Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

NCT ID: NCT05006963

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2027-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Temporomandibular disorder or TMD is characterized by a set of symptoms such as: pain, decreased range of motion and joint noise. It's origin is multifactorial, which may be related to biological aspects, environmental and psychosocial. The multimodal approach has been widely used in physiotherapy for the treatment of TMDs. Physiotherapy has been walking together with technology so that telerehabilitation can be a reality, contributing so that quality care reaches the patient, in the impossibility office-to-face service. The objective of this study is to verify the effect of telerehabilitation on pain outcomes, range of motion, functionality and biopsychosocial aspects in individuals with temporomandibular disorders. Will be a randomized, controlled and blinded clinical trial was carried out. The study will be divided into two moments: evaluation and intervention. Evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Clinical Protocol and Assessment Instruments (DC/TMD), the Fonseca Anamnesis Index (IAF), the Numerical Pain Scale (END) and the Functional Limitation Questionnaire (MFIQ). Individuals will be randomized into 2 groups: Group A (in person) Group B (telerehabilitation). Both groups will receive treatment physical therapy for 12 weeks. After collecting the data, they will be tabulated and analyzed using a 5% significance level.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorder Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Two researchers will be part of the protocol. One will be responsible for pre and post intervention assessments and will be blind to the type of intervention. The other will be responsible for the treatment phase: face-to-face and telerehabilitation. A third party collaborator will process and statistically analyze the collected data. Individuals will be randomized using the statistical program present at www.randomization.com , in two groups. Randomization and concealment of allocation will be made by a fourth external employee, not research participant, who will organize the allocation in individual opaque envelopesand keep it confidential. There will be 2 blocks of 25 envelopes: face-to-face (GA) and telerehabilitation (GB). With this process, participants will have the same probability of being allocated to one of the two treatment groups. Blinding of the evaluator will be maintained until the end of the research and data tabulation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

face-to-face group

The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, totaling 24 face-to-face consultations lasting 40 minutes each. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms.Techniques of manual therapy and therapy by exercise. In general, extra-oral and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will be mouth opening exercise will be also performed with the tongue on the palate, proprioceptive exercises with hyperboloid. In addition to these, additional exercises may be performed, according to the patient's need. The conducts will be adapted according to the needs of each patient. The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene.

Group Type EXPERIMENTAL

manual therapy and therapy by exercise

Intervention Type OTHER

In general, patients will receive extra-oral massage and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will bemouth opening exercise was also performed with the tongue on the palate, proprioceptive lateralization and protrusion exercises with hyperboloid and exercises with combinations of movements of laterality and opening, or protrusion and opening.

telerehabilitation

The patient will be submitted to multimodal treatment, twice a week, for twelve weeks, by telerehabilitation lasting 40 minutes each.A physiotherapist through video call via WhatsApp application. In the first session, the patient will be explained what is TMD, what is the correct placement of the tongue and teeth, influence of parafunctional and sleep habits in TMD signs and symptoms. Patients will be instructed to perform extra-oral and intra-oral self-massage and in the cranio-cervical musculature, bone mobilization hyoid, which would replace the mobilization unspecific articulation performed in person.Exercise will also be carried out mouth opening with tongue on the palate, exercises proprioceptives with hyperboloid. The conducts will be adapted according to the needs of each patient.The conducts will be adapted according to the needs of each patient.The use of post its may be indicated to help maintain the correct posture of the tongue and jaw, as well as sleep hygiene

Group Type ACTIVE_COMPARATOR

manual therapy and therapy by exercise

Intervention Type OTHER

In general, patients will receive extra-oral massage and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will bemouth opening exercise was also performed with the tongue on the palate, proprioceptive lateralization and protrusion exercises with hyperboloid and exercises with combinations of movements of laterality and opening, or protrusion and opening.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

manual therapy and therapy by exercise

In general, patients will receive extra-oral massage and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will bemouth opening exercise was also performed with the tongue on the palate, proprioceptive lateralization and protrusion exercises with hyperboloid and exercises with combinations of movements of laterality and opening, or protrusion and opening.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age between 18 and 60 years;
2. presence of pain in the facial region in the last 6 months;
3. diagnosis of myalgia, arthralgia, headache attributed to temporomandibular disfunction and/or subluxation temporomandibular joint.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniela Ap. Biasotto-Gonzalez

PhD, professor and researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Nove de Julho

São Paulo, , Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Margarete Nobilo Leonardis, Master

Role: primary

+5511 984577584

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Tele-Reabilitação em TMD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.