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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778881
Recruitment Status : Unknown
Verified June 2016 by University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2013
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Bruxism Other: Massage and stretching exercises Other: Relaxation and imagination therapies Other: Dental treatment Other: Massage, exercises, relaxation and imagination therapies Not Applicable

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!

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Physical Therapy Interventions, Relative to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. Pain / Mandibular opening [ Time Frame: 6 weeks ]
    Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)

Secondary Outcome Measures :
  1. Sleep Quality [ Time Frame: 6 weeks ]
    Pittsburgh Sleep Quality Index (PSQI)

  2. Anxiety [ Time Frame: 6 weeks ]
    State-Trait Anxiety Inventory (STAI)

  3. Stress [ Time Frame: 6 weeks ]
    Perceived Stress Scale (PSS)

  4. Depression [ Time Frame: 6 weeks ]
    Beck Depression Inventory (BDI)

  5. Oral Health Quality [ Time Frame: 6 weeks ]
    Oral Health Impact Profile (OHIP-14)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01778881

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital Identifier: NCT01778881     History of Changes
Other Study ID Numbers: cinthiamiotto
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
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:
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Tooth Diseases
Stomatognathic Diseases