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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-4j6xfx
Date of registration: 01/02/2012
Primary sponsor: Universidade Metodista de Piracicaba - Brazil
Public title: Treatment of mouth articulation's dysfunction.
Scientific title: Effects of upper cervical spinal's manipulation on electromyographic activity os masticatory muscles, signs and symptons os temporomandibular disorders.
Date of first enrolment: 01/06/2010
Target sample size: 20
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-4j6xfx/
Study type: 
Study design:  Clinical trial, double-arm, randomized, blinded  
Countries of recruitment
Brazil
Contacts
Name: Gustavo  Bortolazzo
Address:  Av. Limeira, 901 13414903 Piracicaba Brazil
Telephone: 19 2106-5200
Email: gustavobfisio@hotmail.com
Affiliation:  Unicamp
Name: Gustavo  Bortolazzo
Address:  Av. Limeira, 901 13414903 Piracicaba Brazil
Telephone: 19 2106-5200
Email: gustavobfisio@hotmail.com
Affiliation:  Unicamp
Key inclusion & exclusion criteria
Inclusion criteria: The subjects of both groups must have a diagnosis of TMD according to the DRC, axis I, accompanied by pain and / or fatigue in the muscles of mastication during functional activities for a minimum period of one year and maximum of five years, with body mass index (BMI) to 25 kg/m2.
Exclusion criteria: Are being excluded from the study women with any missing teeth (except third molars), open bite, crossbite, suffering from partial or complete dentures, orthodontic treatment and / or medication (analgesics, anti-inflammatories and muscle relaxants), those who received treatment with cervical spine manipulation in the past 6 months and those in physiotherapy. Also, are also excluded women with systemic neuromuscular diseases, migraine, history of trauma to the face and / or ATM, joint dislocation and testing extension and rotation of the head, which assesses the flow of the vertebral artery and the Sharp-Purser , indicating upper cervical spinal instability positive.

Age minimum: 18Y
Age maximum: 40Y
Gender: F
Health Condition(s) or Problem(s) studied
Temporomandibular disorders
E02.779.867.466
Intervention(s)
Experimental group: high-speed and short range´s tecnichal in the upper cervical spine.
Held on 20 volunteers, with a frequency of once per week for a period of 5 weeks.
In the placebo group: positioning the head in rotation and maintaining the position for 15 seconds.
Held on 20 volunteers, with a frequency of once per week for a period of 5 weeks.
Primary Outcome(s)
It is expected that the upper cervical spine manipulation in promoting an improvement in the agonist-antagonist in masticatory muscles measured by EMG, increased range of motion of the jaw of depression assessed with calipers and decrease the severity of TMD evaluated by anamnesis index of Fonseca.
Secondary Outcome(s)
The data regarding the effect of upper cervical spine manipulation in the evaluation of the cervical spine are being processed.
Secondary ID(s)
01/09
Source(s) of Monetary Support
Coordenação de aperfeiçoamento de pessoal de nível superior - Brazil
Secondary Sponsor(s)
Universidade Metodista de Piracicaba - Brazil
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