adult population. Little is known about the efficacy and side-effects of oralappliances for children without craniofacial abnormalities [6, 7]. Orthodontic treatment forchildren with OSAH and craniofacial anomalies has been shown to be effective not only for thedentition, but also in decreasing respiratory disturbances in children [8, 9].

Appliance

Types of appliances

A large number of different oral appliances are currently available for the treatment of OSAH. Oralappliances increase the size of the upper airway by either advancing the mandible or the tongue. Thereare other minor design differences in currently available oral appliances that may also impact on theirsuccess and treatment adherence. MAS are most widely used and utilise traditional dental techniquesto attach the appliance to both dental arches and maintain the mandible in a forward position.

Figure 1 illustrates some common appliances used for the treatment of sleep apnoea: 1) tonguestabilising device Aveo-TSD1 (Innovative Health Technologies, Christchurch, New Zealand),SomnoDent1 MAS (SomnoMed, Denton, TX, USA), PM Positioner1 (Great Lakes OrthodonticsLtd, Tonawanda, NY, USA), Monoblock appliance (courtesy of M. Marklund, Umea University,Sweden), HerbstTM (Great Lakes Orthodontics Ltd), MDSA1 (Medical Dental Sleep Appliance; R.J. andV.K. Bird Pty Ltd, Melbourne, VIC, Australia) and KlearwayTM (Great Lakes Orthodontics Ltd).Construction usually requires dental impressions, bite registration and fabrication by a dental laboratory.

Some MAS are available in a prefabricated form and are sometimes referred to as ‘‘boil and bite’’[10], but have limited efficacy [11]. These can either be fitted by the patient, themselves, ormoulded to the patient’s teeth in an office setting. Some MAS restrict mouth opening by means ofscrew mechanisms, whereas others allow relatively unhindered movement.

There have been two significant advances in the MAS design over the past 15 yrs. Adjustableappliances that allow the progressive advancement of the mandible, and the use of materials anddesigns that improve intraoral retention, are major improvements. Determining the optimaldegree of mandibular advancement is the most important step when using MAS therapysuccessfully. The amount of anteroposterior mandibular movement, similar to the amount ofCPAP and the speed with which this can be changed, varies considerably between patients. MAShave been developed with an adjustable hinge that allows progressive advancement of themandible, after initial construction, until the optimal mandibular position is achieved. Single-piece or nonadjustable appliances often need to be remade if the initial jaw advancement proves to

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be insufficient. MAS sometimesinclude anterior tubes or openingsthat allow for oral breathing orpressure relief. Some oral appliancesfeature a posterior extension of themaxillary component to modify theposition of the soft palate or tongue,but this type of appliance has notbeen widely studied. A subgroupof patients, particularly those whosuffer from sleep bruxism [12],seem to experience jaw discomfortin the morning after wearing a rigid,hard acrylic, single-jaw positionedMAS. MAS have been further devel-oped to allow lateral jaw movement,as well as some degree of vertical jawopening.

There have been major advancesmade in dental materials, whichhave lead to improved flexibilityand strength of thermosensitiveacrylic resin materials. MAS madeof temperature-sensitive material,which the patient can heat in hotwater prior to insertion and thatcool and harden intraorally, pro-vide considerably more retentionthan traditionally designed cold-cure acrylic MAS. The combina-tion of adjustability, lateral andvertical jaw movement, increasedretention and better defined titra-tion protocols, have significantlyimproved the effectiveness of MASover the last decade.

The other major type of oralappliance available is the TRD ortongue stabiliser device (TSD),which keeps the tongue in ananterior position during sleep bymeans of negative pressure in a softplastic bulb. It fits over both the mandibular and maxillary arches and has a flange that is placedbetween the lips and teeth, keeping the appliance stable in the mouth. This appliance was one ofthe first to be developed and is available in both a fabricated and prefabricated form [13–15]. It hasrecently been evaluated for dentate patients [16]. It is mainly used in edentulous patients and is theoral appliance of choice for patients with no teeth, limited anterior-posterior mandibularmovement or a very large tongue.

