The outcome of oral appliance therapy on position-dependent obstructive sleep apnea: A multicenter randomized controlled trial.

INTRODUCTION: This multicenter trial on patients with obstructive sleep apnea (OSA) treated with an oral appliance aimed to determine the effect of sleeping positions. METHODS: A cohort of 314 patients with OSA were enrolled and evaluated at 8 weeks and 1 year, focusing on treatment effects. At baseline and the 2 follow-ups, new polygraphic registration comparing the proportion of treatment responders without position-dependent OSA (non-position-dependent OSA [non-POSA]) and with POSA was used. RESULTS: At the 8-week and 1-year follow-up, 205 and 139 patients were included, respectively. The proportion of responders (apnea-hypopnea index [AHI] <10 and/or ≥50% reduction in AHI) was 56% for the non-POSA group and 69% for the POSA group (not significant [NS]). The responders increased at the 1-year follow-up: 68% and 77% for the non-POSA and POSA groups (NS), respectively. The absolute change in AHI in all sleeping positions at 8 weeks was -12.9 (interquartile range, -25.0 to -0.5) in the non-POSA group and -10.5 (interquartile range, -19.9 to -5.3; NS) in the POSA group. However, the decrease in supine AHI was significantly greater among subjects with POSA. In contrast, the decrease in nonsupine AHI was significantly greater in the non-POSA group, an effect that remained at the 1-year follow-up. CONCLUSIONS: Our hypothesis that subjects with POSA at baseline would have a higher treatment response rate after oral appliance treatment compared with subjects without POSA was rejected. However, those with POSA had a significantly higher supine AHI decrease, and those without POSA had significantly less nonsupine AHI.

A prospective 10-year cephalometric follow-up study of patients with obstructive sleep apnea and snoring who used a mandibular protruding device.

INTRODUCTION: This 10-year prospective cephalometric study evaluates the influence of a mandibular protruding device (MPD) in people with obstructive sleep apnea and snoring. METHODS: A baseline study population of 77 people was followed biennially. After 10 years, 65 people (45 MPD users and 20 stopped-MPD users) were reexamined. At baseline and after 10 years, a lateral cephalogram was taken in the upright position. RESULTS: MPD users showed significant changes in all cephalometric variables except for maxillary protrusion. The maxillary incisors were retroclined by a mean -4.2° (standard deviation [SD] 3.95; P <0.001), mandibular incisors were proclined by a mean 3.2° (SD, 5.02; P <0.001), and SNB was reduced by a mean -0.6° (SD 1.41; P = 0.01). In those who had stopped MPD use, these initial cephalometric values were retained. Significant changes in decreased overjet and overbite were seen in the MPD group but not in the MPD-stopped group. The length of the mandible (Cd-Pg) increased by a mean of 5.1 mm (SD 6.78; P <0.001) and 6.1 mm (SD 5.99; P <0.001) in MPD and MPD-stopped groups, respectively. The hyoid bone-mandibular plane distance (hy-ML) increased by a mean of 3.3 mm (SD, 2.90; P <0.001) and 3.8 mm (SD 3.67; P = 0.001) in MPD and MPD-stopped groups, respectively. CONCLUSIONS: Long-term nocturnal MPD use causes retroclination of the maxillary incisors and proclination of the mandibular incisors with consequent decreased overjet and overbite. Both MPD and MPD-stopped users obtained increased mandibular length and lower position of the hyoid bone, which can be a normal physiological change with age.

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

Background: The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA. Objective: To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective. Patients and methods: In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy. Results: Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively). Limitations: The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive. Conclusion: In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude. Trial registration: Registered with ClinicalTrials.gov (#NCT02148510).

A prospective 10-year follow-up dental cast study of patients with obstructive sleep apnoea/snoring who use a mandibular protruding device.

