ProSomnus® Sleep Technologies
Announces Publication of a 2-Year Clinical Study
Assessment of Potential Tooth Movement and Bite Changes with a Hard-Acrylic Sleep Appliance(1)
ProSomnus Sleep Technologies is the Leader in Precision Oral Appliance Therapy for OSA
San Francisco, CA, May 8, 2019 – ProSomnus Sleep Technologies announced publication of a longitudinal study investigating tooth movement side effects of Oral Appliance Therapy for patients with Obstructive Sleep Apnea. Prior research and clinical practice have established tooth mobility as a side effect for patients with OSA, treated with traditional OAT devices. The outcomes of this study suggest that clinicians may be able to avoid the tooth mobility side effect by prescribing precision OAT Medical Devices.
“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, study co-author. “The ball clasps found on traditional OAT devices, though retentive, can create interproximal gaps, one of the side effects we are trying to avoid.”
Published in the Journal of Dental Sleep Medicine, this study showed that there was no significant tooth movement upon regular wear over a minimum 2-year period (see fig. 1 & 2). Additionally, patients reported excellent acceptance and compliance during the time period reported. The result of this study addressed one of the key concerns of Physicians(2). Tooth mobility has been identified as one of the main barriers for prescribing OAT to non-compliant CPAP patients or to patients who prefer alternative therapies.
“Managing side effects is critical to patient and Physician acceptance of OAT, this research and the ProSomnus Sleep Device help reduce unwanted tooth movement as a barrier to treatment,” stated Dr. Gene Santucci, DDS, study co-author. 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.”
“As a referring Physician, studies like this increase my confidence in prescribing OAT for patients with OSA. The results of the study are representative of what we observe clinically when a precision Medical Device for OAT is prescribed,” commented Dr. Edward T. Sall, DDS, MD. “It is encouraging to see companies utilizing technology to improve outcomes for patients with OSA.”
(1)Vranjes N, Santucci G, Schulze K, Kuhns D, Khai A. Assessment of potential tooth movement and bite changes with a hard-acrylic sleep appliance: A 2-year clinical study. J Dent Sleep Med. 2019;6(2).
(2)Oral Appliance Therapy Awareness and Perceptions Survey, by Sree Roy. Sleep Review. January 2016.
About ProSomnus Sleep Technologies
ProSomnus® Sleep Technologies designs, manufactures and markets FDA Cleared Class II Medical Devices for the treatment of Obstructive Sleep Apnea. Diagnosed by Medical Doctors and provided by Dentists, ProSomnus Devices are the first, precision oral appliance therapy devices designed to enhance compliance, mitigate side effects and, enable providers to achieve excellent patient experiences and outcomes. They have been used to treat thousands of patients, with clinical performance that has been validated in numerous studies.
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