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Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism (Bruxism)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Sao Paulo General Hospital Identifier:
First received: January 24, 2013
Last updated: June 21, 2016
Last verified: June 2016
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.

Condition Intervention
Other: Massage and stretching exercises
Other: Relaxation and imagination therapies
Other: Dental treatment
Other: Massage, exercises, relaxation and imagination therapies

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Pain / Mandibular opening [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)

Secondary Outcome Measures:
  • Sleep Quality [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index (PSQI)

  • Anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    State-Trait Anxiety Inventory (STAI)

  • Stress [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Perceived Stress Scale (PSS)

  • Depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Beck Depression Inventory (BDI)

  • Oral Health Quality [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Oral Health Impact Profile (OHIP-14)

Estimated Enrollment: 72
Study Start Date: March 2013
Estimated Study Completion Date: July 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

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 ( -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!


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sleep Bruxism identified by the interview, clinical assessment and diagnostic criteria of the International Classification for Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM);
  • Awake bruxism identified by the interview, clinical assessment and questionnaire of Pintado;
  • Aged between 18 to 60 years;
  • A minimum pain intensity score of 3 on the Visual Analogical Scale.

Exclusion Criteria:

  • More than two missing teeth, except third molars;
  • Systemic and/or degenerative diseases;
  • Arthrogenic or mixed temporomandibular disorder (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), axis I;
  • Neurological or psychiatric diseases (with the exception of anxiety and depression);
  • Using medications that influence sleep or motor behavior;
  • Periodontal disorders;
  • Abuse of alcohol and/or illicit drugs;
  • Removable dentures, superior and/or inferior;
  • Total dentures;
  • Direct trauma or past surgery in the orofacial region;
  • On physical, speech, dental, or psychological therapy at the time of study entry.
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Please refer to this study by its identifier: NCT01778881

Medicine School of the University Of São Paulo
São Paulo, SP, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Study Director: Amélia P Marques, PhD University of Sao Paulo
Principal Investigator: Cinthia SM Amorim, MSc University of Sao Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Sao Paulo General Hospital Identifier: NCT01778881     History of Changes
Other Study ID Numbers: cinthiamiotto 
Study First Received: January 24, 2013
Last Updated: June 21, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Sao Paulo General Hospital:
Physical therapy modalities
Muscle stretching exercises
Relaxation therapy

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases processed this record on October 21, 2016