Chewing, Swallowing and Orofacial Motricity in Severe Obese

NCT05516693 | Unknown DMC

• 1 other identifier: UniEv005/22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Obesity is considered an epidemic disease of great repercussion on the world and its prevalence has increased in recent decades. The treatment of obesity aims to improve health and quality of life, by reducing body weight. The clinical approach to obesity is routinely the first line of treatment. 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 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 to adapt to the new way of ingesting food. Objectives: 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. Methods: 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 (FAG) 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 (FAG) and referred to the Speech Therapy Clinic according to the eligibility criteria of the research protocol. After the initial assessment, patients will be randomly assigned to an intervention group (MOG) and a control group (COG). The COG and MOG groups will be evaluated before and after bariatric surgery. Only the GMO will be submitted to the speech therapy training program before bariatric surgery. The myofunctional characteristics will be evaluated through the Orofacial Myofunctional Assessment protocol with Scores (AMIOFE). The AMIOFE protocol was designed according to the assessment models 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.

Conditions

Mastication Disorder; Swallowing Disorder; Orofacial Dyskinesia

Keywords

Mastication Disorder; Swallowing Disorder; Orofacial Dyskinesia

Outcome Measures

Primary Outcomes (1)

• Masticatory and swallowing profile

  Orofacial Myofunctional Assessment Protocol with scores ranging from 0 to 4, the closer to four, the higher the normality index.

  1 year

Study Arms (2)

Intervention group (MOG)

EXPERIMENTAL

Patients in the experimental group (MOG) will undergo a myofunctional training protocol.

Other: Myofacial muscle training protocol.

Control group (COG)

NO INTERVENTION

Patients in the control group (COG) will not undergo any intervention, being only evaluated at the beginning and at the end of the protocol.

Interventions

Myofacial muscle training protocol. OTHER

Muscle training for orofacial motricity stimulation

Intervention group (MOG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe obesity, candidates for bariatric surgery, participants in the Bariatric Surgery program at Hospital São Lucas;
• both genders;
• over 18 years of age;
• agree to participate in the study and sign the informed consent form.

You may not qualify if:

• significant dental changes and/or use of dental prostheses
• temporomandibular joint alterations
• clinical and/or mental instability
• sequelae of cerebrovascular disease
• any active cancer;
• pregnancy;
• psychopathies and/or psychiatric illness.

Sponsors & Collaborators

• Centro Universitário de Anapolis: lead
• Centro Universitário Fundação Assis Gurgacz: collaborator

Study Sites (1)

Centro Universitário de Anápolis - UniEVANGÉLICA

Anápolis, Goiás, 75083-515, Brazil

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Dyskinesias

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis VF Oliveira, PhD

  University Center of Anápolis

  STUDY CHAIR

Central Study Contacts

Luis VF Oliveira, PhD

CONTACT

0055 62 999052309; oliveira.lvf@gmail.com

Jenane Topanotti, MSc

CONTACT

0055 45 991560999; fonojenane@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcomes Advisor will be blind to the analysis of the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Model Details: This is a randomized, controlled clinical trial with two intervention arms, involving severely obese adult patients of both sexes referred for bariatric surgery.

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: August 25, 2022
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the end of the study.
• Access Criteria: As per request.

Locations

BR (1)