A randomized prospective long-term study of two oral appliances for sleep apnoea treatment.

Various types of mandibular protrusive appliances have revealed different treatment success in mild-to-moderate obstructive sleep apnoea (OSA). The present study compared the long-term effect of two different appliances in the treatment of OSA. A total of 103 patients with OSA were randomized and treated with an IST((R)) or Thornton Anterior Positioner (TAP()) appliance. They were followed-up after a short-term treatment period of 6 months and long-term treatment period of over 24 months. Sleep studies in the sleep laboratory were conducted with and without the appliances, and various questionnaires assessing subjective daytime sleepiness, sleep quality, quality of life and symptom scores were administered at each time interval. Quality of life, sleep quality, sleepiness, symptoms and sleep outcome showed significant improvement in the short-term evaluation with both appliances, but the TAP() appliance revealed a significantly greater effect. After more than 2 years of treatment, sleep outcomes revealed an equal effect with both appliances. The subjective benefits achieved initially lessened significantly. This study illustrates that both the IST((R)) and the TAP() appliances are effective therapeutic devices for OSA after a period of over 24 months. Lack of compliance may be due to insufficient improvement in anticipated subjective symptoms and/or a recurrence of symptoms over time.

Dental side effects of mandibular advancement appliances - a 2-year follow-up.

BACKGROUND AND OBJECTIVES: Mandibular advancement appliances are employed in treating snoring and various forms of obstructive sleep apnea syndrome (OSAS). The splints facilitate the displacement of the mandible anteriorly and widens the pharyngeal lumen during sleep. Two-splint systems are anchored on the dental arches in the maxilla and mandible. The resulting reciprocal forces are transferred onto the teeth, leading to dental side effects when used long-term. We retrospectively examined the dental changes that occurred after patients had worn the Thornton Adjustable Positioner (TAP) for over two years. PATIENTS AND METHODS: We enrolled all patients consecutively in whom the diagnosis of OSAS was made following polysomnography in a sleep laboratory between January 2004 and December 2005 and who had been treated primarily with a TAP. We compared the patients' baseline findings with follow-up findings after more than 24 months of continuous appliance wear. RESULTS: 24/47 of the patients were still wearing the splints regularly after an average of 33 +/- 9.1 months. Overbite was highly significantly reduced (p = 0.006). We noted a reduction in the frontal overbite of more than 1 mm in ten patients (47.6%), and the overbite of one patient decreased by 4 mm. The maxillary front teeth showed significant palatal tipping and those in the mandible significant labial tipping. CONCLUSIONS: Clinically small but statistically significant dental side effects predominantly affecting the incisors' inclination occur after long-term wear of a TAP appliance. The clinical relevance of these dental changes to the patient can only be judged individually within the scope of an entire assessment.

Severe obstructive sleep apnea alleviated by oral appliance in a three-year-old boy.

This clinical report describes a 3.5-year-old boy suffering from chronic daytime fatigue, accumulated snoring and dramatically appearing apnea during sleep. Oxycardiorespirography revealed a breathing pattern similar to repetitive obstructive apnea and an oxygen saturation periodically dropping to 80%. During tidal breathing, fiberoptic bronchoscopy showed aspiration of the aryepiglottic folds and the epiglottis during inspiration. Adenotonsillar hypertrophy was excluded. Due to the acknowledged side effects from various surgical approaches and nasal continuous positive airway pressure, a removable, functional Fraenkel II oral appliance was applied during sleep. Clinical assessment demonstrated resolution of the main respiratory symptoms, and oxycardiorespirography revealed a fundamental reduction in periodic obstructive apnea and desaturation. In conclusion, we consider the use of an oral functional appliance for severe obstructive sleep apnea in children to be a valuable alternative to other treatment methods.

Orthodontic procedures in the treatment of obstructive sleep apnea in children.

INTRODUCTION: Even minor dimensional changes in the child's upper airway can already affect the resistance therein. Craniofacial anomalies may constrict the upper airway and are suspected to be a direct cause of obstructive sleep apnea syndrome (OSAS) in children. CASE REPORTS: In the present two cases we report on the successful orthodontic treatment of an 8-year-old girl and a 6 1/2-year-old boy with craniofacial anomalies and severe OSAS diagnosed during a sleep study. The primary treatment aim was to improve the cardio-respiratory situation during sleep by enlarging the upper airway and preventing its collapse. Prior to the onset of treatment we had ruled out the presence in both children of any adenotonsillar hypertrophy requiring surgical treatment. Patient 1 (the girl) presented mouth breathing predominantly while sleeping and a narrow skeletal maxilla that was treated via rapid maxillary expansion followed by a Fränkel-II appliance. A function regulator type-II was applied in the second patient, a boy suffering from OSAS, and spinal muscular dystrophy with a narrow skeletal upper jaw and mandibular retrognathism. We were able to successfully treat both cases of obstructive sleep apnea with these orthodontic procedures. CONCLUSION: Orthodontic therapeutic measures should be considered as a causal treatment option in children with OSAS and craniofacial anomalies restricting the upper airway. Parents and patient cooperation, as well as good interdisciplinary care within the field of sleep medicine are mandatory for this kind of treatment.

The value of oral appliances in the treatment of obstructive sleep apnoea.

Oral appliances have long been used to treat snoring and mild to moderate obstructive sleep apnoea. This kind of treatment is considered an alternative, non-invasive treatment option. Mandibular protrusive appliances enlarge and stabilise the oro- and hypo-pharyngeal airway space by advancing the mandible, and stretching the attached soft tissue, in particular the tongue, soft palate, uvula, and the pharyngeal tissues. This article summarises the indications, contraindications, and possible side-effects of using oral appliances. Therapeutic efficacy is influenced by multiple parameters that are clinically difficult to control. One major parameter is the patient`s stomatognathic situation of the patient. Thus oral appliances are restricted to patients whose dental retention is adequate for permanent treatment and who do not suffer from temporomandibular joint dysfunction. Regular follow-up sleep studies and dental evaluations are necessary to ensure adequate permanent treatment.

Case control study in the treatment of obstructive sleep-disordered breathing with an intraoral protrusive appliance.

BACKGROUND: Mandibular protrusive appliances have long been used to treat obstructive sleep apnea/hypopnea syndrome (OSAHS). Their efficacy regarding respiration during sleep varies greatly and remains difficult to predict. In this study the efficacy of a two-splint appliance on nocturnal breathing disorders, sleep profile, and daytime sleepiness were evaluated according to a specially-designed treatment process. PATIENTS AND METHODS: In this study 42 consecutive OSAHS patients who had been fitted with a mandibular protrusive appliance according to a preset treatment regimen were included in a follow-up analysis. The diagnosis and the degree of severity of OSHAS were determined by polysomnography in the sleep laboratory. The treatment regimen was established with the sleep laboratory physician. Treatment regimen included the diagnostic procedure in the sleep laboratory, each patient's dental requirements, the fabrication of the appliance used, and the titration of the mandibular protrusion. After having grown accustomed to the appliance for 24.5 +/- 7.8 days, 34 patients underwent overnight polysomnography. RESULTS: The mean apnea/hypopnea index decreased significantly from 19.6 +/- 12.8 to 3.3 +/- 7.8 events per hour to 83%; the apnea index also improved significantly, as did minimal oxygen saturation and the desaturation index. Changes in sleep profile did not reach statistical significance; the arousal index (p < 0.02) and the subjectively-assessed daytime sleepiness (p < 0.02) decreased significantly. A therapeutically-required AHI of below 5 events per hour was achieved in 88.2% of the patients. CONCLUSION: A significant improvement in the respiratory situation of the vast majority of OSAHS patients, particularly in their AHI, can be achieved when one applies the procedural steps and employs the mandibular protrusive appliance we describe herein.

Mucocele on the lower lip--a case report.

A patient with a superficial oral mucocele on the lower lip is presented. The lesion developed in temporal relationship with the insertion of a functional appliance. The etiology and pathogenesis of this lesion are discussed.

Cephalometric assessment of the posterior airway space in patients with cleft palate after palatoplasty.

OBJECTIVE: Upper airway obstruction and mouth breathing influence facial growth and development, which may result in breathing disorders while asleep. The purpose of the present investigation was to analyze cephalometric alterations between patients with cleft palate and a noncleft control group in an obstructive sleep disordered breathing-specific tracing. SETTING: The study was conducted in the cleft palate clinic of a university hospital. PARTICIPANTS: Fifty-three subjects with a mean age of 12.3 +/- 3.7 years (range 6.3 to 17.2 years). The cohort included 33 subjects (13 females, 20 males; mean age 12.1 +/- 3.8 years, mean body mass index 17.5 +/- 2.9 kg/m(2)) with surgical closure of a unilateral or bilateral cleft palate and a matched control of noncleft participants. None of the subjects suffered from sleep disordered breathing syndrome. RESULTS: Compared with the controls, patients with cleft palate had a significant narrow anterior-posterior dimension of the pharynx at the level of the maxillary plane and the narrowest width, a more downward hyoid position, and a longer uvula. CONCLUSIONS: Patients with cleft palate appear to present pharyngeal and craniofacial distinctive features that characterize patients with obstructive sleep disordered breathing and differ from those of a noncleft control.

Clinical comparison of a multistranded wire and a direct-bonded polyethylene ribbon-reinforced resin composite used for lingual retention.

OBJECTIVE: The reliability of posttreatment canine-to-canine retention with resin composite retainers reinforced with plasma-treated woven polyethylene ribbons was compared to the reliability of directly bonded, multistranded wire retainers. METHOD AND MATERIALS: This prospective study was based on an assessment of 20 consecutive patients (eight women and 12 men with a mean age of 22.4 years) who required a fixed canine-to-canine retainer after undergoing orthodontic treatment. The type of retainer used was randomized for each patient. A follow-up examination was carried out once every 3 months. The length of time the retainers stayed in place without resin fracture or loosening from the teeth at one or more points was evaluated. The study's endpoint was 24 months after the retainer had been bonded. RESULTS: The ribbon-reinforced retainer remained in place for an average of 11.5 months, and the multistranded wire for a mean of 23.6 months. The difference was statistically significant. CONCLUSION: In terms of reliability for permanently fixed orthodontic retention from canine to canine, the direct-bonded multistranded wire is superior to the plasma-treated polyethylene woven ribbon and resin retainer.

Occlusal and skeletal effects of an oral appliance in the treatment of obstructive sleep apnea.

STUDY OBJECTIVE: s: Oral appliances (OAs) are considered to be a treatment option for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS). Although the effectiveness of these appliances has been evaluated in a number of clinical trials, there are few follow-up studies concerning the dental and skeletal side effects that, theoretically, could be caused by OAs. We sought to examine the long-term skeletal and occlusal effects of a nocturnally worn activator in adult patients treated for OSAHS. DESIGN: We analyzed the dental casts and lateral radiographs of 34 patients (mean age, 52.9 years; SD, 9.6 years; range, 27.1 to 64.6 years) before initiating treatment and after at least 24 months of treatment (mean length of treatment, 29.6 months; range, 24.1 to 43.5 months; SD, 5.1 months). The OA was worn by each patient 6 to 8 h nightly for > 5 days per week. SETTING: Department of Orthodontics, Dental Medical School, Freiburg, Germany. MEASUREMENTS AND RESULTS: Follow-up polysomnography studies confirmed improved breathing parameters with the use of OAs. A statistically significant alteration in the occlusion was found. The anteroposterior position of the molars and the inclination of the upper and lower incisors were changed. No skeletal changes in the position of the mandible were noted. CONCLUSIONS: The data suggest that in addition to control polysomnographic examinations, regular dental follow-up visits are mandatory when lifelong OSAHS treatment with an OA is being considered for patients with obstructive sleep apnea/hypopnea.

Cephalometric analysis in patients with obstructive sleep apnea. Part II: Prognostic value in treatment with a mandibular advancement device.

BACKGROUND: The mandibular advancement device (MAD) is accepted as an additional treatment option for snoring and mild obstructive sleep disorders. Its therapeutic efficacy can only be verified through nocturnal polysomnography with the appliance in situ. The relevance of the craniofacial skeletal and soft-tissue structures as an etiological cofactor is controversial. While the lateral cephalogram of the facial skeleton is of no direct diagnostic relevance, it remains unclear to what extent cephalometric assessment can provide prognostic information to better ensure treatment success with an MAD. METHODS AND RESULTS: This study is based on the evaluation of 57 patients diagnosed polysomnographically with obstructive sleep apnea (OSA). The patients were treated primarily with a modified activator; after 6-12 weeks, control polysomnography was carried out in the sleep laboratory. The cephalometric variables were analyzed using a multivariate regression procedure with the response variable of treatment outcome. In addition to a horizontal craniofacial morphology, the downward and forward posture of the hyoid is a prognostic variable for effective therapy with an MAD.

Sleep-related obstructive disordered breathing in cleft palate patients after palatoplasty.

Sleep-disordered breathing is frequently associated with children presenting congenital midface defects. Because of structural and functional anomalies in the upper airway, children with cleft palate, especially after surgery, may carry a higher risk of developing sleep-disordered breathing. However, the presence of such sleep-disordered breathing in older cleft palate children has not been emphasized. The aim of this comparative overnight cardiorespiratory sleep study was to evaluate cleft palate patients according to sleep-disordered breathing. A group of 43 cleft palate children (17 girls and 26 boys; mean age, 12.1 +/- 3.8 years) was compared with a control group of 20 randomly selected, noncleft children matched for age, sex, and body mass index. None of the patients suffered from manifest sleep-disordered breathing. Cleft palate patients had a statistically significantly higher respiratory disturbance index and snoring index, but no increased apnea index. The data suggest that cleft palate patients having undergone primary closure of the palate demonstrate microsymptoms of nocturnal upper airway obstruction.

A comparative study of two mandibular advancement appliances for the treatment of obstructive sleep apnoea.

Mandibular advancement appliances (MAAs) are accepted as a treatment option for snoring and mild obstructive sleep disorders. In the present clinical study two differently designed devices were examined for their effectiveness in treating obstructive sleep apnoea (OSA). The study was based on an assessment of 26 patients with a polysomnographic diagnosis of mild OSA [22 men, four women; mean body mass index 27.3 kg/m2 (SD 3.1); mean age 56.8 years (SD 5.2); mean respiratory disturbance index (RDI): 16.0 events/hour (SD 4.4)]. After insertion of the first MAA and a 6-8-week habituation period, a cardio-respiratory home-sleep study was carried out. Following a 2-3-week period with no treatment, the second appliance was inserted. The sequence of the devices was randomized. Once the patients had become accustomed to the second appliance, another somnographic registration was carried out. Daytime sleepiness, snoring, and sleep quality were assessed subjectively on a visual analogue scale. The results showed that a statistically significant improvement in the respiratory parameters was achieved with both appliances (P < 0.01). However, the activator [RDI: 5.5 events/hour, SD 3.3; apnoea index (AI): 3.4 events/hour, SD 2.1] was significantly more effective (P < 0.01) than the Silencor (RDI, 7.3 events/hour, SD 5.3; AI: 5.8 events/hour, SD 3.2). No difference was recorded in the subjective assessment of the therapeutic effects. Both appliances reduced daytime sleepiness and snoring and improved sleep quality, and both influenced the treatment outcome.

Treatment of obstructive sleep apnea with the Karwetzky oral appliance.

The aims of this retrospective study were to assess the effect of a Karwetzky mandibular protrusion appliance for treating patients with mild, moderate, and severe obstructive sleep apnea. Eighty-one of 116 patients (69.8%) suffering from obstructive sleep apnea were treated with an activator model according to Karwetzky. After 4 months (SD 4.0 months) treatment outcome was controlled by polysomnography. Therapeutic outcome depended on the severity of obstructive sleep apnea. The median apnea-hypopnea index decreased from 10.6 events/h (range 2.0-14.9) to 5.8 events/h (range 0.2-17.3, P<0.01) in the mild group, from 21.7 events/h (range 17.3-28.4) to 7.7 events/h (range 1.0-30.1, P<0.001) in the moderate group, and from 42.1 events/h (range 33.2-64.9) to 18.1 events/h (range 2.4-48.8, P<0.001) in the severe group. Sleep variables did not show consistent improvement except for a trend towards more REM sleep and slow-wave sleep. The numbers of retentive teeth did not statistically influence treatment efficacy. Comparing the pre- and post-treatment polysomnographic variables, it was found that the respiratory events rather than sleep stages were significantly reduced by the Karwetzky appliance investigated.

Therapeutic efficacy of an oral appliance in the treatment of obstructive sleep apnea: a 2-year follow-up.

The purpose of this study was to investigate the long-term efficacy of an oral appliance, the Karwetzky activator, on respiratory and sleep parameters in patients with obstructive sleep apnea (OSA). Those selected for this study were 26 patients polysomnographically diagnosed with mild-to-moderate OSA. They were initially treated successfully with this appliance, as documented by a second polysomnographic study after 6 to 12 weeks. Further polysomnographic registrations 6 to 12 months and 18 to 24 months later were performed for each patient wearing the appliance. For 21 patients (81%), therapeutic efficacy was maintained; 5 patients (19%) showed a deterioration in respiratory parameters. We corrected this by adjusting the device in 2 patients. The mean apnea-hypopnea index decreased significantly from 17.8 events per hour at the baseline registration to 4.2 events per hour (P <.001) after 6 to 12 weeks of treatment. After 6 to 12 months, the apnea-hypopnea index was 8.2 events per hour. The index remained at this level 18 to 24 months later, with 8.3 events per hour. Mean oxygen saturation was not improved with the activator, but the number of desaturations had decreased at the 6-to-12 week review. Again, the improvement declined with time, but the number of oxygen desaturations was still significantly decreased at 18 to 24 months (P <.01). Although the respiratory parameters remained statistically improved throughout the study (P <.01), sleep architecture did not change statistically. In most patients, therapeutic efficacy was maintained at the 2-year follow-up, although there was a tendency for effectiveness to fall over time. We concluded that the Karwetzky activator may be an effective treatment alternative for patients with mild-to-moderate OSA, but therapy requires diligent and regular polysomnographic follow-ups. Further long-term studies are needed to assess the continued efficacy of this oral appliance in treating OSA.

Cephalometric analysis in patients with obstructive sleep apnea. Part I: diagnostic value.

BACKGROUND: Morphological soft-tissue and skeletal anomalies of the upper extrathoracic airways are considered to be an etiological cofactor of nocturnal obstructive respiratory disorders. PATIENTS AND METHOD: In this study 106 patients with a mean age of 56.1 +/- 8.4 years and a polysomnographic diagnosis of obstructive sleep apnea (OSA) were evaluated roentgenocephalometrically for soft-tissue and skeletal anomalies. Using cluster analysis and multivariate regression analysis, 18 skeletal variables, six pharyngeal variables and five hyoid variables were evaluated as predictor variables under the criterion variable "severity of the disorder". The body mass index (BMI), as a recognized risk factor of OSA, was taken separately into account. RESULTS: No direct correlation was found between the skeletal cephalometric findings and severity of OSA. Only the position of the hyoid as an expression of a probably adaptive alteration to a changed head posture and tongue position was found to be a significant parameter correlating with the severity of OSA. CONCLUSION: Whether cephalometric radiography is of direct diagnostic relevance in the diagnosis of OSA seems questionable in the light of the results of the present study.

Improvement in Daytime Sleepiness by the Use of an Oral Appliance in a Patient with Upper Airway Resistance Syndrome.

This case report details the treatment outcome of an oral appliance (OA) used in a patient suffering from excessive daytime sleepiness (EDS) caused by an upper airway resistance syndrome (UARS). The patient demonstrated significant improvement in the multiple sleep latency test (MSLT) and the maintenance of wakefulness test (MWT) after treatment with an OA. The presented case suggests that an OA may be considered as a further treatment option for UARS.