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Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

Primary Purpose

Temporomandibular Joint Disorders, Musculoskeletal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Jaw exercise program
Occlusal Splint and counseling
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Jaw exercise, Occlusal splint, Treatment, Muscular pain, Mandibular movement

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of CearaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jaw exercise program

Occlusal splint and counseling

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Mandibular excursions
Lateral and protrusive movement, measured with a millimeter ruler considering the right and left lateral excursion and protrusive excursion.

Full Information

First Posted
March 18, 2015
Last Updated
March 23, 2015
Sponsor
Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT02397070
Brief Title
Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients
Official Title
Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Musculoskeletal Diseases
Keywords
Jaw exercise, Occlusal splint, Treatment, Muscular pain, Mandibular movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jaw exercise program
Arm Type
Experimental
Arm Title
Occlusal splint and counseling
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Jaw exercise program
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Occlusal Splint and counseling
Other Intervention Name(s)
Occlusal appliances,, Occlusal plates
Intervention Description
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).
Primary Outcome Measure Information:
Title
Muscular pain
Description
Pain on masticatory muscles (masseter and temporal) pressure, scored 0-3 (0=no pain, 3= severe pain).
Time Frame
Three months
Title
Articular pain
Description
Pain on bilateral digital pressure on articular region, scored 0-3 (0=no pain, 3= severe pain).
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Maximum mouth opening
Description
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.
Time Frame
Three months
Title
Mandibular excursions
Description
Lateral and protrusive movement, measured with a millimeter ruler considering the right and left lateral excursion and protrusive excursion.
Time Frame
Three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wagner A Negreiros, PhD
Phone
55 85 91629894
Email
wagnerufc@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Romulo R Regis, PhD
Phone
55 85 99559045
Email
romuloregis@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wagner A Negreiros, PhD
Organizational Affiliation
Universidade Federal do Ceara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Ceara
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-160
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose ET Rocha, Master
Phone
55 88 99353502
Email
eugeniorocha@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25000163
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(R)) with standard physical therapy exercise. Cranio. 2014 Jul;32(3):208-16. doi: 10.1179/0886963413Z.00000000016. Epub 2014 Jan 24.
Results Reference
result
PubMed Identifier
22318373
Citation
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.
Results Reference
result
PubMed Identifier
12555926
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 temporomandibular joint. Cranio. 2003 Jan;21(1):10-6. doi: 10.1080/08869634.2003.11746226.
Results Reference
result
PubMed Identifier
22789869
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 Craniomaxillofac Surg. 2013 Jul;41(5):356-8. doi: 10.1016/j.jcms.2012.05.009. Epub 2012 Jul 11.
Results Reference
result

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Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

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