ProSomnus® Sleep Technologies Product Platform Takes Aim at Key Oral Appliance Side Effects


On 3rd August, ProSomnus Sleep Technologies announced acceptance and presentation of evidence-based research on Oral Appliance Therapy as presented at the American Academy of Dental Sleep Medicine 27th Annual Meeting held 1st-3rd June 2018 in Baltimore, MD. ProSomnus supported research that resulted in study data demonstrating no significant tooth movement in 2.3 years.

The AADSM published a guidance paper on Management of Side Effects1 and called out “unwanted tooth movement” as the most common side effect in oral appliance therapy and calls for clinicians to “to minimise the side effects of OAT”. Norrhem, Nemeczek and Marklund2 reported the benefits of a rigid appliance over a flexible appliance in reducing tooth movement. The ProSomnus research further confirms the benefit of a rigid appliance to control the side effect of unwanted tooth movement.

The poster presented, “Tooth movement and bite changes for a hard-acrylic sleep appliance; two-year results using the ProSomnus® MicrO2® Sleep Appliance”. Nikola Vranjes, DDS; Gene Santucci, DDS; Karen Schulze, PhD, DDS; David Kuhns, PhD; Allen Khai; Janelle Brown. Models and measurements were made independently at the Orthodontic department at the University of the Pacific.

• Used the Littles Irregularity Index to measure the impact of a hard-acrylic appliance on tooth movement over several years period of time.

• Reported results showed no significant tooth movement change over a 2.3-year period using the Littles Index.

• Addtionally, no statistical significant change was reported in overjet or overbite when the patient’s models were placed in MIP (Maximum Intercuspation).

• ProSomnus Sleep Device was used without ball clasps or a soft liner and initially confirms the goal of a retainer-like fit.

“What is interesting about these results is that the ProSomnus Sleep Device is able to achieve excellent fit and retention without the use of ball clasps or soft liners and this enables successful control of tooth movement,” comments Dr. Nikola Vranjes, DDS. “Ball clasps themselves, though retentive, can create interproximal gaps, one of the side effects we are trying to avoid.”

“Managing side effects is critical to patient and physician acceptance of oral appliance therapy, this research and the ProSomnus appliances help reduce unwanted tooth movement as a barrier to treatment,” stated Dr. Gene Santucci, DDS. "Therefore, it was important that at the University of Pacific in SF, we scanned all the models and made all the measurements blinding the patient data and time points to ensure the lowest level of bias.”

“This research validates the goal of the ProSomnus platform to provide a comfortable, efficacious treatment while mitigating key side effects such as unwanted tooth movement,” stated Mr. David Kuhns, VP of Technology for ProSomnus Sleep Technologies. “Clinicians now have a choice in appliance therapy that aligns with the AADSM guideline to minimize unwanted tooth movement using ProSomnus Sleep Devices.”