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Not yet recruitingNCT07297251Updated Dec 22, 2025

Temporomandibular Joints Mobility and Head Posture: Influence of Manual Therapy and Exercises in Dental Patients.

An interventional study of Manual therapy in Temporomandibular Joint Disorders, sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice. Not yet recruiting. Open to participants aged 11 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
11 Years to 65 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Temporomandibular Joint Disorders

Keywords

  • temporomandibular joint
  • range of motion
  • cervical spine
  • kinematic
  • manual therapy
  • exercices
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice is the lead sponsor of 30 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Pregnancy.
  • Lack of consent from a parent or legal guardian (for minors).
  • Lack of cooperation from the participant (especially children).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Manual therapy

    Manual therapy, exercises

    Other: Manual therapy

Interventions

  • OtherManual 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

06

What researchers measure

Primary outcomes

  1. CROM device

    Cervical spine movements

    Time frame: Baseline and after 1 and 2 months

  2. JMA (Jaw Motion Analyzer) Axiograph

    TMJ movements

    Time frame: Baseline and after 1 and 2 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297251
Lead sponsor
The Jerzy Kukuczka Academy of Physical Education in Katowice
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Jan 20, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Dec 22, 2025

Study contacts

Łukasz Kaczmarek
Contact
lukaszkaczmarek@holimedica.pl
+48785992512

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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