Temporomandibular DisorderNCT07210957
Effect of Manual Therapy on Temporomandibular Joint Dysfunction
A study testing Manual Therapy in people with Temporomandibular Disorder and Neck Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular disorders (TMD) are multifactorial conditions involving the temporomandibular joint and masticatory muscles, often presenting with pain and functional limitations. Conventional management includes splints, pharmacological approaches, physiotherapy, and manual therapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Temporomandibular Disorder, Neck Pain
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 15 Jul 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
- No healthy volunteers
- Adult
Who may be able to join
- Myalgia, and both myalgia and arthralgia according to Diagnostic Criteria for Temporomandibular Disorders
- Completing signing the informed consent form
Who cannot join
- Any rheumatological or metabolic disease
- Receiving any treatment for temporomandibular joint in the last 2 years (such as botulinum toxin, manual therapy, splint, orthodontics)
- A history of traumatic temporomandibular joint
- A history of diagnosed psychological diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University Department of Physiotherapy and Rehabilitation
Bolu, 14300
About this study
Official title: The Effect of Manual Therapy in Individuals With Temporomandibular Disorders
Temporomandibular disorders (TMD) are multifactorial conditions involving the temporomandibular joint and masticatory muscles, often presenting with pain and functional limitations. Conventional management includes splints, pharmacological approaches, physiotherapy, and manual therapy. This study aims to evaluate the effects of manual therapy compared to therapeutic exercise on muscle thickness, pain pressure threshold, range of motion, pain, mandibular function, and anxiety in individuals with TMD.
Read the detailed description
TMD affects approximately one-quarter of the population and is characterized by pain, restricted movement, and impaired mandibular function. Etiology is multifactorial, including occlusal issues, trauma, bruxism, stress, and postural alterations. Bruxism in particular contributes to repetitive loading and hypertonia of the masticatory and cervical muscles, potentially influencing global posture. Current treatment approaches range from occlusal splints and surgery to conservative physiotherapy, manual therapy, and exercise. While manual therapy may reduce pain and restore mobility through techniques such as joint mobilization, myofascial release, and muscle inhibition, exercise supports improvements in strength, endurance, coordination, and joint stability. Evidence suggests that combined approaches may provide additive benefits. This trial will compare manual therapy and therapeutic exercise interventions in patients with TMD over six weeks. Objective outcomes will include ultrasound-based muscle thickness, pain pressure threshold, mandibular range of motion, pain intensity, and mandibular function. Anxiety levels will also be assessed using validated questionnaires. The primary hypothesis is that manual therapy will produce greater improvements across these measures compared to exercise.
- Conditions
- Temporomandibular Disorder, Neck Pain
- Being tested
- Manual Therapy, Sham manual therapy
- Keywords
- Ultrasound, Muscle Thickness, Manual Therapy
- Medical subject headings
- Temporomandibular Joint Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Myofascial Release:
Myofascial techniques will be implemented to masseter, temporalis, suboccipital, scalene, levator scapula and trapezius muscles. These techniques will be lasted for 90 seconds and using with a sliding motion between the origin and insertion of the muscles.
Trigger Point Therapy:
The ischemic compression approach will be implemented for 45-60 seconds to stretch the soft tissue over the trigger points of muscles. The emphasis will be on masseter, temporalis and scalene muscles
. The emphasis will be on the fascial chains of cranio-cervical and cranio-mandibular transition areas.
Sham manual therapyOther
The duration of each session will be lasted around 40-45 minutes (same as the therapy in the intervention group). The sham techniques will be implemented such as light contact by the therapist's hands, the impression of tissue manipulation, the touches with the effect of gravity and the performing non-therapeutic pressure to muscles. These sham techniques will not be implemented to the actual treatment points; however, they will be on the neck and jaw regions.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Other | The manual therapy sessions implemented to individuals, will include one session per week for 6 weeks, will be lasted about 40-45 minutes. Myofascial techniques will be implemented to masseter, temporalis, suboccipital, scalene, levator scapula and trapezius muscles. These techniques will be lasted for 90 seconds and using with a sliding motion between the origin and insertion of the muscles. Dura mater (dural tube traction), suboccipital muscle release, pterygopalatine ganglion technique, and C0-C1-C2 mobilization as osteopathic techniques will be implemented. Receives: Other: Manual Therapy |
| Sham manual therapy | Sham comparator | The control group will receive sham manual therapy protocol. Sham manual therapy includes implementations conducted under the same conditions and positions, however, without any therapeutic effect. The duration of each session will be lasted around 40-45 minutes (same as the therapy in the intervention group). The sham techniques will be implemented such as light contact by the therapist's hands, the impression of tissue manipulation, the touches with the effect of gravity and the performing non-therapeutic pressure to muscles. Receives: Other: Sham manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Assessment
Muscle thickness of the masseter and temporalis will be measured with a linear probe in neutral rest and during submaximal teeth clenching (supine). The probe will be aligned to standard anatomical landmarks, kept perpendicular to the skin without compressing soft tissue. Thickness will be recorded in millimeters as the distance between the internal and external fascia. Each muscle will be assessed once per condition.
Measured: Baseline, sixth week
Secondary outcomes (5)
Pain Pressure Threshold
A handheld algometer (1 cm² probe tip, 0-40 kg/cm² range, 0.1 kg increments) will be applied perpendicularly to the masseter, temporalis, upper trapezius, suboccipital muscles, and the C5 facet joint bilaterally. Participants will signal at first pain. Three measurements per site will be taken at 30-second intervals; the mean value (kg/cm²) will be used.
Measured: Baseline, sixth week
Maximum Mouth Opening and Lateral Excursion
Measured in millimeters using a manual ruler between the upper and lower central incisors. Maximum unassisted opening will be recorded in supine. For lateral excursion, participants will move the mandible to the right and left as far as possible; distances will be recorded for each side. Pain or discomfort will be noted.
Measured: Baseline, sixth week
Mandibular Function Scale
Self-report questionnaire with two parts: functional activities (speaking, smiling, chewing, etc.) and nutrition (difficulty with oral feeding). Each item is scored 0 (no difficulty) to 4 (severe difficulty). Higher total scores indicate greater dysfunction.
Measured: Baseline, sixth week
State-Trait Anxiety Inventory
Consists of 40 items: 20 assessing state anxiety and 20 assessing trait anxiety. Each item is scored 1-4, giving subscale totals of 20-80. Higher scores indicate higher anxiety.
Measured: Baseline, sixth week
Generalized Anxiety Disorder Scale
A 7-item self-report questionnaire assessing generalized anxiety over the past 2 weeks. Each item is scored 0 (not at all) to 3 (nearly every day). Total score ranges 0-21; scores 5, 10, and 15 represent cut-offs for mild, moderate, and severe anxiety.
Measured: Baseline, sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Nov 2024
- Primary completion1 Jul 2025
- Study completion15 Jul 2025
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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Prospective, double-blinded, parallel, randomized controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- numan yener, phd, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210957
- Sponsor's protocol ID
- AIBU-FTR-RK-12
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset can be obtained from the principal investigator upon any reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy in Individuals With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT07210957
- Acronym / sponsor ID
- AIBU-FTR-RK-12
- Conditions
- Temporomandibular Disorder, Neck Pain
- Keywords
- Ultrasound, Muscle Thickness, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 7 Oct 2025 (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 (TMD) are multifactorial conditions involving the temporomandibular joint and masticatory muscles, often presenting with pain and functional limitations. Conventional management includes splints, pharmacological approaches, physiotherapy, and manual therapy. This study aims to evaluate the effects of manual therapy compared to therapeutic exercise on muscle thickness, pain pressure threshold, range of motion, pain, mandibular function, and anxiety in individuals with TMD.
Detailed description
TMD affects approximately one-quarter of the population and is characterized by pain, restricted movement, and impaired mandibular function. Etiology is multifactorial, including occlusal issues, trauma, bruxism, stress, and postural alterations. Bruxism in particular contributes to repetitive loading and hypertonia of the masticatory and cervical muscles, potentially influencing global posture. Current treatment approaches range from occlusal splints and surgery to conservative physiotherapy, manual therapy, and exercise. While manual therapy may reduce pain and restore mobility through techniques such as joint mobilization, myofascial release, and muscle inhibition, exercise supports improvements in strength, endurance, coordination, and joint stability. Evidence suggests that combined approaches may provide additive benefits. This trial will compare manual therapy and therapeutic exercise interventions in patients with TMD over six weeks. Objective outcomes will include ultrasound-based muscle thickness, pain pressure threshold, mandibular range of motion, pain intensity, and mandibular function. Anxiety levels will also be assessed using validated questionnaires. The primary hypothesis is that manual therapy will produce greater improvements across these measures compared to exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, double-blinded, parallel, randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Other | Other: Manual TherapyThe manual therapy sessions implemented to individuals, will include one session per week for 6 weeks, will be lasted about 40-45 minutes. Myofascial techniques will be implemented to masseter, temporalis, suboccipital, scalene, levator scapula and trapezius muscles. These techniques will be lasted for 90 seconds and using with a sliding motion between the origin and insertion of the muscles. Dura mater (dural tube traction), suboccipital muscle release, pterygopalatine ganglion technique, and C0-C1-C2 mobilization as osteopathic techniques will be implemented. |
| Sham manual therapy | Sham comparator | Other: Sham manual therapyThe control group will receive sham manual therapy protocol. Sham manual therapy includes implementations conducted under the same conditions and positions, however, without any therapeutic effect. The duration of each session will be lasted around 40-45 minutes (same as the therapy in the intervention group). The sham techniques will be implemented such as light contact by the therapist's hands, the impression of tissue manipulation, the touches with the effect of gravity and the performing non-therapeutic pressure to muscles. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Myalgia, and both myalgia and arthralgia according to Diagnostic Criteria for Temporomandibular Disorders
- Completing signing the informed consent form
Key exclusion criteria (4 listed)
- Any rheumatological or metabolic disease
- Receiving any treatment for temporomandibular joint in the last 2 years (such as botulinum toxin, manual therapy, splint, orthodontics)
- A history of traumatic temporomandibular joint
- A history of diagnosed psychological diseases
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 TherapyMyofascial Release: Myofascial techniques will be implemented to masseter, temporalis, suboccipital, scalene, levator scapula and trapezius muscles. These techniques will be lasted for 90 seconds and using with a sliding motion between the origin and insertion of the muscles. Trigger Point Therapy: The ischemic compression approach will be implemented for 45-60 seconds to stretch the soft tissue over the trigger points of muscles. The emphasis will be on masseter, temporalis and scalene muscles . The emphasis will be on the fascial chains of cranio-cervical and cranio-mandibular transition areas. | Other | Manual therapy |
| Sham manual therapyThe duration of each session will be lasted around 40-45 minutes (same as the therapy in the intervention group). The sham techniques will be implemented such as light contact by the therapist's hands, the impression of tissue manipulation, the touches with the effect of gravity and the performing non-therapeutic pressure to muscles. These sham techniques will not be implemented to the actual treatment points; however, they will be on the neck and jaw regions. | Other | Sham manual therapy |
Primary outcome
Ultrasound Assessment
Time frame: Baseline, sixth week
Muscle thickness of the masseter and temporalis will be measured with a linear probe in neutral rest and during submaximal teeth clenching (supine). The probe will be aligned to standard anatomical landmarks, kept perpendicular to the skin without compressing soft tissue. Thickness will be recorded in millimeters as the distance between the internal and external fascia. Each muscle will be assessed once per condition.
5 secondary outcomes
Pain Pressure Threshold
Time frame: Baseline, sixth week
Maximum Mouth Opening and Lateral Excursion
Time frame: Baseline, sixth week
Mandibular Function Scale
Time frame: Baseline, sixth week
State-Trait Anxiety Inventory
Time frame: Baseline, sixth week
Generalized Anxiety Disorder Scale
Time frame: Baseline, sixth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. The dataset can be obtained from the principal investigator upon any reasonable request.
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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.
numan yener, phd principal investigator
Abant Izzet Baysal 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 in people with Temporomandibular Disorder and Neck Pain, run by Abant Izzet Baysal 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 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 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. Some participants in this study may receive a placebo. 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?
Ultrasound Assessment (time frame: Baseline, sixth week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.