NCT07297251

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 8, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

temporomandibular jointrange of motioncervical spinekinematicmanual therapyexercices

Outcome Measures

Primary Outcomes (2)

  • CROM device

    Cervical spine movements

    Baseline and after 1 and 2 months

  • JMA (Jaw Motion Analyzer) Axiograph

    TMJ movements

    Baseline and after 1 and 2 months

Study Arms (1)

Manual therapy

OTHER

Manual therapy, exercises

Other: Manual therapy

Interventions

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

Manual therapy

Eligibility Criteria

Age11 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40346746BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 22, 2025

Study Start

January 20, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share