Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

Musculoskeletal Diseases Clinical Trial

Official title:

Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02397070
• Other study ID #: Federal University of Ceara
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2015
• Last updated: March 23, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Universidade Federal do Ceara
• Contact: Wagner A Negreiros, PhD
• Phone: 55 85 91629894
• Email: wagnerufc[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Musculoskeletal Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

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).

Locations

Country	Name	City	State
Brazil	Federal University of Ceara	Fortaleza	Ceara

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8. — View Citation

Kraaijenga S, van der Molen L, van Tinteren H, Hilgers F, Smeele L. Treatment of myogenic temporomandibular disorder: a prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite®) with standard physical therapy exercise. C — View Citation

Yoda T, Sakamoto I, Imai H, Honma Y, Shinjo Y, Takano A, Tsukahara H, Morita S, Miyamura J, Yoda Y, Sasaki Y, Tomizuka K, Takato T. A randomized controlled trial of therapeutic exercise for clicking due to disk anterior displacement with reduction in the — View Citation

Yoshida H, Kashiwagi K, Sakata T, Tanaka M, Kawazoe T, Morita S. Prognostic factor of mandibular condylar movement exercise for patients with internal derangement of the temporomandibular joint on initial presentation: preliminary report. J Craniomaxillof — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular pain	Pain on masticatory muscles (masseter and temporal) pressure, scored 0-3 (0=no pain, 3= severe pain).	Three months	No
Primary	Articular pain	Pain on bilateral digital pressure on articular region, scored 0-3 (0=no pain, 3= severe pain).	Three months	No
Secondary	Maximum mouth opening	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	No
Secondary	Mandibular excursions	Lateral and protrusive movement, measured with a millimeter ruler considering the right and left lateral excursion and protrusive excursion.	Three months	No