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Trial record 4 of 6 for:    Open Studies | "Bruxism"
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Effect of Two Interventions of Physical Therapy Compared to Dental Treatment in Individuals With Bruxism

This study is not yet open for participant recruitment.
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: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

Introduction: Bruxism is an oral parafunctional habit of clenching and / or grinding of teeth, which can occur during daytime (diurnal bruxism) and / or during sleep (nocturnal bruxism), whose prevalence in adults is 20% and 8% respectively. The peripheral, psychosocial and centers factors are associated with the origin of bruxism, which can trigger masticatory muscle pain, neck pain, headache, low threshold of pain sensitivity, limited jaw opening, negatively influence sleep quality and oral health and be related to affective disorders (anxiety, stress and depression). The objective of this study is to compare two physiotherapy interventions with dental treatment in pain, limited jaw opening, sleep quality, anxiety, stress and depression and oral health quality in individuals with bruxism. Methods: Participants will be randomly assigned to three groups: Group 1 (n = 20) will perform massage techniques and muscle stretching exercises, Group 2 (n = 20) relaxation therapy and imagination and Group 3 (n = 20)dental treatment. All participants will perform the same assessment procedures (pre, post and two months after intervention). The intensity of the pain will be assessed by visual analog scale (VAS), pain threshold by algometer, mandibular depression by paquimeter, sleep quality by Pittsburgh Sleep Quality Index, anxiety by State-Trait Anxiety Inventory, stress by Perceived Stress Scale, depression by Beck Depression Inventory and oral health quality by Oral Health Impact Profile (OHIP-14). Significance is considered 5%.


Condition Intervention
Bruxism
 Other: Massage therapy and muscle stretching exercises
Other: Relaxation therapy and imagination
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: Effect of Two Interventions of Physical Therapy Compared to Dental Treatment in Individuals With Bruxism: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Pain / Mandibular depression [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Visual Analogue Scale (VAS) and Algometer (pain threshold)/Paquimeter


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 muscle stretching exercises
Intra and extra oral massage therapy and muscle stretching exercises (mastigatory and head/neck muscles)
 Other: Massage therapy and muscle stretching exercises
The group will perform intra and extra oral massage and muscle stretching exercises (mastigatory and head/neck muscles).
Active Comparator: Relaxation therapy and imagination
Relaxation therapy (progressive muscle relaxation) and imagination (guided imagery)
 Other: Relaxation therapy and imagination
The group will perform relaxation therapy (progressive muscle relaxation) and imagination (guided imagery).
Active Comparator: Dental treatment
Restorative treatment
 Other: Dental treatment
The group will perform restorative treatment.

Detailed Description:

Objetive: To compare two interventions of physical therapy with dental treatment in individuals with bruxism.

Design: Sixty individuals will be randomized into three group: Group 1 (n=20) massage therapy and muscle stretching exercises, Group 2 (n=20) relaxation therapy and imagination and Group 3 (n=20) dental treatment. The primary clinical outcomes will be pain, assessed with the Visual Analogue Scale (VAS) and Algometer (pain threshold) and mandibular depression asseded with paquimeter. Secondary outcomes will be sleep quality (Pittsburgh Sleep Quality Index -PSQI), anxiety (State-Trait Anxiety Inventory - STAI), stress(Perceived Stress Scale -PSS), depression (Beck Depression Inventory (BDI) and oral health quality (Oral Health Impact Profile -OHIP-14). Evaluations will be performed before(baseline), after (6 weeks) and with a follow-up 2 months after treatment. Data will be collected by a blinded examiner. Individuals of physiotherapy intervention groups will hold 12 individual sessions, lasting 40 minutes each, twice a week, by the same therapist, duly qualified. Will be requested to carry out specific exercises at home. Individuals of dental treatment group will be two sessions of individual restoration, with an interval of one week and will last two hours. Participants will be reassessed 30, 60 and 90 days after treatment ended. Significance level is established at 5%.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of sleep bruxism according to the International Classification of Sleep Disorders of the American Academy of Sleep Medicine
  • Self-reported diagnosis of diurnal bruxism

Exclusion Criteria:

  • Individuals with more than five dental flaws
  • Systemic and/or degenerative disease
  • Arthrogenic or mixed temporomandibular dysfunction
  • Neurological and/or psychiatric disorders (except anxiety and depression)
  • Medications with possible effects on sleep and motor behavior
  • Periodontal disease
  • Abuse of alcohol and/or drugs
  • Complete removable denture
  • Direct trauma and/or surgery in orofacial region and
  • Being under physical therapy, dental, speech therapy, psychological and others
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778881

Contacts
Contact: Cinthia SM Amorim, MSc +55 11 98228-3699 ci_miotto@yahoo.com.br

Locations
Brazil
Medicine School of the University Of São Paulo Not yet recruiting
São Paulo, SP, Brazil, 01246903
Contact: Cinthia SM Amorim, MSc     +55 11 98228-3699     ci_miotto@yahoo.com.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

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: January 28, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Bruxism
Physical Therapy
Massage
 Muscle Stretching Exercises
Relaxation therapy
Imagination

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013