NCT06883825

Brief Summary

In the study, a questionnaire form will be applied to the participants using a face-to-face interview technique. Through the questionnaires, demographic characteristics, pain intensity, location of pain, symptoms of dysfunction, oral habits, and loss of function in the jaw joint will be evaluated. Soft tissue (muscle) affections, spine structure, and mobility will be evaluated and recorded in the questionnaire form to be used for the evaluation of jaw joint dysfunctions. Pain level, depression, stress, anxiety level, and sleep quality will be evaluated with the help of a questionnaire. The aims of this study were;

  1. 1.To investigate the effects of muscle and function therapy on dysfunction, spinal structure and mobility, depression, stress, anxiety, and sleep quality in patients with jaw joint dysfunction,
  2. 2.To investigate the effects of breathing exercises added to muscle and function therapy on dysfunction, spine structure and mobility, depression, stress, anxiety, and sleep quality in patients with jaw joint dysfunction,
  3. 3.To investigate the effects of back exercises added to muscle and function therapy on dysfunction, spinal structure and mobility, depression, stress, anxiety and sleep quality in patients with jaw joint dysfunction,
  4. 4.To compare the effects of muscular and functional therapy alone, respiratory exercises added to muscular and functional therapy, and back exercises on dysfunction, spinal structure and mobility, depression, stress, anxiety, and sleep quality in patients with jaw joint dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 16, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 13, 2026

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 24, 2025

Last Update Submit

January 11, 2026

Conditions

Keywords

temporomandibular joint dysfunctionmyofunctional therapyrehabilitationexercisethoracic regiondiapragmatic breathing

Outcome Measures

Primary Outcomes (6)

  • Evaluation of Temporomandibular Joint Dysfunction

    Diagnosis of TMD - Evaluated using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), reported as categorical data (diagnosis classification).

    At baseline and from enrollment to the end of treatment at week 8

  • Pain Assessment

    Measured using the Visual Analog Scale (VAS), reported in centimeters (cm)

    At baseline and from enrollment to the end of treatment at week 8

  • Symptom Severity

    Assessed with the Symptom Questionnaire for Temporomandibular Disorders, reported in units on a scale.

    At baseline and from enrollment to the end of treatment at week 8

  • Oral Habits Frequency

    Measured with the Oral Habits Checklist, reported in units on a scale.

    At baseline and from enrollment to the end of treatment at week 8

  • Jaw Function Limitation

    Assessed using the Jaw Function Restriction Scale, reported in units on a scale.

    At baseline and from enrollment to the end of treatment at week 8

  • Soft Tissue Examination

    Assessed using ultrasound to measure masseter muscle thickness and elastography at rest and during contraction, reported in millimeters (mm) and kilopascals (kPa), respectively.

    At baseline and from enrollment to the end of treatment at week 8

Secondary Outcomes (5)

  • Head Position

    At baseline and from enrollment to the end of treatment at week 8

  • Thoracic Region Evaluation

    At baseline and from enrollment to the end of treatment at week 8

  • Thoracic Rotation

    At baseline and from enrollment to the end of treatment at week 8

  • Depression, Anxiety, and Stress

    At baseline and from enrollment to the end of treatment at week 8

  • Sleep Quality

    At baseline and from enrollment to the end of treatment at week 8

Study Arms (3)

Myofunctional Therapy

ACTIVE COMPARATOR

Participants will only receive myofunctional rehabilitation therapy. This treatment includes massage and exercises to improve the function of the jaw muscles.

Other: Myofunctional Therapy

Myofunctional Therapy + Respiratory Exercises

EXPERIMENTAL

Participants will receive breathing exercises as well as myofunctional therapy. This treatment includes exercises to improve jaw function and support the respiratory system.

Other: Myofunctional Therapy + Respiratory Exercises

Myofunctional Therapy + Thoracic Region Exercises

EXPERIMENTAL

Participants will receive myofunctional therapy as well as exercises for the thoracic region. This treatment includes exercises to improve jaw function and increase the flexibility of the chest area.

Other: Myofunctional Therapy + Thoracic Region Exercises

Interventions

Participants will only receive myofunctional rehabilitation therapy. This treatment includes massage and exercises to improve the function of the jaw muscles.

Myofunctional Therapy

Participants will receive breathing exercises as well as myofunctional therapy. This treatment includes exercises to improve jaw function and support the respiratory system.

Myofunctional Therapy + Respiratory Exercises

Participants will receive myofunctional therapy as well as exercises for the thoracic region. This treatment includes exercises to improve jaw function and increase the flexibility of the chest area.

Myofunctional Therapy + Thoracic Region Exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old,
  • According to the Temporomandibular Disorders Research Diagnostic Criteria;
  • With muscle involvement,
  • With muscle+joint involvement
  • Those who volunteer to participate in the study will be included

You may not qualify if:

  • According to the Temporomandibular Disorders Research Diagnostic Criteria;
  • Those with disc displacement without reduction,
  • Those with arthritis
  • Those with a known neurological, systemic or psychological disease,
  • Pregnant and lactating women,
  • Those who have had any trauma/surgical operation in the last 6 months,
  • Those with severe to severe local and/or general musculoskeletal pain,
  • Patients with an obstructive or restrictive respiratory problem,
  • Those with scoliosis that may cause respiratory problems will not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Çiğli, İzmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersMotor Activity

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 19, 2025

Study Start

October 16, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 13, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations