Göran Isacsson

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 ≥ 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.

Intra-articular morphine as analgesic in temporomandibular joint arthralgia/osteoarthritis

&NA; The aim of this study was to determine the analgesic efficacy of a single dose intra‐articular injection (i.a.) of morphine in 53 patients with unilateral arthralgia/osteoarthritis of the temporomandibular joint (TMJ). This randomized, double‐blind, parallel group, multicenter study included a screening visit, a treatment visit, and a follow‐up visit 1 week after treatment. Recordings of visual analog scales (VAS) pain intensity scores at maximum mouth opening (main efficacy variable) and at jaw rest were made directly before a 1‐ml i.a. injection into one TMJ of either 1.0 mg morphine–HCl, 0.1 mg morphine–HCl, or saline (placebo). The pain intensity was also recorded at the follow‐up and in a diary 3 days before and 5 days after the injection. The VAS pain score at maximum mouth opening was considerably reduced 1–10 h after injection but without significant differences between groups. At the follow‐up, the median VAS pain score at maximal mouth opening was significantly lower in the 0.1‐mg morphine group than in the 1.0‐mg morphine group (P<0.043) or the saline group (P<0.021). A significant increase in pain pressure threshold over the affected joint was seen in the 0.1‐mg morphine group compared with the saline group at the follow‐up but not 1 and 2 h post‐injection. The incidence of adverse events was small and did not differ between the treatment groups. In conclusion, one i.a. injection of 0.1 mg morphine significantly increased the pain pressure threshold and mouth opening ability, but evidence for the analgesic property of the locally applied opioid was inconclusive. No dose–effect relation and no significant short‐term analgesic property were seen. Although statistically significant, the magnitude of the reduced VAS pain intensity score was not clinically relevant at the 1‐week follow‐up.

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.

Treatment of Snoring and Obstructive Sleep Apnea with a Mandibular Protruding Device: An Open-Label Study

The study objectives were to describe the changes in signs and symptoms of obstructive sleep apnea (OSA) and snoring using a mandibular protruding device (MPD) and to define the group of responders. The design of the study was a nonrandomized, open-labeled, prospective clinical study with a duration of 6 months. The setting was a hospital sleep laboratory and an ear, nose, and throat and dental outpatient clinic. Patients included 35 individuals treated: 22 with a diagnosis of OSA and 13 who snored without apnea.The intervention before MPD prescription entailed a medical examination, a one-night somnographic registration, a questionnaire, and a clinical jaw function examination. All procedures were iterated at the 6-month follow-up. When the patients used the MPD, the subjective symptoms decreased significantly (p < 0.001). Twenty-four of the 35 patients were classified as responders, i.e., reduced their symptoms ≥50%. In the groups of OSA patients, the mean peak intensity of the snoring sound decreased from 71.6 dB to 62.0 dB (p < 0.001) and in the group of snorers, from 63.5 dB to 57.5 dB (p < 0.05). Eighteen of the 22 OSA patients decreased their ODI values by ≥50% (responders). The mean ODI decreased from 15.4 to 3.5 (p < 0.001) and the blood oxygen saturation, SaO2 nadir, increased from mean 81.9 to 85.7 (n.s.). Most patients with tongue base hyperplasia were classified as responders to the MPD treatment.In conclusion, a 6-month perspective shows that the MPD could be an effective treatment in reducing signs and symptoms of OSA and/or snoring, the compliance was acceptable and only minor adverse events occurred.

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.

Pain relief following a single-dose intra-articular injection of methylprednisolone in the temporomandibular joint arthralgia-A multicentre randomised controlled trial

Summary Background Temporomandibular joint (TMJ) arthralgia is a painful condition assumed to be associated with local inflammation. Objective The objective of the present study was to determine the efficacy for reducing pain of a single‐dose intra‐articular (IA) injection of methylprednisolone to the TMJ. The hypothesis was that methylprednisolone would effectively reduce TMJ pain. Methods This randomised, double‐blind, parallel‐group, multicentre, controlled study included visits for enrolment, treatment and 4‐week follow‐up. The study included patients 18 years and older who had been diagnosed with unilateral TMJ arthralgia. All participants were randomly assigned to receive 1 mL IA injections of methylprednisolone or saline. The primary outcome was change in recorded pain intensity on a visual analogue scale (VAS) at maximum jaw opening, analysed in the per protocol population. Results In total, 54 patients were randomly assigned to single‐dose IA injections with methylprednisolone (n = 27) or saline (n = 27). Between baseline and the 4‐week follow‐up, VAS‐rated pain intensity at maximum jaw opening decreased from a mean of 61.0 (95% confidence interval [CI]: 50.1; 70.7) to 33.9 (95% CI: 21.6; 46.2) in the methylprednisolone group and from 59.6 (95% CI: 50.7; 65.9) to 33.9 (95% CI: 23.8; 43.9) in the saline group. The between‐group difference was not significant (P = 0.812). Treatment‐related adverse events were doubled in the methylprednisolone group. Conclusion Methylprednisolone provided no additional benefit for reducing pain, but caused more harm compared with saline following a single‐dose IA injection in patients with TMJ arthralgia.

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

Summary 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).

Bibloc and monobloc oral appliances in the treatment of obstructive sleep apnoea: a multicenter, randomized, blinded, parallel-group trial

Bibloc and monobloc oral appliances in the treatment of obstructive sleep apnoea : a multicenter, randomized, blinded, parallel-group trial