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

ProSomnus® Sleep Technologies Product Platform Takes Aim at Key Oral Appliance Side Effects
San Francisco, CA, July 31, 2018 – Today, ProSomnus Sleep Technologies announces 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 June 1-3, 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 Effects(1) and called out “unwanted tooth movement” as the most common side effect in oral appliance therapy and calls for clinicians to “to minimize the side effects of OAT”. Norrhem, Nemeczek and Marklund(2) 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; 2-year results using the ProSomnus® MicrO2® Sleep Appliance”. Nikola Vranjes, DDS; Gene Santucci, DDS; Karen Schulze, PhD, ; 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 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.”
    About ProSomnus Sleep Technologies
    ProSomnus® Sleep Technologies designs, manufactures and markets FDA Cleared Class II Medical Devices dentists use to treat patients diagnosed with Obstructive Sleep Apnea. ProSomnus Devices are the first, precision oral appliance therapy devices designed to enhance compliance, mitigate side effects and, enable dentists to achieve excellent patient experiences and outcomes. They have been used to treat thousands of patients, with clinical performance that has been validated in randomize controlled trials, retrospective cohort studies, and numerous clinical case reports.
    1 Rose D. Sheats, DMD; Thomas G. Schell, DMD; Alan O. Blanton, DDS; Patricia M. Braga, DDS; B. Gail Demko, DMD; Leslie C. Dort, DDS; Donald Farquhar, DDS; Sheri G. Katz, DDS; Jean-Francois Masse, DMD; Robert R. Rogers, DMD; Steven C. Scherr, DDS; David B. Schwartz, DDS; Jamison Spencer, DMD, MS. Management of Side Effects of Oral Appliance Therapy for Sleep-Disordered Breathing. Journal of Dental Sleep Medicine 2017; Vol. 4, No. 4.
     2 Norrhem, N., Nemeczek, H. & Marklund, M. Sleep Breath (2017) 21: 607.
    Media Contact :Heather Whalen, Associate VP, Marketing Communications

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