myofunctional therapy, safety study, orofacial hypotonia, speech therapy


With respect to the stomatognathic system, as a rule, speech therapy used to be restricted to the function of deglutition. At present, the importance of chewing and breathing for both the development and growth of the stomatognathic system is better understood. This study investigates the safety of PRELI DAEMON (AD) in healthy adults and children (i.e., showing no symptoms, signs or complaints of acute illness), and collects impressions on AD use and safety. Method: this is an intervention study with a convenience sample of 10 adults and 20 children. Exclusion criteria: lesions in the oral cavity, and use of orthodontic appliances. Subjects kept prototype device AD in the mouth for 30 uninterrupted minutes while performing routine activities. Participants and trained observers filled in questionnaires about the use of the device. A descriptive analysis with frequency distribution, measures of central tendency and of dispersion were carried out; qualitative data were assessed by reading all responses to the questionnaire, identifying core themes, and categorizing. Results: all volunteers kept AD in their mouths for 30 uninterrupted minutes; no adverse effects occurred during or after use. Discomfort at use was found in 40% of adults and 20% of children. Hypercontraction and lip sealing, lateralization and suction were observed during the use of the device. Conclusions: The device was safe in both age groups.