Temporomandibular Disorders (TMD)TMD-BPSNCT07320144
Effects of a Biopsychosocial Approach Added to Physiotherapy in Temporomandibular Disorders
A study testing Physiotherapy Program and Biopsychosocial Intervention in people with Temporomandibular Disorders (TMD), run by Betül Özata.
Trial summary
Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Physiotherapy Program and Biopsychosocial Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with temporomandibular disorders
- Age between 18 and 65 years
- Presence of stress, sleep disturbance, or bruxism symptoms
- Ability to understand and follow study instructions
- Willingness to participate and provide informed consent
Who cannot join
- History of temporomandibular joint surgery
- Presence of neurological, rheumatological, or systemic diseases affecting the musculoskeletal system
- Current orthodontic treatment
- Use of medications that may affect pain perception or sleep
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effects of a Biopsychosocial Approach Added to Physiotherapy on Stress, Sleep Disturbance, and Bruxism in Individuals With Temporomandibular Disorders
Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms.
The purpose of this study is to examine whether adding a biopsychosocial approach to physiotherapy improves stress levels, sleep quality, and bruxism in individuals with temporomandibular disorders. Participants will receive either physiotherapy alone or physiotherapy combined with education about pain, stress management, and sleep habits. The results of this study may help improve treatment strategies for people with temporomandibular disorders.
Read the detailed description
This randomized interventional study aims to investigate the effects of adding a biopsychosocial approach to physiotherapy in individuals with temporomandibular disorders. Temporomandibular disorders are multifactorial conditions influenced by physical, psychological, and social factors. While physiotherapy is effective in reducing pain and improving function, psychosocial factors such as stress, sleep disturbance, and bruxism may contribute to symptom persistence.
Participants will be randomly assigned to one of two groups. The control group will receive a standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures. The intervention group will receive the same physiotherapy program in addition to a biopsychosocial intervention consisting of pain neuroscience education, stress management strategies, and sleep hygiene education.
Outcome measures will include stress levels, sleep disturbance, and bruxism severity as primary outcomes, and pain intensity and jaw function as secondary outcomes. Assessments will be conducted at baseline and after the intervention period. This study is expected to provide evidence on the effectiveness of integrating a biopsychosocial approach into physiotherapy for temporomandibular disorders.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Physiotherapy Program, Biopsychosocial Intervention
- Keywords
- Temporomandibular joint, Pain education, Bruxism, Sleep quality, Biopsychosocial approach
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy ProgramOther
A standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures.
Biopsychosocial InterventionOther
A biopsychosocial intervention including pain neuroscience education, stress management strategies, and sleep hygiene education.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | Participants in this arm will receive a standardized physiotherapy program for temporomandibular disorders, including therapeutic exercises and manual therapy targeting the temporomandibular joint and associated musculoskeletal structures. Receives: Other: Physiotherapy Program |
| Physiotherapy Plus Biopsychosocial Approach | Experimental | Participants in this arm will receive the same physiotherapy program combined with a biopsychosocial intervention including pain education, stress management strategies, and sleep hygiene education. Receives: Other: Physiotherapy Program; Other: Biopsychosocial Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Level
Stress level will be assessed using a validated self-reported questionnaire to evaluate perceived stress in individuals with temporomandibular disorders.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Sleep Disturbance
Sleep disturbance will be assessed using a validated questionnaire evaluating sleep quality and sleep-related problems.
Measured: Baseline and 6 weeks
Bruxism Severity
Bruxism severity will be evaluated based on self-reported measures assessing teeth grinding and clenching behaviors.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies 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
- Model description
- Participants will be randomly assigned to either physiotherapy alone or physiotherapy combined with a biopsychosocial approach.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betül Özata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Betül Özata, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320144
- Sponsor's protocol ID
- TMD-BPS-2025
- Other IDs
- 2025310
- Acronym
- TMD-BPS
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves sensitive personal and health-related information, and data sharing was not included in the original ethical approval. Data will be used solely for the purposes of this study and related scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of a Biopsychosocial Approach Added to Physiotherapy on Stress, Sleep Disturbance, and Bruxism in Individuals With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07320144
- Acronym / sponsor ID
- TMD-BPS / TMD-BPS-2025
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Temporomandibular joint, Pain education, Bruxism, Sleep quality, Biopsychosocial approach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Betül ÖzataUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms.
The purpose of this study is to examine whether adding a biopsychosocial approach to physiotherapy improves stress levels, sleep quality, and bruxism in individuals with temporomandibular disorders. Participants will receive either physiotherapy alone or physiotherapy combined with education about pain, stress management, and sleep habits. The results of this study may help improve treatment strategies for people with temporomandibular disorders.
Detailed description
This randomized interventional study aims to investigate the effects of adding a biopsychosocial approach to physiotherapy in individuals with temporomandibular disorders. Temporomandibular disorders are multifactorial conditions influenced by physical, psychological, and social factors. While physiotherapy is effective in reducing pain and improving function, psychosocial factors such as stress, sleep disturbance, and bruxism may contribute to symptom persistence.
Participants will be randomly assigned to one of two groups. The control group will receive a standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures. The intervention group will receive the same physiotherapy program in addition to a biopsychosocial intervention consisting of pain neuroscience education, stress management strategies, and sleep hygiene education.
Outcome measures will include stress levels, sleep disturbance, and bruxism severity as primary outcomes, and pain intensity and jaw function as secondary outcomes. Assessments will be conducted at baseline and after the intervention period. This study is expected to provide evidence on the effectiveness of integrating a biopsychosocial approach into physiotherapy for temporomandibular disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either physiotherapy alone or physiotherapy combined with a biopsychosocial approach.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Other: Physiotherapy ProgramParticipants in this arm will receive a standardized physiotherapy program for temporomandibular disorders, including therapeutic exercises and manual therapy targeting the temporomandibular joint and associated musculoskeletal structures. |
| Physiotherapy Plus Biopsychosocial Approach | Experimental | Other: Physiotherapy Program, Other: Biopsychosocial InterventionParticipants in this arm will receive the same physiotherapy program combined with a biopsychosocial intervention including pain education, stress management strategies, and sleep hygiene education. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with temporomandibular disorders
- Age between 18 and 65 years
- Presence of stress, sleep disturbance, or bruxism symptoms
- Ability to understand and follow study instructions
- Willingness to participate and provide informed consent
Key exclusion criteria (5 listed)
- History of temporomandibular joint surgery
- Presence of neurological, rheumatological, or systemic diseases affecting the musculoskeletal system
- Current orthodontic treatment
- Use of medications that may affect pain perception or sleep
- Pregnancy
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 |
|---|---|---|
| Physiotherapy ProgramA standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures. | Other | Physiotherapy, Physiotherapy Plus Biopsychosocial Approach |
| Biopsychosocial InterventionA biopsychosocial intervention including pain neuroscience education, stress management strategies, and sleep hygiene education. | Other | Physiotherapy Plus Biopsychosocial Approach |
Primary outcome
Stress Level
Time frame: Baseline and 6 weeks
Stress level will be assessed using a validated self-reported questionnaire to evaluate perceived stress in individuals with temporomandibular disorders.
2 secondary outcomes
Sleep Disturbance
Time frame: Baseline and 6 weeks
Bruxism Severity
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves sensitive personal and health-related information, and data sharing was not included in the original ethical approval. Data will be used solely for the purposes of this study and related scientific publications.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Program and Biopsychosocial Intervention in people with Temporomandibular Disorders (TMD), run by Betül Özata.
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 5 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: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Özata, MSc (+905395669393, ptbetulozata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Level (time frame: Baseline and 6 weeks). 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 6 Jan 2026.