Efficacy of the Myofunctional Therapy on Oral Dysphagia

August 23, 2021 updated by: Hazel Çelik Güzel, Hasan Kalyoncu University

The Efficacy of the Myofunctional Therapy on Oral Dysphagia in Patients With Temporomandibular Disorders

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Şanlıurfa, Turkey
        • Umut Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Home Exercise
Home Exercise program includes educational training program about parafunctional activities of patients having oral dysphagia with temporomandibular disorders. Program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.
Procedure: Home Exercise
Educational training program about oral dysphagia in patients with temporomandibular disorders.
Active Comparator: Manual Therapy Combined with Home Exercise

Manual Therapy includes deep friction massage and myofascial relaxation techniques to masticatory and neck muscles, active and resistant temporomandibular joint movements, temporomandibular joint distraction and mobilization, stretching techniques to the temporomandibular joint, mobilization of upper cervical joints.

Home Exercise program includes educational training program about parafunctional activities of patients having oral dysphagia with temporomandibular disorders. Program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.
Procedure: Manual Therapy Combined with Home Exercise
Manual therapy program combined with educational training program about oral dysphagia in patients with temporomandibular disorders.
Active Comparator: Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise

Orofacial Myofunctional therapy includes stretching the tongue muscles, tongue rotation exercises, isometric and isotonic strengthening of the tongue, special maneuver, effortful swallow exercise, strengthening exercise of hyoidal muscles.

Manual Therapy includes deep friction massage and myofascial relaxation techniques to masticatory and neck muscles, active and resistant temporomandibular joint movements, temporomandibular joint distraction and mobilization, stretching techniques to the temporomandibular joint, mobilization of upper cervical joints.

Home Exercise program includes educational training program about parafunctional activities of patients having oral dysphagia with temporomandibular disorders. Program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.
Procedure: Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise
Orofacial Myofunctional Therapy program with combination of Manual therapy and educational training program about oral dysphagia in patients with temporomandibular disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pain at 10 weeks and 6 months
Time Frame: Baseline, 10 weeks, 6 months
Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 10 weeks intervention and at the end 6 months from baseline.
Baseline, 10 weeks, 6 months
Change from Baseline in Tongue strength and endurance at 10 weeks and 6 months
Time Frame: Baseline, 10 weeks, 6 months

Tongue strength will be assessed by Iowa Oral Performance Instrument with the measurement of muscle strength by tongue muscle pressure.

Tongue endurance will be measured with the Iowa Oral Performance Instrument by quantifying the length of time that a patient may maintain 50% of his or her maximum pressure.
Baseline, 10 weeks, 6 months
Change from Baseline in Jaw Function limitation at 10 weeks and 6 months
Time Frame: Baseline, 10 weeks, 6 months
Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients will be asked from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).
Baseline, 10 weeks, 6 months
Change from Baseline in Swallowing dysfunction at 10 weeks and 6 months
Time Frame: Baseline, 10 weeks, 6 months

The first evaluation for swallowing dysfunction will be assessed with 100 ml water swallow test (WST). For the WST, we will be ask participants to consume 100ml of water in the shortest amount of time. Patients will be assessed to have failed the WST according to published criteria of, (1) coughing or choking post swallow, (2) having a wet voice quality post swallow, or (3) being unable to drink the whole amount of water. Furthermore, the swallowing speed will be evaluated as the amount of consumed water divided by the elapsed time.

The second evaluation for swallowing dysfunction will be assessed with Eating Assessment Tool-10 (EAT-10) questionnaire. The EAT-10 is a self-administered, symptom-specific outcome assessment for swallowing dysfunction, demonstrating good consistency, reproducibility, and validity. It consists of 10 questions answered in a scale of 0 to 4 (0: no problem to 4: severe problem), with the higher scores indicating severe dysphagic symptoms.
Baseline, 10 weeks, 6 months
Change from Baseline in Quality of life at 10 weeks and 6 months
Time Frame: Baseline, 10 weeks, 6 months
The quality of life will be evaluated with Swallowing-related Quality of Life questionnaire (Swal-QoL). The SWAL-QoL is a dysphagia specific quality of life instrument consisting of 44 items (11 scales) assessing ten QOL domains: food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Sleep and fatigue contribute to general QOL, whereas the other domains are contributors to dysphagia-specific QOL. The total SWAL-QOL score includes 23 items from seven domains.
Baseline, 10 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

June 25, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

November 15, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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