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Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

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ClinicalTrials.gov Identifier: NCT02397070
Recruitment Status : Unknown
Verified March 2015 by Wagner Araujo de Negrieiros, Universidade Federal do Ceara.
Recruitment status was:  Recruiting
First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Wagner Araujo de Negrieiros, Universidade Federal do Ceara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Musculoskeletal Diseases Procedure: Jaw exercise program Device: Occlusal Splint and counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients
Study Start Date : January 2015
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Muscular pain [ Time Frame: Three months ]
    Pain on masticatory muscles (masseter and temporal) pressure, scored 0-3 (0=no pain, 3= severe pain).

  2. Articular pain [ Time Frame: Three months ]
    Pain on bilateral digital pressure on articular region, scored 0-3 (0=no pain, 3= severe pain).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397070


Contacts
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Contact: Wagner A Negreiros, PhD 55 85 91629894 wagnerufc@yahoo.com.br
Contact: Romulo R Regis, PhD 55 85 99559045 romuloregis@hotmail.com

Locations
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Brazil
Federal University of Ceara Recruiting
Fortaleza, Ceara, Brazil, 60430-160
Contact: Jose ET Rocha, Master    55 88 99353502    eugeniorocha@hotmail.com   
Sponsors and Collaborators
Universidade Federal do Ceara
Investigators
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Principal Investigator: Wagner A Negreiros, PhD Universidade Federal do Ceara
Publications of Results:
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Responsible Party: Wagner Araujo de Negrieiros, Wagner Araujo de Negreiros, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT02397070    
Other Study ID Numbers: Federal University of Ceara
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Wagner Araujo de Negrieiros, Universidade Federal do Ceara:
Jaw exercise
Occlusal splint
Treatment
Muscular pain
Mandibular movement
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents