Temporomandibular DisordersNCT05927545
Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache
A study testing Patient education and preventive exercise, Patient education, preventive exercise combined with Manual Therapy protocol and Patient education, preventive exercise combined with BETY approach in people with Temporomandibular Disorders and Headache, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of Manual Therapy and the Cognitive Exercise Therapy Approach treatment in patients with TMD-related headaches. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders, Headache
- What is being tested?
- Patient education and preventive exercise, Patient education, preventive exercise combined with Manual Therapy protocol and Patient education, preventive exercise combined with BETY approach
- Type of treatment
- 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 Sep 2023to 25 May 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages between 18 and 60 years old
- Getting a diagnosis of TMD-related headache
- Not having received FTR and manual therapy in the last 3 months
- Having pain ≥ 50 or more according to the headache impact test (HIT 6)
- Patients who have not received medical treatment in the last 3 months and will not receive medical treatment during the treatment
- Patients who describe pain in the jaw, face, temporal region or ear for at least 6 months and who have pain in the chewing muscles with palpation
Who cannot join
- Ages under 18 and over 60 years old
- Patients with disc displacement and/or attachment degeneration
- Patients with dental infection
- Patients who have undergone facial and ear surgery in the last six months
- Patients undergoing orthodontic treatment
- Patients using regular analgesics or anti-inflammatory drugs
Show all 12Show fewer
- Patients with a history of trauma (whiplash injury, condylar trauma, fracture),
- Patients who have undergone any surgery related to the cervical and/or TMJ
- Patients with facial paralysis
- Patients with missing teeth in the upper jaw
- Patients with cognitive deficits
- Participation rate lower than 80% of the program schedule
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdulkadir Konukoğlu Sağlıklı Hayat Merkezi
Gaziantep, 27560
About this study
Official title: The Efficacy of Manual Therapy and BETY on Headache and Quality of Life in Patients With Temporomandibular Dysfunction Related Headache
The aim of the study is to investigate the effects of Manual Therapy and the Cognitive Exercise Therapy Approach treatment in patients with TMD-related headaches.
Read the detailed description
60 subjects with TMD-related headaches, according to ICHD-3, will be included in the study after the voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.
Group 1: Patient education and exercise group: The patients in this group will be taught an exercise program after general education. Education training program about parafunctional activities of TMD and active exercises for masticatory and neck muscles. Patients will be asked to complete and follow-up home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. The continuity of the exercises will be ensured by sending reminder messages to this group of patients about doing their exercises once a week by the physiotherapist.
Group 2; Manuel Therapy group: This group will receive the same patient education and exercises additionally manual therapy program which is planned to last 45 minutes will be applied twice a week, for 8 weeks.
Group 3; BETY group: This group will receive the same patient education and exercises in addition BETY approach, which is the Cognitive Exercise Therapy Approach treatment, will be applied in 2 sessions a week for 45 minutes and a total of 8 weeks of treatment.
- Conditions
- Temporomandibular Disorders, Headache
- Being tested
- Patient education and preventive exercise, Patient education, preventive exercise combined with Manual Therapy protocol, Patient education, preventive exercise combined with BETY approach
- Keywords
- Temporomandibular Disorders, Headache, Quality of Life, Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education and preventive exerciseProcedure or surgery
Educational training program and prevention exercises about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Patient education, preventive exercise combined with Manual Therapy protocolProcedure or surgery
Manual therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Patient education, preventive exercise combined with BETY approachProcedure or surgery
BETY therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise: Patient Education and Preventive Exercise | Active comparator | Group 1: The home Exercise Program includes an educational training program about parafunctional activities and correction exercises for patients having TMD-related headaches. The program includes tongue resting position, diaphragmatic breathing, head posture correction exercises, stretching and strengthening exercises for shoulder and back muscles, and active cervical and thoracic mobilization. Receives: Procedure: Patient education and preventive exercise |
| Manual Therapy Combined with Home Exercise | Active comparator | Group 2: MT group includes in addition to the home exercise program, deep friction massage, myofascial release techniques and stretching techniques to masticatory and neck muscles, temporomandibular joint and cervical mobilization will be applied. Receives: Procedure: Patient education, preventive exercise combined with Manual Therapy protocol |
| Cognitive Exercise Therapy Approach Combined with Home Exercise | Active comparator | Group 3: Cognitive Exercise Therapy Approach (CETA) includes cognitive exercise therapy and the home exercise program. The Cognitive Exercise Therapy approach is an innovative exercise approach that aims to change the patient's cognition about the disease through exercise and is suitable for the biopsychosocial model. CETA is an exercise approach aimed at changing the patient's cognitive perception of the disease through exercise, placing the responsibility of disease management on the patient. The approach will be explained in the first session, and patients will be taught proper posture for the neck, shoulders, thoracic, and lumbopelvic region, as well as correct breathing control. Each 1-hour session will include a warm-up, exercise period, and cool-down. Receives: Procedure: Patient education, preventive exercise combined with BETY approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pain at 8 weeks and 5 months
A 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 8 weeks of intervention and at the end of 5 months from baseline.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 5 months
A short form of the McGill Pain Questionnaire (SF-MPQ) will be used. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in pain threshold at 8 weeks and 5 months
A digital pressure pain threshold algometer measuring device will be used to narrow trigger point sensitivity (Wagner Instruments, Greenwich, USA). Pain measurements of pressure to the masseter, temporal, SCM, upper trapezius, suboccipital, and levator scapula muscles will be recorded.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 5 months
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life.
Measured: Baseline, 8 weeks, 5 months
Change from baseline head posture analysis at 8 weeks and 5 months
Head posture will be measured in degrees with the goniometer as the angle between the horizontal plane and the seventh cervical vertebra and the ear line.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 5 months
TMJ ROM: A linear ruler will be used for maximal mouth opening, right and left lateralization, and protrusion values by looking at active and passive.
Cervical ROM: In order to measure its patency, the cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees will be measured and recorded with a goniometer.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in the viscoelastic properties at 8 weeks and 5 months
A digital MyotonPro (Myoton AS, Estonia) instrument measuring device will be used to evaluate the viscoelastic properties of the facial and neck muscles.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in jaw function limitation at 8 weeks and 5 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, 8 weeks, 5 months
Change from baseline in the neck disability index at 8 weeks and 5 months
The neck disability index (NDI) has become a standard tool for measuring self-assessed disability due to neck pain. Each of the 10 items receives a score from 0 to 5. The maximum score is 50.Scoring intervals for interpretation; 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe, Above 34 = complete
Measured: Baseline, 8 weeks, 5 months
Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 5 months
The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in Fatigue severity at 8 weeks and 5 months
The fatigue severity scale has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in anxiety and depression at 8 weeks and 5 months
Hospital Anxiety and Depression scale consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 5 months
The quality of life will be evaluated with Quality of Life-Oral health impact profile-14 (OHIP-14) questionnaire. The index provides a comprehensive measure of self-reported dysfunction, discomfort, and disability resulting from oral conditions whose dimensions are based on Locker's conceptual model of oral health. Responses are rated on a 5-point Likert scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = quite often; 4 = very often/every day. OHIP-14 scores can range from 0 to 56 and are calculated by adding the rank values for 14 items. Area scores can range from 0 to 8. Higher OHIP-14 scores indicate worse, lower scores indicate better OHRQol.
Measured: Baseline, 8 weeks, 5 months
Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 5 months
It is a measurement tool developed in accordance with the biopsychosocial model and evaluating the biopsychosocial status of patients with rheumatic disease. This scale consists of 30 items and consists of questions assessing cognitions related to functionality, mood, fatigue, sleep, pain, sociability and sexuality. The BETY Scale is a total likert-type scale consisting of 30 items. Each item is scored between 0 and 4, and a high score is associated with poor biopsychosocial status. Responses are rated on a 5-point Likert scale; 4: Always, 3: Often, 2: Sometimes, 1: Rarely, 0: No, never
Measured: Baseline, 8 weeks, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2023
- Primary completion25 Feb 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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, Feride ATAY, Hasan Kalyoncu University
- Investigators
- Aysenur TUNCER, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927545
- Sponsor's protocol ID
- 2023-101
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Manual Therapy and BETY on Headache and Quality of Life in Patients With Temporomandibular Dysfunction Related Headache
- ClinicalTrials.gov ID
- NCT05927545
- Acronym / sponsor ID
- 2023-101
- Conditions
- Temporomandibular Disorders, Headache
- Keywords
- Temporomandibular Disorders, Headache, 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 Sep 2023 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 3 Jul 2023 (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 investigate the effects of Manual Therapy and the Cognitive Exercise Therapy Approach treatment in patients with TMD-related headaches.
Detailed description
60 subjects with TMD-related headaches, according to ICHD-3, will be included in the study after the voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.
Group 1: Patient education and exercise group: The patients in this group will be taught an exercise program after general education. Education training program about parafunctional activities of TMD and active exercises for masticatory and neck muscles. Patients will be asked to complete and follow-up home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. The continuity of the exercises will be ensured by sending reminder messages to this group of patients about doing their exercises once a week by the physiotherapist.
Group 2; Manuel Therapy group: This group will receive the same patient education and exercises additionally manual therapy program which is planned to last 45 minutes will be applied twice a week, for 8 weeks.
Group 3; BETY group: This group will receive the same patient education and exercises in addition BETY approach, which is the Cognitive Exercise Therapy Approach treatment, will be applied in 2 sessions a week for 45 minutes and a total of 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Exercise: Patient Education and Preventive Exercise | Active comparator | Procedure: Patient education and preventive exerciseGroup 1: The home Exercise Program includes an educational training program about parafunctional activities and correction exercises for patients having TMD-related headaches. The program includes tongue resting position, diaphragmatic breathing, head posture correction exercises, stretching and strengthening exercises for shoulder and back muscles, and active cervical and thoracic mobilization. |
| Manual Therapy Combined with Home Exercise | Active comparator | Procedure: Patient education, preventive exercise combined with Manual Therapy protocolGroup 2: MT group includes in addition to the home exercise program, deep friction massage, myofascial release techniques and stretching techniques to masticatory and neck muscles, temporomandibular joint and cervical mobilization will be applied. |
| Cognitive Exercise Therapy Approach Combined with Home Exercise | Active comparator | Procedure: Patient education, preventive exercise combined with BETY approachGroup 3: Cognitive Exercise Therapy Approach (CETA) includes cognitive exercise therapy and the home exercise program. The Cognitive Exercise Therapy approach is an innovative exercise approach that aims to change the patient's cognition about the disease through exercise and is suitable for the biopsychosocial model. CETA is an exercise approach aimed at changing the patient's cognitive perception of the disease through exercise, placing the responsibility of disease management on the patient. The approach will be explained in the first session, and patients will be taught proper posture for the neck, shoulders, thoracic, and lumbopelvic region, as well as correct breathing control. Each 1-hour session will include a warm-up, exercise period, and cool-down. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages between 18 and 60 years old
- Getting a diagnosis of TMD-related headache
- Not having received FTR and manual therapy in the last 3 months
- Having pain ≥ 50 or more according to the headache impact test (HIT 6)
- Patients who have not received medical treatment in the last 3 months and will not receive medical treatment during the treatment
Key exclusion criteria (12 listed)
- Ages under 18 and over 60 years old
- Patients with disc displacement and/or attachment degeneration
- Patients with dental infection
- Patients who have undergone facial and ear surgery in the last six months
- Patients 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 |
|---|---|---|
| Patient education and preventive exerciseEducational training program and prevention exercises about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches. | Procedure or surgery | Home Exercise: Patient Education and Preventive Exercise |
| Patient education, preventive exercise combined with Manual Therapy protocolManual therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches. | Procedure or surgery | Manual Therapy Combined with Home Exercise |
| Patient education, preventive exercise combined with BETY approachBETY therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches. | Procedure or surgery | Cognitive Exercise Therapy Approach Combined with Home Exercise |
Primary outcome
Change from baseline in Pain at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
A 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 8 weeks of intervention and at the end of 5 months from baseline.
Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
A short form of the McGill Pain Questionnaire (SF-MPQ) will be used. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Change from baseline in pain threshold at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
A digital pressure pain threshold algometer measuring device will be used to narrow trigger point sensitivity (Wagner Instruments, Greenwich, USA). Pain measurements of pressure to the masseter, temporal, SCM, upper trapezius, suboccipital, and levator scapula muscles will be recorded.
Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often", or "always". These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life.
Change from baseline head posture analysis at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
Head posture will be measured in degrees with the goniometer as the angle between the horizontal plane and the seventh cervical vertebra and the ear line.
Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
TMJ ROM: A linear ruler will be used for maximal mouth opening, right and left lateralization, and protrusion values by looking at active and passive. Cervical ROM: In order to measure its patency, the cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees will be measured and recorded with a goniometer.
Change from baseline in the viscoelastic properties at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
A digital MyotonPro (Myoton AS, Estonia) instrument measuring device will be used to evaluate the viscoelastic properties of the facial and neck muscles.
Change from baseline in jaw function limitation at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 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 the neck disability index at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
The neck disability index (NDI) has become a standard tool for measuring self-assessed disability due to neck pain. Each of the 10 items receives a score from 0 to 5. The maximum score is 50.Scoring intervals for interpretation; 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe, Above 34 = complete
Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Change from baseline in Fatigue severity at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
The fatigue severity scale has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.
Change from baseline in anxiety and depression at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
Hospital Anxiety and Depression scale consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
The quality of life will be evaluated with Quality of Life-Oral health impact profile-14 (OHIP-14) questionnaire. The index provides a comprehensive measure of self-reported dysfunction, discomfort, and disability resulting from oral conditions whose dimensions are based on Locker's conceptual model of oral health. Responses are rated on a 5-point Likert scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = quite often; 4 = very often/every day. OHIP-14 scores can range from 0 to 56 and are calculated by adding the rank values for 14 items. Area scores can range from 0 to 8. Higher OHIP-14 scores indicate worse, lower scores indicate better OHRQol.
Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 5 months
Time frame: Baseline, 8 weeks, 5 months
It is a measurement tool developed in accordance with the biopsychosocial model and evaluating the biopsychosocial status of patients with rheumatic disease. This scale consists of 30 items and consists of questions assessing cognitions related to functionality, mood, fatigue, sleep, pain, sociability and sexuality. The BETY Scale is a total likert-type scale consisting of 30 items. Each item is scored between 0 and 4, and a high score is associated with poor biopsychosocial status. Responses are rated on a 5-point Likert scale; 4: Always, 3: Often, 2: Sometimes, 1: Rarely, 0: No, never
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 3 Sep 2025.
- 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 Patient education and preventive exercise, Patient education, preventive exercise combined with Manual Therapy protocol and Patient education, preventive exercise combined with BETY approach in people with Temporomandibular Disorders and Headache, 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 6 inclusion and 12 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 3 Sep 2025. 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 8 weeks and 5 months (time frame: Baseline, 8 weeks, 5 months). The study lists 14 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 3 Sep 2025.