NCT07556510

Brief Summary

This randomized controlled trial will be conducted among 18-25-year-old participants who present with temporomandibular joint dysfunction symptoms, including pain, limited range of motion, and joint crepitation. Participants will be randomly allocated into control and intervention groups using block randomization. The control group will receive a standard physiotherapy program, while the intervention group will additionally perform telerehabilitation-based dual-task exercises. The intervention will last for six weeks, with progressive increases in exercise and cognitive task difficulty. Outcomes will be assessed at baseline and at the end of the 6th week. Primary and secondary outcome measures include pain intensity (Visual Analog Scale), jaw functional limitation (Jaw Functional Limitation Scale-20), oral habits, static balance (Tetrax system), and dynamic balance (Timed Up and Go Test). Within-group and between-group comparisons will be performed. The sample size was calculated using power analysis, resulting in 30 participants in total (15 per group), accounting for potential dropouts.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jun 2026

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2026

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 16, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

temporomandibular joint dysfunctiondual-taskpainbalance

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Pain intensity will be assessed using a 10-cm Visual Analog Scale. Participants will rate their pain at rest, during chewing, and at night. Scores range from 0 (no pain) to 10 (worst imaginable pain).

    Measurements will be recorded at baseline and at week 6. Change in pain intensity will be analyzed.

  • Jaw Functional Limitation

    (Jaw Functional Limitation Scale - JFLS-20): Jaw function will be evaluated using the JFLS-20, a 20-item self-report scale assessing functional limitations in mastication, speech, and jaw movement. Each item is scored from 0 (no limitation) to 10 (severe limitation). Higher scores indicate greater functional impairment.

    Assessments will be performed at baseline and week 6.

Secondary Outcomes (7)

  • Temporomandibular Disorder Classification

    Assessment will be performed at baseline.

  • Oral Habits

    Assessments will be performed at baseline and week 6.

  • Dynamic Balance

    Assessments will be performed at baseline and week 6.

  • Stability Index (SI)

    Baseline and after 6 weeks

  • Weight Distribution Index (WDI)

    Baseline and after 6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Conventional Physiotherapy and TMJ Exercise Program

ACTIVE COMPARATOR

Standard Physiotherapy Program

Behavioral: Standard Physiotherapy Program

Telerehabilitation-Based Dual-Task Training

EXPERIMENTAL

Standard Physiotherapy Program plus Telerehabilitation-Based Dual-Task Training

Behavioral: Standard Physiotherapy ProgramBehavioral: Dual-Task Training

Interventions

Cervical range of motion exercises, cervical lateral flexion stretching, upper trapezius stretching, pectoral stretching, breathing exercises, seated cervical postural correction exercises, supine and prone cervical postural exercises, postural training exercises, temporomandibular joint (TMJ) rotation control exercises, TMJ opening, closing, protrusion, and retrusion exercises, tongue resting position training, isometric TMJ elevation, depression, and lateral deviation exercises in sitting position, post-isometric relaxation techniques, abdominal strengthening exercises, and back extensor strengthening exercises.

Conventional Physiotherapy and TMJ Exercise ProgramTelerehabilitation-Based Dual-Task Training

Backward counting from 200 by threes during cervical range of motion exercises and pectoral stretching, naming cities starting with the letter "A" during supine cervical postural exercises, naming animals starting with the letter "A" during TMJ rotation control exercises, simple arithmetic tasks (addition and subtraction) during isometric TMJ elevation and depression exercises, and more complex arithmetic tasks during lateral deviation exercises in sitting position. Cognitive task difficulty will be progressively increased over time.

Telerehabilitation-Based Dual-Task Training

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of temporomandibular joint dysfunction according to the
  • Temporomandibular Disorders Research Diagnostic Criteria and Diagnostic
  • Criteria for Temporomandibular Disorders
  • No neurological, orthopedic, or systemic condition that may affect balance
  • Ability to comply with a telerehabilitation program
  • Willingness to provide written informed consent
  • No prior physiotherapy treatment for temporomandibular joint dysfunction

You may not qualify if:

  • Inability to participate in regular exercise or telerehabilitation programs
  • Presence of severe systemic diseases (cardiac, rheumatologic, neurological) or other severe chronic conditions
  • Presence of psychiatric disorders or cognitive impairment
  • Use of medications that may affect balance (such as sedatives)
  • History of jaw or dental surgery within the last 6 months
  • Receipt of physiotherapy, splint therapy, or similar treatment for temporomandibular joint dysfunction within the last 3-6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Serkan Bakırhan, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the interventions, participants and care providers cannot be blinded to group allocation. However, outcome assessors will be blinded to participant group assignment to minimize assessment bias. In addition, data analysts will be blinded by using coded group labels during statistical analysis to further reduce potential bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled parallel-group trial with two groups. Participants will be allocated by block randomization to either a control or an intervention group. The control group will receive a standard physiotherapy program including cervical range of motion, stretching, postural, temporomandibular joint mobility and control, isometric, and strengthening exercises. The intervention group will receive the same standard physiotherapy program plus telerehabilitation-based dual-task training involving concurrent physical exercises and cognitive tasks (e.g., counting, category naming, and simple arithmetic).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 29, 2026

Study Start (Estimated)

June 16, 2026

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

February 16, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared upon reasonable request after publication of the main study results. De-identified data may be provided to qualified researchers for academic and non-commercial purposes. Data sharing will be subject to ethical approval and data use agreements.