NCT02021357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

December 19, 2013

Last Update Submit

May 11, 2022

Conditions

Keywords

Facial PainPhysical Therapy ModalitiesTemporomandibular Joint DisordersExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

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

    1 Year

Secondary Outcomes (1)

  • Electromyographic Activity

    1 Year

Study Arms (3)

Hyperbolid combined with tongue exercises on the palate

EXPERIMENTAL

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.

Behavioral: hyperbolid combined with tongue exercises on the palate

Hyperbolid

ACTIVE COMPARATOR

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.

Other: hyperbolid

Control

NO INTERVENTION

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

Interventions

Hyperbolid combined with tongue exercises on the palate
Hyperbolid

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nove de Julho

São Paulo, 02117-020, Brazil

Location

Related Links

MeSH Terms

Conditions

Facial PainTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Eric Arruda

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Anatomy

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 27, 2013

Study Start

January 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations