Obstructive sleep apnea treated with custom-made bibloc and monobloc oral appliances: a retrospective comparative study

Abstract

PurposeThe primary purpose of this hypothesis-generating retrospective study was to compare the effect of monobloc and bibloc (Narval™) appliances on the apnea–hypopnea index (AHI) and the total cost of treatment during the first year of treatment.MethodsObstructive sleep apnea (OSA) subjects treated with a monobloc or bibloc during two different time periods were identified from medical records and data were extracted. Subjects treated with either of the appliances passed the same primary examination, follow-up visits, and follow-up polygraphic examination. A 1-year clinical follow-up was made on the bibloc group.ResultsThe study analysis included 110 monobloc- and 55 bibloc-treated subjects with baseline mean AHI of 23 and 22, respectively. AHI responders (AHI < 10 and/or a ≥50 % reduction of baseline AHI) were seen at follow-up in 61 % of the monobloc group and 56 % of the bibloc group. The improvement of the AHI value was similar in the two groups, with mean declines of 12.7 and 13.8, respectively. The ODI (oxygen desaturation index), lowest SpO2, longest apnea, and the mean Epworth sleepiness scale (ESS) score were significantly reduced by 3.1 (monobloc) and 2.2 (bibloc), i.e., at the same level for both groups. The total direct cost of treatment for a 1-year treatment was 17 % higher for the bibloc-treated subjects than for the monobloc-treated subjects.ConclusionsThe results indicate that the monobloc and bibloc appliances are equally effective but the cost of treatment over 1 year was higher with the bibloc. However, prospective randomized controlled trials are needed to adequately test the assumption that the two treatment modalities are equally effective.

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

“…However, in a retrospective study that compared 55 bibloc- and 110 monobloc-treated patients, Isacsson et al . (5) found similar efficacy and incidence of adverse events. Thus, there are conflicting data about whether either of the construction types provides better efficacy and fewer adverse events.…”

“…The size of the study sample was calculated on the basis of data from a retrospective comparative study of the bibloc and monobloc (5). For a two-sided confidence interval (CI) approach, the sample size per group required to demonstrate the equivalence of two means in a 1:1 randomized design based on anticipated common mean, with standard deviation (SD) 15 and level of equivalence set as ±5, was 155 at the 0.05 significance level and 80 per cent power.…”

“…Using as the background the data of Isacsson et al . (5), we tested the hypothesis that bibloc mandibular advancement appliances are equally effective as monobloc appliances in treating OSA from the short-term perspective.…”

Oral appliance therapy in obstructive sleep apnea: Long-term adherence and patients' (TM) experiences

“…Most of the patients in our study (68%) were treated with a monobloc appliance, which was the most frequent type of MAA at the time. Some studies report that monobloc appliances are as effective as bibloc appliances although the effect remains uncertain ( 26 ). Patient satisfaction has also been found to be comparable for these different appliance types ( 23 ).…”

Obstructive sleep apnea: focus on myofunctional therapy

“… 28 Continuous positive airway pressure (CPAP) is the treatment of choice for adults with OSA, 20 especially in severe cases, to relieve symptoms and to reduce the sequelae. 18 , 29 However, mandibular advancement device (MAD), an intraoral dental splint used to protrude the mandible in a forward position during sleep and thus enlarge the upper airway, 30 , 31 is mainly indicated as the first-stage treatment of adults with mild-to-moderate OSA and in severe cases in which attempts with CPAP treatment fail. 30 – 32 MAD has been considered as a treatment option for children, 33 although it is still under study, and it requires accurate indication and follow-up due to the craniofacial growth and development.…”