An interventional study of Massage and stretching exercises and Relaxation and imagination therapies in Bruxism, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
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 primary variables: pain (VAS) and mandibular opening in this platform in 2013, and in the protocol published in 2014 (http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15 -8); symptoms like clenching, headaches and sleep difficulties were also assessed by VAS, and no included posteriorly to trial registration. They were evaluated, but not described in this platform. The same happened with intention to treat analysis.
June 20, 2016- Updates for clarifications and suggested by the PRS Team.
Please, any doubts, send me a e-mail! Thank you!
166 studies on the registry are indexed under Bruxism; 38 are open to participants now.
This study's planned enrollment of 72 is above the median of 38 across 103 interventional studies indexed under Bruxism.
Browse Bruxism studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Massage and stretching exercises
Other: Massage and stretching exercises
Relaxation and Imagination therapies
Other: Relaxation and imagination therapies
Reconstruction with composite resin
Other: Dental treatment
Massage, stretching exercises, relaxation and imagination
Other: Massage, exercises, relaxation and imagination therapies
The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).
Pain / Mandibular opening
Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)
Time frame: 6 weeks
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks
Anxiety
State-Trait Anxiety Inventory (STAI)
Time frame: 6 weeks
Stress
Perceived Stress Scale (PSS)
Time frame: 6 weeks
Depression
Beck Depression Inventory (BDI)
Time frame: 6 weeks
Oral Health Quality
Oral Health Impact Profile (OHIP-14)
Time frame: 6 weeks
Plan to share: No
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital