- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297251
Temporomandibular Joints Mobility and Head Posture: Influence of Manual Therapy and Exercises in Dental Patients.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Łukasz Kaczmarek
- Phone Number: +48785992512
- Email: lukaszkaczmarek@holimedica.pl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Manual therapy
Manual therapy, exercises
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CROM device
Time Frame: Baseline and after 1 and 2 months
|
Cervical spine movements
|
Baseline and after 1 and 2 months
|
|
JMA (Jaw Motion Analyzer) Axiograph
Time Frame: Baseline and after 1 and 2 months
|
TMJ movements
|
Baseline and after 1 and 2 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resolution No. 5-II/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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