Clinical Trial: Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Effectiveness of Physical Therapy Interventions, Relative to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial

Brief Summary: Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central, and psychosocial factors influence the disorder, which may predispose to pain in the masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and cervical muscles, limitation mandibular opening, sleep disorders, stress, anxiety, depression, and overall impairment of oral health. The aim of this study is to compare physical therapy interventions with dental treatment in pain, mandibular opening, sleep quality, anxiety, stress, depression, and oral health in individuals with bruxism.

Detailed Summary:

Participants will be randomized into one of four groups: Group 1 (n = 24) intervention will consist of massage and stretching exercises; Group 2 (n = 24) will consist of relaxation and imagination therapies; Group 3 (n = 24) will receive dental treatment and Group 4 (n=24) will consist of massage, exercises, relaxation and imagination. The evaluations will be performed at baseline, immediately after treatment, and at 2-month follow-up. Pain intensity will be assessed using the visual analogical scale, while pain thresholds will be determined using algometry. Mandibular opening will be assessed using digital pachymeter. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, anxiety by the State-Trait Anxiety Inventory, stress by the Perceived Stress Scale-10, depression by the Beck Depression Inventory, and oral health will be assessed using the Oral Health Impact Profile - 14. Significance level will be determined at the 5% level.

Valid Reasons of updates:

2014 - Changes made according requeriments of plattform of ClinicalTrials.

2015 - In 2014, in my qualification examination at University of São Paulo, the professors suggested my transfer from master degree to direct doctorate and the inclusion of more one intervention group, whereas the other three groups were still in the randomization process. I updated the registration in 2015 with the inclusion of this fourth group. However, as the protocol published in 2014 reports 3 groups (initial idea of the master degree before the transition to the direct doctorate), this fourth group started the treatment (massage, exercises, relaxation and imagination) after the end of treatment of other three groups (Groups:1,2 and 3).

2016- Although I have listed as prima
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Pain / Mandibular opening [ Time Frame: 6 weeks ]

Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)


Original Primary Outcome: Pain / Mandibular depression [ Time Frame: 6 weeks ]

Visual Analogue Scale (VAS) and Algometer (pain threshold)/Paquimeter


Current Secondary Outcome:

  • Sleep Quality [ Time Frame: 6 weeks ]
    Pittsburgh Sleep Quality Index (PSQI)
  • Anxiety [ Time Frame: 6 weeks ]
    State-Trait Anxiety Inventory (STAI)
  • Stress [ Time Frame: 6 weeks ]
    Perceived Stress Scale (PSS)
  • Depression [ Time Frame: 6 weeks ]
    Beck Depression Inventory (BDI)
  • Oral Health Quality [ Time Frame: 6 weeks ]
    Oral Health Impact Profile (OHIP-14)


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: January 24, 2013
Date Started: March 2013
Date Completion: December 2016
Last Updated: October 24, 2016
Last Verified: June 2016