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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bruxism
• Intervention / Treatment: Other: Massage and stretching exercises; Other: Relaxation and imagination therapies; Other: Dental treatment; Other: Massage, exercises, 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 (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!

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01246903
      • Medicine School of the University Of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain / Mandibular opening	Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Director: Amelia P Marques, PHD, University of Sao Paulo; Principal Investigator: Cinthia SM Amorim, MSc, University of Sao Paulo

Publications and helpful links

General Publications

• Santos Miotto Amorim C, Firsoff EF, Vieira GF, Costa JR, Marques AP. Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial. Trials. 2014 Jan 7;15:8. doi: 10.1186/1745-6215-15-8.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (ESTIMATE): January 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Physical therapy modalities; Massage; Bruxism; Muscle stretching exercises; Relaxation therapy; Imagination
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism
• Other Study ID Numbers: cinthiamiotto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO