Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial

Abstract

RationaleCustom-made mandibular advancement devices (MADs) are reported as providing higher efficacy rates compared with thermoplastic heat-moulded MADs but at the price of higher costs and treatment delays.ObjectiveTo determine whether a thermoplastic heat-moulded titratable MAD (ONIRIS; ONIRIS SAS, Rueil Malmaison, France) is non-inferior to a custom-made acrylic titratable MAD (TALI; ONIRIS SAS, Rueil Malmaison, France) for obstructive sleep apnoea (OSA).MethodsWe conducted a multicentre, open, randomised controlled trial of patients with OSA refusing or not tolerating continuous positive airway pressure (CPAP). Participants were randomly assigned to a thermoplastic heat-moulded titratable device or a custom-made acrylic device for 2 months with stratification by centre and OSA severity. The non-inferiority primary outcome was a ≥50% reduction in apnoea–hypopnoea index (AHI) or achieving AHI <10 events/hour at 2 months. The non-inferiority margin was preset as a difference between groups of 20% for the primary outcome in the per-protocol analysis.Main resultsOf 198 patients (mean age 51 [SD, 12] years; 138 [72.6%] men; mean body mass index 26 [SD, 2.7] kg/m2; mean AHI 26.6/hour [SD, 10.4]), 100 received TALI and 98 ONIRIS. In per-protocol analysis, the response rate was 51.7% in the TALI group versus 53.6% in the ONIRIS group (absolute difference 1.9%; 90% CI: 11% to 15%, within the non-inferiority margin). Effectiveness was the same for severity, symptoms, quality of life and blood pressure reduction. Patients in ONIRIS group reported more side effects and adherence was slightly better with TALI.ConclusionIn patients with OSA refusing or not tolerating CPAP, the thermoplastic heat-moulded titratable MAD was non-inferior in the short-term to the custom-made acrylic MAD.Trial registration number NCT02348970.

Oral Appliances in Obstructive Sleep Apnea

“…A randomized controlled trial demonstrated that a thermoplastic heat-molded titratable MAD was non-inferior in the short-term to a custom-made acrylic MAD. Therefore, such a thermoplastic titratable MAD can be used as a simple, cheap, and ready to use method to identify patients likely to benefit from long-term MAD therapy [22].…”

Effectiveness of different mandibular advancement device designs in obstructive sleep apnoea therapy: A systematic review of randomised controlled trials with meta‐analysis

“…50,51,53 Twenty-one studies were included in the meta-analysis that evaluated minimum oxygen saturation. Twenty-nine investigations were excluded: 12 22,23,29,30,32,38,44,54,57,66,67,69 did not report the data, 12 24,33,36,40,49,50,59,[62][63][64][65]68 reported ODI instead of minimum oxygen saturation, 3 report together data of study and control groups at baseline, 26,48,56 1 study did not report standard deviations but only P-values without specific reference to baseline data 52 and 1 study reported the mean oxygen saturation instead of minimum oxygen saturation. 51 The MB showed higher effectiveness than DB in improving both the success rate ( Figure 2) and the minimum oxygen saturation (Figure 3).…”

“…Six studies compared MB MADs with DB MADs, 21‐26 12 studies compared DB MADs with CPAP, 27‐38 7 studies compared DB MADs with placebo, 39‐45 one study compared DB MAD with CPAP and placebo, 46 one study compared DB MADs with different vertical degrees, 47 one study compared different mandibular advancement degrees of the same DB MAD 48 . Five papers compared different titratable DB MADs, 49‐53 another investigation compared a titratable DB MAD with a non‐titratable DB MAD, 54 one study compared the efficacy of the same DB MAD with and without vertical elastic bands, 55 2 studies compared a DB customised MAD with a non‐customised MAD 56,57 and 3 studies compared DB MADs with other therapies like a tongue retaining device 58 and the positional therapy 59,60 . Three studies compared different mandibular advancement degrees of a MB MAD, 61‐63 2 studies compared a MB MAD with ENT surgery, 64,65 one study compared a customised with a non‐customised MB MAD 62 and 4 studies compared a MB MAD with placebo 66‐70 …”

“…This systematic review included investigations using customised MADs despite two recent papers 40,57 concluded that they are not superior to non-customised MADs in the reduction of AHI. Nevertheless, a recent systematic review 76 concludes that custom-made MADs are significantly more effective and register a higher adherence.…”

Fake it till you custom-make it: a non-inferior thermoplastic mandibular advancement device?

“…In this issue of Thorax , Pepin and colleagues present a parallel group, non-inferiority trial of two titratable devices: one thermoplastic and one customised acrylic 13. The study recruited CPAP treatment failures or refusers who were non-obese (body mass index <30 kgm 2 ) with moderate–severe OSA (AHI >15).…”