Rehabilitative Management of Mastication

Rehabilitative Management of Mastication After Orthognathic Surgery: A Randomized Controlled Trial

The purpose of this study is to verify the effectiveness of a systematic rehabilitative program for mastication in patients submitted to orthognathic surgery.

Study Overview

• Status: Completed
• Conditions: Surgery; Malocclusion
• Intervention / Treatment: Other: orofacial myofunctional treatment protocol; Other: counseling; Other: Control Group

Detailed Description

Orthognathic surgery can produce complications during the postoperative period - i.e. situations of acute pain and inflammation - as a consequence of fractures and incisions in the mucosa. The inadequate management of soft tissue and prolonged surgical time could be the causes of acute facial oedema, hematoma and ecchymosis in the face and neck, as well as functional disorders involving swallowing and breathing, which can affect patients' integrity.

Despite the fact that decreased muscular extensibility and strength, increased muscular fatigability, hipomobility, and alteration of the biomechanical efficiency and length of the masticatory muscles are documented clinical consequences, no systematic method of obviating such problems through muscular rehabilitation has yet been published

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas, University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Skeletal Class III orthognathic surgery patients
• adults (age above 18 years)
• agreement to perform orthognathic surgery
• agreement to undergo all of the necessary procedures determined by the multidisciplinary team

Exclusion Criteria:

• previous orthognathic surgery
• previous head and neck surgery
• neurologic and/or systemic diseases
• facial trauma
• syndromes
• cognitive impairment
• communication and hearing deficits

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Inclusion criteria were: Skeletal Class III orthognathic surgery patients; adults (age above 18 years), agreement to perform orthognathic surgery and to undergo all of the necessary procedures determined by the multidisciplinary team (i.e. orthodontic preparation, clinical orofacial myofunctional and electromyographic assessment, surgery, post surgery orthodontic treatment, post surgery clinical orofacial myofunctional and electromyographic assessment and orofacial myofunctional treatment when necessary). Exclusion criteria were: previous orthognathic surgery; previous head and neck surgery; neurologic and/or systemic diseases; facial trauma; syndromes; cognitive impairment; and communication and hearing deficits.	Other: orofacial myofunctional treatment protocol; Once a week for six weeks, the experimental group received a forty minutes session of orofacial myofunctional treatment. A home exercise program was prescribed during each session. The protocol implies in continuous and daily practices - participants were asked to perform exercises at least three times a day. After the first six weeks, the experimental group underwent four sessions for maintenance purposes (two sessions twice a month and two sessions once a month). The total treatment duration was of five months.; Other Names: rehabilitative orofacial myofunctional protocol
Active Comparator: Instruction Group; Inclusion criteria were: Skeletal Class III orthognathic surgery patients, adults (age above 18 years), agreement to perform orthognathic surgery and to undergo all of the necessary procedures determined by the multidisciplinary team (i.e. orthodontic preparation, clinical orofacial myofunctional and electromyographic assessment, surgery, post surgery orthodontic treatment, post surgery clinical orofacial myofunctional and electromyographic assessment and orofacial myofunctional treatment when necessary). Exclusion criteria were: previous orthognathic surgery; previous head and neck surgery; neurologic and/or systemic diseases; facial trauma; syndromes; cognitive impairment; and communication and hearing deficits.	Other: counseling; The instruction group underwent two supervised forty minutes therapy sessions along the six weeks following surgery. These sessions involved the perception of the stomatognathic system, especially in terms of adequate performance during mastication. Specific exercises were not given and patients were instructed to try to reproduce the adequate pattern of mastication at all meals (i.e. alternated bilateral, with lip closure; with coordination activity of the tongue and mandible).; Other Names: supervised instruction
No Intervention: Control group; Inclusion criteria for this group were: adults (age above 18 years); absence of stomatognathic system alterations; absence of alterations in the scapular region; complete permanent dentition (absence/extraction of the third molar was accepted); Skeletal and Angle's Class I facial pattern; and absence of malocclusion. Exclusion criteria were: previous orthodontic treatment; and history of previous oral motor intervention.	Other: Control Group; As the sEMG test-retest is a critical issue, participants of CG were also tested in two distinct moments (testing occurred with 1 year interval) in order to verify possible changes in the sEMG measurements as a result of retesting.; Other Names: no intervention; healthy individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of clinical improvement in mastication after oral-motor rehabilitative program	improvement is verified through a clinical orofacial myofunctional evaluation using a standardized protocol with scores (orofacial mobility, masticatory/deglutition clinical performance, jaw movements) and by variations in the activation of the masseter and temporal muscles (surface electromyography)	within the first year after surgery (plus or minus 2 weeks)

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Chair: Claudia RF Andrade, Professor, School of Medicine, University of Sao Paulo; Principal Investigator: Laura D Mangilli, Ph.D., School of Medicine, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): March 23, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: electromyography; motor control; controlled clinical trial; exercise program; clinical evaluation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: ORTHOGSURG01