NCT06994910

Brief Summary

This study aims to investigate the effectiveness of the Maitland joint mobilization technique in alleviating symptoms related to (temporomandibular disorders) TMD and to investigate its influence on patient clinical outcomes, including pain intensity, TMJ range of motion (ROM), functional limitations, disability, and oral behaviors.

Trial Health

87
On Track

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
Completed

Started Aug 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

May 20, 2025

Last Update Submit

May 20, 2025

Conditions

Keywords

Temporomandibular DisordersPhysiotherapyMaitland Mobilization Technique

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

    Pain intensity will be assessed using a 10-centimeter Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Participants will be asked to indicate the average intensity of their jaw-related pain experienced over the past week. This tool is used to evaluate the effect of the intervention on subjective pain levels in patients diagnosed with temporomandibular disorders.

    Pain will be measured at baseline (pre-intervention) and after completion of the 4-week intervention (post-intervention)

  • Temporomandibular joint range of motion

    The range of motion (ROM) of the temporomandibular joint will be measured using the TheraBiteⓇ Range of Motion Scales, a standardized tool designed to accurately assess mandibular movements including maximum mouth opening, lateral excursion, and protrusion. Measurements will be taken in millimeters by trained assessors to evaluate functional improvement following the intervention in patients with temporomandibular disorders.

    Temporomandibular joint range of motion will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).

  • Jaw functional disability

    Jaw functional disability will be evaluated using the Jaw Functional Limitation Scale (JFLS-20), a validated and reliable questionnaire designed to assess limitations in jaw function across three domains: mastication, jaw movements, and verbal communication. Patients will self-report the degree of difficulty experienced during specific functional activities related to the temporomandibular joint. This measure will assess the impact of the intervention on improving jaw function in patients with temporomandibular disorders.

    Jaw functional disability will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).

  • Oral behaviors

    Oral behaviors will be evaluated using the Oral Behavior Checklist (OBC), a validated self-report questionnaire designed to assess the frequency and type of oral behaviors during waking hours and sleep. This includes activities such as clenching, grinding, and other parafunctional habits that may influence temporomandibular disorder symptoms. The OBC will help determine changes in oral behaviors as a result of the intervention.

    Oral behaviors will be assessed at baseline (pre-intervention) and after the 4-week intervention (post-intervention).

Study Arms (2)

Before Maitland joint mobilization

EXPERIMENTAL

Participants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention)

Other: Maitland mobilization techniques

After Maitland joint mobilization

EXPERIMENTAL

Participants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention).

Other: Maitland mobilization techniques

Interventions

Participants with temporomandibular joint dysfunction received Maitland mobilization techniques applied to the TMJ over a defined treatment period. Outcomes were assessed at baseline (pre-intervention) and after completion of the intervention (post-intervention)

After Maitland joint mobilizationBefore Maitland joint mobilization

Eligibility Criteria

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

You may qualify if:

  • Diagnosis: individuals diagnosed with TMD, whether it is unilateral or bilateral.
  • Myofascial pain and myo-spasm.
  • Anterior disk displacement with reduction and anterior disk displacement without reduction.
  • Craniofacial and craniomandibular pain.
  • Myofascial pain with or without limited mouth opening.

You may not qualify if:

  • Patients with a documented history of surgical procedures involving the TMJ.
  • Patients with a confirmed diagnosis of systemic diseases (e.g., rheumatic and metabolic diseases).
  • Patients with congenital or developmental craniofacial anomalies, including conditions like as ankylosis.
  • Patients with diagnosed cancer.
  • Patients with mental, physical disorders and language difficulties.
  • Patients with diagnosed neuropathic and dental pain.
  • Patients with diagnosed general myopathy (e.g., fibromyalgia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestine Polytechnic University

Hebron, Palestinian Territories

Location

Related Links

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A single group of participants received the intervention. Outcomes were measured before and after the intervention within the same group to assess changes over time
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

August 7, 2023

Primary Completion

October 30, 2024

Study Completion

December 24, 2024

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared for research purposes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available starting 6 months after publication of the main results, for a period of 3 years
Access Criteria
IPD and supporting documents (such as the study protocol and statistical analysis plan) will be made available to qualified researchers upon reasonable request. Requests must include a clear research purpose and be approved by an independent ethics committee or institutional review board. Requests can be submitted by email to Dr. Mohammad Al-Talahma at \[mtalahma@ppu.edu\], and approved data will be shared via secure electronic transfer.

Locations