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

Primary Purpose

Bruxism

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Massage and stretching exercises
Relaxation and imagination therapies
Dental treatment
Massage, exercises, relaxation and imagination therapies
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism focused on measuring Bruxism, Physical therapy modalities, Massage, Muscle stretching exercises, Relaxation therapy, Imagination

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medicine School of the University Of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Massage + Exercise

Relaxation +Imagination

Dental treatment

Massage + Exercise + Relaxation + Imagination

Arm Description

Massage and stretching exercises

Relaxation and Imagination therapies

Reconstruction with composite resin

Massage, stretching exercises, relaxation and imagination

Outcomes

Primary Outcome Measures

Pain / Mandibular opening
Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)

Secondary Outcome Measures

Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Anxiety
State-Trait Anxiety Inventory (STAI)
Stress
Perceived Stress Scale (PSS)
Depression
Beck Depression Inventory (BDI)
Oral Health Quality
Oral Health Impact Profile (OHIP-14)

Full Information

First Posted
January 24, 2013
Last Updated
October 24, 2016
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01778881
Brief Title
Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism
Acronym
Bruxism
Official Title
Effectiveness of Physical Therapy Interventions, Relative to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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!

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism
Keywords
Bruxism, Physical therapy modalities, Massage, Muscle stretching exercises, Relaxation therapy, Imagination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massage + Exercise
Arm Type
Experimental
Arm Description
Massage and stretching exercises
Arm Title
Relaxation +Imagination
Arm Type
Experimental
Arm Description
Relaxation and Imagination therapies
Arm Title
Dental treatment
Arm Type
Experimental
Arm Description
Reconstruction with composite resin
Arm Title
Massage + Exercise + Relaxation + Imagination
Arm Type
Experimental
Arm Description
Massage, stretching exercises, relaxation and imagination
Intervention Type
Other
Intervention Name(s)
Massage and stretching exercises
Intervention Description
The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
Intervention Type
Other
Intervention Name(s)
Relaxation and imagination therapies
Intervention Description
The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.
Intervention Type
Other
Intervention Name(s)
Dental treatment
Intervention Description
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
Intervention Type
Other
Intervention Name(s)
Massage, exercises, relaxation and imagination therapies
Intervention Description
The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).
Primary Outcome Measure Information:
Title
Pain / Mandibular opening
Description
Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
6 weeks
Title
Anxiety
Description
State-Trait Anxiety Inventory (STAI)
Time Frame
6 weeks
Title
Stress
Description
Perceived Stress Scale (PSS)
Time Frame
6 weeks
Title
Depression
Description
Beck Depression Inventory (BDI)
Time Frame
6 weeks
Title
Oral Health Quality
Description
Oral Health Impact Profile (OHIP-14)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amélia P Marques, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cinthia SM Amorim, MSc
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine School of the University Of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24398115
Citation
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.
Results Reference
derived

Learn more about this trial

Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism

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