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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02021357
Other study ID # ERC-2205-AR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 2017

Study information

Verified date May 2022
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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%.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Facial Pain
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral:
hyperbolid combined with tongue exercises on the palate

Other:
hyperbolid


Locations

Country Name City State
Brazil University of Nove de Julho Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain intensity was assessed using the visual analog scale, RDC/TMD Pain Index. 1 Year
Secondary Electromyographic Activity 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 1 Year
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