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.

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.

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.

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.