SML – Space Maintainers Laboratories’ Clear Sleep reduces nighttime snoring and mild-to-moderate obstructive sleep apnea (OSA) in adults by moving the mandible forward in 1 mm increments and opening the airway for easier, unrestricted breathing. The device received FDA clearance in 2017 and SML began fabricating it in April 2018.
The appliance consists of the following features:
- Customized upper and lower trays to meet the needs of each individual patient
- Patented strong and durable stabilizing posts for attachment of connector rods
- A series changeable connector rods that provide for mandibular advancement in 1 mm increments
- Up to 7 mm advancement (based on protrusive bite provided with the working models)
The customized trays can be fabricated using various materials based on individual patient needs as follows:
- The standard design is comprised of two lightweight, low volume (PMT) pressure molded trays using dual laminate material that BPA-free. This design requires fairly well aligned teeth with few edentulous spaces.
- All acrylic trays: In the event of numerous mal-aligned teeth, several edentulous areas, or lack of sufficient natural undercuts, the recommended design is fabricated using MMPA splint acrylic and incorporates several ball clasps for retention. This allows for fine-tuning the retention based on the patients needs.
- If patient is a heavy bruxer or clencher: an anterior discluding element, and/or bilateral posterior acrylic pads, can be added to both the PMT and the all Acrylic designs to help control bruxism or to increase vertical if needed for patients with TMD. These additions can be easily modified as needed during treatment.