Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

March 23, 2015 updated by: Wagner Araujo de Negrieiros, Universidade Federal do Ceará
This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular disorder patients (TMD). An eligible group of patients will be treated with that therapy (experimental group) and another group will be treated with counseling and occlusal splint (control group), considered the standard therapy for TMD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Mandibular exercises may have behavioral and cognitive action, educating the patient and serving as an instrument of control of parafunctional activity. It is a simple, easy, which seeks adherence to treatment and has negligible cost. A disadvantage is the need of motivation and discipline of the patient in carrying out the therapy daily. The occlusal splints, associated with educational guidance and counseling have world indication the possibility of promoting teeth protection, joint decompression, equalization of electromyographic activity, conscious control of parafunctional activity and strong placebo effect.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-160
        • Recruiting
        • Federal University Of Ceara
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females, aged 20-45 years, clinical diagnosis of muscular TMD form mild to moderate according to the Criteria of the Diagnostic and Research of TMD (RDC / TMD), good reception and understanding of spoken Portuguese, able to provide a informed consent, and be available to attend the evaluation returns.

Exclusion Criteria:

  • Rheumatic, vascular, neurological, infectious or neoplastic disease, cognitive or motor problems, pregnancy status or use of abusive drugs, chronic facial pain history (2 years or more), refuses to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jaw exercise program
Procedure: Jaw exercise program
The jaw exercise program will consist of three cycles: 1st CYCLE - simple opening and closing mouth, right and left lateral excursions with mechanisms of proprioceptive neuromuscular facilitation and muscle coordination; 2 ° CYCLE - opening and closing exercises, right and left lateral excursions with a counter-resistance force imposed by the participant, with reciprocal inhibition, stretching, and muscular endurance mechanisms; 3rd CYCLE - specific exercises to disk capture attempt in cases of disk displacement with reduction and acute disk displacement without reduction (mouth opening and closing in protrusion) or chronic disk displacement without reduction (forced mouth opening in order to push the disc), with remodeling articulate mechanisms. The conduct will be individualized according to the need and symptoms of patients, which will be monitored fortnightly. It will be proposed 3 times a day, lasting a minute and a half per turn, in front of the mirror, during three months.
Active Comparator: Occlusal splint and counseling
Device: Occlusal Splint and counseling
The occlusal splints will be made from obtaining a plaster type IV model of upper arch using alginate and metal stock tray. A 2mm thick polyacetate blade will be adapted to the vacuum device plasticizer, heated and pressed over the previously cut U-shaped plaster model. After cooling, it will be added the self-curing acrylic resin on occlusal surface in order to increase the vertical dimension of occlusion in 2mm (anterior region). After polishing, the splints will be intraorally adjusted using carbon paper and clamp Muller, and installed obtaining maximum tooth contacts in centric relation. The splints will be flat and of full coverage for night use. Patients will be monitored every two weeks for the occlusal adjustment for three months. It will also be done counseling measures through a printed guide in relation to the daily care and the various contributing factors of TMD (diet, stress reduction, elimination of parafunctions and posture correction).
Other Names:
  • Occlusal appliances,
  • Occlusal plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular pain
Time Frame: Three months
Pain on masticatory muscles (masseter and temporal) pressure, scored 0-3 (0=no pain, 3= severe pain).
Three months
Articular pain
Time Frame: Three months
Pain on bilateral digital pressure on articular region, scored 0-3 (0=no pain, 3= severe pain).
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening
Time Frame: Three months
Mouth opening amplitude, measured with a millimeter ruler from the tip of the lower incisors to the tip of the upper incisors, counting the vertical crossover.
Three months
Mandibular excursions
Time Frame: Three months
Lateral and protrusive movement, measured with a millimeter ruler considering the right and left lateral excursion and protrusive excursion.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Ceará

Investigators

  • Principal Investigator: Wagner A Negreiros, PhD, Universidade Federal Do Ceara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Federal University of Ceara

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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