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.
- [Show abstract] [Hide abstract]
ABSTRACT: Objectives: To assess outcomes including efficacy, adverse effects, and quality of life (QOL) of adjustable thermoplastic mandibular advancement device (AT-MAD) fitted by an otolaryngologist for obstructive sleep apnea (OSA) treatment. Study Design: Prospective, non-randomized, "before-after" study Methods: Sixty-four adult patients (40 men and 24 women) were recruited. Inclusion criteria were OSA patients who had failed or refused CPAP and surgery. Exclusion criteria were insufficient teeth, active intraoral disease, and temporomandibular joint (TMJ) disorders. Outcomes were measured using polysomnography, symptom questionnaires, Epworth sleepiness scale (ESS), and functional outcomes of sleep questionnaires (FOSQ) before treatment and 4-6 months thereafter. Results: Mean apnea-hypopnea index (AHI) and ESS scores decreased from 17.7 ± 14.6 to 7.5 ± 10.9 and from 8.7 ± 4.9 to 6.5 ± 4.4 respectively, after treatment (p < 0.001). Thirty-nine patients (60.9%) achieved post-treatment AHI of <5 with the highest success rate in those with mild OSA (75%). FOSQ global scores increased from 16.4 ± 2.8 to 17.7 ± 3.0 (p < 0.05), along with most FOSQ subscale scores. Thirty-four patients (53.1%) regularly used the device for ≥5 nights per week. Adverse effects include TMJ discomfort, dry mouth, and excessive salivation which were largely tolerable. Only 4 patients withdrew from the study because of adverse effects. Conclusion: This is the first study in Asians demonstrating that AT-MAD, if done properly, is a practical short-term treatment of OSA with good outcomes including improved QOL. Its advantages are its low cost and ready-to-use nature. However, further randomized-controlled trials are required.The Laryngoscope 01/2014; 124(10). · 2.03 Impact Factor
- [Show abstract] [Hide abstract]
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. · 2.26 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: The present study addresses the need for a validated tool that prospectively identifies favorable candidates for oral appliance therapy in treatment of obstructive sleep apnea. The objective of the study was to evaluate the ability of a mandibular titration study, performed with a remotely controlled mandibular positioner (RCMP), to predict treatment outcome with a mandibular repositioning appliance (MRA) and to predict an effective target protrusive position (ETPP). A prospective, blinded, outcome study. Standard clinical care with tests performed in the polysomnographic laboratory. Consecutive patients (n = 67) recruited from a sleep center or a dental practice using broad inclusion criteria (age 21-80 years; AHI > 10/h; BMI < 40 kg/m(2)). Therapeutic outcome with a mandibular protruding oral appliance was predicted following a mandibular protrusive titration study in the polysomnographic laboratory using a remotely controlled positioner and prospectively established predictive rules. An ETPP was also prospectively determined for participants predicted to be therapeutically successful with MRA therapy. All participants were blindly treated with a MRA, at either the predicted ETPP or a sham position, and therapeutic outcome was compared against prediction. At the final protrusive position, standard predictive parameters (sensitivity, specificity, positive and negative predictive values) showed statistically significant predictive accuracy (P < 0.05) in the range of 83% to 94%. The predicted ETPP provided an efficacious protrusive position in 87% of participants predicted to be therapeutically successful with MRA therapy (P < 0.05). Using prospectively established rules for interpreting the polysomnographic data, the mandibular titration study predicted mandibular repositioning appliance therapeutic outcome with significant accuracy, particularly with regard to accurately predicting therapeutic success. As well, among the participants predicted to be therapeutically successful with mandibular repositioning appliance therapy, the effective target protrusive position provided efficacious mandibular protrusion in the majority. Remmers J; Charkhandeh S; Grosse J; Topor Z; Brant R; Santosham P; Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. SLEEP 2013;36(10):1517-1525.Sleep 01/2013; 36(10):1517-1525. · 5.06 Impact Factor