Clinical trial NCT04636606: Efficacy of the Myofunctional Therapy on Oral Dysphagia
Official title: The Efficacy of the Myofunctional Therapy on Oral Dysphagia in Patients With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia, Oral Phase
Temporomandibular Disorders
Keywords: Oral Dysphagia
Temporomandibular Disorders
Quality of Life
Pain
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to analyze the effects of orofacial myofunctional therapy (OMT) on oral dysphagia (OD) in patients with temporomandibular disorders (TMD).

Detailed description: 60 subjects with TMD, according to the Research Diagnostic Criteria, will be included in the study after voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.

Home Exercise (n=20) will be the Group 1, Home Exercise combined with Manual Therapy (n=20) will be the Group 2, and Orofacial Myofunctional Therapy combined with Home Exercise and MT treatment (n=20) will be the Group 3.

Group 1 will include educational training program about parafunctional activities of TMD disorders and active exercises for masticatory and neck muscles with 10 repetitions, 3 times a day, and for 10 weeks.

Group 2 will receive home exercise training program and manual therapy program which is planned to last 30 minutes; will be applied twice a week, for 10 weeks.

Group 3 will include stretching and strengthening of the tongue muscles, tongue rotation exercises, effortful swallowing, strengthen the hyoidal muscles, which is planned to last 40 minutes, will be applied twice a week, for 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 65 years old
* Patients with diagnosis of Group Ia, Ib, IIa and and III according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
* Having pain ≥ 4 according to the Visual Analog Scale
* Having score ≥2 points on the Eating Assessment Tool-10 questionnaire
* Patients who had difficulty in water swallowing tests

Exclusion Criteria:

* Ages under 18 and over 65 years old
* Patients with a diagnosis of Group II b,c according to the RDC / TMD evaluation
* Diagnosis of psychiatric illness
* Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and / or temporomandibular joint (TMJ) problem malignancy, fracture, rheumatoid disease is proven
* Patients who have undergone any surgery related to the cervical and/or TMJ
* Patients with facial paralysis
* Patients with swallowing difficulties due to the neurological disorders
* Patients who have received physical therapy associated with TMJ in less than 6 months
* Patients with cognitive deficits
* Participation rate lower than 80% of the program schedule

Primary outcomes:
measure: Change from Baseline in Pain at 10 weeks and 6 months
timeFrame: Baseline, 10 weeks, 6 months
measure: Change from Baseline in Tongue strength and endurance at 10 weeks and 6 months
timeFrame: Baseline, 10 weeks, 6 months
measure: Change from Baseline in Jaw Function limitation at 10 weeks and 6 months
timeFrame: Baseline, 10 weeks, 6 months
measure: Change from Baseline in Swallowing dysfunction at 10 weeks and 6 months
timeFrame: Baseline, 10 weeks, 6 months
measure: Change from Baseline in Quality of life at 10 weeks and 6 months
timeFrame: Baseline, 10 weeks, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Umut Rehabilitation Center
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References: