Temporomandibular Joints Mobility and Head Posture: Influence of Manual Therapy and Exercises in Dental Patients.
NCT ID: NCT07297251
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-20
2027-12-30
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Manual therapy
Manual therapy, exercises
Manual therapy
1. 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
Interventions
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Manual therapy
1. 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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Pregnancy.
* Lack of consent from a parent or legal guardian (for minors).
* Lack of cooperation from the participant (especially children).
11 Years
65 Years
ALL
Yes
Sponsors
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The Jerzy Kukuczka Academy of Physical Education in Katowice
OTHER
Responsible Party
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Central Contacts
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References
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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.
Other Identifiers
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Resolution No. 5-II/2024
Identifier Type: -
Identifier Source: org_study_id