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Completed

NCT Number: NCT02021357

Proprioceptive Treatment for Temporomandibular Dysfunction

The project aims to assess the effects of proprioceptive treatment through the use of hyperbolid mastication apparatus on pain intensity, muscle activity and joint mobility in subjects with TMD. A randomized, blind, clinical trial will be conducted. Volunteers aged between 18 and 40 years will be recruited, with a diagnosis of muscle- and joint-related TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in three different groups: Group 1 (G1) - treated with HB device combined with tongue exercises on the palate; Group 2 (G2) - treated HB alone and Group 3 (G3) - control. Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in two stages: before applying the treatment and after the last session.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho

São Paulo, 02117-020, Brazil

About this study

The temporomandibular disorder (TMD) are characterized by a set of clinical abnormalities involving the masticatory muscles, the temporomandibular joint (TMJ) and other associated structures. Several studies have supported the use of physical therapy in the treatment of this condition, especially electrotherapy, laser therapy and manual resources. However, despite advances in the search for scientific evidence, it is necessary to prove to other commonly used clinical measures in subjects with TMD, such as the use of hyperbolid, which is a feature that stimulates the proprioceptive function. Thus, this project aims to assess the effects of proprioceptive treatment through the use of hyperbolid on pain intensity, muscle activity and joint mobility in subjects with TMD. A randomized, blind, clinical trial will be conducted. Volunteers aged between 18 and 40 years will be recruited, with a diagnosis of muscle- and joint-related TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in three different groups, the first group constituted by treatment with hyperbolid associated with tongue exercises on the palate, the second group consists of treatment with hyperbolid alone and the third group will not receive any type of intervention (proprioceptive treatment will be offered after the study period). Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in two stages: before applying the treatment and after the last session. The variables that will be investigated are: pain assessed using visual analog scale and algometry; muscle activity, investigated by electromyography of masticatory muscles; and joint mobility, measured by the use of a caliper. Regarding the analysis of the data will be held intragroup comparisons, considering the pre-treatment and after twelve sessions, and comparisons between groups. To this end it will be applied the Shapiro-Wilk test for checking the normality of data, and the statistical test applied consistent, then parametric or nonparametric. Is assumed a significance level of 5%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Temporomandibular Joint Disorders according to the RDC / TMD questionnaire,
  • 18 to 40 years

Exclusion criteria

  • History of neurological disorders
  • Submit dental flaws,
  • Sull or partial denture,
  • Systemic diseases, neuromuscular,
  • History of trauma to the face and or ATM
  • History of TMJ luxation.
  • Being in orthodontic treatment or medication that affects the musculoskeletal system.

Treatment and study plan

hyperbolid combined with tongue exercises on the palate

Behavioral

hyperbolid

Other

Primary outcomes

  1. Pain intensity

    Time frame: 1 Year

    Pain intensity was assessed using the visual analog scale, RDC/TMD Pain Index.

Secondary outcomes

  1. Electromyographic Activity

    Time frame: 1 Year

    Muscle activity was assessed using the EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

The Influence of Proprioceptive Treatment for the Intensity of Pain, Muscle Activity, Level of Severity and Mandible Mobility in Individuals With Temporomandibular Dysfunction: Clinical Trial, Randomized, Controlled, Double-Blind

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 27, 2013
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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