ABSTRACT
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).
Subject(s)
Mandibular Advancement/instrumentation , Orthodontic Appliances, Removable , Sleep Apnea, Obstructive/therapy , Adult , Aged , Female , Humans , Male , Mandibular Advancement/adverse effects , Middle Aged , Orthodontic Appliance Design , Orthodontic Appliances, Removable/adverse effects , Patient Compliance , Polysomnography , Single-Blind Method , Treatment OutcomeABSTRACT
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.
