Compliance and Efficacy of Titratable Thermoplastic versus Custom Mandibular Advancement Devices
ABSTRACT To share our experiences treating patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) with titratable thermoplastic (TPD) and custom-made mandibular advancement devices (MAD) and to compare these devices in terms of objective improvement and cure and treatment success (improvement/cure plus adherence at 6 months).
Case series with planned data collection.
Tertiary care center.
Patients with OSAHS who failed or refused both continuous positive airway pressure (CPAP) and surgery had a titratable oral appliance fitted. Patients were offered an office-fitted TPD or a custom-made dentist-fitted device. Assessment included pretreatment and appliance-titration polysomnography (PSG). Improvement was defined as ≥ 50% apnea-hypopnea index (AHI) reduction plus posttreatment AHI <20, and cure was defined as AHI <5. Patients were contacted at 1 and 6 months regarding treatment adherence.
A total of 180 patients (123 TPD, 57 custom) with complete PSG data were reviewed. Improvement/cure were significantly better with the custom device overall (91.2%/71.9% vs 77.2%/52.0%, P = .024/.012). Adherence data at 1 and 6 months were obtained from 128/180 and 119/180 patients, respectively. Using an intention-to-treat analysis, those lost to follow-up were considered nonadherent. Adherence at 1/6 months was 64.9%/50.9% for custom versus 53.7%/32.5% for TPD (P = .156/.018), yielding treatment success rates (with initial improvement/cure) of 49.1%/40.4% for custom versus 27.6%/17.1% for TPD (P = .005/<.001) at 6 months.
Custom-fit devices achieve higher rates of objective improvement and cure of OSAHS than TPD at the time of titration-PSG. TPDs have a high acceptance rate, low cost, and reasonable initial improvement and cure rates of 77.2% and 52.0%, respectively, but significantly poorer 6-month compliance.
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ABSTRACT: Oral appliance (OA) therapy with a mandibular advancement device (OAm) is a non-invasive, alternative approach to maintaining upper airway patency. The main requirement for an OAm to be effective is the adequate retention on the teeth while the patient is asleep. We evaluated the retentive forces of a new low-cost, customizable, titratable, thermoplastic OAm (BluePro (®); BlueSom, France). Dental impressions and casts were made for one patient with complete upper and lower dental arches including the third molars and class II bite proportions. A setup based on Frasaco ANA-4 models was also used. Two protrusive positions of the mandible were investigated: 3 mm and 8 mm, representing respectively 25% and 65% of the maximal protrusion. The forces required to remove the BluePro (®) device from the carriers were recorded continuously over 730 cycles (=365 days, twice a day) to simulate 1 year of clinical use. At 8 mm protrusion the BluePro (®) device showed retentive forces of ~27N. There was a slight but non-significant decrease in retentive forces in the tests on the epoxified carriers which was not found on the ANA-4 carriers. There were no significant differences between the carriers as a function of protrusion. The BluePro (®) device tested in the present study possesses sufficient retention forces to resist initial jaw opening forces and full mouth opening forces estimated to be ~20N. It could therefore broaden the indications for use of thermoplastic OAms. It could provide a temporary OAm while a custom-made OAm is being manufactured or repaired. Patients could be provided with a low-cost try-out device capable of reliable titration, providing an indication of effectiveness and of patient acceptance of an OAm, although the effect of device shape and size on therapeutic outcome is not yet known. Finally it could provide an affordable OAm solution in resource-restricted healthcare settings.01/2015; 4:56. DOI:10.12688/f1000research.6061.1
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ABSTRACT: In order for a mandibular advancement device (MAD) to be efficacious, it must remain seated on the teeth during sleep. Quantitative data on the retentive characteristics of MADs are currently unavailable. The present pilot study is the first to describe an in vitro setup testing the retentive characteristics of different monobloc MADs. A hydraulic cyclic test machine was used with MADs seated on dental casts to measure retention forces upon removal of the MADs. A custom-made monobloc (CM-mono), a thermoplastic monobloc (TP-mono), and a thermoplastic duobloc (TP-duo) configured as a monobloc were tested. Two protrusions were investigated, representing 25 and 65 % of the maximal protrusion. The effects of the type of MAD, duration of the test, and amount of protrusion on removal forces were measured. The measured removal forces of all three MADs tested differed significantly, with the TP-duo showing the highest values (P < 0.0001). The effects of wear due to the repetitive cyclic loading became obvious by the production of wear particles in all MADs tested. However, only the TP-duo showed a significant reduction in time in removal forces for both protrusion positions (P < 0.0001; P = 0.0011). The effect of the amount of protrusion on the removal forces differed significantly between all three MADs tested (P = 0.0074). This in vitro pilot study reveals significant differences in retention forces for the MADs tested. The findings are consistent with clinical effects of nightly loss of MADs as reported in the literature and are within the range of reported physiological mouth-opening forces. Future research is needed to determine the key design features of MADs that explain these differences.Sleep And Breathing 05/2014; 18(2):313-8. DOI:10.1007/s11325-013-0886-4 · 2.87 Impact Factor
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ABSTRACT: While continuous positive airway pressure is the first-line treatment for obstructive sleep apnea, many patients find this form of therapy undesirable leading to treatment nonadherence. Both mandibular advancement devices and surgical therapy offer alternative solutions for such patients. This article serves to compare the types of surgical interventions and mandibular advancement devices available, their mechanisms of action, and expected side effects. Emphasis is made on the limitations and challenges in the interpretation of the available literature due to the varying definitions of curative success. The effects of mandibular advancement devices and surgical therapy on the apnea-hypopnea index and oxygen saturation are reviewed. Patient-centered outcomes of sleepiness, quality of life, treatment preference, adherence, and their effects on disease-related outcomes of hypertension are summarized. When available, comparative effectiveness trials between these therapies versus continuous positive airway pressure are emphasized. Patient selection criteria, practice parameters, and treatment limitations are discussed.Seminars in Respiratory and Critical Care Medicine 10/2014; 35(5):613-20. DOI:10.1055/s-0034-1390047 · 3.02 Impact Factor