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Completed

NCT Number: NCT01874041

Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder

The objectives of this study were to investigate the effects of massage therapy and occlusal splint therapy in the electromyographic activity and mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with those obtained in a group of individuals without this disorder. Twenty-eight volunteers with TMD were randomly distributed into two groups, massage therapy and occlusal splint. Both treatments lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control group. The Fonseca's anamnestic index was used to characterize TMD and allocate the volunteers to either the intervention groups or control group. The electromyographic activity and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way analysis of variance with the Bonferroni test was used for inter and intragroup comparisons (level of significance was set to 5%). Cohen's d was used to calculate the effect size.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male and female volunteers
  • aged 18 to 40 years

Exclusion criteria

  • occurrence of missing teeth
  • current use of orthodontic appliance
  • history of systemic or joint disease
  • current use of analgesic, anti-inflammatory agent or muscle relaxant and currently undergoing physical therapy.

Treatment and study plan

Massage

Other

Occlusal splint

Other

Primary outcomes

  1. Mandibular range of motion

    Time frame: 1 year

    Mandibular range of motion(maximum active mouth opening, and right and left lateral excursion) was evaluated by a blinded examiner on two occasions (before and after treatment) using a digital caliper.

Secondary outcomes

  1. Electromyographic activity

    Time frame: 1 year

    Electromyographic activity in the masseter and anterior temporal muscles. The right and left masseter and anterior temporal muscles were analyzed with surface EMG.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 10, 2013
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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