Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism (Bruxism)
|Bruxism||Other: Massage and stretching exercises Other: Relaxation and imagination therapies Other: Dental treatment Other: Massage, exercises, relaxation and imagination therapies|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Physical Therapy Interventions, Relative to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial|
- Pain / Mandibular opening [ Time Frame: 6 weeks ]Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)
- 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)
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Massage + Exercise
Massage and stretching exercises
Other: Massage and stretching exercises
The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
Experimental: Relaxation +Imagination
Relaxation and Imagination therapies
Other: Relaxation and imagination therapies
The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.
Experimental: Dental treatment
Reconstruction with composite resin
Other: Dental treatment
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
Experimental: Massage + Exercise + Relaxation + Imagination
Massage, stretching exercises, relaxation and imagination
Other: Massage, exercises, relaxation and imagination therapies
The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).
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!
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778881
|Medicine School of the University Of São Paulo|
|São Paulo, SP, Brazil, 01246903|
|Study Director:||Amélia P Marques, PhD||University of Sao Paulo|
|Principal Investigator:||Cinthia SM Amorim, MSc||University of Sao Paulo|