Temporomandibular Disorder (TMD)NCT07534540
OMT vs Exercise in TMD
A study testing Home-based Exercise Program and Osteopathic Manipulative Treatment (OMT) in people with Temporomandibular Disorder (TMD), run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate whether different rehabilitation approaches can improve pain, function, and postural control in individuals with temporomandibular disorders (TMD). The study focuses on adults diagnosed with myogenic TMD. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder (TMD)
- What is being tested?
- Home-based Exercise Program and Osteopathic Manipulative Treatment (OMT)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 26 Dec 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- TMD Group:
- Diagnosis of temporomandibular disorder (TMD) confirmed by a dentist
- Pain intensity ≥ 3.5 cm on the Visual Analog Scale (VAS)
- Presence of TMD-related pain for at least 3 months
- Aged between 18 and 50 years
- Willingness to participate in the study
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- Control Group:
- No history or clinical signs of temporomandibular disorder (TMD)
- Aged between 18 and 50 years
- Willingness to participate in the study
Who cannot join
- TMD Group:
- Presence of any condition other than TMD that may affect the assessment outcomes
- Presence of musculoskeletal pain in any other body region
- Any orthopedic or neurological condition that may interfere with assessments
- Diagnosed psychiatric disorder
- Conditions impairing communication or ability to complete assessments
Show all 16Show fewer
- Illiteracy
- History of orthopedic surgery in any body region
- Presence of systemic pathological conditions such as fractures, rheumatoid arthritis, or suspected malingering
- Receipt of physiotherapy or other treatment targeting the temporomandibular joint or spinal region within the last 6 months
- Control Group:
- History of chronic musculoskeletal disorders within the past year
- Any orthopedic or neurological condition that may interfere with assessments
- Diagnosed psychiatric disorder
- Conditions impairing communication or ability to complete assessments
- Illiteracy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University
Antalya, Alanya, 07400
About this study
Official title: Effects of Osteopathic Manipulative Treatment Versus Exercise on Pain, Function, and Dynamic Postural Control in Individuals With Temporomandibular Disorders: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether different rehabilitation approaches can improve pain, function, and postural control in individuals with temporomandibular disorders (TMD). The study focuses on adults diagnosed with myogenic TMD.
The main questions it aims to answer are:
Read more
Does osteopathic manipulative treatment (OMT) reduce pain and improve functional outcomes in individuals with TMD? Does a structured home-based exercise program improve postural control and sensorimotor function in individuals with TMD? Researchers will compare osteopathic manipulative treatment (OMT) and a home-based exercise program to determine their relative effects on pain, function, and postural stability.
Participants will:
Be randomly assigned to either the OMT group or the exercise group Receive the assigned intervention over the study period Undergo assessments before and after treatment, including pain intensity, pressure pain threshold, mandibular movements, cervical range of motion, postural stability, and quality of life
Read the detailed description
Temporomandibular disorders (TMD) are multifactorial conditions characterized by pain, functional limitations, and alterations in sensorimotor control. Although various rehabilitation approaches are commonly used in clinical practice, the relationship between TMD and postural stability remains unclear, particularly regarding the differential effects of specific treatment strategies.
This randomized controlled trial aims to compare the effects of osteopathic manipulative treatment (OMT) and a structured home-based exercise program on pain, functional outcomes, and postural control in individuals with myogenic TMD.
Participants diagnosed with myogenic TMD are randomly allocated to either an OMT group or a home-based exercise group. The OMT intervention consists of manual techniques targeting the temporomandibular joint and related musculoskeletal structures, while the exercise program includes structured therapeutic exercises designed to improve mobility, muscle function, and sensorimotor control.
Outcome measures include pain intensity assessed using the Visual Analog Scale (VAS), pressure pain threshold, mandibular movements, cervical range of motion (ROM), postural stability parameters, and quality of life. All assessments are performed before and after the intervention period by a blinded assessor.
This study is designed to explore whether different rehabilitation approaches produce distinct effects on pain reduction, functional improvement, and postural control, thereby contributing to a better understanding of mechanism-based rehabilitation strategies in TMD.
- Conditions
- Temporomandibular Disorder (TMD)
- Being tested
- Home-based Exercise Program, Osteopathic Manipulative Treatment (OMT)
- Keywords
- Temporomandibular Joint Disorders, Manipulation, Osteopathic, Exercise Therapy, Pain Measurement, Postural Balance
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Exercise ProgramBehavioural
A structured home-based exercise program designed to improve mandibular mobility, cervical function, and sensorimotor control.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
A manual therapy intervention consisting of osteopathic manipulative techniques applied to the temporomandibular joint and related musculoskeletal structures. The treatment aims to reduce pain, improve joint mobility, and enhance functional outcomes.
| Study group | Role | What they receive |
|---|---|---|
| OMT Group | Experimental | Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures. Receives: Behavioral: Home-based Exercise Program; Procedure: Osteopathic Manipulative Treatment (OMT) |
| Home-Based Exercise Group | Active comparator | Participants perform a structured home-based exercise program targeting jaw and cervical function. Receives: Behavioral: Home-based Exercise Program; Procedure: Osteopathic Manipulative Treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Visual Analog Scale, VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: Before intervention and immediately after the intervention period
Secondary outcomes (5)
Pressure Pain Threshold
Pressure pain threshold will be measured using a digital algometer applied to the anterior temporalis muscle, masseter muscle, and temporomandibular joint region. The average of three measurements will be recorded.
Measured: Before intervention and immediately after the intervention period
Mandibular Range of Motion
Mandibular movements, including maximum mouth opening, lateral movements, and protrusion, will be measured in millimeters using a digital caliper.
Measured: Before intervention and immediately after the intervention period
Cervical Range of Motion
Cervical range of motion will be assessed to evaluate neck mobility associated with temporomandibular function.
Measured: Before intervention and immediately after the intervention period
Postural Stability
Postural stability will be assessed using the Lockhart Monitor mobile application during a 30-second static standing task, measuring mediolateral and anteroposterior sway.
Measured: Before intervention and immediately after the intervention period
Quality of Life (Short Form-12 Health Survey, SF-12)
Quality of life will be assessed using the Short Form-12 Health Survey (SF-12), a validated instrument that evaluates health-related quality of life across physical and mental domains. The SF-12 generates two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Each component score is standardized and typically ranges from 0 to 100, with higher scores indicating better health-related quality of life. Scores are calculated using weighted algorithms based on population norms.
Measured: Before intervention and immediately after the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Apr 2024
- Primary completion15 May 2024
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (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
- This study is designed as a randomized, parallel-group controlled trial comparing two intervention arms: osteopathic manipulative treatment (OMT) and a structured home-based exercise program. Participants are randomly allocated to one of the two groups using a concealed randomization method. Outcome assessments are conducted by a blinded assessor before and after the intervention period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534540
- Sponsor's protocol ID
- 10.04.2026
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns in accordance with data protection regulations. De-identified data may be made available from the corresponding author upon reasonable request, subject to ethical approval and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Manipulative Treatment Versus Exercise on Pain, Function, and Dynamic Postural Control in Individuals With Temporomandibular Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07534540
- Acronym / sponsor ID
- 10.04.2026
- Conditions
- Temporomandibular Disorder (TMD)
- Keywords
- Temporomandibular Joint Disorders, Manipulation, Osteopathic, Exercise Therapy, Pain Measurement, Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 16 Apr 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.
The goal of this clinical trial is to evaluate whether different rehabilitation approaches can improve pain, function, and postural control in individuals with temporomandibular disorders (TMD). The study focuses on adults diagnosed with myogenic TMD.
The main questions it aims to answer are:
Does osteopathic manipulative treatment (OMT) reduce pain and improve functional outcomes in individuals with TMD? Does a structured home-based exercise program improve postural control and sensorimotor function in individuals with TMD? Researchers will compare osteopathic manipulative treatment (OMT) and a home-based exercise program to determine their relative effects on pain, function, and postural stability.
Participants will:
Be randomly assigned to either the OMT group or the exercise group Receive the assigned intervention over the study period Undergo assessments before and after treatment, including pain intensity, pressure pain threshold, mandibular movements, cervical range of motion, postural stability, and quality of life
Detailed description
Temporomandibular disorders (TMD) are multifactorial conditions characterized by pain, functional limitations, and alterations in sensorimotor control. Although various rehabilitation approaches are commonly used in clinical practice, the relationship between TMD and postural stability remains unclear, particularly regarding the differential effects of specific treatment strategies.
This randomized controlled trial aims to compare the effects of osteopathic manipulative treatment (OMT) and a structured home-based exercise program on pain, functional outcomes, and postural control in individuals with myogenic TMD.
Participants diagnosed with myogenic TMD are randomly allocated to either an OMT group or a home-based exercise group. The OMT intervention consists of manual techniques targeting the temporomandibular joint and related musculoskeletal structures, while the exercise program includes structured therapeutic exercises designed to improve mobility, muscle function, and sensorimotor control.
Outcome measures include pain intensity assessed using the Visual Analog Scale (VAS), pressure pain threshold, mandibular movements, cervical range of motion (ROM), postural stability parameters, and quality of life. All assessments are performed before and after the intervention period by a blinded assessor.
This study is designed to explore whether different rehabilitation approaches produce distinct effects on pain reduction, functional improvement, and postural control, thereby contributing to a better understanding of mechanism-based rehabilitation strategies in TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized, parallel-group controlled trial comparing two intervention arms: osteopathic manipulative treatment (OMT) and a structured home-based exercise program. Participants are randomly allocated to one of the two groups using a concealed randomization method. Outcome assessments are conducted by a blinded assessor before and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| OMT Group | Experimental | Behavioral: Home-based Exercise Program, Procedure: Osteopathic Manipulative Treatment (OMT)Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures. |
| Home-Based Exercise Group | Active comparator | Behavioral: Home-based Exercise Program, Procedure: Osteopathic Manipulative Treatment (OMT)Participants perform a structured home-based exercise program targeting jaw and cervical function. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Diagnosis of temporomandibular disorder (TMD) confirmed by a dentist
- Pain intensity ≥ 3.5 cm on the Visual Analog Scale (VAS)
- Presence of TMD-related pain for at least 3 months
- Aged between 18 and 50 years
- Willingness to participate in the study
Key exclusion criteria (16 listed)
- Presence of any condition other than TMD that may affect the assessment outcomes
- Presence of musculoskeletal pain in any other body region
- Any orthopedic or neurological condition that may interfere with assessments
- Diagnosed psychiatric disorder
- Conditions impairing communication or ability to complete assessments
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-based Exercise ProgramA structured home-based exercise program designed to improve mandibular mobility, cervical function, and sensorimotor control. | Behavioural | Home-Based Exercise Group, OMT Group |
| Osteopathic Manipulative Treatment (OMT)A manual therapy intervention consisting of osteopathic manipulative techniques applied to the temporomandibular joint and related musculoskeletal structures. The treatment aims to reduce pain, improve joint mobility, and enhance functional outcomes. | Procedure or surgery | Home-Based Exercise Group, OMT Group |
Primary outcome
Pain Intensity (Visual Analog Scale, VAS)
Time frame: Before intervention and immediately after the intervention period
Pain intensity will be assessed using the Visual Analog Scale (VAS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
5 secondary outcomes
Pressure Pain Threshold
Time frame: Before intervention and immediately after the intervention period
Mandibular Range of Motion
Time frame: Before intervention and immediately after the intervention period
Cervical Range of Motion
Time frame: Before intervention and immediately after the intervention period
Postural Stability
Time frame: Before intervention and immediately after the intervention period
Quality of Life (Short Form-12 Health Survey, SF-12)
Time frame: Before intervention and immediately after the intervention period
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 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns in accordance with data protection regulations. De-identified data may be made available from the corresponding author upon reasonable request, subject to ethical approval and institutional policies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-based Exercise Program and Osteopathic Manipulative Treatment (OMT) in people with Temporomandibular Disorder (TMD), run by Alanya Alaaddin Keykubat 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 10 inclusion and 16 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 22 Apr 2026. 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?
Pain Intensity (Visual Analog Scale, VAS) (time frame: Before intervention and immediately after the intervention period). 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 22 Apr 2026.