Characterization of Chewing and Swallowing and Verification of the Effectiveness of Orofacial Motricity Stimulation in Severe Obese Pre and Post Bariatric Surgery: a Randomized Controlled Clinical Trial.

Obesity is considered an epidemic disease of great repercussion on the world stage and its prevalence has increased in recent decades. It is considered that around 1.9 billion adults worldwide are overweight, of which 600 million are obese. The treatment of obesity aims to improve health and quality of life, by reducing body weight, enough to eliminate or reduce comorbidities and promote psychological well-being. The clinical approach to obesity is routinely the first line of treatment prescribed by medical staff. Clinical treatment usually involves a combination of restriction of caloric intake, modification of behavior and habits, regular practice of physical activity, and pharmacotherapy. Clinical treatment of obesity leads to considerable weight loss but is often not sustained in most patients. This long-term sustained weight loss is an attribute of bariatric surgery since severe obesity remains largely refractory to dietary and drug therapy. Changes in lifestyle that occur in severely obese patients undergoing bariatric surgery, especially in terms of food, lead to the need for the contribution of speech therapy, always aiming at a better quality of life for these individuals. These patients will need to adapt to the new way of ingesting food, paying attention to the particularities of masticatory mechanics. The main objective of this study is to analyze the stomatognathic functions of mastication and swallowing and to verify the effectiveness of orofacial motricity stimulation in adults, severely obese before and after bariatric surgery. As specific objectives, it is intended to characterize the masticatory profile after the oral myofunctional intervention, verify the swallowing function for liquids and solids, measure the quality of life and verify a possible correlation between the variables analyzed before and after bariatric surgery in patients with severe obesity. The hypothesis of this study is based on the masticatory and swallowing profile in severely obese patients before and after bariatric surgery, which will present significant differences in muscle mobility while maintaining functionality without major changes.

This is a randomized, controlled clinical trial involving severely obese adult patients of both sexes referred for bariatric surgery. This study was approved by the Research Ethics Committee of the Centro Universitário Fundação Assis Gurgacz in the city of Cascavel (PR), Brazil, protocol number CEP FAG no. 4,169,295. Patients will be consecutively recruited from the Bariatric Surgery Department of Hospital São Lucas, linked to the Fundação Assis Gurgacz University Center (FAG), and referred to the institution's Speech Therapy Clinic according to the eligibility criteria of the research protocol.

The inclusion criteria will be patients with severe obesity, candidate for bariatric surgery, and participant of the Unified Health System (SUS) of the Department of Bariatric Surgery of Hospital São Lucas. Both sexes, aged over 18 years, agreed to participate in the study and signed the Free and Informed Consent Form (FICT). The exclusion criteria will be patients with significant dental alterations, without the use of dental prostheses; diagnosed temporomandibular joint disorders; patients with clinical and/or mental instability; cerebrovascular disease; any type of active cancer and patients with psychopathies and/or psychiatric illness.

After the initial assessment, patients will be randomly assigned to an intervention group (GMO) and a control group (GCO). The numbers for randomization will be created from a random table in the Speech-Language Pathology and Audiology Laboratory-FAG. In this place, a sequence of sealed, opaque, and serial numbered envelopes will be created, thus ensuring secrecy. Each envelope will contain a card, with the inscription of which group the patient should participate. After randomization of patients, the GMO intervention group will use oral myofunctional therapy as clinically indicated, for 60 days before bariatric surgery.

The GCO and GMO groups will be evaluated before and after bariatric surgery. Only the GMO will be submitted to the speech therapy training program before bariatric surgery. After bariatric surgery, all subjects will be reassessed. The clinical evaluation of oral motricity will be performed through palpation of the masseter and temporal muscles. The myofunctional characteristics will be evaluated through visual inspection, using the Orofacial Myofunctional Assessment protocol with Scores (AMIOFE). The AMIOFE protocol was designed according to the assessment models, with the addition of numerical scales that reflect the physical characteristics and orofacial behaviors of individuals. In this way, the components and functions of the stomatognathic system will be evaluated in terms of appearance/posture, mobility, and swallowing functions - liquid and solid - chewing and breathing.