Temporomandibular Joint DisordersNCT07297251
Temporomandibular Joints Mobility and Head Posture: Influence of Manual Therapy and Exercises in Dental Patients.
A study testing Manual therapy in people with Temporomandibular Joint Disorders, run by The Jerzy Kukuczka Academy of Physical Education in Katowice.
Trial summary
Goal: This clinical study aims to investigate how the range of motion of the temporomandibular joints (TMJ) changes in relation to the patient's head posture. Furthermore, we will assess the efficacy of a specific physiotherapy program in improving TMJ mobility and influencing head alignment in patients undergoing… Read more about this study
- Who is it for?
- Ages 11 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 30 Dec 2027
- 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 11 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged 11 to 13 years with a confirmed occlusion class (Class I, II, or III) with parental/legal guardian consent.
- Patients aged 13 to 17 years with personal assent and parental/legal guardian consent.
- Adult patients (up to 65 years of age) who have provided informed consent.
Who cannot join
- Inability to perform required study tests or procedures.
- Positive safety tests indicating contraindications to manual intervention.
- History of surgeries or trauma to the maxillofacial region.
- Genetic defects or neurological disorders.
- Current orthodontic treatment with fixed appliances.
- Current splint therapy.
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- Pregnancy.
- Lack of consent from a parent or legal guardian (for minors).
- Lack of cooperation from the participant (especially children).
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: Assessment of Temporomandibular Joint Mobility With Different Head Postures. Analysis of the Influence of Selected Manual Therapy Techniques on Temporomandibular Joint Mobility and Head Posture.
Goal: This clinical study aims to investigate how the range of motion of the temporomandibular joints (TMJ) changes in relation to the patient's head posture. Furthermore, we will assess the efficacy of a specific physiotherapy program in improving TMJ mobility and influencing head alignment in patients undergoing orthodontic treatment or prosthetic reconstruction.
Scope: The project will evaluate TMJ function and head alignment in orthodontic or prosthetic patients aged 11-65. The core focus is to analyze the correlation between head posture and TMJ mobility and to measure changes in these parameters before and after the manual physiotherapy intervention.
Read the detailed description
This study is designed to address the complex and often debated biomechanical relationship between craniocervical posture (head-to-neck alignment) and the function of the temporomandibular joint (TMJ). Clinical evidence suggests a strong link between forward head posture and temporomandibular disorders (TMDs). However, objective quantification of TMJ mobility changes induced purely by varying head position remains insufficiently documented. This trial seeks to establish a clear, quantifiable relationship and evaluate a targeted manual therapy intervention designed to optimize both head posture and TMJ function.
Objectives and Specific Aims
The overarching goal is to determine the dependence of temporomandibular joint mobility on the patient's head posture relative to the body, and to assess the impact of a defined physiotherapy program on these parameters.
Specific Aims include:
Functional Assessment: To perform a baseline functional evaluation of the TMJ in patients (aged 11 to 65) who are undergoing orthodontic treatment or require prosthetic reconstruction.
Postural Measurement: To objectively assess the resting position of the head relative to the cervical spine in the context of the current dental state (orthodontic appliance use or pre-prosthetic condition).
Correlational Analysis: To establish and quantify the relationship between measured TMJ mobility (e.g., maximum mouth opening, lateral excursion) and various head postures (e.g., neutral, forward, retracted).
Intervention Efficacy: To conduct a detailed pre- and post-intervention functional evaluation of the TMJ and head posture following the completion of a defined physiotherapy program for all eligible participants.
Change Quantification: To determine the magnitude and direction of changes in both TMJ mobility and head alignment resulting from the implemented physiotherapy protocol.
Study Design and Methodology
This will be a multi-center, prospective, interventional study with a pre- and post-intervention assessment design. Participants will be recruited from dental and physiotherapy clinics.
Participants: The study population will include patients aged 11 to 65 years who are either undergoing active orthodontic treatment or are scheduled for complex prosthetic reconstruction.
Intervention: The intervention group will receive a standardized program of manual physiotherapy and exercises. The program will be delivered over a fixed duration (e.g., 6 weeks, 12 sessions).
Outcome Measurement: All measurements will be performed at baseline (Pre-Intervention) and upon completion of the physiotherapy program (Post-Intervention).
TMJ Mobility: Measured objectively using a Jaw Motion Analyzer Axiograph
Maximum unassisted and assisted mouth opening (MIO/MMO), left and right lateral excursions, protrusion/retrusion.
Head Posture: Measured objectively using established clinical photography methods and.CROM device
Duration and Follow-up
The total duration of the study is anticipated to be 3 years for recruitment and data collection. Each participant's active involvement will span [e.g., 8 weeks], encompassing baseline assessment, the physiotherapy period, and the final assessment. No long-term follow-up beyond the final assessment is currently planned.
Data Analysis
Statistical analysis will employ methods appropriate for repeated measures. Primary analysis will focus on calculating Pearson's correlation coefficients to assess the relationship between initial head posture and TMJ mobility. Secondary analysis will utilize paired t-tests (or non-parametric equivalents) to determine the statistical significance of changes in TMJ mobility and head posture between the pre- and post-intervention phases. (Include specific statistical software, e.g., SPSS or R, if applicable).
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Manual therapy
- Keywords
- temporomandibular joint, range of motion, cervical spine, kinematic, manual therapy, exercices
- 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.
Manual therapyOther
- Performance of 2 manual therapy techniques immediately following the participant's initial examination. The participant remains secured in the device. The examiner performs manual therapy on each temporomandibular joint (TMJ) sequentially. The following procedures are performed consecutively: 6 sec. of Grade II distraction (traction) according to F. Kaltenborn on the TMJ, repeated 6 times; 6 seconds of Grade II lateral glide on the TMJ, repeated 6 times. Following the completed physiotherapy intervention, the digital axiograph examination is performed again. A comparative analysis of the performed examinations will be conducted
- Instruction on homework exercises performed by the patient. The exercises are performed 6 times per day, each in a series of 6 repetitions, for a period of 4 to 6 weeks. They include: a) Head flexion in the cranio-cervical joint - Standing position near a door frame; the patient performs maximum head flexion while simultaneously resting the occiput against
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Other | Manual therapy, exercises Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CROM device
Cervical spine movements
Measured: Baseline and after 1 and 2 months
JMA (Jaw Motion Analyzer) Axiograph
TMJ movements
Measured: Baseline and after 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297251
- Sponsor's protocol ID
- Resolution No. 5-II/2024
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaczmarek B, Kaczmarek L, Mysliwiec A, Lipowicz A, Dowgierd K. Kinematic Relationship Between Temporomandibular and Cervical Spine Joints. J Oral Rehabil. 2025 Sep;52(9):1496-1504. doi: 10.1111/joor.14015. Epub 2025 May 9.
PubMed 40346746
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Temporomandibular Joint Mobility With Different Head Postures. Analysis of the Influence of Selected Manual Therapy Techniques on Temporomandibular Joint Mobility and Head Posture.
- ClinicalTrials.gov ID
- NCT07297251
- Acronym / sponsor ID
- Resolution No. 5-II/2024
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- temporomandibular joint, range of motion, cervical spine, kinematic, manual therapy, exercices
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Dec 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.
Goal: This clinical study aims to investigate how the range of motion of the temporomandibular joints (TMJ) changes in relation to the patient's head posture. Furthermore, we will assess the efficacy of a specific physiotherapy program in improving TMJ mobility and influencing head alignment in patients undergoing orthodontic treatment or prosthetic reconstruction.
Scope: The project will evaluate TMJ function and head alignment in orthodontic or prosthetic patients aged 11-65. The core focus is to analyze the correlation between head posture and TMJ mobility and to measure changes in these parameters before and after the manual physiotherapy intervention.
Detailed description
This study is designed to address the complex and often debated biomechanical relationship between craniocervical posture (head-to-neck alignment) and the function of the temporomandibular joint (TMJ). Clinical evidence suggests a strong link between forward head posture and temporomandibular disorders (TMDs). However, objective quantification of TMJ mobility changes induced purely by varying head position remains insufficiently documented. This trial seeks to establish a clear, quantifiable relationship and evaluate a targeted manual therapy intervention designed to optimize both head posture and TMJ function.
Objectives and Specific Aims
The overarching goal is to determine the dependence of temporomandibular joint mobility on the patient's head posture relative to the body, and to assess the impact of a defined physiotherapy program on these parameters.
Specific Aims include:
Functional Assessment: To perform a baseline functional evaluation of the TMJ in patients (aged 11 to 65) who are undergoing orthodontic treatment or require prosthetic reconstruction.
Postural Measurement: To objectively assess the resting position of the head relative to the cervical spine in the context of the current dental state (orthodontic appliance use or pre-prosthetic condition).
Correlational Analysis: To establish and quantify the relationship between measured TMJ mobility (e.g., maximum mouth opening, lateral excursion) and various head postures (e.g., neutral, forward, retracted).
