Since it is attached to the dentition, the FCM features both mandibular stabilization and mask integrity. The connected oral appliance-PAP interface is designed to withstand high PAP pressures needed for those with severe obstructive sleep apnea.
In obstructive sleep apnea (OSA) treatment, combination therapy refers to two therapies being employed simultaneously in the same patient. Oral appliance therapy used together with PAP (positive airway pressure) therapy is one such combination, of which there are two types: “dual therapy,” which describes when the oral appliance and PAP device are not physically connected; and “integrated therapy,” in which the PAP interface connects directly to the oral appliance.
A new device for integrated therapy is now available—the Fusion Custom Mask (FCM). In a study I conducted with Todd Swick, MD, we found FCM to be an effective therapeutic option for those with severe OSA or those who are CPAP intolerant.1 Patented by Keith Thornton, DDS, FCM is a custom CPAP face mask made from an impression of the face, with the interface attached to a post protruding from an upper and lower oral appliance. The upper and lower oral appliances are dual laminate shells that are luted together with thermoplastic material that has a stainless steel post protruding out the lips (called a Fusion Monoblock). The mandible is protruded about 3 mm to augment the PAP to make it more effective. The mask is then securely attached to the stainless steel post. The result is a superior seal on the face as well as with mandibular stabilization.
The mask is fabricated by Space Maintainers Laboratories (SML). I have the exclusive license by Airway Management Inc to teach and fabricate the FCM and have launched company Fusion Sleep Solutions LLC (FSS) to teach all means of combination therapy, including the FCM as a way to do integrated therapy.
The FCM is fabricated on a model from an impression of the face with the patient in a relaxed supine position. The two-stage impression technique is described in The Journal of Prosthetic Dentistry.2 The FCM is designed to lay on the skin of the face, so when PAP pressure enters the nose and expands the tissue towards the mask, the seal is maintained. With the mask attached to the dental arches via the Fusion Monoblock, the mask is stable and will not shift or leak. Patients also appreciate the lack of mask straps.3
There are several modifications that can be done to the FCM to accommodate certain medical conditions. For example, the mask is designed to have a nasal vestibule and a separate mouth vestibule. The PAP pressure comes into the nasal vestibule, while the mouth vestibule seals the oral cavity so pressure will not escape the mouth. If the patient has a nasal obstruction, the PAP pressure can be guided through the mouth vestibule instead of, or in conjunction with, the nasal vestibule. Another modification is to cut off the mouth vestibule all together (see photo), for example, for patients with trigeminal neuralgia where the pain trigger is touching the facial skin. The process of taking the face impression and the ability to integrate this therapeutic option into a dental sleep practice requires special training. Fusion Sleep Solutions (www.fusioncustommask.com) offers courses in understanding combination therapy and integrated therapy using the FCM and other devices such as the TAP-PAP CS.
Ronald S. Prehn, ThM, DDS, is the owner of Restore TMJ & Sleep Therapy, a patient-centered dental practice that focuses on the diagnosis and treatment of headaches/facial pain, temporomandibular disorders, and sleep-breathing disorders in The Woodlands, Tex. He is a member of the American Academy of Orofacial Pain, the American Academy of Dental Sleep Medicine, and is currently president-elect of the American Board of Dental Sleep Medicine. He is president of Fusion Sleep Solutions, LLC, which teaches courses in combination therapy including how to employ the Fusion Custom Mask.
1. Prehn RS, Swick T. A descriptive report of combination therapy (custom face mask for CPAP integrated with a mandibular advancement splint) for long-term treatment of OSA with literature review. Journal of Dental Sleep Medicine. In Print.
2. Prehn RS, Colquitt T. Fabrication technique for a custom face mask for the treatment of obstructive sleep apnea. JProsthet Dent. 2016;115:551-55.
3. Prehn RS. Sleep and Breathing, 19th Annual Meeting of the American Academy of Dental Sleep Medicine, San Antonio, Texas. 4–6 June 2010;14(4):283.