ClinicalTrials.gg
RecruitingNCT05006963Updated Mar 4, 2025

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction

An interventional study of manual therapy and therapy by exercise in Temporomandibular Disorder, Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-04.

Primary conditionTemporomandibular Joint Dysfunction SyndromeRegistry: Temporomandibular Joint DisordersReclassifiedWhy we changed it
Registry
Temporomandibular Joint Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Temporomandibular Joint Dysfunction Syndrome
Why
  1. The study's listed conditions name Temporomandibular Joint Dysfunction Syndrome, a narrower term within Temporomandibular Joint Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Temporomandibular Disorder
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

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Keywords

  • temporomandibular joint disorders
  • clinical protocols
  • physiotherapy
  • remote consultation
  • telemedicine
  • telehealth
  • telerehabilitation
  • teletherapy
  • telepractice
03

In context

Temporomandibular Joint Dysfunction Syndrome Reclassified

54 studies on the registry are indexed under Temporomandibular Joint Dysfunction Syndrome; 14 are open to participants now.

This study's planned enrollment of 50 is close to the median of 49 across 43 interventional studies indexed under Temporomandibular Joint Dysfunction Syndrome.

Browse Temporomandibular Joint Dysfunction Syndrome studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Compared within Temporomandibular Joint Dysfunction Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Temporomandibular Joint Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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.

    Other: manual therapy and therapy by exercise

  • Active comparator
    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

    Other: manual therapy and therapy by exercise

Interventions

  • Othermanual 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.

06

What researchers measure

Primary outcomes

  1. Score in Numerical Pain Scale

    intensity of pain

    Time frame: The level of pain at 12 weeks

  2. Score in Numerical Pain Scale

    intensity of pain

    Time frame: The level of pain at 6 months

  3. measure range of motion

    range of motion

    Time frame: The range of motion at range of motion at 12 weeks .

  4. measure range of motion

    range of motion

    Time frame: The range of motion at 6 months.

Secondary outcomes

  1. measure Functionality

    Mandibular Functional Limitation Questionnaire

    Time frame: The functionality at 12 weeks .

  2. measure Functionality

    Mandibular Functional Limitation Questionnaire

    Time frame: The functionality at 6 months.

  3. Biopsychosocial analysis.

    Axis II of the diagnostic criterion for temporomandibular disorders

    Time frame: The biopsychosocial analysis at 12 weeks .

  4. Biopsychosocial analysis.

    Axis II of the diagnostic criterion for temporomandibular disorders

    Time frame: The biopsychosocial analysis at 6 months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — The data is confidential, but if any journal requests open data for publication for sure we will provide our database

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Dec 2026, 63 months after the start.

Of 24 interventional studies with no phase under Temporomandibular Joint Dysfunction Syndrome, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's planned 63 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2020
First posted
Aug 16, 2021
StartActual
Sep 30, 2021
Primary completionEst.
Dec 30, 2026
CompletionEst.
Mar 30, 2027
Last update
Mar 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05006963
Responsible party
Daniela Ap. Biasotto-Gonzalez (PhD, professor and researcher, University of Nove de Julho) — Principal investigator
First posted
Aug 16, 2021
Start date
Sep 30, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Mar 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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