Intervention Efficacy: To conduct a detailed pre- and post-intervention functional evaluation of the TMJ and head posture following the completion of a defined physiotherapy program for all eligible participants.
Change Quantification: To determine the magnitude and direction of changes in both TMJ mobility and head alignment resulting from the implemented physiotherapy protocol.
Study Design and Methodology
This will be a multi-center, prospective, interventional study with a pre- and post-intervention assessment design. Participants will be recruited from dental and physiotherapy clinics.
Participants: The study population will include patients aged 11 to 65 years who are either undergoing active orthodontic treatment or are scheduled for complex prosthetic reconstruction.
Intervention: The intervention group will receive a standardized program of manual physiotherapy and exercises. The program will be delivered over a fixed duration (e.g., 6 weeks, 12 sessions).
Outcome Measurement: All measurements will be performed at baseline (Pre-Intervention) and upon completion of the physiotherapy program (Post-Intervention).
TMJ Mobility: Measured objectively using a Jaw Motion Analyzer Axiograph
Maximum unassisted and assisted mouth opening (MIO/MMO), left and right lateral excursions, protrusion/retrusion.
Head Posture: Measured objectively using established clinical photography methods and.CROM device
Duration and Follow-up
The total duration of the study is anticipated to be 3 years for recruitment and data collection. Each participant's active involvement will span [e.g., 8 weeks], encompassing baseline assessment, the physiotherapy period, and the final assessment. No long-term follow-up beyond the final assessment is currently planned.
Data Analysis
Statistical analysis will employ methods appropriate for repeated measures. Primary analysis will focus on calculating Pearson's correlation coefficients to assess the relationship between initial head posture and TMJ mobility. Secondary analysis will utilize paired t-tests (or non-parametric equivalents) to determine the statistical significance of changes in TMJ mobility and head posture between the pre- and post-intervention phases. (Include specific statistical software, e.g., SPSS or R, if applicable).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Other | Other: Manual therapyManual therapy, exercises |
Who may qualify
- Ages
- 11 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 11 to 13 years with a confirmed occlusion class (Class I, II, or III) with parental/legal guardian consent.
- Patients aged 13 to 17 years with personal assent and parental/legal guardian consent.
- Adult patients (up to 65 years of age) who have provided informed consent.
Key exclusion criteria (9 listed)
- Inability to perform required study tests or procedures.
- Positive safety tests indicating contraindications to manual intervention.
- History of surgeries or trauma to the maxillofacial region.
- Genetic defects or neurological disorders.
- Current orthodontic treatment with fixed appliances.
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 therapy1. Performance of 2 manual therapy techniques immediately following the participant's initial examination. The participant remains secured in the device. The examiner performs manual therapy on each temporomandibular joint (TMJ) sequentially. The following procedures are performed consecutively: 6 sec. of Grade II distraction (traction) according to F. Kaltenborn on the TMJ, repeated 6 times; 6 seconds of Grade II lateral glide on the TMJ, repeated 6 times. Following the completed physiotherapy intervention, the digital axiograph examination is performed again. A comparative analysis of the performed examinations will be conducted 2. Instruction on homework exercises performed by the patient. The exercises are performed 6 times per day, each in a series of 6 repetitions, for a period of 4 to 6 weeks. They include: a) Head flexion in the cranio-cervical joint - Standing position near a door frame; the patient performs maximum head flexion while simultaneously resting the occiput against | Other | Manual therapy |
Primary outcome
CROM device
Time frame: Baseline and after 1 and 2 months
Cervical spine movements
JMA (Jaw Motion Analyzer) Axiograph
Time frame: Baseline and after 1 and 2 months
TMJ movements
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 22 Dec 2025.
- Background: PubMed 40346746Kaczmarek B, Kaczmarek L, Mysliwiec A, Lipowicz A, Dowgierd K. Kinematic Relationship Between Temporomandibular and Cervical Spine Joints. J Oral Rehabil. 2025 Sep;52(9):1496-1504. doi: 10.1111/joor.14015. Epub 2025 May 9.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Temporomandibular Joint Disorders, run by The Jerzy Kukuczka Academy of Physical Education in Katowice.
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 3 inclusion and 9 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 22 Dec 2025. 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 Łukasz Kaczmarek (+48785992512, lukaszkaczmarek@holimedica.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CROM device (time frame: Baseline and after 1 and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07297251, which also lists 1 linked publication.
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 Dec 2025.