Mechanisms of action

The majority of oral appliances are designed to maintain the mandible and/or tongue in a protrudedposture, thereby preventing upper airway obstruction during sleep. Proposed mechanisms of action

a) b)

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Figure 1. Different types of oral appliances used for the treatmentof obstructive sleep apnoea–hypopnoea. a) Aveo-TSD1 (InnovativeHealth Technologies, Christchurch, New Zealand). b) SomnoDent1

MAS (SomnoMed, Denton, TX, USA). c) PM positioner1 (GreatLakes Orthodontics Ltd, Tonawanda, NY, USA). d) Monoblockappliance (courtesy of M. Marklund, Umea University, Sweden).e) HerbstTM (Great Lakes Orthodontics Ltd). f) MDSA1 (MedicalDental Sleep Appliance; R.J. and V.K. Bird Pty Ltd, Melbourne, VIC,Australia). g) KlearwayTM (Great Lakes Orthodontics Ltd), lateralview. h) KlearwayTM, hinge view.

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for oral appliances include increased upper airway size, decreased upper airway collapsibility,activation of upper airway dilator muscles, and stabilisation of mandibular posture.

Several different upper airway-imaging techniques have been used to assess changes in upperairway size and function with oral appliances in patients with OSAH. These imaging techniquesinclude cephalometry, computed tomography (CT), magnetic resonance imaging (MRI) andvideoendoscopy [17]. Voluntary mandibular and tongue protrusion have been shown to increaseupper airway size and alter upper airway shape, particularly in the velopharynx, in subjects withand without OSAH [18]. Several studies have demonstrated an increase in the anteroposteriordiameter of the upper airway following MAS insertion [19–21], an example is shown in figure 2.This increase was predominantly in the oropharynx and hypopharynx, but some studies have alsosuggested an effect on the velopharynx [22]. Nonadjustable MAS constructed in the mostadvanced position without causing discomfort or at 75% of mandibular advancement, have shownan increase in the total volume of the upper airway and cross-sectional areas of the retropalataland retroglossal regions using CT [23, 24]. Two studies, which used MRI, showed that withmandibular advancement the velopharynx cross-sectional area and volume increases, and that thischange was predominantly attributed to an increase in the lateral dimensions [25, 26]. Theseupper airway changes were associated with an increase in lower anterior facial height, higherposition of the hyoid, lateral displacement of the parapharyngeal fat pads away from the airwayand anterior positioning of the base of tongue muscles [26].

Almost all of these upper-airway imaging studieshave been performed during wakefulness and it isunknown whether the same changes occur duringsleep. MAS have also been shown to increase upperairway muscle tone, which may also contribute toan increased upper airway patency [27].

Contradictions

MAS normally requires at least eight teeth in eachof the maxillary and mandibular arches to supportthe appliance in the absence of advanced period-ontal disease. Furthermore, the patient should beable to advance their mandible by at least 5 mmwithout discomfort.

Temporomandibular joint disease is common inpatients with OSAH [28] and should not beconsidered as a contraindication. The concernabout MAS treatment in patients with tempor-omandibular joint disease was raised because ofmild initial and transitory side-effects of MAS wear,such as pain in the temporomandibular joint andmasticatory muscles. It is important to determine,during the clinical exam, whether there is any noiseand/or pain in the temporomandibular joint, thedegree of mandibular movement and any mastica-tory muscle tenderness. When temporomandibularjoint disease was assessed with MRI, MAS appearednot to cause or increase temporomandibular jointdisease over a 1-yr treatment period [29]. Fur-thermore, if MAS are used in combination withmandibular physiotherapy, patients with previous

a)

b)

Figure 2. Lateral cephalometry of a malepatient a) without and b) with a mandibularadvancement oral appliance. Note the advance-ment of the mandible and an increase in the sizeof the velopharynx with the mandibular advance-ment oral appliance (b).

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temporomandibular disease are able to use MAS [30].Therefore, the presence of temporomandibular diseaseis not currently a contraindication for MAS treatment.

Sleep bruxism has been reported to be more prevalentin patients with OSAH [12, 31], and MAS treatmentcan be used in patients with bruxism. The MAS canhelp prevent tooth wear and has been associated with aremarkable reduction in sleep bruxism motor activityin patients with OSAH [32]. Finally, bruxism occlusalsplints have been shown to exacerbate OSAH [33].

Treatment optimisation

The optimisation of MAS treatment is quite differentfrom CPAP treatment, which can either be performedduring polysomnography (PSG) or with an automaticCPAP machine. Patients may not be able to initiallytolerate the degree of mandibular advancementrequired to completely relieve the OSAH. There are avariety of studies that show how the decrease inapnoea/hypopnoea index (AHI) is dependent upon theamount of mandibular advancement (figs 3 and 4) [19, 34–37]. MAS cannot easily be tried for asingle night to predict treatment success and patient adherence, and may require up to 6 monthsof progressive mandibular advancement.

One study has used a prefabricated boil and bite mandibular advancement appliance as a screeningtool for MAS therapy [11]. This randomised controlled cross-over study found that aprefabricated appliance had a 31% compliance failure, whereas a custom-made appliance showedonly a 6% compliance failure. The prefabricated appliance showed an exceptionally high totalfailure rate of 69%, while the failure rate of the custom-made appliance was 40%. The studyconcluded that prefabricated boil and bite appliances cannot be recommended as a therapeuticoption, nor can they be used as a tool to identify good candidates for MAS therapy.

Several studies have evaluated whether titration of mandibular advancement during PSG could beused to optimise MAS treatment, similar to CPAP titration [38–42]. The first study of overnighttitration used MAS that was removed from the patient’s mouth and adjusted manually [38]. Othertitration studies have used a temporary appliance that can be adjusted by either waking or notwaking the patient [39, 40]. The MAS was advanced either manually, after the removal of thetemporary appliance [41], by using either a hydraulic system [39], or by remote control of amotorised system [40]. These studies had mixed results in predicting the amount of mandibularadvancement needed for successful MAS therapy. Overnight titration of MAS remains anexperimental approach and the technology for remote controlled advancement is not yet widelyavailable.

The efficacy of titration and timing for repeat-sleep monitoring concerning MAS titrationsrequires further study. KRISHNAN et al. [42] have shown that although 55% of patients achievesuccessful self-titration at home, another 32% can reach success with further PSG-guided titration.ALMEIDA et al. [43] showed that titration at night can improve the results, after the usual clinicaladvancement of the MAS, by up to 35%. The protocol is simple to implement in the sleeplaboratory, with the technologist asking the patient to advance the appliance in 1-mm incrementsif the patient continues to snore or have persistent apnoea, hypopnoea or arterial oxygendesaturation episodes. However, the patients should not be woken more than three times per nightin order to achieve an adequate total sleep time.

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Figure 3. Increase in cross-sectional areaof the velopharynx after the insertion of amandibular advancement splint (MAS).#: median values. n515 and p,0.005.Reproduced from [19] with permission fromthe publisher.

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Effectiveness

The treatment of OSAH shouldalways be individualised for eachpatient and the future goal is todevelop customised treatment,based on each patient’s phenotype.The patient’s age, occupation,severity of symptoms, body massindex, comorbid disease, lifestyleand treatment-outcome expecta-tions, may all influence the OSAHtreatment decision taken. Approxi-mately 50% of patients achieve aAHI f10 events?h-1 with MAStreatment [1], and it is often thepatient’s preferred choice of treat-ment over CPAP. Although not asefficacious as CPAP, oral appli-ances should be considered first-line treatment in patients withmild-to-moderate OSAH and whoprefer oral appliances to CPAP, arenot appropriate candidates forCPAP, or fail treatment attemptswith CPAP or treatment with be-havioural measures. Patients withsevere OSAH should always have aninitial trial of nasal CPAP becausegreater effectiveness has been shownwith this treatment than with oralappliances [5]. Despite MAS ther-

apy being less effective in severe OSAH, HENKE et al. [44] suggested that severity of OSAH and thesite of airway closure should not be used to exclude patients from MAS treatment.

In the first practice parameters paper by the American Sleep Disorder Association,on the efficacyof oral appliance treatment for OSAH, published in 1995 [45], the majority of the data were fromuncontrolled case series studies, which were subject to study design issues such as regression to themean, and selection and reporting bias. The second practice parameters paper by the AmericanAcademy of Sleep Medicine was published in 2006 [5], and included six randomised, controlledtrials comparing MAS with an inactive control [4, 46–49]. Furthermore, there are approximatelyten randomised controlled trials comparing MAS with CPAP, and 12 studies comparing differenttypes of oral appliances.

MAS versus placebo

There are six randomised controlled trials on 375 patients comparing active MAS with control oralappliances [46–51], and there are two randomised controlled trials on 39 patients comparingTRD with placebo [52, 53]. MAS has been shown to significantly improve objective sleepmeasurements, such as AHI, arousal index, snoring and in some but not all studies, arterial oxygendesaturation. MAS have also been shown to improve objective measurements for sleepiness whenexamined using the multiple sleep latency test [47], but not the multiple vigilance test [50]. MASimproved subjective measurements of sleepiness (Epworth Sleepiness Scale) in all but one study [51].

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Figure 4. Relationship between the change in apnoea/hypopnoeaindex (DAHI) and a) the absolute (r50.64, p50.01) and b) theproportional (r50.64, p50.01) change in cross-sectional area(DCSA) of the velopharynx, following the insertion of a mandibularadvancement splint. Reproduced from [19] with permission from thepublisher.

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Neurobehavioral and cognitive function have only been evaluated in a few studies, whichdemonstrated that MAS can improve cognitive function, tension-anxiety, vigor activity, fatigue-inertia, reaction time and quality of life when compared with placebo [49, 50]. MAS therapy was wellaccepted and o68% of patients report MAS adherence for most nights and for 6–7 hours per night.MAS has also been shown to significantly reduce systolic (mean 3.03 mmHg), diastolic (mean3.4 mmHg) and mean (mean 3.6 mmHg) blood pressure measurements when compared withplacebo [48]. Finally, with MAS treatment of OSAH, a significant proportion of nondipper subjectsregained their normal nocturnal dip in blood pressure when compared with placebo [50]. Table 1summarises the randomised controlled trials comparing MAS with placebo.

MAS versus CPAP

There are at least 10 randomised controlled trials, with seven crossover studies, which havecompared the efficacy of MAS with CPAP [4, 50, 54–61, 62]. Although both CPAP and MAS led toimprovements in objective sleep measurements, such as AHI, arousal index and minimum arterialoxygen saturation, the magnitude of improvement in AHI was significantly greater with CPAP.Subjectively and objectively, MAS decrease sleepiness to the same degree as CPAP. MAS decreasesubjective and objective measurements of snoring in the majority of the patients. MAS and CPAPare effective treatments compared with placebo in improving quality of life and symptoms, andsome studies have shown MAS to be superior to CPAP. BARNES et al. [50] showed that CPAPimproved vigilance, complex cognitive function, and several mood subscales, whereas MASimproved the complex cognitive function task. These results are controversial and additionalstudies are needed to establish any differences between MAS and CPAP therapy for OSAH onneurobehavioral outcomes [63]. Table 2 summarises the randomised controlled trials comparingMAS with CPAP.

OSAH is considered a potential risk factor for cardiovascular disease and recent studies havedemonstrated a significant increased risk of fatal cardiovascular events in untreated sleep apnoeapatients [64]. There are limited randomised trial data comparing cardiovascular health outcomeswith MAS and CPAP. In a crossover study, no change in blood pressure was observed with the useof CPAP, but MAS decreased nocturnal diastolic blood pressure and significantly increased theproportion of subjects with a normal night-time dip in blood pressure [50]. In a parallel designstudy, there were no echocardiogram changes with either CPAP or MAS treatment; MAS but notCPAP treatment did decrease brain natriuretic peptide in this study [62].

At present, all of the randomised controlled trials have been short-term studies over 3–6 months.There are only nonrandomised studies establishing long-term efficacy over 4–5 yrs [65, 66],confirming high acceptance of MAS treatment. MAS therapy may also be indicated as an adjuvantto nasal CPAP when the patient is away from home or electrical power [67], or in conjunctionwith CPAP, in an effort to decrease CPAP pressure and therefore increase CPAP adherence [68].

Comparisons of different oral appliances

Oral appliance design has been proposed as an important determinant regarding treatmentcompliance and success; there have been at least ten prospective comparative studies evaluatingdifferent oral appliance designs [4, 69, 70]. There have been varying degrees of improvement in theindices of sleep-disordered breathing and side-effects with different MAS. These differences maybe related to the degree of vertical opening and mandibular advancement achieved with each MAS.In an evaluation of different custom-made, titratable mandibular advancement appliances, withsimilar vertical opening and similar advancement, the design does not appear to play a major rolein the different efficacy between the various oral appliances [69–74]. Therefore, there are nopreferred MAS, as long they are properly adjusted and patient comfort is achieved.

Despite the similarities in efficacy, there are differences in patient preference and side-effects, whichemphasises the importance of a dentist with experience in this field being involved. Only one

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randomised crossover study hasexamined the impact of verticalopening and efficacy of MAS[75], and it demonstrated a ten-dency for MAS with less verticalopening to be more effective, andthe less vertical opening resultedin better patient acceptance.

There are also studies that haveexamined other oral appliances,such as soft palate lift, TRD andprefabricated devices. In a smallcrossover design study compar-ing MAS, soft palate lift appli-ance and TRD, the MAS wasfound to be an effective and well-tolerated oral appliance, whilethe soft palate lift was neithereffective in reducing AHI or ac-cepted by patients, and the TRDthough well accepted showedlimited efficacy in the treatmentof severe OSAH [76]. A rando-mised crossover trial of a newdesign of TRD, called a TSD,showed that the MAS and TSDhad similar efficacy in the reduc-tion of AHI and improvementon oxygen saturation. However,the MAS was found to be over-whelmingly better accepted thanthe tongue stabilising device [16].

Comparison of oralappliance with surgery

There is one longitudinal parallelgroup study [77], which com-pared the effectiveness of MASwith uvulopalatopharygoplasty(UPPP), in patients with mild-to-moderate OSAH over a 4-yrperiod, with subsequent reportson the same patient pool [37, 78,79]. This randomised parallelstudy, assessed 45 patients trea-ted with a MAS and 43 withUPPP. At the 1-yr follow-up,MAS showed a higher successrate in controlling the AHI whencompared with UPPP (78 versus51%). A total of 32 MAS and 40UPPP patients completed the

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4-yr follow-up [65]. According to predetermined criteria for OSAH (apnoea index (AI) o5 orAHIo10 events?h-1), 63% of the patients in the MAS group attained normalisation after 4 yrs, aproportion that was significantly higher than the 33% among the patients in the UPPP group. Thisstudy suggests that MAS was more effective than UPPP in improving indices of sleep-disorderedbreathing. However, the significance of this finding is questionable, as there is no definitive evidence ofthe effectiveness of this type of corrective upper airway surgery. MAS have also been used ascombination therapy in patients who have had an unsuccessful response to UPPP [80].

Cardiovascular health

There are two randomised controlled trials with intention-to-treat analysis [48, 50] and threenonrandomised prospective studies [81–83] in which MAS treatment of OSAH has been shown toreduce blood pressure measurements. These changes are primarily in diastolic blood pressure andre-establishing the nocturnal dip. One study found a correlation between the improvement in AHIand a decrease in blood pressure after MAS treatment [81]. Another study, found that there wasno change in blood pressure with CPAP, whereas MAS significantly improved the nocturnaldiastolic blood pressure and increased the proportion of subjects with a normal night-time dip inblood pressure [50]. In the evaluation of biomarkers for oxidative stress and inflammation, onestudy has shown that treatment with MAS improves cardiovascular pathophysiologic factors, suchas endothelial function after 3 months and 1 yr of MAS treatment [84]. The endothelial functionin the MAS group was not different from a reference non-OSA group. A year of treatment resultedin a normalisation of malondialdehyde levels and a decrease in thiobarbituric acid-reactivesubstance levels, despite residual sleep-disordered breathing (average AHI of 19 events?h-1). In aparallel study, comparing MAS with CPAP, MAS improved amino-terminal fragment of pro-brainnatriuretic peptide [64].

Partner health status

Partners of patients with OSAH have impaired health status, probably due to sleep fragmentationrelated to the patient’s loud snoring and restless sleep pattern. Treatment of patients with snoringand OSAH might be beneficial, not only for the patient, but for the bed partner and the couplerelationship. MCARDLE et al. [85] reported significant impairment in sleep quality of OSAH bedpartners without improvement in objective sleep quality after treatment with CPAP. In contrast,DOHERTY et al. [86], showed significant improvements in bed partner health status followingCPAP. In one study sleep changed to better or much better in 64.1% of the bed partners followingMAS treatment for OSAH [87] in another report, an improvement in intimate relationships andsexual activity following MAS treatment for OSAH was seen [71].

Treatment

Predictors of treatment success

A variety of clinical, physiological and PSG variables have been identified as possible predictors ofMAS treatment success [88–91]. It has been suggested that, a younger patient [92, 93] with a lowerAHI [46, 88, 93], a smaller neck circumference [50], a lower body mass index [91] and positionalOSAH [86, 92, 94] would be more likely to achieve treatment success with MAS. Patients whoachieve a greater degree of mandibular advancement have the highest decrease in AHI [35, 95],and females have higher success rates than males. Treatment success may be inversely related topre-treatment severity, but this relationship may just be a function of the definition of treatmentsuccess, although one study has shown that the higher the AHI pre-treatment, the greater thedecrease in AHI that could be achieved [44].

Several upper airway skeletal and soft tissue measurements made from pre-treatment lateralcephalometry have been shown to be associated with treatment success. These include a more

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micrognathic or retrognathic mandible, small soft palate and tongue and larger retropalatal area[19, 50, 96, 97]. Upper airway fluoroscopy has also been proposed as a technique to guidesuccessful MAS therapy. A hypopharyngeal site of obstruction may be associated with a bettertreatment outcome. A study of upper airway MRI during a Muller manoeuvre, together withmandibular advancement, has shown that improvement in upper airway patency correlates withtreatment success [98]. However, there is considerable overlap between good and poor treatmentresponse in these studies. More recently, physiological assessments of nasal resistance andpulmonary function have shown to be of some predictive value [99, 100]. The utility of anytreatment recommendation for MAS based on clinical features, OSAH severity or upper airwayanatomy is still questionable and requires prospective validation.

Treatment adherance

The treatment adherence and side-effects of oralappliance treatment differ depending on the typeof the appliance, disease severity and patient supervision [101, 102]. Adherence is usuallymeasured subjectively, with the exception of one study in which a compliance monitor indicatedthat the MAS was worn for a mean of 6.8 h per night [103]. Self-reported treatment adherence hasbeen reported as high as 96% for patients using MAS .75% of the nights and 80% of patientsusing MAS .75% of each night [54].

Treatment adherence varies between each oral appliance type and appears better with mandibularadvancement rather than tongue retaining appliance or boil and bite type appliances. 40% of non-adherence occurs within the first 6 months [104]. The most common reasons to stop using theappliance are discomfort and/or because the patient finds it cumbersome (46%) and it has no orlittle effect (36%).

Adherence rates vary widely between studies with a minimum of 4% to a maximum of 82% ofadherence after 1 yr of treatment [78]. Adherence rates appear to decrease with the duration ofuse. In a study of 630 patients, MARKLUND et al. [88] described an adherence of 75% of the patientsafter 12 months of treatment. After a 2–5-yr follow-up period, studies have revealed adherencerates from 48% up to 90% [105–107], and this has been reported as 60% at 1 yr and 48% at 2 yrs.Previous experience with nasal CPAP suggests that self-reported treatment adherence tends tooverestimate actual use. Studies with CPAP have identified that subjective adherence is oftenhigher than objective adherence. Therefore, until there is an adherence monitor available for oralappliance therapy, caution should be taken in the reporting of subjective oral appliance adherence.Table 3 provides a summary of studies evaluating oral appliance adherence rates after a minimumof 1-yr treatment plan.

Side-effects

The main reasons for discontinuing treatment have been reported to be insufficient reduction ofsnoring and the presence of side-effects [95]. Most side-effects caused by MAS are usuallydescribed as mild and transient, most frequently reported as dry mouth, excessive salivation,mouth or teeth discomfort, muscle tenderness and jaw stiffness. Significant and persistenttemporomandibular joint (TMJ) problems are rare [1]. One study evaluated the TMJ of sevenpatients, using MRI, over a mean period of 11 months and concluded that MAS, in the titratedposition, appeared to be innocuous to the TMJ in OSA patients [95]. Excessive salivation, mouthdryness, morning-after occlusal changes and discomfort in the gums, teeth or jaw are commonside-effects in the first weeks of MAS therapy, but usually resolve with time [104, 109]. Morepersistent and severe side-effects, which include TMJ dysfunction and dental crown damage,appear uncommon [108]. MAS adjustment can decrease side-effects by reducing pressure on theanterior teeth and excessive mandibular advancement. Side-effects vary between the types of oralappliance used, with tongue pain occurring in tongue retention appliances and gagging associatedwith appliances that have a maxillary component to modify soft palate position. Long-term side-effects are more recently described evaluating oral appliance side-effects over a period of more

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than 5 yrs. ALMEIDA and co-workers [109, 110], using a titratable MAS, demonstrated that MASused for a mean period of 7.3 yrs have a significant impact on occlusal and dental structures.Changes observed in craniofacial structures were mainly related to significant tooth movements.MARKLUND [109] observed that the frequent use of a single piece MAS with full occlusal coveragefor 5 yrs resulted in median reductions in overjet and overbite of 0.6 mm in patients with eithersnoring or OSAH. Table 4 summarises the long-term side-effects of MAS on occlusalmeasurements [111–114].

Cost

The cost of oral-appliance therapy varies depending on the types of oral appliances used and theextent and expertise of the dental supervision. Consensus opinion indicates that a prefabricatedoral appliance can range from J35 to J75 and custom made oral appliances range from J75 toover J700 [1]. Oral appliances usually remain effective for 2–5 yrs, but they can break and requireeither repair or replacement. Dental service fees vary greatly between J150–1,800, depending onthe time spent caring for the patient and geographical economical factors. Costs can equal orexceed those associated with nasal CPAP therapy. There is increasing evidence that both oralappliances and nasal CPAP are cost-effective treatments for OSAH [115, 116].

Treatment recommendations

A Cochrane systematic review performed a variety of meta-analyses on data from 16 randomisedcontrolled trials involving 745 patients available up to 2005, and concluded that there was

Table 3. Adherence rates of mandibular advancement splints in selected studies that evaluated adherenceafter a minimum of 1 year

First author [Ref.] Year of study Interval months Patients n Comliance rateWCS/BCS

MCGOWN [101] 2001 22 166 42/56DORT [102] 2004 22 110 40/57MARKLUND [88] 2004 12 630 75/76DE ALMEIDA [104] 2005 68 544 30/64MARKLUND [108] 2006 60 450 56/56GINDRE [34] 2008 17 66 82/82

WCS: worst case scenario, which relates to an analysis interpretation of patients who did not return thequestionnaires as compliance failures. BCS: best case scenario, which relates only to the percentage ofpatients who responded to the questionnaire.

Table 4. Long-term side-effects of mandibular advancement stent on occlusal measurements

First author [Ref.] Year ofstudy

Patients n Intervalyears

Change in OBmm

Change in OJmm

MARKLUND [66] 2001 75 2.5 -0.5 -0.6ROBERTSON [111] 2001 100 2.5 -1.02 -1.06ROSE [112] 2002 34 2.5 -1.1 -1.3GHAZAL [113] 2008 24 2.5 3.2 2.5ALMEIDA [109, 110] 2006 70 7.6 -1.9/-2.8 -1.2/-2.6MARKLUND [108] 2006 450 5.4 -0.6 -0.6HAMMOND [114] 2007 64 2.1 -0.3 -0.2

OB: overbite, vertical overlapping of upper teeth over lower teeth. OJ: overjet, horizontal projection of upperteeth beyond the lower teeth.

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increasing evidence that oral appliances improve subjective sleepiness and sleep-disorderedbreathing compared with control appliances [4]. However, it recommended that until there wasmore definitive evidence on the effectiveness of oral appliance compared with CPAP, oralappliance therapy should be restricted to patients with mild, symptomatic OSAH and thosepatients who are unwilling or unable to comply with CPAP therapy. The American Academy ofSleep Medicine [5] reviewed similar data to the Cochrane Collaboration and recommended thatoral appliances were indicated for use in patients with mild–moderate OSAH who prefer them toCPAP, or who do not respond to, are not appropriate candidates for, or who fail treatment withCPAP. They recommended CPAP therapy whenever possible for patients with severe OSAH.

These practice parameters emphasise the importance of a combined medical and dental approachto oral appliance treatment. MAS therapies should not be used in patients who have majorperiodontal disease. Follow-up sleep monitoring is needed to verify the efficacy of oral appliancetherapy. OSAH is a chronic disease and therefore patients treated with oral appliances requirelifelong follow-up to monitor patient adherence, long-term dental follow-up, evaluations of theoral appliance deterioration or maladjustment, and evaluation of the health of the oral structuresand integrity of the occlusion.

Statement of Interest

None declared.

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