Dysphagia, Oral PhaseNCT04636606
Efficacy of the Myofunctional Therapy on Oral Dysphagia
A study testing Home Exercise, Manual Therapy Combined with Home Exercise and Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise in people with Dysphagia, Oral Phase and Temporomandibular Disorders, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysphagia, Oral Phase, Temporomandibular Disorders
- What is being tested?
- Home Exercise, Manual Therapy Combined with Home Exercise and Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Dysphagia, Oral Phase, Temporomandibular Disorders
- Being tested
- Home Exercise, Manual Therapy Combined with Home Exercise, Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise
- Keywords
- Oral Dysphagia, Temporomandibular Disorders, Quality of Life, Pain
- Medical subject headings
- Deglutition Disorders, Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ExerciseProcedure or surgery
Educational training program about oral dysphagia in patients with temporomandibular disorders.
Manual Therapy Combined with Home ExerciseProcedure or surgery
Manual therapy program combined with educational training program about oral dysphagia in patients with temporomandibular disorders.
Orofacial Myofunctional Therapy combined with Manual Therapy and Home ExerciseProcedure or surgery
Orofacial Myofunctional Therapy program with combination of Manual therapy and educational training program about oral dysphagia in patients with temporomandibular disorders.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise | Active comparator | 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. Receives: Procedure: Home Exercise |
| Manual Therapy Combined with Home Exercise | Active comparator | 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. Receives: Procedure: Manual Therapy Combined with Home Exercise |
| Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise | Active comparator | 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. Receives: Procedure: Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain at 10 weeks and 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.
Measured: Baseline, 10 weeks, 6 months
Change from Baseline in Tongue strength and endurance at 10 weeks and 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.
Measured: Baseline, 10 weeks, 6 months
Change from Baseline in Jaw Function limitation at 10 weeks and 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).
Measured: Baseline, 10 weeks, 6 months
Change from Baseline in Swallowing dysfunction at 10 weeks and 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.
Measured: Baseline, 10 weeks, 6 months
Change from Baseline in Quality of life at 10 weeks and 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.
Measured: Baseline, 10 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Dec 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, Oral PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636606
- Sponsor's protocol ID
- 2019/131
- Status last verified
- Aug 2021
- First submitted
- 15 Nov 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Myofunctional Therapy on Oral Dysphagia in Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04636606
- Acronym / sponsor ID
- 2019/131
- Conditions
- Dysphagia, Oral Phase, Temporomandibular Disorders
- Keywords
- Oral Dysphagia, Temporomandibular Disorders, Quality of Life, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Exercise | Active comparator | Procedure: Home ExerciseHome 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. |
| Manual Therapy Combined with Home Exercise | Active comparator | Procedure: Manual Therapy Combined with Home ExerciseManual 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. |
| Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise | Active comparator | Procedure: Orofacial Myofunctional Therapy combined with Manual Therapy and Home ExerciseOrofacial 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home ExerciseEducational training program about oral dysphagia in patients with temporomandibular disorders. | Procedure or surgery | Home Exercise |
| Manual Therapy Combined with Home ExerciseManual therapy program combined with educational training program about oral dysphagia in patients with temporomandibular disorders. | Procedure or surgery | Manual Therapy Combined with Home Exercise |
| Orofacial Myofunctional Therapy combined with Manual Therapy and Home ExerciseOrofacial Myofunctional Therapy program with combination of Manual therapy and educational training program about oral dysphagia in patients with temporomandibular disorders. | Procedure or surgery | Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise |
Primary outcome
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.
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.
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise, Manual Therapy Combined with Home Exercise and Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise in people with Dysphagia, Oral Phase and Temporomandibular Disorders, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain at 10 weeks and 6 months (time frame: Baseline, 10 weeks, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.