OBJECTIVES: This 10-year prospective study aimed to measure and evaluate the teeth position and occlusion following 10-year nocturnal use of a mandibular protruding device (MPD) in subjects with obstructive sleep apnoea (OSA) or snoring. MATERIALS AND METHODS: Seventy-seven consecutive patients diagnosed with OSA/snoring were treated with an MPD. Fabrication of dental casts with jaw registration indexes in the intercuspal position was carried out at baseline and at follow-up, a construction bite was made, and an MPD was fitted. At the 10-year follow-up, all subjects (n = 74) were invited to participate. The dental casts were analysed in a series of measurements. RESULTS: Sixty subjects were included in the follow-up examination-41 were still using the device and 19 had ceased using the MPD. The MPD users showed significant changes in all analysed variables-decrease of overjet (-1.8 mm), overbite (-1.5 mm)-except the mandibular intercanine width and the maxillary anteroposterior relationship. Subjects who had ceased using their MPD retained their initial values, with the exception of a decreased overbite. The MPD users also showed an increased number of subjects with mesio-occlusion and posterior infra-occlusion; those who had ceased using their MPD mostly retained their initial status. CONCLUSIONS: Long-term nocturnal use of an MPD may cause both favourable and unfavourable occlusion changes, such as a decrease of the overjet and overbite or posterior infra-occlusion, and these changes may continue to develop during treatment with an MPD. Subjects with a Class III relationship may not be a suitable group for treatment with an MPD due to the mesial drift of the mandibular teeth.

Influence on the masticatory system in treatment of obstructive sleep apnea and snoring with a mandibular protruding device: a 2-year follow-up.

The aim was to identify the incidence and types of possible adverse events in the masticatory system after treatment with a mandibular protruding device (MPD) during a 2-year period in patients with obstructive sleep apnea (OSA) or snoring. The subjects comprised 65 middle-aged patients (44 OSA patients, 21 snorers). A clinical examination and a questionnaire concerning signs and symptoms from the masticatory system were performed before, after 6 months, and after 2 years of MPD use. The frequencies of registered signs from the masticatory system, such as muscle and joint tenderness, palpation, and pain during mandibular movement, decreased significantly between baseline and the 2-year follow-up. There were significant changes in the mandibular range of protrusion (+0.7 mm, P < .001), overjet (-0.5 mm, P < .001), and overbite (-0.6 mm, P < .001) compared with the initial examination. Nine patients developed a lateral open bite during treatment, and 2 of them experienced subjective symptoms related to the altered occlusion but still used the MPD every night. No patient reported pain on opening the mouth wide or during jaw movements. Two reported tiredness on jaw function. The reported frequency of headaches was also significantly reduced (P < .01). The high compliance rate in MPD use showed that the therapy is well tolerated, but there is a risk of minor alterations in the occlusion during MPD treatment.

Effects of a mandibular protruding device on the sleep of patients with obstructive sleep apnea and snoring problems: a 2-year follow-up.

OBJECTIVES: To evaluate subjective discomfort and somnographic measures of patients with obstructive sleep apnea and snoring problems who had been treated for 2 years with a mandibular protruding device (MPD). METHODS: The study population comprised 65 patients with a pretreatment diagnosis of obstructive sleep apnea (OSA) ( n = 44) or habitual snoring without apnea (n = 21). After a baseline medical and somnographic examination, a functional examination of the stomatognathic system, and a questionnaire focused on sleep-related qualities, each patient received an MPD. Two follow-ups were made 6 months and 2 years after MPD treatment had been initiated, and all initial examinations were repeated. RESULTS: At the 2-year follow-up, significant subjective improvements were registered in 90% of the patients regarding a reduction of snoring and apneas, in 76% regarding a reduction in daytime tiredness, and in 84% regarding an improvement in the quality of the night sleep (change of > or = 50% from baseline data). At the 2-year follow-up of the OSA group, the oxygen desaturation index (ODI) had dropped significantly from a mean value of 14.7 (SD, 12.7) to 3.1 (SD, 4.2) ( P < 0.001), and the mean SaO2 nadir rose from 78.2% (SD, 8.1) to 89.0% (SD, 4.7) ( P < 0.001). Only one of the snorers increased his ODI value; the others retained their initial healthy values. The OSA patients significantly reduced the amount of time they snored during their sleep. CONCLUSION: MPD treatment is associated with a significant reduction in subjective complaints such as disturbing snoring, apneas, daytime tiredness, and poor quality of night sleep, and with a significant reduction in ODI values in the OSA group. In addition, favorable 6-month results were unchanged after 2 years.

Validation of measurements of mandibular protrusion in the treatment of obstructive sleep apnoea and snoring with a mandibular protruding device.

The aims of this study were to compare the maximum range of protrusion determined with a ruler with measurements made using a George Gauge (GG) and to validate the methods of measurement (ruler and GG) of the advancement established by mandibular protruding devices (MPDs), using cephalograms as the gold standard. The study comprised 77 patients (63 males, 14 females, mean age 54 years, range 31-73 years) with obstructive sleep apnoea (OSA) (n = 50) or complaints of snoring (n = 27). After a medical examination that included an overnight somnographic registration and a dental and stomatognathic examination, each patient was given a MPD. Measurements of the maximum range of protrusion with the GG and a ruler were compared. Pairs of upright cephalograms were taken with and without the MPD. The position of the mandible on the cephalograms was compared with ruler measurements of the device-induced protrusion in the incisor and premolar regions, the vertical opening in the anterior region, and GG construction bite registration. The maximum range of protrusion was significantly greater with GG than ruler measurements, on average +1.2 mm (P < 0.001). The mandibular position as measured in the incisor or premolar region with a ruler or on the cephalogram was not significantly different. GG values, however, were higher and differed significantly from ruler and cephalometric measurements (P < 0.001). The degree of anterior mandibular advancement with a MPD measured with a ruler in the incisor or premolar regions compared well with corresponding cephalometric measurements. The ruler and cephalometric measurements of the vertical opening with the MPD coincided well in the incisor region. The GG overestimated the maximum range of protrusion compared with ruler measurements.

Influence of mandibular protruding device on airway passages and dentofacial characteristics in obstructive sleep apnea and snoring.

The aim of the study was to evaluate the influence of a mandibular protruding device (MPD) after 2 years of nocturnal use on the upper airway and its surrounding structures. Lateral cephalograms in the upright position were taken of patients with obstructive sleep apnea (OSA) and of patients with snoring problems at the beginning of treatment and at the 2-year follow-up. Two computer programs were used to analyze the cephalograms. A total of 65 patients, 44 with OSA and 21 snorers, were analyzed. The linear distances in the pharynx had increased significantly at the 2-year follow-up; the calculated pharyngeal area had increased on average by 9% (mean, +58.3 mm(2)). The velum area had decreased (mean, -31.5 mm(2)), which accounts for about half the increase in the relative area of the pharynx. The average linear distances between the hyoid bone and the 2 reference lines, ie, nasal line (NL) and mandibular line (ML), had increased significantly. Mandibular protrusion (SNB) was slightly reduced, on average -0.4 degrees (P <.01), and the lower incisors were proclined (ILi/ML), on average +1.5 degrees (P <.05). In conclusion, nocturnal use of an MPD for 2 years increased the airway passage because of an increase in the relative area of the pharynx by a mean of 9% in OSA patients and snorers. A mandibular posterior rotation and a proclination of the lower incisors were observed but considered modest.

The effect of posture and a mandibular protruding device on pharyngeal dimensions: a cephalometric study.

The objectives were to evaluate the impact of body posture on cephalometric measures and the level and the extent to which treatment with a mandibular protruding device (MPD) affects pharyngeal width. The study was composed of 77 patients: 50 were diagnosed with obstructive sleep apnea (OSA) and 27 snored. After each patient underwent a baseline medical (including a somnographic registration), dental and stomatognathic examination, an MPD that would protrude the mandible 75% of the maximal protrusion range was fabricated. In a radiographic examination, four cephalograms were taken: two in the upright position with and without the MPD and two in the supine position with and without the MPD. The cephalometric measures focused on the pharyngeal structures. MPD treatment significantly increased the relative pharyngeal area (at the level of the oropharynx and the hypopharynx) by a mean of +89.6 mm2 (P < 0.01) in the upright posture. The relative pharyngeal area, however, was reduced by more than 50% in the supine position compared with the upright position, independent of MPD treatment. In the supine position, compared with upright, most pharyngeal measures decreased significantly; the hyoid was significantly lower and displaced posteriorly, and the area of the velum increased by a mean of +201.2 mm2 (P < 0.001). We conclude that the MPD significantly increased most pharyngeal measures except the linear distance between the hyoid bone and the third vertebra and decreased the area of the velum.