Physical Therapy Interventions Relative to Dental Treatment in Individuals With Bruxism

NCT01778881 | Unknown DMC

• 1 other identifier: cinthiamiotto
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism

Keywords

Bruxism; Physical therapy modalities; Massage; Muscle stretching exercises; Relaxation therapy; Imagination

Outcome Measures

Primary Outcomes (1)

• Pain / Mandibular opening

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

  6 weeks

Secondary Outcomes (5)

• Sleep Quality

  6 weeks

• Anxiety

  6 weeks

• Stress

  6 weeks

• Depression

  6 weeks

• Oral Health Quality

  6 weeks

Study Arms (4)

Massage + Exercise

EXPERIMENTAL

Massage and stretching exercises

Other: Massage and stretching exercises

Relaxation +Imagination

EXPERIMENTAL

Relaxation and Imagination therapies

Other: Relaxation and imagination therapies

Dental treatment

EXPERIMENTAL

Reconstruction with composite resin

Other: Dental treatment

Massage + Exercise + Relaxation + Imagination

EXPERIMENTAL

Massage, stretching exercises, relaxation and imagination

Other: Massage, exercises, relaxation and imagination therapies

Interventions

Massage and stretching exercises OTHER

The routine to be used in this group (stretching, massage, and diaphragmatic breathing).

Massage + Exercise

Relaxation and imagination therapies OTHER

The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.

Relaxation +Imagination

Dental treatment OTHER

Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.

Dental treatment

Massage, exercises, relaxation and imagination therapies OTHER

The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).

Massage + Exercise + Relaxation + Imagination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Medicine School of the University Of São Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24398115 DERIVED

MeSH Terms

Conditions

Bruxism

Interventions

Massage; Dental Care; Exercise

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amélia P Marques, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Cinthia SM Amorim, MSc

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)