Respiratory outcomes after a 1-year treatment of obstructive sleep apnoea with bibloc versus monobloc oral appliances: a multicentre, randomized equivalence trial

Abstract

Objective: The benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that these types of appliances would be equally effective. Material and methods: In this multicentre, randomized equivalence trial, patients with OSA received one type of bibloc or one type of monobloc treatment. At baseline, a 1-night polygraphy study was done, and this was repeated after 1 year. The outcome was any change in the apnoea-hypopnoea index (AHI) and the limits of equivalence between the two devices were set at ±5 AHI units. Results: Of 302 patients, 146 were randomly assigned to bibloc and 156 to monobloc appliances. In 88 and 104 patients, respectively, there were significant reductions in the AHI (p < .001) with a mean change of À16.7 (95% CI À19.4 to À14.1) in the bibloc and À11.8 (À14.9 to À8.7) in the monobloc groups. The proportions of responders defined as having an AHI <10 were 68% and 65% for the bibloc and monobloc groups, respectively. Treatment-related adverse events were mild, transient and the dropouts were more frequent in the bibloc group. Conclusions: Both types of treatments positively and significantly reduced respiratory disturbances, but at the 1-year follow-up, they were not significantly different in treating OSA, with a numerically greater reduction of the AHI value with the bibloc appliance. However, the higher proportion of treatment-related adverse events and higher proportion of dropouts among bibloc users should be balanced against the advantage of a greater reduction in the AHI.

Dropout and adherence of obstructive sleep apnoea patients to mandibular advancement device therapy: A systematic review of randomised controlled trials with meta‐analysis and meta‐regression

“…Table 1 reports the results of the individual studies. Seven studies [29][30][31][32]36,37,54 assessed the adherence only in terms of nights per week: all of them reported a mean nights per week adherence greater than 4. All the studies that assessed the adherence in term of hours per night [33][34][35]42,47,48,53 reported a mean adherence greater than 5.…”

“…26,[33][34][35][40][41][42][43][44][45]47,48,50,53,55 Since only one study reported data of MB MAD, 57 it was excluded. Other 16 studies were excluded: 12 because they did not report the data , [27][28][29][30][31][32]36,37,49,51,52,54 three studies reported only a range of values 38,39,46 and one study because it reported only a range of values without the standard deviation or the p-value referred to baseline data. 56 Concerning the nights per week adherence, seven studies were included in the quantitative syntheses.…”

“…12 studies because they did not report the data 27,28,[33][34][35]42,[47][48][49][51][52][53] and 10 studies because they reported only a range of values without the standard deviation or the p-value referred to baseline data. [30][31][32][36][37][38][39]46,54 The meta-regression analysis evaluating the influence of time on dropout rate was performed only for study subgroups investigating Meta-regression analysis showed that the time significantly influenced the dropout rate both for DB MADs (Q = 10.936, p = .001) and for MB MADs (Q = 6.256, p = .012), as shown in Figure 2.…”

“…At the end 32 RCT were included in the review. Table 1 reports the characteristics and the results of the individual studies and Figure 1 Three studies compared two DB MADs, [26][27][28] four studies compared DB MADs with MB MADs, [29][30][31][32] four studies compared DB MADs with placebo, [33][34][35][36] two studies compared MB MADs with placebo, 37,38 two studies compared DB MADs with NCM MADs, 39,40 eight studies compared DB MADs with cPAP, [41][42][43][44][45][46][47][48] two studies compared a DB MAD with cPAP and placebo, 49,50 one study compared DB MAD with or without exercise support therapy, 51 two studies compared DB MADs with positional therapy, 52,53 one study compared MB MAD with surgery, 54 one study compared an NCM MAD, a semi-customised MAD, a MB MAD and no treatment, 55 one study compared NCM MAD with cPAP 56 and one study compared MB MAD with conservative treatment and cPAP. 57 The follow-up period varied among the studies included from 1 week to 42.7 months.…”

Terapéutica del SAHOS (Síndrome de Apnea/Hipopnea Obstructiva del Sueño) desde el punto de vista Ortopédico y Ortodóntico: Una revisión de literatura

“…Después de este periodo de tiempo, fue concluyente que ambos aparatos lograron muy buenos resultados disminuyendo drásticamente las alteraciones respiratorias durante el sueño. Sin embargo, los autores declararon que varios participantes que utilizaron el bibloque abandonaron el ensayo 21 .…”