Clinical Impact of 2 types of Mandibular Retention Devices (MRD) - Narval CADCAM vs Narval nonCADCAM – on OSA: ESTAMPS STUDY

This crossover randomized study evaluated the impact of 2 custom-made MRD: computer aided design (CAD)/computer aided manufacturing (CAM) (Narval CC™) or nonCADCAM process (Narval™) on OSA patient’s oropharyngeal airway volume (OV). Methods: 12 OSA patients were enrolled. Order of the 2 MRD designs was randomly assigned. At inclusion, a diagnostic PG, a dental cone beam CT exam and a dental impression were performed. Patients wore each device for one month (after a titration period of 3 weeks max). A washout period of 2 weeks is done between the 2 therapy follow-up (FU). A control PG and cone beam with device in the mouth were performed at FU. Results: Population: mean Age: 53±9 y, BMI: 27±4 kg/m², 8 men (73%), mean AHI: 22±7.8, mean ODI: 19±6, mean ESS: 6.7±4.8, mean occlusal vertical dimension (OVD): 64±5, mean OV: 20 007±4442 mm3. OV improved significantly only with the Narval CADCAM (27 732±7381 mm3 p=0.008) vs Narval nonCADCAM (23812 ± 9538 mm3, p=NS). AHI with CADCAM & nonCADCAM decreased respectively to 11±6.3 evt/h (p=0.005) & 14.7±12 evt/h (p=0.083). ODI with CADCAM and nonCADCAM decreased respectively to 12±7 (p=0.011) and 14±13 (p=0.074). Variation of OVD was significantly less with CADCAM (73±5 mm) than nonCADCAM (75±5mm), p=0.003. ESS improves significantly with both MRD. Mandibular advancement at FU (MA) was the same between 2 MRD 6.4±1.2 mm (CADCAM) vs 6.3±1.3mm (nonCADCAM) p=0.317. Univiariate analysis revealed a link between the difference of OVD variation and OV changes with the 2 MRD (p=0.014) independently of MA variation difference Conclusion: CADCAM increase more efficiently OV than nonCADCAM. This difference is likely due to a smaller OVD.