Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

Not Applicable

• Conditions: Temporomandibular Joint Disorders; Musculoskeletal Diseases
• Interventions: Procedure: Jaw exercise program; Device: Occlusal Splint and counseling

• Registration Number: NCT02397070
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01
• Status Verified: 2015-03
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-23
• Last Update Submitted: 2015-03-23
• Study First Posted: 2015-03-24
• Last Update Posted: 2015-03-24
• Primary Completion: 2015-04
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaw exercise program	Jaw exercise program	-
Occlusal splint and counseling	Occlusal Splint and counseling	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening	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.
Mandibular excursions	Three months	Lateral and protrusive movement, measured with a millimeter ruler considering the right and left lateral excursion and protrusive excursion.

Trial Locations

Locations (1)

Federal University of Ceara; 🇧🇷 Fortaleza, Ceara, Brazil