Proprioceptive Treatment for Temporomandibular Dysfunction

NCT ID: NCT02021357

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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%.

Conditions

Facial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hyperbolid combined with tongue exercises on the palate

The proprioceptive treatment protocol if run in the use of exercises with hyperboloid based on studies of Biasotto-Gonzalez (2005), for each exercise will be held 6 sets of 6 reps. Between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain, and after that period you will be asked to volunteer the proprioceptive exercise of ´ ´ tongue on the hard palate ´ ´ Biasotto-Gonzalez-based (2005), which consists of the language supported in the hard palate, you must open and close the mouth, having as the principle language as a physical reference.

Group Type: EXPERIMENTAL

hyperbolid combined with tongue exercises on the palate

Intervention Type: BEHAVIORAL

Hyperbolid

The proprioceptive treatment protocol if run in the use of the hyperboloid, based on studies of Biasotto-Gonzalez (2005), but without the proprioceptive exercise of language in ´ ´ hard palate ´ ´.

For each exercise will be held 6 series of 6 repetitions, and between exercises, 1 minute will be established for rest of the volunteer, in order to avoid muscle fatigue and possible exacerbation of pain.

Group Type: ACTIVE_COMPARATOR

hyperbolid

Intervention Type: OTHER

Control

The individuals in control group did not receive any type of intervention, being offered proprioceptive treatment after the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

hyperbolid combined with tongue exercises on the palate

Intervention Type: BEHAVIORAL

hyperbolid

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Daniela Ap. Biasotto-Gonzalez

Doctor of Anatomy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Arruda

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

University of Nove de Julho

São Paulo, , Brazil

Countries

Brazil

Related Links

http://www.uninove.br

University web site

Other Identifiers

ERC-2205-AR

Identifier Type: -

Identifier Source: org_study_id