Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism

Bruxism Clinical Trial

— Bruxism  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01778881
• Other study ID #: cinthiamiotto
• Status: Active, not recruiting
• Phase: N/A
• First received: January 24, 2013
• Last updated: October 24, 2016
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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!

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruxism

Intervention

Other:
• Massage and stretching exercises
The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
• Relaxation and imagination therapies
The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.
• Dental treatment
Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
• Massage, exercises, relaxation and imagination therapies
The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).

Locations

Country	Name	City	State
Brazil	Medicine School of the University Of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain / Mandibular opening	Visual Analogical Scale (VAS), pain thresholds (algometry) and mandibular opening (digital pachymeter)	6 weeks	No
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index (PSQI)	6 weeks	No
Secondary	Anxiety	State-Trait Anxiety Inventory (STAI)	6 weeks	No
Secondary	Stress	Perceived Stress Scale (PSS)	6 weeks	No
Secondary	Depression	Beck Depression Inventory (BDI)	6 weeks	No
Secondary	Oral Health Quality	Oral Health Impact Profile (OHIP-14)	6 weeks	No