Proprioceptive Treatment for Temporomandibular Dysfunction
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
1 other identifier
interventional
33
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 18, 2022
May 1, 2022
2.8 years
December 19, 2013
May 11, 2022
Conditions
Keywords
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
EXPERIMENTALThe 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.
Hyperbolid
ACTIVE COMPARATORThe 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.
Control
NO INTERVENTIONThe individuals in control group did not receive any type of intervention, being offered proprioceptive treatment after the study period.
Interventions
Eligibility Criteria
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Arruda
University of Nove de Julho
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