Temporomandibular Disorders (TMD)TMD/VAS/ROMNCT06994910
Temporomandibular Disorders Physiotherapy
A study testing Maitland mobilization techniques in people with Temporomandibular Disorders (TMD), run by Palestine Polytechnic University at 1 site in Palestinian Territories.
Trial summary
This study aims to investigate the effectiveness of the Maitland joint mobilization technique in alleviating symptoms related to (temporomandibular disorders) TMD and to investigate its influence on patient clinical outcomes, including pain intensity, TMJ range of motion (ROM), functional limitations, disability, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Maitland mobilization techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 7 Aug 2023to 24 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: individuals diagnosed with TMD, whether it is unilateral or bilateral.
- Myofascial pain and myo-spasm.
- Anterior disk displacement with reduction and anterior disk displacement without reduction.
- Craniofacial and craniomandibular pain.
- Myofascial pain with or without limited mouth opening.
Who cannot join
- Patients with a documented history of surgical procedures involving the TMJ.
- Patients with a confirmed diagnosis of systemic diseases (e.g., rheumatic and metabolic diseases).
- Patients with congenital or developmental craniofacial anomalies, including conditions like as ankylosis.
- Patients with diagnosed cancer.
- Patients with mental, physical disorders and language difficulties.
- Patients with diagnosed neuropathic and dental pain.
- Patients with diagnosed general myopathy (e.g., fibromyalgia).
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Palestine Polytechnic University
Hebron
About this study
Official title: Investigation Into the Effectiveness of Maitland Joint Mobilization in Alleviating Symptoms of Temporomandibular Disorders, Enhancing Joint Function, and Oral Behaviors
This study aims to investigate the effectiveness of the Maitland joint mobilization technique in alleviating symptoms related to (temporomandibular disorders) TMD and to investigate its influence on patient clinical outcomes, including pain intensity, TMJ range of motion (ROM), functional limitations, disability, and oral behaviors.
Read the detailed description
Physiotherapeutic procedures for TMD aim to reduce pain, enhance neuromuscular coordination and strength, and promote joint range of motion (ROM), mastication, mouth opening, and general mobility. The literature highlights a variety of physiotherapy techniques used to treat TMD, including manual therapy, stretching, active and passive exercises, as well as modalities like thermotherapy, ultrasound, electrotherapy, iontophoresis, laser therapy, shockwave therapy, infrared therapy, kinesiology taping, and dry needling. Clinical research supports the efficacy of physiotherapy as a conservative treatment for TMD, effectively addressing pain, muscular dysfunctions, and psychosocial factors. Optimal results are achieved through a combination of therapeutic exercises and manual therapy, which is considered one of the most effective approaches.
The Maitland joint mobilization technique is a key physiotherapeutic procedure for managing TMD. This technique involves passive, rhythmic joint mobilizations aimed at restoring joint functionality and alleviating pain. The technique employs five grades of mobility, each designed for specific therapeutic goals. Grades I and II are used to reduce pain and relax soft tissues, while Grades III, IV, and V focus on addressing joint hypomobility by stretching soft tissues and improving joint mobility. The technique enhances both osteokinematic and arthrokinematic movements, with osteokinematic referring to voluntary joint motion, and arthrokinematic to the small, involuntary movements that occur during normal joint ROM. Maitland joint mobilization utilizes controlled forces in specific directions, based on Kaltenborn's concave-convex rule, to optimize both movements and improve joint function. This research is essential for providing further evidence that supports enhanced physiotherapeutic techniques, resulting in enhancing patient clinical outcomes and enhancing professional practices for the optimal management of TMD.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Maitland mobilization techniques
- Keywords
- Temporomandibular Disorders, Physiotherapy, Maitland Mobilization Technique
- 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.
