Biomimetic Oral Appliance Therapy in Adults with Mild to Moderate Obstructive Sleep Apnea

Research Article

Austin J Sleep Disord. 2014;1(1): 5.

Biomimetic Oral Appliance Therapy in Adults with Mild to Moderate Obstructive Sleep Apnea

Singh GD1*, Griffin TM2 and Chandrashekhar R3

1BioModeling Solutions, Inc., Beaverton, USA

2Emerald Coast Dental Sleep Medicine, Panama City Beach, USA

3Sleep Medicine, Ravindra Chandrashekhar Inc., Victorville, USA

*Corresponding author: Prof. Singh GD, BioModeling Solutions, Inc., Cornell Oaks Corporate Center, 15455 NW Greenbrier Parkway, Commons Building, Suite 250, Beaverton, OR 97006, USA

Received: August 29, 2014; Accepted: October 11, 2014; Published: October 16, 2014


Introduction: For the management of obstructive sleep apnea (OSA) in adults, some professionals prescribe continuous positive airway pressure (CPAP) while others prefer mandibular advancement devices (MADs). However, both CPAP and MADs represent life-long therapy. In this study, we investigated the use of a biomimetic oral appliance system (the DNA appliance® system) to test the hypothesis that the upper airway can be improved in adults that have been diagnosed with OSA.

Methods and Sample: We recruited 10 consecutive adults for this study who underwent an overnight sleep study, which was interpreted by a sleep physician. Subjects diagnosed with mild to moderate OSA were treated using biomimetic oral appliance therapy (BOAT). Each subject had monthly follow-up visits, including examinations for progress and adjustments of the devices. The mean AHI of the sample was calculated prior to and after BOAT with no appliance in the mouth. The findings were subjected to statistical analysis.

Results: The mean treatment time was 8.7 mos. ± 5.8. Prior to treatment the mean AHI was 13.2 ± 7.2. The mean AHI fell by 65.9% to 4.5 ± 3.6 (p = 0.021) after BOAT with nothing in the mouth when the final overnight sleep study was performed.

Conclusion: This preliminary study suggests that BOAT may be able to reduce the AHI to within normal limits perhaps to the extent that life-long therapy may not potentially be necessary. However, long-term follow up is needed to determine whether these subjects need a maintenance program to retain their initial upper airway improvements.

Keywords: Oral appliance therapy; Biomimetic; Obstructive sleep apnea; Mandibular advancement device


OSA: Obstructive Sleep Apnea; MAD: Mandibular Advancement Device; CPAP: Continuous Positive Airway Pressure; AHI: Apnea-hypopnea Index; DNA appliance: Daytime-Nighttime Appliance; BOAT: Biomimetic Oral Appliance Therapy; TMJ: Temporo-mandibular Joint; SWS: Slow Wave Sleep; REM: Rapid Eye Movement


For the management of obstructive sleep apnea (OSA) in adults, some healthcare professionals prefer to prescribe continuous positive airway pressure (CPAP) masks while others prefer mandibular advancement devices (MADs). White and Shafazand [1] assessed whether MADs had similar health outcomes to CPAP in the short term. In terms of the primary outcomes e.g. improvements in blood pressure, they reported no statistically significant difference between the two types of therapy. However, neither treatment lowered the blood pressure from baseline values in either group after one month of therapy. Thus, both CPAP therapy and MADs may represent lifelong use. But earlier, Aarab et al. [2] investigated the efficacy of both MAD and CPAP use. Their results indicated that while the initial improvements in the AHI remained stable over time within both groups, the AHI improved more in the CPAP group compared to the MAD group. In contrast, more patients withdrew from treatment due to side effects in the CPAP group compared to the MAD group. Nevertheless, while there is a large amount of evidence to support the use of MADs for the management of mild to moderate OSA, and while numerous cases have been treated successfully, there are some concerns about the unwanted side-effects of MADs. For example, Doff et al. [3] reported significant dental changes compared with CPAP use, concluding that MADs should be considered as a lifelong treatment with a risk of dental side effects. Earlier, Doff et al. [4] had found that, compared to CPAP, MADs are associated with increased, transient pain in the temporo-mandibular joint (TMJ) in the initial period of use, which they presumed would remain limited with long-term MAD use.

On the other hand, Tsuda et al. [5] used a questionnaire to study compliance and side effects of non-customized MADs. The majority of the study sample had previously used CPAP therapy. Approx. 80% of non-compliant subjects discontinued MAD use after about 3 months. The most frequent reasons for non-compliance with non-customized MADs were discomfort, dry mouth, excessive salivation and ill-fitting appliances. Thus, long-term or lifelong, non-customized MAD therapy may not be possible in all adults diagnosed with OSA that are CPAP-intolerant. On the other hand, de Almeida et al. [6] quantified compliance and side effects of customized MAD use after approx. 5.5 years in patients diagnosed with OSA. Over 60% of the sample was still complying with MAD therapy but there was no significant difference in the baseline and post-titration respiratory indices used to assess the success of treatment if the appliance was not worn while sleeping. The most frequent reasons why patients discontinued MAD use were discomfort, or the MAD had no effect and the subject used CPAP instead. Other side effects of customized MAD use included; dry mouth, tooth pain, jaw discomfort, and TMJ symptoms. Thus, subjects who were compliant with customized MAD for long periods of use had adequate improvements as long as they continued wearing the MAD.

Cohen-Levy et al. [7] measured forces created in patients wearing MADs. They reported an almost linear relation, with a mean force of approx. 1Nmm-1 of mandibular protrusion, and this level of force is similar to that used during adult orthodontic therapies. Thus, the force values recorded in that study may explain both the dental and skeletal side effects associated with long-term MAD use, in a possible dose-dependent effect. Conversely, biomimetics is a science that uses natural designs or mechanisms to solve human problems. Accordingly, in a manner similar to orthodontic correction, the judicious use of the vectors induced in oral appliance therapy might provide an alternative protocol for the resolution of OSA, with the upper airway being the target in mild to moderate cases. Therefore, the aim of this current study is to test the hypothesis that OSA can be resolved in adults using a novel protocol that utilizes biomimetic oral appliance therapy (BOAT).

Methods and Sample

After obtaining informed consent, 10 consecutive patients were recruited for this study. The rights of the subjects were protected by following the Declaration of Helsinki. Inclusion criteria were: adults aged >21yrs. diagnosed with mild to moderate OSA following an overnight sleep study that had been interpreted by a sleep physician; good oral appliance compliance; no history of hospitalization for craniofacial trauma or surgery; no congenital craniofacial anomalies, and a fully-dentate upper arch. The exclusion criteria included: age <21yrs.; lack of oral appliance compliance; active periodontal disease; tooth loss during treatment; poor oral hygiene, and systemic bisphosphonate therapy. The study protocol (#121310) was reviewed and approved by the institution’s review board.

After careful history-taking and craniofacial examination, a bite registration was obtained in the upright-sitting position with corrected jaw posture in the vertical axis specific for each subject. Upper and lower polyvinyl siloxane impressions were also obtained. The upper model was then mounted on an articulator and the lower model was mounted relative to the upper model, using the bite registration captured in the physiologic rest position. Following a diagnosis of mild to moderate OSA, a biomimetic, upper Daytime- Nighttime Appliance (DNA appliance®; Figure 1) was prescribed for each subject. The biomimetic oral appliance therapy (BOAT) is designed to correct maxillo-mandibular hypoplasia in both children and adults [8-16]. The biomimetic oral appliance used in this study had: 6 (patented) anterior 3-D axial springs™, a beaded pharyngeal extension, a midline screw, bilateral occlusal coverage, retentive clasps, and a labial bow (Figure 1a). All subjects were instructed to wear the appliance during the evening and at nighttime (for approx. 12-16hrs. in total), but not during the day time and not while eating, partly in line with the circadian rhythm of tooth eruption [17] although this only occurs in children. Proffit [18] notes that an appliance needs to be worn for at least the mouth to have a clinical effect. Written and verbal instructions were given to all subjects.