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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01778881
First received: January 24, 2013
Last updated: August 20, 2014
Last verified: January 2013
  Purpose

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 range of motion, sleep disorders, stress, anxiety, depression, and overall impairment of oral health. The aim of this study is to compare two distinct physical therapy interventions with dental treatment in pain, mandibular range of motion, sleep quality, anxiety, stress, depression, and oral health in individuals with bruxism.


Condition Intervention
Bruxism
Other: Massage and stretching
Other: Relaxation and imagination therapies
Other: Dental treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Two 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 range of motion [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Visual Analogical Scale (VAS), pain thresholds (dolorimetry) and mandibular range of motion (digital pachymeter)


Secondary Outcome Measures:
  • Sleep Quality [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Pittsburgh Sleep Quality Index (PSQI)

  • Anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    State-Trait Anxiety Inventory (STAI)

  • Stress [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Perceived Stress Scale (PSS)

  • Depression [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Beck Depression Inventory (BDI)

  • Oral Health Quality [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Oral Health Impact Profile (OHIP-14)


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Massage and stretching
The routine to be used in this group (stretching, massage, and diaphragmatic breathing)
Other: Massage and stretching
The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
Active Comparator: Relaxation and imagination therapies
The routines to be adopted will focus on progressive muscular relaxation associated to imagination and diaphragmatic breathing.
Other: Relaxation and imagination therapies
The routines to be adopted will focus on progressive muscular relaxation associated to imagination and diaphragmatic breathing.
Active Comparator: Dental treatment
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
Other: Dental treatment
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.

Detailed Description:

Participants will be randomized into one of three groups: Group 1 (n = 24) intervention will consist of massage and stretching exercises; Group 2 (n = 24) will consist of relaxation and imagination therapies; and Group 3 (n = 24) will receive dental treatment. 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 dolorimetry. Mandibular range of motion 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sleep Bruxism diagnosed according to the criteria of the International Classification for Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM);
  • Self-report of awake bruxism, documented by positive response to the question developed following the recommendations 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778881

Contacts
Contact: Cinthia SM Amorim, MSc +55 11 98228-3699 cinthia_miotto@usp.br

Locations
Brazil
Medicine School of the University Of São Paulo Recruiting
São Paulo, SP, Brazil, 01246903
Contact: Cinthia SM Amorim, MSc    +55 11 98228-3699    cinthia_miotto@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Amélia P Marques, PhD University of Sao Paulo
Principal Investigator: Cinthia SM Amorim, MSc University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01778881     History of Changes
Other Study ID Numbers: cinthiamiotto
Study First Received: January 24, 2013
Last Updated: August 20, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 26, 2014