Temporomandibular DisorderNCT05352438
Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction
A study testing Manual Therapy Group and Splint Therapy Group in people with Temporomandibular Disorder and Myofascial Pain, run by Turkoglu Dr. Kemal Beyazit State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Temporomandibular Disorder, Myofascial Pain, Bruxism
- What is being tested?
- Manual Therapy Group and Splint Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2019to 27 Jul 2020
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ages between 18 and 50 years old,
- Patients with a diagnosis of myofascial TMD with Bruxism according to the diagnostic criteria for temporomandibular disorders (DC/TMD),
- Having pain severity ≥3 according to the Visual analogue scale (VAS),
- Probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment.
Who cannot join
- Patients with a diagnosis other than myofascial TMD according to the research DC/TMD,
- a history of surgery associated with cervical and/or TMJ problems,
- a proven specific pathological condition such as cervical and/or TMJ malignancy, fracture, or systemic rheumatoid disease,
- a history of facial paralysis, a diagnosed psychiatric disease,
- if they were undergoing orthodontic treatment,
- had received physiotherapy within the last 3 months,
- or could not be co-operative.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Türkoğlu Dr. Kemal Beyazıt State Hospital
Kahramanmaraş
About this study
Official title: Investigation of the Effectiveness of Manual Therapy and Splint Therapy in Patients With Myofascial Temporomandibular Dysfunction Combined With Bruxism
The aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.
Read the detailed description
A total of 56 patients were evaluated. Among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study.
The patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope.
Those who selected a double-digit number were assigned to the manual therapy (MT) group (n:18) and those with a single-digit number to the splint therapy (ST) group (n:18).
After the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 MT and 14 ST) who completed the 4-week treatment process.
- Conditions
- Temporomandibular Disorder, Myofascial Pain, Bruxism
- Being tested
- Manual Therapy Group, Splint Therapy Group
- Keywords
- Temporomandibular Dysfunction, Bruxism, Manual Therapy, Splint
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy GroupOther
Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.
In addition to the patient education and home exercises, the Manual Therapy group received a manual therapy program applied as 2 sessions of 45 mins each week for 4 weeks (total 8 sessions) by an investigator. Soft tissue and joint mobilizations were applied to the TMJ and surrounding structures and to cervical segments, trigger point treatment was applied to trigger points, and myofascial loosening was performed. Patients were instructed to perform the exercises learned in the home exercise program in 3 sets of 10 repetitions every day.
Splint Therapy GroupOther
Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.
In addition to the patient education and home exercises, the Splint Therapy group was given a static occlusal splint, and adjustments were made as necessary. All the patients in this group were instructed to use the splint when sleeping for a period of one month.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | Manual Therapy combined with education and home exercises Receives: Other: Manual Therapy Group |
| Splint Therapy Group | Experimental | Splint Therapy combined with education and home exercises Receives: Other: Splint Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain severity at 4 weeks
Pain severity was measured with a Visual Analogue Scale (VAS), marked from 0 to 10, where 0 indicates no pain and 10 indicates intolerable pain. The patients were instructed to mark the scale corresponding to the severity of pain felt.
Measured: Baseline, 4 weeks
Change frim Baseline in Fatigue severity at 4 weeks
Fatigue level was measured with the Fatigue Severity Scale, where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Measured: Baseline, 4 weeks
Change from Baseline in Sleep quality at 4 weeks
The sleep quality of patients was analyzed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI includes 24 items related to both daytime and nocturnal sleep. The responses were scored from 0-3, as 7 subscores to give a global score of total points in the range of 0-21. A score of ≥5 indicated poor sleep quality.
Measured: Baseline, 4 weeks
Change from Baseline in Jaw Function limitation at 4 weeks
Jaw function limitation was measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients asked for 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, 4 weeks
Change from Baseline in Neck Disability at 4 weeks
Neck Disability Index, consists of 10 items. Individuals included in the study were asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).
Measured: Baseline, 4 weeks
Change from Baseline in Patient Satisfaction questionnaire at 4 weeks.
The Patient Satisfaction questionnaire was used to assess the patient's satisfaction with the treatment received. The patient satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.
Measured: Baseline, 4 weeks
Change from Baseline in Headache severity at 4 weeks
The Headache Impact Test-6 (HIT-6) was used to assess the headache. The 6-item scale evaluates the frequency, the degree of restriction to daily life and social life, and changes in the mood. The total score of 50-59 reflects the important impact, and scores ≥60 indicate severe impact.
Measured: Baseline, 4 weeks
Secondary outcomes (4)
Change from Baseline in Head Posture at 4 weeks
Head posture is defined as the craniovertebral angle. It is the angle formed by the intersection of a horizontal line along the spinous process of C7 and the line drawn towards the ear tragus. A craniovertebral angle of <48-50° is accepted as an anterior tilt of the head.
Measured: Baseline, 4 weeks
Change from Baseline in Cervical Range of Motion at 4 weeks
A goniometer was used to measure the cervical region's range of motion (ROM). Cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees were measured and recorded.
Measured: Baseline, 4 weeks
Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks
For maximal mouth opening, the distance between the upper and lower incisors was measured and recorded. For protrusion, the distance between the lower and upper incisors was measured horizontally by asking the patient to bring the lower jaw forward as far as possible while the posterior teeth were in contact with each other. For right and left lateral shifts, the distance between the upper and lower incisors was measured by asking the patient to slide it to the right and left separately as much as possible.
Measured: Baseline, 4 weeks
Change from Baseline in Trigger points at 4 weeks
While the participants were in the supine position the masseter, temporalis, pyterigoideus lateralis, pyterigoideus medialis, and digastric muscles were evaluated. In the sitting position, the sternoclavicular, suboccipital, and upper trapezius muscles were palpated, and the trigger points in these muscles and their number were evaluated.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start21 Jan 2019
- Primary completion28 Feb 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkoglu Dr. Kemal Beyazit State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süreyya DAMAR ÖRENLER, Turkoglu Dr. Kemal Beyazit State Hospital
- Investigators
- Aysenur Tuncer, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352438
- Sponsor's protocol ID
- 2019-67
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Manual Therapy and Splint Therapy in Patients With Myofascial Temporomandibular Dysfunction Combined With Bruxism
- ClinicalTrials.gov ID
- NCT05352438
- Acronym / sponsor ID
- 2019-67
- Conditions
- Temporomandibular Disorder, Myofascial Pain, Bruxism
- Keywords
- Temporomandibular Dysfunction, Bruxism, Manual Therapy, Splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Turkoglu Dr. Kemal Beyazit State HospitalUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 28 Apr 2022 (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 this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.
Detailed description
A total of 56 patients were evaluated. Among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study.
The patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope.
Those who selected a double-digit number were assigned to the manual therapy (MT) group (n:18) and those with a single-digit number to the splint therapy (ST) group (n:18).
After the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 MT and 14 ST) who completed the 4-week treatment process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Other: Manual Therapy GroupManual Therapy combined with education and home exercises |
| Splint Therapy Group | Experimental | Other: Splint Therapy GroupSplint Therapy combined with education and home exercises |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages between 18 and 50 years old,
- Patients with a diagnosis of myofascial TMD with Bruxism according to the diagnostic criteria for temporomandibular disorders (DC/TMD),
- Having pain severity ≥3 according to the Visual analogue scale (VAS),
- Probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment.
Key exclusion criteria (7 listed)
- Patients with a diagnosis other than myofascial TMD according to the research DC/TMD,
- a history of surgery associated with cervical and/or TMJ problems,
- a proven specific pathological condition such as cervical and/or TMJ malignancy, fracture, or systemic rheumatoid disease,
- a history of facial paralysis, a diagnosed psychiatric disease,
- if they were undergoing orthodontic treatment,
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 |
|---|---|---|
| Manual Therapy GroupPatient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day. In addition to the patient education and home exercises, the Manual Therapy group received a manual therapy program applied as 2 sessions of 45 mins each week for 4 weeks (total 8 sessions) by an investigator. Soft tissue and joint mobilizations were applied to the TMJ and surrounding structures and to cervical segments, trigger point treatment was applied to trigger points, and myofascial loosening was performed. Patients were instructed to perform the exercises learned in the home exercise program in 3 sets of 10 repetitions every day. | Other | Manual Therapy Group |
| Splint Therapy GroupPatient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day. In addition to the patient education and home exercises, the Splint Therapy group was given a static occlusal splint, and adjustments were made as necessary. All the patients in this group were instructed to use the splint when sleeping for a period of one month. | Other | Splint Therapy Group |
Primary outcome
Change from Baseline in Pain severity at 4 weeks
Time frame: Baseline, 4 weeks
Pain severity was measured with a Visual Analogue Scale (VAS), marked from 0 to 10, where 0 indicates no pain and 10 indicates intolerable pain. The patients were instructed to mark the scale corresponding to the severity of pain felt.
Change frim Baseline in Fatigue severity at 4 weeks
Time frame: Baseline, 4 weeks
Fatigue level was measured with the Fatigue Severity Scale, where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Change from Baseline in Sleep quality at 4 weeks
Time frame: Baseline, 4 weeks
The sleep quality of patients was analyzed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI includes 24 items related to both daytime and nocturnal sleep. The responses were scored from 0-3, as 7 subscores to give a global score of total points in the range of 0-21. A score of ≥5 indicated poor sleep quality.
Change from Baseline in Jaw Function limitation at 4 weeks
Time frame: Baseline, 4 weeks
Jaw function limitation was measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients asked for 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 Neck Disability at 4 weeks
Time frame: Baseline, 4 weeks
Neck Disability Index, consists of 10 items. Individuals included in the study were asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).
Change from Baseline in Patient Satisfaction questionnaire at 4 weeks.
Time frame: Baseline, 4 weeks
The Patient Satisfaction questionnaire was used to assess the patient's satisfaction with the treatment received. The patient satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.
Change from Baseline in Headache severity at 4 weeks
Time frame: Baseline, 4 weeks
The Headache Impact Test-6 (HIT-6) was used to assess the headache. The 6-item scale evaluates the frequency, the degree of restriction to daily life and social life, and changes in the mood. The total score of 50-59 reflects the important impact, and scores ≥60 indicate severe impact.
4 secondary outcomes
Change from Baseline in Head Posture at 4 weeks
Time frame: Baseline, 4 weeks
Change from Baseline in Cervical Range of Motion at 4 weeks
Time frame: Baseline, 4 weeks
Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks
Time frame: Baseline, 4 weeks
Change from Baseline in Trigger points at 4 weeks
Time frame: Baseline, 4 weeks
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 28 Apr 2022.
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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 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 Manual Therapy Group and Splint Therapy Group in people with Temporomandibular Disorder and Myofascial Pain, run by Turkoglu Dr. Kemal Beyazit State Hospital 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 4 inclusion and 7 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 28 Apr 2022. 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 severity at 4 weeks (time frame: Baseline, 4 weeks). The study lists 7 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 28 Apr 2022.