Maitland mobilization techniquesOther
Participants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention)
| Study group | Role | What they receive |
|---|---|---|
| Before Maitland joint mobilization | Experimental | Participants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention) Receives: Other: Maitland mobilization techniques |
| After Maitland joint mobilization | Experimental | Participants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention). Receives: Other: Maitland mobilization techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be assessed using a 10-centimeter Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Participants will be asked to indicate the average intensity of their jaw-related pain experienced over the past week. This tool is used to evaluate the effect of the intervention on subjective pain levels in patients diagnosed with temporomandibular disorders.
Measured: Pain will be measured at baseline (pre-intervention) and after completion of the 4-week intervention (post-intervention)
Temporomandibular joint range of motion
The range of motion (ROM) of the temporomandibular joint will be measured using the TheraBiteⓇ Range of Motion Scales, a standardized tool designed to accurately assess mandibular movements including maximum mouth opening, lateral excursion, and protrusion. Measurements will be taken in millimeters by trained assessors to evaluate functional improvement following the intervention in patients with temporomandibular disorders.
Measured: Temporomandibular joint range of motion will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).
Jaw functional disability
Jaw functional disability will be evaluated using the Jaw Functional Limitation Scale (JFLS-20), a validated and reliable questionnaire designed to assess limitations in jaw function across three domains: mastication, jaw movements, and verbal communication. Patients will self-report the degree of difficulty experienced during specific functional activities related to the temporomandibular joint. This measure will assess the impact of the intervention on improving jaw function in patients with temporomandibular disorders.
Measured: Jaw functional disability will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).
Oral behaviors
Oral behaviors will be evaluated using the Oral Behavior Checklist (OBC), a validated self-report questionnaire designed to assess the frequency and type of oral behaviors during waking hours and sleep. This includes activities such as clenching, grinding, and other parafunctional habits that may influence temporomandibular disorder symptoms. The OBC will help determine changes in oral behaviors as a result of the intervention.
Measured: Oral behaviors will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start7 Aug 2023
- Primary completion30 Oct 2024
- Study completion24 Dec 2024
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A single group of participants received the intervention. Outcomes were measured before and after the intervention within the same group to assess changes over time
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palestine Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Talahma, Palestine Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994910
- Sponsor's protocol ID
- CAMS/PTBR/3/127
- Acronym
- TMD/VAS/ROM
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Effectiveness of Maitland Joint Mobilization in Alleviating Symptoms of Temporomandibular Disorders, Enhancing Joint Function, and Oral Behaviors
- ClinicalTrials.gov ID
- NCT06994910
- Acronym / sponsor ID
- TMD/VAS/ROM / CAMS/PTBR/3/127
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Temporomandibular Disorders, Physiotherapy, Maitland Mobilization Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Palestine Polytechnic UniversityUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 29 May 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.
This study aims to investigate the effectiveness of the Maitland joint mobilization technique in alleviating symptoms related to (temporomandibular disorders) TMD and to investigate its influence on patient clinical outcomes, including pain intensity, TMJ range of motion (ROM), functional limitations, disability, and oral behaviors.
Detailed description
Physiotherapeutic procedures for TMD aim to reduce pain, enhance neuromuscular coordination and strength, and promote joint range of motion (ROM), mastication, mouth opening, and general mobility. The literature highlights a variety of physiotherapy techniques used to treat TMD, including manual therapy, stretching, active and passive exercises, as well as modalities like thermotherapy, ultrasound, electrotherapy, iontophoresis, laser therapy, shockwave therapy, infrared therapy, kinesiology taping, and dry needling. Clinical research supports the efficacy of physiotherapy as a conservative treatment for TMD, effectively addressing pain, muscular dysfunctions, and psychosocial factors. Optimal results are achieved through a combination of therapeutic exercises and manual therapy, which is considered one of the most effective approaches.
The Maitland joint mobilization technique is a key physiotherapeutic procedure for managing TMD. This technique involves passive, rhythmic joint mobilizations aimed at restoring joint functionality and alleviating pain. The technique employs five grades of mobility, each designed for specific therapeutic goals. Grades I and II are used to reduce pain and relax soft tissues, while Grades III, IV, and V focus on addressing joint hypomobility by stretching soft tissues and improving joint mobility. The technique enhances both osteokinematic and arthrokinematic movements, with osteokinematic referring to voluntary joint motion, and arthrokinematic to the small, involuntary movements that occur during normal joint ROM. Maitland joint mobilization utilizes controlled forces in specific directions, based on Kaltenborn's concave-convex rule, to optimize both movements and improve joint function. This research is essential for providing further evidence that supports enhanced physiotherapeutic techniques, resulting in enhancing patient clinical outcomes and enhancing professional practices for the optimal management of TMD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single group of participants received the intervention. Outcomes were measured before and after the intervention within the same group to assess changes over time
| Arm | Type | Receives |
|---|---|---|
| Before Maitland joint mobilization | Experimental | Other: Maitland mobilization techniquesParticipants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention) |
| After Maitland joint mobilization | Experimental | Other: Maitland mobilization techniquesParticipants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: individuals diagnosed with TMD, whether it is unilateral or bilateral.
- Myofascial pain and myo-spasm.
- Anterior disk displacement with reduction and anterior disk displacement without reduction.
- Craniofacial and craniomandibular pain.
- Myofascial pain with or without limited mouth opening.
Key exclusion criteria (7 listed)
- Patients with a documented history of surgical procedures involving the TMJ.
- Patients with a confirmed diagnosis of systemic diseases (e.g., rheumatic and metabolic diseases).
- Patients with congenital or developmental craniofacial anomalies, including conditions like as ankylosis.
- Patients with diagnosed cancer.
- Patients with mental, physical disorders and language difficulties.
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 |
|---|---|---|
| Maitland mobilization techniquesParticipants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention) | Other | After Maitland joint mobilization, Before Maitland joint mobilization |
Primary outcome
Pain intensity
Time frame: Pain will be measured at baseline (pre-intervention) and after completion of the 4-week intervention (post-intervention)
Pain intensity will be assessed using a 10-centimeter Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Participants will be asked to indicate the average intensity of their jaw-related pain experienced over the past week. This tool is used to evaluate the effect of the intervention on subjective pain levels in patients diagnosed with temporomandibular disorders.
Temporomandibular joint range of motion
Time frame: Temporomandibular joint range of motion will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).
The range of motion (ROM) of the temporomandibular joint will be measured using the TheraBiteⓇ Range of Motion Scales, a standardized tool designed to accurately assess mandibular movements including maximum mouth opening, lateral excursion, and protrusion. Measurements will be taken in millimeters by trained assessors to evaluate functional improvement following the intervention in patients with temporomandibular disorders.
Jaw functional disability
Time frame: Jaw functional disability will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).
Jaw functional disability will be evaluated using the Jaw Functional Limitation Scale (JFLS-20), a validated and reliable questionnaire designed to assess limitations in jaw function across three domains: mastication, jaw movements, and verbal communication. Patients will self-report the degree of difficulty experienced during specific functional activities related to the temporomandibular joint. This measure will assess the impact of the intervention on improving jaw function in patients with temporomandibular disorders.
Oral behaviors
Time frame: Oral behaviors will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).
Oral behaviors will be evaluated using the Oral Behavior Checklist (OBC), a validated self-report questionnaire designed to assess the frequency and type of oral behaviors during waking hours and sleep. This includes activities such as clenching, grinding, and other parafunctional habits that may influence temporomandibular disorder symptoms. The OBC will help determine changes in oral behaviors as a result of the intervention.
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 29 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared for research purposes.
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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 Maitland mobilization techniques in people with Temporomandibular Disorders (TMD), run by Palestine Polytechnic University at 1 site in Palestinian Territories.
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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 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 Palestinian Territories. 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 (time frame: Pain will be measured at baseline (pre-intervention) and after completion of the 4-week intervention (post-intervention)). The study lists 4 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 29 May 2025.