Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

March 23, 2015 updated by: Wagner Araujo de Negrieiros, Universidade Federal do Ceara
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-160
        • Recruiting
        • Federal University of Ceará
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Ceara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Federal University of Ceara

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